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Item 1. Business

2026-03-12 compared with 2025-03-18 · 2643 added, 2554 removed, 771 unchanged (87% of the section changed)

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

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

and prospects.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Annual Report on Form 10-K.

Additionally, statements concerning future matters are forward-looking statements.

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

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

denoted in this Annual Report on Form 10-K.

Additionally, statements concerning future matters are forward-looking

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

17 unchanged sentences

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

Forward-looking

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

prospects are dependent on the success of TNX 102-SL for the management of Fibromyalgia (“FM”) and progressing

our pipeline through development stages.

To the extent regulatory approval of TNX-102 SL is delayed or not granted or, if

approved, TNX-102 SL is not commercially successful, our business, financial condition and results of operations may be materially

adversely affected and the price of our common stock may decline.

commercial success and market acceptance of our products, including the coverage of our products by payors and pharmacy benefit

our ability to successfully develop and execute our sales, marketing and non-personal and digital promotion strategies,

including developing and maintaining relationships with customers, physicians, payors and other constituencies, the entry

of other products competitive with our commercial products;

ability to successfully execute business development, strategic partnerships, and investment opportunities to build and grow

for the future;

ability to achieve the expected financial performance from our marketed products Tosymra® and Zembrace® Symtouch®,

as well as delays, challenges and expenses, and unexpected costs associated with integrating and operating this commercial

ability of our third-party manufacturers to manufacture adequate quantities of commercially saleable inventory and active

pharmaceutical ingredients for each of our products, and our ability to maintain our supply chain;

ability to raise additional capital, if necessary;

timing and results of any future research and development efforts including potential clinical studies relating to any future

product candidates;

common stock maintaining compliance with Nasdaq’s minimum closing bid requirement of at least $1.00 per share.

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

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

and alleviate suffering.

Tonix’s primary focus is to obtain U.S.

marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual

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

Food and Drug Administration (“FDA”).

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

for TNX-102 SL.

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

a robust pipeline of potential new products.

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

acquisitions and collaborations with academic institutions and non-profit organizations.

Our development portfolio is focused on central

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

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

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

National Institute on Drug

Abuse (NIDA).

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

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

Our infectious disease

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

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

$34 million over five years.

TNX-4200 is being developed at our R&D facility located in Frederick, Maryland, (“RDC”),

which has biosafety level 2 (BSL-2) with BSL-3 components.

Tonix’s product development candidates are investigational new drugs

or biologics and have not been approved for any indication.

Nervous System (CNS) Pipeline

In October 2024, Tonix submitted a New

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

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

August 15, 2025, for a decision on marketing authorization for TNX-102 SL.

FM is a chronic pain disorder characterized by widespread pain,

non-restorative sleep, fatigue and impaired cognition.

TNX-102 SL is a centrally-acting, non-opioid analgesic designed for long-term bedtime

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

FDA granted TNX-102 SL Fast Track designation in July 2024.

We are preparing for a commercial launch of TNX-102 SL in the fourth quarter

of 2025, conditional on FDA approval.

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

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

SL in the U.S.

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

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

Application (“IND”) in partnership with the University of North Carolina (“UNC”) Institute for Trauma

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).

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.

August 2025, we received approval from the U.S.

Food and Drug Administration (“FDA”) for TONMYA for the treatment of fibromyalgia

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:

● Prevention of Lyme Disease :

TNX-4800 (anti-OspA from Borrelia

burgdorferi ), a monoclonal antibody for seasonal prevention of Lyme disease, for which

initiation of a Phase 2 field study is planned for the first half of 2027 and of a Phase 2 human challenge study for 2028, pending FDA

● Prevention of Kidney Transplant Rejection/Treatment of

Autoimmune Diseases :

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

and being developed for the prevention of kidney transplant rejection and for which an investigator-initiated Phase 2 study in

kidney transplant is expected to initiate in mid-2026.

TNX-1500 is also in development for the treatment of autoimmune

● Treatment of Cocaine Intoxication :

TNX-1300, a double-mutant

cocaine esterase, which is in Phase 2 for the treatment of cocaine intoxication.

TNX-1300 has been granted Breakthrough Therapy designation

● Treatment of Prader-Willi Syndrome :

TNX-2900, intranasal oxytocin potentiated with magnesium, in development

for Prader-Willi syndrome and initiation of a Phase 2 study is planned for the first quarter of 2027.

TNX-2900 has been granted Orphan

Drug designation and Rare Pediatric Disease designation.

● Treatment of Acute Stress Disorder and Acute Stress Reaction :

– Collaboration with University of North Carolina, Investigator-initiated IND, currently enrolling Phase 2 study.

● Treatment of Major Depressive

TNX 102-SL – Planning to initiate a potentially pivotal Phase 2 study mid-2026.

Our pre-clinical programs

for Protection against mpox and smallpox :

TNX-801 (horsepox, live virus vaccine) for mpox and smallpox.

TNX-801 is expected to

enter a Phase 1 study in 2027 pending FDA clearance.

TNX-801 is in the pre-IND stages of development.

Spectrum Anti-viral to protect against viral diseases :

TNX-4200, a small molecule broad-spectrum antiviral agent targeting CD45

for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat

environments.

The TNX-4200 program is supported by an up to $34 million contract over five years from the DoD’s Defense Threat

Reduction Agency (“DTRA”).

TNX-4200 is in the pre-IND stages of development.

● Treatment of gastric and colorectal cancer :

TNX-1700, a fusion protein of TFF2 and albumin, is in preclinical development for the treatment of gastric and colorectal cancer in

combination with PD-1 blockade, in-licensed from Columbia University.

TNX-1700 is in the pre-IND stages of development.

● Non-opioid analgesic for neuropathic pain :

highly selective small-molecule Sigma-1 receptor (“S1R”) antagonist, for neuropathic pain, in the pre-IND stages of development.

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:

(cyclobenzaprine HCl sublingual tablets) – Fibromyalgia

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.

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.

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

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

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

(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.

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

) 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.

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

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.

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

About 360 patients will be enrolled at approximately 30 U.S.

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.

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

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

TNX-102 SL for AAD has been granted Fast Track designation by the FDA.

We are currently not actively studying TNX-102 SL in PTSD, AAD or AUD.

Tonix is continuously evaluating further indications for which

TNX-102 SL could potentially provide benefit.

CNS candidate in development is TNX-1300 (double-mutant cocaine esterase) which is in Phase 2 for the treatment of cocaine intoxication.

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.)

In August of 2022, we received a Federal Grant from the U.S.

National Institute on Drug Abuse (“NIDA”) a part

National Institutes of Health (“NIH”) to advance the development of TNX-1300 as a treatment for cocaine intoxication.

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

TNX-1900 is in development through investigator-initiated

studies at Massachusetts General Hospital (“MGH”) for the treatment of binge eating disorder (“BED”), adolescent

obesity, and bone health in pediatric autism.

TNX-1900 is in development through an investigator-initiated study at the University of

Washington for the treatment of social anxiety disorder.

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

monoclonal antibody (“mAb”), directed against CD40-ligand (CD40L, also known as CD154).

TNX-1500 was engineered to modulate

binding to Fc receptors with the goal of maintaining the activity of first-generation mAbs, yet with reduced risk of thrombotic complications.

TNX-1500 is being developed to prevent organ transplant rejection as well as to treat autoimmune conditions.

Topline results from a Phase

1 single ascending dose escalation study at 3 mg/kg, 10 mg/kg and 30 mg/kg of TNX-1500 in healthy volunteers was reported in the first

quarter of 2025.

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

agents in allogeneic transplants in non-human primates at MGH.

In experiments at MGH, TNX-1500 is being studied as monotherapy or in combination

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

Results from experiments in

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

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

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

agents in xenogeneic organ transplants in non-human primates at MGH.

In some of these studies, genetically engineered (“GE”)

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

including TNX-1500.

The results of these preclinical studies were encouraging and demonstrated the potential of GE pig hearts in the context

of a clinically applicable regimen.

The multi-GE pigs were provided by eGenesis and Revivicor.

Revivicor is a subsidiary of United Therapeutics.

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

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

Subsequently, several other GE pig kidney transplants have been performed.

TNX-1500 treatment has not been used in any human transplant

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

was licensed from Columbia University in 2019.

TNX-1700 consists of TFF2 fused to human serum albumin and is a biologic

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

is in the preclinical stage of development.

We presented data that show a murine version of TNX-1700 consisting of a fusion protein

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

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

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

Disease Pipeline

infectious disease portfolio includes vaccines based on our live virus vaccine or recombinant pox vaccine (“RPV”)

Live virus vaccines are believed to protect against poor clinical outcomes of infectious diseases by eliciting T cell

responses in addition to antibody responses.

TNX-801, a live minimally replicative vaccine based on synthesized

horsepox, is in the pre-IND stage of development to protect against smallpox and mpox.

In 2022 the WHO determined that the upsurge of

mpox Clade IIb constituted a public health emergency of international concern (PHEIC).

Mpox Clade IIB subsequently has become endemic

mostly in populations of men who have sex with men.

In August 2024, the WHO determined that the upsurge of mpox clade Ib in

a growing number of countries in Africa constituted a PHEIC.

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

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

Non-human primates

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

journal Vaccines in 2023.

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

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

and no evidence of spreading to blood or tissues, even at high doses, in immunocompromised animals.

After a single-dose vaccination, TNX-801

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

Ia monkeypox.

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

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

characteristics of TNX-801.

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

equipment, and stability at ambient temperature.

Other potential beneficial characteristics include the ability to limit forward transmission,

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

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

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

in both human primary cell lines and immunocompromised mice.

In October 2024, at the World Vaccine Congress - Europe, we highlighted positive

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

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

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

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

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

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.

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.

and Infectious Disease

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

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.

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.

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.

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 (t 1/2 ) 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.

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

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

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

diseases, for which subsequent products will be designed by expressing other viral antigens in the horsepox vector.

The company’s

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

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

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

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

In June 2024, the

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

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

tolerability than modern vaccinia viruses.

TNX-1800 was selected by the NIH’s Project NextGen for inclusion in clinical trials as

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

is able to provide TNX-1800 to NIH, they would conduct a Phase 1 trial and cover the full cost.

However, Tonix has not prioritized the

production of TNX-1800, so it is uncertain whether or how quickly this project will progress.

The COVID-19 vaccines approved for use in

have provided significant health benefits to the vaccinated population;

however, they have shown limitations in the durability

of protection conferred, and in their ability to block forward transmission.

Live virus vaccines that protect against other viral diseases

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

inhibited forward transmission.

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

using live SARS-CoV-2 in the first quarter of 2021.

These data were published in the peer-reviewed journal Vaccines in 2023.

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

to potential inhibition of forward transmission of this respiratory pathogen.

is developing potential broad-spectrum antiviral drugs in three programs:

CD45-targeted therapeutics (TNX-4200), cathepsin inhibitors

(TNX-3900) and viral glycan-targeted engineered biologics (TNX-4000).

The DoD announced in December 2022 a plan to move beyond

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

viruses may be deployed on the battlefield.

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

million over five years by the Defense Threat Reduction Agency (DTRA), an agency within the DoD.

The objective of the contract is to develop

small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military

personnel in biological threat environments.

Tonix’s program will focus on optimization and development of its TNX-4200 program,

to develop an orally available CD45 antagonist with broad-spectrum efficacy against a range of viral families through preclinical evaluation.

The program is expected to establish physicochemical properties, pharmacokinetics, and safety attributes to support an IND submission

and to fund a first-in-human Phase 1 clinical study.

Tonix plans to leverage previous research on phosphatase inhibitors, specifically

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

a complete and cost-effective solution for a broad-spectrum medical countermeasure.

Tonix’s premise is that partial inhibition of

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

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

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

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.

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

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.

Disease Pipeline

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

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

The formulation technology

for TNX-2900 was acquired from Trigemina, Inc.

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

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

on March 21, 2024.

PWS, an orphan condition, is a rare genetic disorder of failure to thrive in infancy, associated with uncontrolled

appetite beginning in childhood with complications of obesity and diabetes.

We have sponsored a research program at Inserm to study oxytocin

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

commercial portfolio consists of two FDA-approved prescription products for the treatment of migraine:

Zembrace SymTouch (sumatriptan

injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg.

Zembrace SymTouch and Tosymra are both indicated for the treatment

of acute migraine with or without aura in adults.

Zembrace SymTouch is the only branded sumatriptan autoinjector professionally

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

Tosymra is a novel

intranasal sumatriptan product formulated with a permeation enhancer that provides rapid and efficient absorption of sumatriptan.

Tosymra was approved on the basis of bioequivalence to subcutaneous ( s.c.

) sumatriptan.

Tonix Medicines is the only manufacturer

with both a branded injectable and nasal spray indicated for the acute treatment of migraine with or without aura in adults.

September 2024, Tonix announced that the United States Patent and Trademark Office (USPTO) issued U.S.

12,097,183 to

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

via subcutaneous administration.

This patent, excluding possible patent term extensions, is expected to fortify protection and

market exclusivity into 2036.

Additionally, Tonix announced that the USPTO issued U.S.

12,090,139 to the Company, claiming

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

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

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

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

This data stressed the

need for customizing treatment of migraine headaches to the needs of patients.

Thus far, real world data show that conformity

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

The data show the

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

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

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

need for non-oral acute migraine therapies.

Relating to our

development programs, we own and operate the RDC in Frederick, Maryland consisting of one building totaling approximately 48,000

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

This facility was decommissioned in 2024 but Tonix has the ability to reactivate it should we choose to do so.

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.

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.

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.

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.

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

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.

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

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

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components of our strategy are to:

CNS, rare disease, immunology, and infectious disease indications with high unmet medical need and significant commercial

We are pursuing multiple indications that are underserved with limited, effective treatment options.

Our latest stage product candidate is TNX-102 SL for the management of FM, a condition which affects between 6-12

million adults in the U.S.

Fewer than half of those treated for FM receive relief from the three FDA-approved drugs.

broader development strategy is to leverage the patented formulation and proven mechanism of action to explore the clinical

potential of TNX-102 SL in multiple other, psychiatric, and addiction conditions, including ASR, ASD, AAD and AUD, all of which are

underserved by currently approved medications or have no approved treatment.

Within CNS, Tonix is also developing TNX-1300 to treat

cocaine intoxication and TNX-1900 to treat binge eating disorder, adolescent obesity, social anxiety disorder and improvement in

bone health in autism.

Cocaine intoxication is one of the leading causes of overdose deaths and for which there is no

currently approved drug.

With TNX-1500, we are pursuing a treatment to prevent organ transplant rejection as well as autoimmune

TNX-1500 is a third generation humanized mAb targeting CD40L that has the potential to deliver efficacy without

compromising safety, based on modulated binding to Fc receptors.

At this time, no mAb against CD40L has been licensed anywhere in

Within infectious diseases, we are currently focusing on the development of TNX-801 to prevent smallpox and mpox.

there are FDA-approved vaccines to prevent smallpox and mpox, we believe TNX-801 has potential to provide durable protection.

there are FDA-approved COVID-19 vaccines which use mRNA technology, or other technologies, we believe that there are limitations to

these vaccines relating to durability of protection and their relative inability to block forward

transmission.

the commercial potential of our lead product candidates .

We plan to commercialize each of our lead product candidates,

including our latest stage candidate, TNX-102 SL, either on our own or through collaboration with partners.

the acquisition of our two FDA-approved, marketed products for the treatment of acute migraine (Zembrace SymTouch and

Tosymra) positions Tonix to build out commercial capability to market the migraine products and to launch TNX-102 SL for

fibromyalgia.

An alternative strategy would be to enter into partnership agreements with drug companies that already have

significant marketing capabilities in the same, or similar, therapeutic areas.

If we determine that such a strategy would

be more favorable than developing our own sales capabilities, we will seek to enter into collaborations with pharmaceutical

or biotechnology companies for commercialization.

preparation for the launch of TNX-102 SL, we have added to our team of professionals to market and distribute our products.

commercial team is engaged in marketing and distributing our products and is also engaged in planning the launch of TNX-102 SL

contingent on FDA approval.

the successful commercialization of TONMYA for the treatment of fibromyalgia in the United

TONMYA was approved by the FDA in August 2025 for the treatment

of fibromyalgia in adults.

We launched TONMYA in the United States in November 2025 and

an important objective is to establish TONMYA as the standard of care for fibromyalgia.

We have approximately 90 U.S.

sales representatives who are focused on promoting TONMYA

to physicians and other healthcare prescribers who treat fibromyalgia, including rheumatologists,

primary care physicians, pain specialists, neurologists and psychiatrists.

the commercial potential of our product candidates .

We plan to commercialize our product candidates,

either on our own or through collaboration with partners.

Alternatively, we could enter into partnership agreements with drug

companies that already have significant marketing capabilities in the same, or similar, therapeutic areas.

additional indications and commercial opportunities for our product candidates .

We plan to maximize the value of certain of our products and product

candidates by pursuing other indications and commercial opportunities for such candidates.

For example, we are exploring the development

and commercialization of TNX-102 SL for MDD, ASD/ASR and other important indications.

For TNX-1900, we are exploring the development for

the treatment of binge eating disorder, adolescent obesity, bone health in pediatric autism, and arginine-vasopressin deficiency.

our live virus platform using our RPV technology may be developed as vaccines for future pandemics, infectious diseases generally, in

addition to smallpox and mpox, and for oncology applications.

Pursue CNS, rare disease, immunology, and

infectious disease indications with high unmet medical need and significant commercial potential.

We are pursuing multiple indications that are underserved with limited,

effective treatment options.

Our broader development strategy is to leverage the patented formulation and proven mechanism of action to

explore the clinical potential of TNX-102 SL in multiple other, psychiatric, and addiction conditions, including MDD, ASR and ASD, all

of which are underserved by currently approved medications or have no approved treatment.

One of our latest stage product candidates is

TNX-102 SL for the treatment of MDD, a condition which affects more than 21 million adults in the U.S.

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.

Cocaine intoxication is one of the leading causes of overdose deaths and for which there is no currently approved

therapy, however, those studies are currently on hold.

Within CNS, Tonix is also developing TNX-1300 to treat cocaine intoxication and

TNX-1900 to treat binge eating disorder, adolescent obesity, bone health in pediatric autism, and arginine-vasopressin deficiency.

TNX-4800, we are pursuing a prevention for Lyme disease, which has the potential to affect millions of people and for which there is no

current prophylaxis.

With TNX-1500, we are pursuing a treatment to prevent organ transplant rejection as well as autoimmune conditions.

TNX-1500 is a third generation humanized mAb targeting CD40L that has the potential to deliver efficacy without compromising safety, based

on modulated binding to Fc receptors.

At this time, no mAb against CD40L has been licensed anywhere in the world.

Within infectious diseases,

we are also focusing on the development of TNX-801 to prevent smallpox and mpox.

While there are FDA-approved vaccines to prevent smallpox

and mpox, we believe TNX-801 has potential to provide durable protection.

a broad intellectual property strategy to protect our product candidates .

We are pursuing a broad patent strategy

for our product candidates, and we endeavor to generate new patent applications as supported by our innovations and conceptions

as well as to advance their prosecution.

In the case of TNX-102 SL, we own patents and patent applications protecting its

composition-of-matter, certain methods of its use, its formulation, and its pharmacokinetic properties.

In the case of TNX-801

and TNX-1800, we own patent applications protecting their composition-of-matter and certain methods of use.

We also own patents

through in-licensing transactions for TNX-1300, TNX-1900, TNX-2900, and TNX-1700.

We have filed patent applications for TNX-1500.

We are pursuing a broad patent strategy for our product candidates, and

we endeavor to generate new patent applications as supported by our innovations and conceptions as well as to advance their prosecution.

In the case of TONMYA, we own patents and patent applications protecting its composition-of-matter, certain methods of its use, its formulation,

and its pharmacokinetic properties.

We plan to opportunistically apply for new patents to protect our product candidates.

additional indications and commercial opportunities for our product candidates.

We plan to maximize the value

of our other product candidates by pursuing other indications and commercial opportunities for such candidates.

we own rights related to the development and commercialization of TNX-102 SL for generalized anxiety disorder, depression,

and fatigue related to disordered sleep.

For TNX-1900, we own the rights to develop this for craniofacial pain, and insulin

Finally, our live virus platform using our RPV technology may be developed as vaccines for future pandemics, infectious

diseases generally, in addition to smallpox and mpox, and for oncology applications.

and Market Overview

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a traumatic event.

In the cases of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic

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

In addition to fibromyalgia cases associated with other conditions or stressors, the U.S.

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

We believe that diagnosing fibromyalgia in Long COVID patients will increase

the potential market for TNX-102 SL as compared to market estimates from before the COVID-19 pandemic.

Tonix has previously

presented its analysis of real-world evidence from the TriNetX claims database suggesting that over 40% of Long COVID patients present

with a constellation of symptoms that overlap with fibromyalgia.

According to reports by Frost

and Sullivan and Eversana that we commissioned, despite the availability of approved medications, the majority of patients fail therapy

due to either insufficient efficacy, poor tolerability, or both.

Prescription pain and sleep medications are frequently prescribed off-label

for symptomatic relief, despite the lack of evidence that such medications provide a meaningful or durable therapeutic benefit, and many

of these medications carry significant safety risks and risk of dependence.

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.

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.

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.

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.

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.

Stress Disorder and Acute Stress Reaction

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.

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.

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.

is an illegal recreational drug taken for its pleasurable effects and associated euphoria.

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in over 24,486 deaths total.

Stress Disorder (ASD)

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

The symptoms are similar

to those of PTSD and can affect both civilian and military populations.

According to the National Center for PTSD, in the U.S.

about 60% of men and 50% of women experience at least one trauma in their lives.

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.

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.

Transplant Rejection

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Mismatched or not

closely matched organs triggers an immune reaction that leads to rejection.

closely matched organs trigger an immune reaction that leads to rejection.

Overcoming this difficulty is paramount to a patient’s

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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.

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.

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

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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.

there were approximately 152,810 new cases with 53,010 deaths.

It is the 3 rd leading cause of cancer death in women, and 2 nd

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.

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

Until 2022, only a few cases of mpox had been reported outside of Africa in patients who had been infected while in Africa.

in May of 2022, mpox clade II cases spread rapidly in the U.S.

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 3 rd leading cause of cancer death in women, and 2 nd in men.

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.

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.

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

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.

The Clade II mpox affects mostly men who have sex with men in the U.S.,

where it has become endemic.

In August 2024, the World Health Organization (“WHO”) declared mpox Clade Ib to be a

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

that spread globally, including to the United States.

Clade Ib affects children as well as adults.

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

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.

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

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

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

a global pandemic in 2019 and has resulted in more than three million deaths.

While the infection and mortality rates have slowed in regions

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

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

variants continue to sweep across the world in successive waves.

With new variants of the virus emerging, therapeutic research is addressing

the challenge of keeping up with this rapidly mutating virus.

The early vaccines have been effective in limiting the severity of disease

in vaccinated individuals.

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

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

frequency and all races and ethnicities.

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

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

morbidity and mortality.

PWS is an orphan disease that occurs in approximately one in 15,000 births.

There is currently no approved

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

Marketed Migraine Products

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

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.

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.

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

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.

Marketed Products

– Treatment of Fibromyalgia

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.

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.

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.

SymTouch is the only actively promoted brand of sumatriptan autoinjector in the United States.

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Tosymra currently has patent protection to 2031.

Product Candidates

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

and patient support capabilities.

Candidates in Development

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

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of Development

submitted and accepted by FDA for review;

PDUFA goal date of August 15, 2025

Stress Reaction

2 ready* – investigator-initiated IND

Adolescent Obesity, Binge Eating Disorder, and Bone Health in Pediatric

Social Anxiety Disorder

Phase 2 currently enrolling*

Phase 2 clinical phase completed*

Depressive Disorder

2 expected to commence mid-2026

Acute Stress Reaction/Acute Stress Disorder

Prevention of Lyme Disease

Phase 2 field study planned first half 2027 and Phase 2 human challenge study planned

2028 (pending FDA clearances)

Transplant Rejection

1 topline reported 1Q’25

2 study planned for mid 2026*

Adolescent Obesity, Binge Eating Disorder, Bone Health in Pediatric

Autism, and arginine-vasopressin deficiency

2 currently enrolling*

2 expected to commence first quarter 2027

and Mpox vaccine

Treatment or Prevention of Viral Disease

Gastric and colorectal Cancer

or Prevention of Viral Disease

and colorectal Cancer

*Investigator

Initiated Studies

TNX-102 SL is a proprietary sublingual tablet formulation of cyclobenzaprine

(“CBP”) that efficiently delivers CBP across the oral mucosal membrane into the systemic circulation.

We have active IND’s

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

The University of North Carolina

has an investigator-initiated IND for ASD that references our INDs.

We own all rights to TNX-102 SL in all geographies, and we bear no

obligations to third parties for any future development or commercialization.

Excipients used in TNX-102 SL are approved for pharmaceutical

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.

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.

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

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.

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

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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.

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.

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.

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

We believe the selected dose

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

tolerability.

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

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

to oral IR CBP tablets.

It also showed that the sublingual route of administration, which bypasses the “first pass”

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

during sleeping hours when taken at bedtime.

We believe the dynamic changes in CBP after TNX-102 SL administration at steady state

during chronic use contribute to its activity in treating fibromyalgia.

We believe this is the first drug designed to

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

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

adverse reactions reported in these studies.

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.

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.

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

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

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

at least 2034 in the U.S., EU, Japan, China and other jurisdictions.

The eutectic protects cyclobenzaprine HCl from interacting

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

The formulation

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

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

We have successfully completed the pivotal exposure bridging study

with TNX-102 SL compared to Amrix.

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

Food, Drug and Cosmetic Act (“FDCA”) with Amrix as the listed drug.

We believe that TNX-102 SL has the potential to provide clinical

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

products or have no approved treatment.

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

characteristics to our historical data in Caucasian volunteers.

We believe this will satisfy one of the criteria for approval

in Japan and China and will allow us to reference the U.S.

efficacy data to support marketing applications in those countries.

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

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

Development Plan

Acceptance and PDUFA Goal Date

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

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

authorization for TNX-102 SL.

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

Meetings and Fast Track Designation

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

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

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

the Company’s pre-NDA meetings.

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

pre-NDA meetings with the FDA for TNX-102 SL for the management of fibromyalgia.

The first, with minutes announced in June 2024, was a

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

the planned NDA submission for TNX-102 SL.

Based on formal meeting minutes, the Company believes it is aligned with the FDA on proposed

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

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

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

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

first patient was enrolled in the pivotal Phase 3 RESILIENT study in April 2022.

The RESILIENT study was a double-blind, randomized,

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

The two-arm trial enrolled

457 participants in the U.S.

The first two weeks of treatment consist of a run-in period in which participants start on TNX-102

SL 2.8 mg (1 tablet) or placebo.

Thereafter, all participants increase their dose to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or

two placebo tablets for the remaining 12 weeks.

The RESILIENT study achieved statistical significance on the pre-specified primary

efficacy endpoint:

change from baseline in the weekly average of daily diary pain severity numerical rating scale (NRS) scores

for TNX-102 SL 5.6 mg (LS mean [SE]:

-1.8 [0.12] units) versus placebo (-1.2 [0.12] units), analyzed by mixed model repeated measures

with multiple imputation (LS mean [SE] difference:

-0.7 [0.16] units, p=0.00005).

In addition, all pre-specified sensitivity analyses

of the primary endpoint were statistically significant (p≤0.001).

We observed reduction in pain across all weeks of the 14-week

study, with nominal p<0.01 for every week.

The rapid onset of action with separation from placebo at Week 1 was sustained throughout

all weeks of dosing.

TNX-102 SL was well tolerated and consistent with prior trials, with no new safety signals observed.

participants randomized to the TNX-102 SL and placebo arms, 81.0% and 79.2%, respectively, completed the 14-week dosing period.

As expected, based on prior TNX-102 SL studies, administration site reactions were the most commonly reported adverse events and

were higher in the TNX-102 SL treatment group.

Hypoaesthesia oral and paraesthesia oral, or tongue and mouth numbness or tingling,

product taste abnormal (typically a bitter aftertaste upon dosing), and tongue discomfort were local effects nearly always temporally

related to dose administration and transiently expressed (<60 minutes) in most occurrences.

The only treatment-emergent adverse

events that occurred at a rate of 3.0% or greater in either arm were these four oral adverse events, along with COVID-19, somnolence,

and headache.

Adverse events resulted in premature study discontinuation in 6.1% of those who received TNX-102 SL compared with

3.5% of placebo recipients.

There were a total of seven serious adverse events in five patients, five of which were experienced

by three patients in the placebo arm, and two of which were in the TNX-102 SL arm.

Of the two in the TNX-102 SL arm, one was renal

cancer, deemed unrelated to study drug, and the other was acute pancreatitis with onset 14 days after dosing was completed, reported

as possibly related to study drug, and was resolved before the final study visit.

Phase 3 RALLY Study (F306)

The RALLY study was a double-blind, randomized, placebo-controlled

adaptive design trial intended to evaluate the efficacy and safety of TNX-102 SL in FM.

The trial was designed to enroll approximately

670 patients across approximately 40 U.S.

For the first two weeks of treatment, there was a run-in period in which patients started

on TNX-102 SL 2.8 mg (1 tablet) or placebo.

After the first two weeks, all patients had the dose increased to TNX-102 SL 5.6 mg (2 x 2.8

mg tablets) or two placebo tablets for 12 weeks.

The primary endpoint was daily diary pain severity score change from baseline to Week

14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation.

We reported pre-planned interim analysis results from a Phase 3 study, RALLY (F306), in July 2021.

Based on the recommendation from the

independent data monitoring committee that the RALLY trial was unlikely to demonstrate a statistically significant improvement in the

primary endpoint, we stopped enrollment of new participants but allowed those participants who were already enrolled to complete the study.

We reported topline data from the completed study in March of 2022.

As expected, based on interim analysis results, TNX-102 SL did not

achieve statistical significance over placebo on the primary endpoint of reduction in daily pain.

Relative to the previous positive

Phase 3 Study (RELIEF), RALLY had an unexpected increase in study participant adverse event-related discontinuations in both drug and

placebo groups (~80% higher in each), which we believe may have been impacted by conducting the study in the period of highest mortality

across the U.S.

from the COVID-19 pandemic (September 2020 through March 2021 for the interim analysis sample).

Phase 3 RELIEF Study (F304) with Statistically Significant Improvement in Primary Endpoint of Pain Reduction

the fourth quarter of 2020, we announced the results of a randomized, double-blind, placebo-controlled, 12-week Phase 3 study

of TNX-102 SL in 503 participants with FM, which we refer to as the RELIEF study.

The primary objective of this study was to evaluate

the potential clinical benefit of using TNX-102 SL to treat FM at a dose of 5.6 mg, administered sublingually once daily at bedtime

for 12 weeks.

The primary endpoint of the RELIEF trial was the daily diary pain severity score change from baseline to Week 14

(using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple

The RELIEF study achieved statistical significance on the primary efficacy endpoint:

change from baseline in the weekly

average of daily diary pain severity numerical rating scale (NRS) scores for TNX-102 SL 5.6 mg (LS mean [SE]:

-1.9 [0.12] units)

versus placebo (-1.5 [0.12] units), analyzed by mixed model repeated measures with multiple imputation (LS mean [SE] difference:

-0.4 [0.16] units, p=0.010).

The statistically significant improvement in pain is further substantiated

when diary pain was analyzed by another standard statistical approach, a 30 percent responder analysis, with 46.8% on active and 34.9%

on placebo having a 30 percent or greater reduction in pain (logistic regression;

odds ratio [95% CI]:

1.67 [1.16, 2.40];

p=0.006, uncorrected).

Consistent with the proposed mechanism that TNX-102 SL acts in fibromyalgia through improving sleep quality, TNX-102 SL showed nominal

improvement of sleep by several measures.

For daily diary sleep quality ratings, TNX-102 SL (-2.0 [0.12] units) compared to placebo (-1.5

[0.12] units) was nominally significant (LS mean difference:

-0.6 [0.17] units;

For the PROMIS Sleep Disturbance instrument,

TNX-102 SL was also nominally significant over placebo on T-scores (LS mean difference:

-2.9 [0.82] units;

The effect sizes

on the diary sleep quality ratings and PROMIS Sleep Disturbance instrument were 0.31 and 0.32, respectively.

the RELIEF study, TNX-102 SL was similarly well tolerated as in the prior Phase 2 BESTFIT and Phase 3 AFFIRM studies, which both studied

TNX-102 SL at a lower dose of 2.8 mg daily.

There were no new safety signals observed in the RELIEF study at the 5.6 mg daily

Among participants randomized to the TNX-102 SL and placebo arms, 82.3% and 83.5%, respectively, completed the 14-week dosing

As expected, based on prior studies, administration site reactions are the most commonly reported adverse events and were

higher in the TNX-102 SL treatment group, including rates of hypoaesthesia oral (17.3% vs.

0.8%), oral pain/discomfort (11.7%

2.0%), product taste abnormal (6.5% vs.

0.4%), and paraesthesia oral (5.6% v.

Hypoaesthesia or paraesthesia oral and

product taste abnormal were local administration site effects nearly always temporally related to dose administration and transiently

expressed (<60 minutes) in most occurrences.

The only systemic treatment-emergent adverse events that occurred at a rate

of 5.0% or greater in either arm was somnolence/sedation at 5.6% in the TNX-102 SL arm vs.

1.2% in placebo, which was consistent

with known side effects of marketed oral cyclobenzaprine.

Adverse events resulted in premature study discontinuation in 8.9% of

those who received TNX-102 SL compared with 3.9% of placebo recipients.

There was a total of seven serious adverse events reported

during the study, none of which were deemed related to investigational product;

five in placebo arm, and two in TNX-102 SL arm.

Of the two in the TNX-102 SL arm, one was a motor vehicle accident with multiple bone fractures, and the other was a case of pneumonia

secondary to an infection.

Global NDA Requirements

We are planning to develop TNX-102 SL for the treatment of FM in Japan.

Cyclobenzaprine, the active ingredient of TNX-102 SL, has not been approved in Japan, and is considered a new chemical entity (NCE).

February 2022, we held an End of Phase 2 Consultation with the Pharmaceuticals and Medical Devices Agency, or PMDA, an independent administrative

institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan, to discuss the

Japan development plan.

Agreement was reached on the design of a Phase 1 bridging study (TNX-CY-F108/F108) in ethnic Japanese healthy

volunteers to enable clinical studies of TNX-102 SL in Japan.

PMDA also provided guidance on the overall nonclinical package to support

a Japan NDA filing for TNX-102 SL for the treatment of FM.

F108 Phase 1 study was initiated in March 2022 and the clinical phase was completed in May 2022.

NDA Requirements

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.

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

Phase 1 PK study was initiated in March 2022 and the clinical phase was completed in May 2022.

Since the similarity in PK profile

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results support similarity in cyclobenzaprine PK between Asian (pooled Japanese and Chinese) and Caucasian samples.

Safety Exposure Study for TNX-102 SL

In October 2019, we completed long-term safety exposure studies in participants

with PTSD to evaluate the tolerability of TNX-102 SL 5.6 mg to support an NDA for the treatment of PTSD.

The data provide us with

exposure data of daily dosing of TNX-102 SL 5.6 mg for at least 12 months in more than 50 individuals, and daily dosing of TNX-102 SL

5.6 mg for at least 6 months in more than 100 individuals.

The data was collected in open-label extension studies of the PTSD program.

FDA’s guidance, the long-term safety exposure studies in PTSD was used to support the NDA for the management of fibromyalgia.

Manufacturing of

SL drug product for Phase 3 and the associated registration batches for the NDA were manufactured at commercial cGMP facilities.

We currently have 36-month stability data in the proposed packaging configurations ready for commercialization.

The FDA has reviewed

the proposed CMC data package to support TNX-102 SL’s NDA approval and commercial manufacturing plans as part of the IND

Tonix is ready to manufacture TNX-102 SL commercial product for the forecasted fibromyalgia market.

second quarter of 2024, Tonix successfully completed a pre-NDA meeting with the FDA for TNX-102 SL for a Type B Chemistry, Manufacturing,

and Controls (CMC) meeting to seek alignment and agreement with the FDA on key CMC topics to support the planned NDA submission

for TNX-102 SL.

Based on formal meeting minutes, the Company believes it is aligned with the FDA on proposed drug substance and

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

In March 2024, Tonix

announced it selected two contract manufacturing organizations (CMOs), one of which is Almac Pharma Services, a member of the

privately owned Almac Group, as dual supply sources for the potential launch and commercialization of TNX-102 SL in the U.S.

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

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.

November 2025, the FDA cleared the IND application to support clinical development of TNX-102 SL 5.6 mg for the treatment of MDD

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

About 360 patients will be enrolled at approximately 30 U.S.

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.

SL – Acute Stress Disorder Program

SL is being developed as a bedtime treatment for ASR in collaboration with the University of North Carolina under an investigator-initiated

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.

2 OASIS Study

This investigator-initiated study will be 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.

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 trial will 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.

We expect enrollment in the OASIS study to

begin in the first half of 2025.

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 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

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.

OASIS trial will build upon a foundation of knowledge and infrastructure developed through the University of North Carolina-led,

$40 million AURORA initiative.

$40 million AURORA study.

The AURORA study is a major national research initiative to improve the understanding, prevention,

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Life Sciences, the health care arm of Google’s parent company Alphabet.

of patient enrollment in the proposed investigator sponsored OASIS trial is anticipated in the first half of 2025.

granted IND clearance in the first quarter of 2024.

In August 2024 at the DoD’s MHSRS conference, the Company presented

clinical data and rationale supporting the potential for TNX-102 SL to be studied for the treatment of ASR and prevention of PTSD.

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/ASD symptoms which are similar to those of 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 PTSD.

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.

– 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 .

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.

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

Serum TNX-4800 was measurable at the earliest sampling time of 24 hours, indicating rapid systemic absorption.

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.

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.

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

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.

– Organ Transplant Rejection/Autoimmune Conditions

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.

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

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.

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 (t 1/2 ) 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.

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.

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.

expected to be initiated mid-2026.

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

– Cocaine Intoxication

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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.

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.

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.

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.

there is no specific pharmacotherapy indicated for cocaine intoxication, a state characterized by acute agitation, hyperthermia,

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has been granted Breakthrough Therapy designation by the FDA.

As a biologic and new molecular entity, TNX-1300 is eligible for 12 years

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 is 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 patients presenting

with cocaine intoxication.

Because of the challenges of recruiting eligible patients into this study, we are not guiding to a timeline

for completion of enrollment or topline data.

–Adolescent Obesity, Binge Eating Disorder.

Social Anxiety and Bone Health in Autism

(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 social anxiety disorder.

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.

–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.

from Stanford University.

TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin

into the nose.

is a naturally occurring human hormone that acts as a neurotransmitter in the brain.

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in both adults and children.

There are three ongoing Phase 2 investigator-initiated studies enrolling

the POWER study for the treatment of adolescent obesity, the STROBE study for the treatment of BED, and the BOX study for the

treatment of bone health in pediatric autism.

In addition to the studies at MGH, University of Washington is conducting an investigator-initiated

study of TNX-1900 in SAD using functional MRI, in which the clinical phase has been completed, and data analyses are in progress.

– Organ Transplant Rejection/Autoimmune Conditions

is a humanized mAb directed against CD40-ligand, or CD40L (also known as CD154), engineered to modulate binding to Fc receptors,

that is being developed to prevent and treat organ transplant rejection as well as to treat autoimmune conditions.

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.

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

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.

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.

The IND was cleared for the prevention of kidney transplant, and a Phase

1 single ascending dose escalation study at 3 mg/kg, 10 mg/kg and 30 mg/kg of TNX-1500 in healthy volunteers was 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 (t 1/2 ) for the 10 mg/kg and 30 mg/kg dose groups of 34-38 days, consistent with monthly

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:

potential pipeline

in a product.

Tonix plans to discuss these results with the FDA in an End-of-Phase 1 meeting.

Pending alignment with the FDA,

a Phase 2 study of TNX-1500 in kidney transplant recipients will be pursued.

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

agents in allogeneic transplants in non-human primates at MGH.

In experiments at MGH, TNX-1500 is being studied as monotherapy or in combination

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

Results from experiments in

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

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

Some results from this collaboration were published in the peer-reviewed journal, American

Journal of Transplantation in 2023.

In June 2024, at the American Transplant Congress 2024, Tonix announced data demonstrating

the combined use of TNX-1500 and anti-CD28 monoclonal antibody, VEL-101 is associated with durable protection and graft survival and function

in a nonhuman primate model.

Further data demonstrated that TNX-1500 has promise to prevent rejection of 9-, or 10-gene-edited (GE) pig

All research has been directed by the faculty of the Center for Transplantation Sciences at Massachusetts General Hospital.

also is being studied in combination with other immunosuppressive agents in xenogeneic organ transplants in non-human primates

In some of these studies, genetically engineered (“GE”) pigs in baboon transplants were treated with cold

perfused ischemia minimization and a novel costimulation-based immunosuppressive regimen including TNX-1500.

The results of these

preclinical studies were encouraging and demonstrated the potential of genetically engineered pig hearts in the context of a clinically

applicable regimen.

The multi-GE pigs were provided by eGenesis and Revivicor.

Revivicor is a subsidiary of United Therapeutics.

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

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

work with TNX-1500.

TNX-1500 therapy was not used in the human transplant recipient.

In pre-clinical experiments at MGH, TNX-1500 is being 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 alloimmunity in animal models of cardiac and kidney allograft model without evidence of clinical thrombosis.

January 2021, the World Intellectual Property Organization published a patent application filed under the Patent Cooperation Treaty

covering TNX-1500, a humanized mAb directed against CD40-ligand, which is also known as CD154.

The patent application is titled

“Anti-CD154 Antibodies and Uses Thereof” and published under International Publication No.

WO 2021/001458 A1.

application entered national phase in December 2021.

The patent applications include claims related to proprietary anti-human

CD40-ligand mAbs that were engineered to have modified effector function, including TNX-1500, which have reduced potential for

Fc binding to FcγRII.

The patent applications also claim uses of TNX-1500 for preventing and treating conditions, such as

organ transplant rejection and autoimmune disorders.

If claims are granted, a patent issuing from a national stage of this application

could potentially provide U.S.

patent coverage for the TNX-1500 composition of matter through 2040 excluding possible patent term

extensions or patent term adjustments.

We also have filed a PCT patent application, PCT/US2022/011404, in January 2022, entitled

“Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies.” It claims methods of inducing immune tolerance

in transplant recipients using anti-CD154 antibodies having modified effector functions.

and Simponi® are trademarks of Janssen;

Humira® is a trademark of AbbVie Inc.;

Cimzia® is a trademark of UCB S.

Enbrel®, Prolia® and Xgeva® are trademarks of Amgen Inc.

TNX-1700 — Gastric and Colorectal Cancers

TNX-1700 is a recombinant Trefoil Family Factor 2 (hTFF2-HSA) fusion protein

in development 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 TFF2 compositions and methods of treatment.

The licensed patents U.S.

There are four ongoing Phase 2 investigator-initiated studies enrolling

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

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.

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.

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

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.

— Gastric and Colorectal Cancers

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.

10,124,037 and U.S.

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.

Preclinical data has shown that mTFF2-CTP augmented the efficacy of mAb

anti-PD-1 therapy.

Anti-PD-1 in combination with mTFF2-CTP showed greater anti-tumor activity in PD-L1-overexpressing mice.

The mechanism

of action is to suppress myeloid-derived suppressor cells and activate anti-cancer CD8+ T cells, which is different from checkpoint inhibitors.

There is potential synergy with anti-PD-1 or anti-PD-L1 mAbs.

TNX-801 –Smallpox and Mpox Vaccine

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.

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.

–Smallpox and Mpox Vaccine

is a novel potential smallpox- and mpox-preventing vaccine based on a synthetic version of live horsepox virus, grown in cell

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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.

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.

We also believe that TNX-801

would require only one dose.

We believe replicating virus vaccines

have potential efficacy advantages over non-replicating vaccines, relating to the stimulation of cell mediated immunity.

Nordic’s Jynneos®, the only non-replicating virus vaccine, is currently approved by the FDA to protect against smallpox

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.

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

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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” (Bipartisan Commission on

vulnerability of populations who stopped routinely vaccinating against smallpox in the 1970s

are developing TNX-801 as a potential smallpox- and mpox-preventing vaccine for the U.S.

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potential widespread immunization in the event of malicious reintroduction of variola, the virus that causes smallpox.

Mpox has become endemic in the U.S.

has become endemic in the U.S.

since it spread in the U.S.

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.

and other countries outside of Africa, mostly in populations of gay

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

These data were published in the peer-reviewed journal Vaccines in 2023.

In November 2024, Tonix announced that it has entered into a sponsored

research agreement with the Kenya Medical Research Institute (KEMRI) to design, plan and seek regulatory approval for a Phase 1 clinical

study in Kenya to test the safety, tolerability, and immunogenicity of TNX-801 as a vaccine to prevent mpox and smallpox.

Tonix will be

the sponsor and KEMRI will lead the execution of the proposed clinical trial.

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

at the World Vaccine Congress in Barcelona, Spain, Tonix presented new data on 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, the Company also announced that the WHO’s preferred TPP aligns with the characteristics

Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability

at ambient temperature.

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.

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.

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.

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

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 August 2024, Tonix and Bilthoven Biologicals, part of the world’s

largest vaccine manufacturer the Cyrus Poonawalla Group, which includes the Serum Institute of India, announced a collaboration to advance

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.

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

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.

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.

1/2 clinical trial will assess the safety, tolerability, and immunogenicity of TNX-801, following the submission and clearance

We are actively working to develop a vaccine meeting cGMP quality to support a clinical study.

January 2020 at the American Society of Microbiology Biothreats conference, we reported the results of experiments on TNX-801

that were performed in collaboration with Southern Research, that showed TNX-801 vaccinated macaques were protected against monkeypox

The TNX-801 vaccinated macaques showed no overt clinical signs after monkeypox challenge.

Furthermore, eight of eight

animals vaccinated with two different doses of TNX-801 showed no lesions after monkeypox challenge.

These results were published

in the peer-reviewed journal Viruses in 2023.

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.

Patent for TNX-801 smallpox and mpox vaccine and Recombinant Pox Virus (RPV) platform technology.

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and Affordable Care Act, or PPACA.

also serves as the live virus vaccine platform for other infectious diseases for which subsequent products will be designed by

expressing other viral antigens in the horsepox vector.

The company’s Good Manufacturing Practice (GMP)-capable advanced

manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated

in case of a national or international emergency.

TNX-1800 – COVID-19 Vaccine

TNX-1800 is a minimally replicative, live virus vaccine based on our RPV

platform that expresses the SARS-CoV-2 spike protein from the ancestral Wuhan strain.

TNX-1800 is being further developed to rapidly address

new variants as they emerge.

The vaccine platform itself can carry a payload of genes.

The vaccine protects against COVID-19 by eliciting

a durable T cell, humoral and mucosal immune response.

It is delivered in only one dose.

In November 2023, Tonix announced that the NIAID,

a part of the NIH, will conduct a Phase 1 clinical trial with TNX-1800 as part of the Project NextGen Covid-19 Vaccine initiative.

NIAID/NIH program is funded to take selected NextGen vaccine candidates into Phase 1 and Phase 2 trials.

Because of extensive reviews

of NIH programs, the future of this program is uncertain.

COVID-19 vaccines that are approved for use in the U.S.

have provided significant health benefits to the vaccinated population;

however, they have shown limitations in the durability of protection conferred and in their limited ability to block the spread

of infection (forward transmission).

Live virus vaccines that protect against other viral diseases by eliciting T cell responses

have shown durability of protection that lasts years to decades and some live virus vaccines have significantly inhibited forward

transmission (e.g.

The TNX-1800 vaccine development plan is wholly consistent with priority vaccine attributes advanced

by the White House Office of Science and Technology Policy’s Pandemic Preparedness Plan from September

2021, the National Biodefense Science Board report from August 2023, and the BARDA Strategic Plan 2022-2026.

Tonix believes its

RPV platform can address a wide variety of disease targets of public health interest.

The results of an animal study data showing the protective effect of TNX-1800

vaccine was published in the peer-reviewed journal Vaccines in 2023 and show that TNX-1800 induces complete protection against

SARS-CoV-2 infection as well as evidence that indicates an impact on spread of infection.

These data also confirm that “take”

is a biomarker of protection of upper and lower airways from SARS-CoV-2 challenge, and a biomarker of immunological response to TNX-1800’s

cargo COVID-19 antigen, which is the CoV-2 spike protein.

Tonix has also began undertaking studies to show attenuation of the RPV platform

itself in order to evaluate the potential use of the live vaccine platform in the immunocompromised host by the use of mouse model system.

These data (detailed below) demonstrate that the RPV vaccine platform that is used for TNX-1800 is >10- to 1,000-fold more minimally

replicative than older VACV-based smallpox vaccines in human primary cell lines and immunocompromised mice.

received pre-IND meeting written responses from the FDA in 2021 regarding our investigational plan to establish the safety and

effectiveness evidence in support of the licensure of TNX-1800.

We believe that the FDA feedback provides a clear pathway forward

towards utilizing its underlying RPV platform for a COVID-19 vaccine.

announced the issuance of U.S.

Patent for TNX-801 smallpox and mpox vaccine and 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,

and also expect 12 years of non-patent-based exclusivity under PPACA.

the World Vaccine Congress in October 2023, Tonix presented its positive, published non-human primate data for the TNX-1800 (spike

from Wuhan strain) from animal challenge studies using live SARS-CoV- 2.

In this study TNX-1800 vaccinated, SARS-CoV-2 challenged

animals had undetectable SARS-CoV-2 in the upper airways, which we believe relates to potential inhibition of forward transmission

of this respiratory pathogen.

Further, as an expected additional outcome, all 16 animals vaccinated with either dose of TNX-1800

or the control TNX-801 manifested a “take”, or cutaneous response, signaling that the horsepox vector elicits a strong

T cell immune response.

These results support the expectation that TNX-1800 at the low dose of 1 x 10 6 PFU is an appropriate

dose for a one-dose vaccine in humans.

These data were published in the peer-reviewed journal Vaccines in 2023.

Additional studies have been undertaken to show attenuation of the RPV

platform alone (TNX-801) in order to evaluate the potential use of this live vaccine in the immunocompromised host.

These data demonstrate

that the RPV platform used with TNX-1800 is >10- to 1,000-fold more minimally replicative than older VACV-based smallpox vaccines in

human primary cell lines and immunocompromised mice.

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

The GMP suites have been decommissioned and may be reactivated the earlier of 2027 or in case of a national or international

– Broad-Spectrum Antiviral

Tonix is developing CD45-targeted therapeutics (TNX-4200).

Tonix was 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.

Tonix’s program will focus on optimization and development of its

TNX-4200 program, to develop an orally available CD45 antagonist, with broad-spectrum efficacy against a range of viral families through

preclinical evaluation.

The program is expected to establish physicochemical properties, pharmacokinetics, and safety attributes to support

an IND submission and to fund a first-in-human Phase 1 clinical study.

Tonix plans to leverage previous research on phosphatase inhibitors,

specifically compounds that target CD45, to optimize lead compounds for therapeutic intervention of biothreat agents and provide the government

with a complete and cost-effective solution for a broad-spectrum medical countermeasure.

Tonix’s 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

– Prader-Willi Syndrome (PWS)

TNX-2900 is based on our patented intranasal potentiated oxytocin formulation,

or TNX-1900, but being developed for PWS.

Tonix 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

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 15,000 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.

2022, Tonix entered into a research collaboration with Inserm involving in vitro and in vivo animal studies designed

to validate and characterize the role of oxytocin in suckling and in the maturation of feeding behavior during infancy in order

to support an intranasal therapeutic approach to restore a normal nutritive suckling.

The studies will include mice that have

been engineered to precisely recapitulate the genetic issue underlying PWS in humans.

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

Intranasal oxytocin has previously been shown to improve suckling in newborn animals and suppress feeding behaviors

in adult animal models.

We are developing CD45-targeted therapeutics (TNX-4200).

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.

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

is a highly selective S1R antagonist with demonstrated analgesic activity in multiple animal models of neuropathic pain.

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 (K i = 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.

Facilities Overview

Research & Development Center (RDC)

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 COVID-19, its variants, and other infectious diseases.

The RDC is the principal site for the research on TNX-4200, a broad-spectrum

antiviral targeting CD45 funded by the U.S.

Department of Defense, Defense Threat Agency contract.

The RDC also conducts

research on CNS and immunology drugs.

We own the approximately 48,000 square foot RDC facility in Frederick,

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.

RDC also conducts research on CNS and immunology drugs.

The RDC facility is biosafety level 2 (BSL-2) with BSL-3 components.

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.

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.

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 but Tonix has the ability to reactivate it should we choose

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.

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.

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.

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

Sales and Distribution

activity for Zembrace Symtouch and Tosymra in the United States is conducted by our wholly-owned subsidiary, Tonix Medicines,

activity for TONMYA, Zembrace Symtouch and Tosymra in the United States is conducted by our wholly-owned subsidiary, Tonix Medicines,

We focus our sales and marketing efforts on physicians in private practice and in public treatment systems.

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and educational outreach aimed at physicians, nurses, social workers, counselors, and other stakeholders involved in treating

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.

Zembrace Symtouch and Tosymra are primarily sold

to pharmaceutical wholesalers, pharmacies, and specialty distributors.

We intend to implement patient access programs and expand

distribution channels in our marketing efforts for our migraine drugs.

In 2024, Tonix engaged EVERSANA to support the launch strategy and commercial

planning of TNX-102 SL for the management of fibromyalgia.

Specifically, EVERSANA worked with Tonix to assess the fibromyalgia landscape

and help plan an efficient go-to-market strategy.

In 2024, Tonix hired a new head of Commercial Operations as well as Vice

Presidents to run Medical Affairs and Marketing, each with decades of experience successfully launching and commercializing new CNS products.

In January 2025, Tonix announced the appointment of a vice president to oversee Market Access.

In 2025, we will continue to build out

our commercial team and capabilities as we look forward to a targeted launch of TNX-102 SL in the fourth quarter of 2025, contingent on

FDA approval.

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.

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.

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.

Access and Patient Support

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.

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.

Compliance and Oversight

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.

sector faces intense competition and experiences rapid, substantial technological advancements both domestically and internationally.

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for the indications where Tonix has product candidates either in or nearing the clinical stages of development.

Zembrace Symtouch and Tosymra are indicated for the treatment of acute

migraine and compete with generic versions of sumatriptan.

Zembrace is an autoinjector formulation of sumatriptan and competes with generic

subcutaneous products.

Tosymra is an intranasal formulation of sumatriptan and competes with generic intranasal products.

Tosymra also compete with the new molecular entities including oral migraine therapies such as Nurtec® (Rimegepant) from Pfizer Inc.

and Ubrelvy® (Ubrogepant) and QULIPTA® (atogepant) from AbbVie Inc.

and intranasal migraine therapies such as Zavzpret™

(vazegepant) by Pfizer, Inc.

Most recently, Axsome Therapeutics announced FDA approval of SYMBRAVO® (meloxicam and rizatriptan) for

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

We also note that the PDUFA goal date for Shin Nippon Biomedical Laboratories,

Ltd and Satsuma Pharmaceuticals is April 30, 2025 for their intranasal asset STS101 (dihydroergotamine) for the treatment of migraine

We are currently awaiting an FDA decision on marketing authorization for

TNX-102 SL for the management of fibromyalgia.

There are 3 products approved for the treatment of fibromyalgia which include Lyrica®

(pregabalin), developed by Pfizer, Inc., Cymbalta® (duloxetine), developed by Eli Lilly and Company, and Savella® (milnacipran)

marketed by AbbVie.

Pregabalin and duloxetine are available as generics, while Savella is still on patent.

There has not been a new product

approved for this indication in 15 years.

Tonix is aware of multiple companies actively developing treatments

for fibromyalgia.

Axsome Therapeutics Inc.

expects to submit an NDA for AXS-14 (esreboxetine) for the management of fibromyalgia to the

FDA for AXS-14 in Q1 2025.

Virios Therapeutics, Inc.

announced the initiation of a Phase 3 trial in the U.S.

for IMC-1 for the treatment

of fibromyalgia.

IMC-1 is a fixed dose combination of famciclovir + celecoxib, is a 505(b)(2) and has been granted Fast Track Designation

Tonix is also focused on developments for fibromyalgia outside of the U.S.

and keeps abreast of the progress made by Australian

company Tryptamine Therapeutics Ltd who announced positive data from a Phase IIa clinical trial of TRP-8802 for fibromyalgia which

was presented in an abstract at the International Association for the Study of Pain (IASP) 2024 World Congress on August 9, 2024.

COVID (Post-Acute Sequelae of SARS-CoV-2 Infection or PASC)

As of now, there are no specific drugs approved by the FDA solely for

the treatment of Long COVID (formerly known as Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)).

Tonix is aware of several companies

developing therapeutics for the treatment of Long COVID including, but not limited to, Direct Biologics, LLC (Phase III for DB-001 was

completed in the fourth quarter of 2024 and American CryoStem Corporation.

Other developments include Organicell Regenerative Medicine,

is conducting a Phase 2 for Zofin as a potential therapeutic for Long COVID.

PaxMedica, Inc.

is developing PAX-101 for the treatment

of Long COVID and currently conducting a Phase1b in South Africa.

In October 2024, Resolve Therapeutics, LLC, announced the results from

its Phase II Long COVID study of RSLV-132.

Furthermore, GeNeuro announced the data from Phase II GNC-501 clinical trial in patients

suffering from Long COVID, testing temelimab against placebo.

Finally, in June 2024, Berlin Cures Holding AG announced that it is preparing

for a Phase III study in Long COVID and Statera BioPharma, Inc.

is comparing STAT-205 with placebo for reducing fatigue in Long

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.

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.

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.

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

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.

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).

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.

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.

Depressive Disorder

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.

Stress Reaction/Acute Stress Disorder (ASR/ASD)

There are no approved drugs for treating ASR or for the prevention

of ASD or PTSD.

In October 2024, BioXcel Therapeutics announced a Phase IIa efficacy and safety trial of BXCL501 in patients experiencing

ASD resulting from motor vehicle collisions to begin in the first half of 2025.

BXCL501 is an orally dissolvable film formulation

of the α2A adrenergic receptor agonist dexmedetomidine that is FDA approved as IGALMI® for the acute treatment of agitation

associated with schizophrenia or bipolar I or II disorder in adults.

There are no approved antidotes for the treatment of cocaine intoxication.

are currently no approved drugs specifically for treating acute stress reaction (ASR) or for the prevention of acute stress disorder

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

are no approved drugs for Lyme disease prevention.

We are aware of several companies currently developing Lyme Disease vaccines.

in collaboration with Valneva, is developing VLA15, a multivalent recombinant protein subunit vaccine designed to prevent Lyme in the

The program has completed its Phase 3 VALOR trial vaccinations, with a data readout expected in the first half of 2026.

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

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.

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.

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.

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).

and Colorectal Cancer

are aware of several companies that are focused on developing treatments for Gastric and Colorectal Cancer, including but not

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.

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.

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.

are aware of companies that are targeting cocaine use disorder and we monitor their progress.

Embera NeuroTherapeutics currently lists

EMB-001 in Phase II development for the treatment of cocaine use disorder in its pipeline.

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 including Sanofi, UCB, Eledon Pharmaceuticals, and Amgen

Eledon Pharmaceuticals revealed promising results from the Phase I/II trial of tegoprubart, aimed at preventing islet transplant

rejection in individuals with type 1 diabetes.

The trial showed that the first human cases of insulin independence were achieved using

an anti-CD40L monoclonal antibody therapy, without relying on tacrolimus, the current standard treatment for preventing transplant rejection.

Sanofi’s SAR441344 (Frexalimab), a second-generation anti-CD40L monoclonal antibody, is being tested in multiple sclerosis.

a Phase II trial involving participants with relapsing multiple sclerosis (NCT04879628), frexalimab demonstrated effectiveness in quickly

reducing the number of new gadolinium-enhancing T1-lesions at week 12.

is currently conducting a Phase III trial to test Dazodalibep for Sjogren’s

Syndrome (NCT06104124) with an estimated completion date for the first half of 2026.

Lundbeck is testing Lu AG22515 for Thyroid Eye

Disease (TED) and plans to report results from the Phase Ib TED study in the second half of 2026.

In 2024, UCB and Biogen announced positive

results from a Phase III trial testing Dapirolizumab Pegol for Systemic Lupus Erythematosus.

In November 2024, UCB and Biogen

announced the initiation of their potentially confirmatory Phase III trial to test Dapirolizumab Pegol for Systemic Lupus Erythematosus

(NCT06617325).

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

Somatropin, which targets

the Growth Hormone Receptor is approved in the U.S.

and marketed by Pfizer Inc.

and Novo Nordisk.

Novartis AG markets Omnitrope® in

There are no approved products for the treatment of hyperphagia or over-eating in PWS.

Patients generally receive care to best

manage individual symptom presentation.

ACADIA Pharmaceuticals Inc.

currently have ACP-101 (intranasal carbetocin) (acquired Levo Therapeutics

in June 2022) in a Phase 3, randomized, double-blind, placebo-controlled, 8-week clinical study to assess the efficacy, safety, and tolerability,

of ACP-101 in PWS with long term follow-up.

Acadia anticipates the enrollment of the final patient in by the fourth quarter of 2025, with

top-line results expected to be announced in the first half of 2026.

Soleno is developing diazoxide chloride controlled release (DCCR)

which had positive results in a randomized withdrawal study of PWS.

The PDUFA goal date for a decision on marketing authorization is in

Carmot Therapeutics Inc.

announced that they plan to release Phase I single ascending dose (SAD)/MAD data for CT-PYY in 2025 for the treatment of PWS.

Biosciences Holdings, Inc.

received Orphan Drug Designation for their asset Wakix (pitolisant hydrochloride) for the treatment of PWS.

Harmony Biosciences announced initial topline results from its Phase II proof-of-concept study in patients with PWS, which showed a signal

on improvement in the primary outcome related to excessive daytime sleepiness in November 2022.

At the end of 2024, Neuren Pharmaceuticals

Limited announced the suspension of its Phase II open-label study of the safety, tolerability, and pharmacokinetics of oral NNZ-2591

in Prader-Willi syndrome (PWS-001) due to a revised development strategy.

is knowledgeable about several companies dedicated to developing a therapy for the treatment of PWS including, but not limited

to, Aardvark Therapeutics, ConSynance Therapeutics, Lipidio Pharma, Helsinn, Inversago Pharma, Saniona, 9 Meters Biopharma, Neuracle

Science, Harmony Biosciences Holding Inc., and Notitia Biotechnologies.

Gastric and Colorectal Cancer

TNX-1700 asset is a recombinant TFF2 (albumin fusion peptide) and has

demonstrated that by targeting myeloid derived suppressor cells (MDSCs) using TFF2-MSA fusion protein synergizes well with PD-1 blockade

therapy in advanced and metastatic syngeneic mouse models of colorectal cancer.

Tonix is aware of several companies that are focused on

MDSCs to treat Gastric and Colorectal Cancer.

Anbogen announced a drug supply collaboration to evaluate the combination of Anbogen’s

ABT-301, with BeiGene’s tislelizumab, in patients with mismatch repair–proficient or microsatellite stable metastatic colorectal

cancer (“mCRC”) in a global Phase II trial.

Gilead Sciences and Arcus Biosciences announced new data from Cohort

B of ARC-9, a Phase Ib/II study evaluating the safety and efficacy of etrumadenant, a dual A2a/b adenosine receptor antagonist, plus anti-PD-1

monoclonal antibody zimberelimab, FOLFOX chemotherapy and bevacizumab (EZFB) in third-line mCRC.

In 2023, TriSalus Life Sciences announced

it plans to initiate a Phase II trial of SD-101 (Nelitolimod) for colorectal cancer.

NextCure, Inc.

have NC410 in the clinic

for Colorectal Cancer.

Faron Pharmaceuticals Oy have Bexmarilimab in the clinic for Colorectal Cancer.

Merck & Co., Inc.

Agenus are collaborating on MK-4830 for Colorectal Cancer.

SE is conducting a Phase I/II study in the U.S.

evaluating the safety, tolerability, reactogenicity and immunogenicity of the

investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against mpox.

The study is expected to

complete in the first quarter of 2026.

In 2023, Moderna announced it has mRNA-1769 in preclinical development for the treatment

Moderna is conducting a P1/2 study of mpox vaccine in the U.K.

Emergent BioSolutions, Inc.

has enabled the enrolment

of the first patients for the MOSA, a pan-African randomized platform adaptive trial to test Tembexa to treat mpox at Mbandaka

Hospital in Equateur Province, Democratic Republic of Congo.

A first interim analysis is expected by the end of the first

quarter of 2025.

Other companies we monitor include GeoVax Labs, Inc., NanoViricides, Inc., EpiVax, Inc., Gylden Pharma

are many vaccine products in development for the treatment or prevention of Covid-19 globally.

Approved products include

Pfizer-BioNTech’s (BNT162b2), Moderna’s (mRNA-1273) and Novavax’s (NVX-CoV2373) which are routinely updated to

address new variants.

CSL and Arcturus announced that the European Commission has granted marketing authorization for

KOSTAIVE (ARCT-154), an mRNA COVID-19 vaccine, KOSTAIVE is currently marketed in Japan against COVID-19.

developing CoviLiv™ as an intranasal vaccine candidate and in Phase 3 for COVID-19.

Other companies working in the area

which is developing a potentially orally administered vaccine based on the adenovirus serotype 5 (Ad-5) vector

to express the spike protein of SARS-CoV-2;

CastleVax USA which is developing a potential nasally administered vaccine based on

a Newcastle disease virus (NDV) vector to express the Spike protein of SARS-CoV-2.

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 10,

2025, the patents we are either the owner of record of or own the contractual right to include 42 issued U.S.

patents and 432 issued

We are not aware of

any drugs in development for the treatment of cocaine intoxication.

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.

We are actively pursuing an additional 22 U.S.

non-provisional patent applications, 3 international patent applications,

and 244 non-U.S./non-international patent applications.

non-provisional

patent applications, 4 international patent applications (PCT), and 238 non-U.S./non-PCT patent applications.

strive to protect the proprietary technology that we believe is important to our business, including our proprietary technology

35 unchanged sentences

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 use.

patent portfolios for our proprietary technology platform and our most advanced product candidates as of February 10, 2025 are

summarized below.

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.

SL — Central Nervous System Conditions

192 unchanged sentences

reaction (ASR) or acute stress disorder (ASD) and associated symptoms thereof using a composition with cyclobenzaprine or its

— Oxytocin-Based Treatments for Obesity, Eating Disorders, Pain, Insulin Resistance, and Diabetes

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

Arginine-Vasopressin Deficiency

have acquired the migraine and pain treatment technologies of Trigemina, Inc., and have assumed its license rights to related

8 unchanged sentences

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.

entitled “Magnesium-Containing Oxytocin Formulations and Methods of Use,” issued.

also acquired International Patent Application No.

6 unchanged sentences

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.

also have rights to International Patent Application No.

3 unchanged sentences

11,970,554, entitled “Labeled Oxytocin and Method of Manufacture and Use,” issued.

On November 11, 2025,

12,466,855, entitled “Labeled Oxytocin and Method of Manufacture and Use,” issued.

have entered into an exclusive license to the University of Geneva’s technology for using oxytocin to treat insulin resistance

9 unchanged sentences

or extensions.

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.”

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

35 unchanged sentences

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.

August 28, 2024, European Patent No.

3 unchanged sentences

compositions for treating or preventing a transplant rejection.

April 22, 2025, Chinese Patent No.

ZL202080059891.1, entitled “Anti-CD154 antibodies and uses thereof,” issued.

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.

November 14, 2025, Japanese Patent No.

7775080, entitled “Anti-CD154 antibodies and uses thereof,” issued.

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.

— Live Horsepox Vaccine for Prevention of Smallpox and Mpox

21 unchanged sentences

chimeric horsepox virus (scHPXV), methods of generating the scOPV and scHPXV, and compositions comprising the scOPV or scHPXV.

July 22, 2025, U.S.

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.

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

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-19 preventing vaccine against different strains of SARS-CoV-2.

On February 26, 2021, we filed International Patent Application

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.

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

Application No.

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-19.

— Recombinant Trefoil Family Factor 2 (rTFF2) to Treat Gastric and Colorectal

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.

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.

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

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.

patents, U.S.

10,124,037 and U.S.

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.

— Antiviral Drugs

have acquired the intellectual property rights of Healion Bio, Inc.

to develop antiviral drugs.

These rights include International

Patent Application No.

PCT/US2021/032461 (nationalized in 6 countries) and U.S.

Patent Application No.

18/055,596, both entitled

“Compositions and Methods for Increasing Efficacy of a Drug.”

— Estianeptine for Psychiatric and Neurodegenerative Diseases

are developing TNX-4300, the (S)-isomer of tianeptine, for psychiatric and neurodegenerative diseases.

On March 27, 2024, we filed

International Patent Application No.

PCT/US2024/021799, entitled “(S)-Tianeptine and Use in Treating Disorders and Conditions

Associated with Peroxisome Proliferator-Activated Receptor.”

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,

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.

and Tosymra — Sumatriptan

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.

3 unchanged sentences

10,603,305, U.S.

11,337,962, U.S.

10,537,554, and U.S.

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

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.

Issued Patents

Our current patents owned or licensed include:

Anti-Cocaine Therapeutics

Country / Region

Expiration Date

Anti-Cocaine Compositions and Treatment

February 14, 2029

Anti-Cocaine Compositions and Treatment

December 30, 2027

Anti-Cocaine Compositions and Treatment

July 10, 2027

Anti-Cocaine Compositions and Treatment

July 10, 2027

Anti-Cocaine Compositions and Treatment

July 10, 2027

Anti-Cocaine Compositions and Treatment

July 10, 2027

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

PCT/IB2010/001708, entitled “Formulations Comprising Triptan Compounds,” (nationalized in 11 countries, excluding

rights in Brazil, Russia, India, and China).

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.

current patents owned or licensed include:

Compositions and Treatment

(602007045044.6 in Germany;

502016000056543 in Italy)

Anti-Cocaine Compositions and Treatment

European Patent Office – Germany, Spain, France, United Kingdom, and Italy

July 10, 2027

Anti-Cocaine Compositions and Treatment

July 10, 2027

Anti-Cocaine Compositions and Treatment

July 10, 2027

Mutants of Cocaine Esterase (CocE) Polypeptide, Nucleic Acids Encoding Them, Pharmaceutical Compositions Comprising Them and Uses Thereof

July 10, 2027

Sublingual CBP/Amitriptyline

Country / Region

Expiration Date

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and Methods for Transmucosal Absorption

Taiwan R.O.C.

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and Methods for Transmucosal Absorption

Taiwan R.O.C.

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and Methods for Transmucosal Absorption

Taiwan R.O.C.

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

(AL/P/2022/458 in Albania;

Compositions and Treatment

Patent Office – Germany, Spain, France, United Kingdom, and Italy

Compositions and Treatment

of Cocaine Esterase (CocE) Polypeptide, Nucleic Acids Encoding Them, Pharmaceutical Compositions Comprising Them and Uses

CBP/Amitriptyline

and Methods for Transmucosal Absorption

(AL/P/2022/458

P20221325T in Croatia;

602013082236.0

602013082236.0 in Germany;

3111421 in Greece;

502022000069474 in Italy;

P912561 in North Macedonia;

North Macedonia;

SM-T-202200436 in San Marino;

RS63822B1 in Serbia;

and 2022-GE-787024 in Turkey)

Compositions and Methods for Transmucosal Absorption

European Patent Office – Italy, Albania, Austria, Belgium, Bulgaria, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, San Marino, Serbia, Croatia, North Macedonia and Turkey

June 14, 2033

Compositions for Transmucosal Delivery and Uses Thereof

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

and Methods for Transmucosal Absorption

Patent Office – Italy, Albania, Austria, Belgium, Bulgaria, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany,

Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Romania,

Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, San Marino, Serbia, Croatia, North Macedonia and Turkey

for Transmucosal Delivery and Uses Thereof

and Methods for Transmucosal Absorption

BR112014031394-6

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and Methods for Transmucosal Absorption

June 14, 2033

CBP – Depression

Country / Region

Expiration Date

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 5, 2032

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

(AL/P/2020/15 in Albania;

and Methods for Transmucosal Absorption

and Compositions for Treating Depression Using Cyclobenzaprine

(AL/P/2020/15

P20200142 in Croatia;

in North Macedonia;

MK/P/2020/68 in North Macedonia;

602012066717.6 in Germany;

3103147 in Greece;

HU/E048596 in Hungary;

502020000014740 in Italy;

10476 in North

10476 in North Macedonia;

SM-T-202000083 in San Marino;

60240 in Serbia;

2773834 in Spain;

and 2020-GE-5216 in Turkey)

Methods and Compositions for Treating Depression Using Cyclobenzaprine

European Patent Office – Albania, Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czechia, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Monaco, Republic of North Macedonia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sweden, Slovenia, Slovakia, San Marino, and Turkey

March 6, 2032

Country / Region

Expiration Date

Methods and Compositions for Treating Symptoms Associated with Post-Traumatic Stress Disorder Using Cyclobenzaprine

November 18, 2030

Country / Region

Expiration Date

Methods and Compositions for Treating Fatigue Associated with Disordered Sleep Using Very Low Dose Cyclobenzaprine

CBP – Agitation in Neurodegenerative

Country / Region

Expiration Date

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

December 11, 2038

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

December 11, 2038

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

December 11, 2038

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

December 11, 2038

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

December 11, 2038

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

December 11, 2038

CBP/Amitriptyline Eutectic Formulations

Country / Region

Expiration Date

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

and Compositions for Treating Depression Using Cyclobenzaprine

Patent Office – Albania, Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czechia, Germany, Denmark, Estonia, Spain,

Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Monaco,

Republic of North Macedonia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sweden, Slovenia, Slovakia, San

Marino, and Turkey

and Compositions for Treating Symptoms Associated with Post-Traumatic Stress Disorder Using Cyclobenzaprine

and Compositions for Treating Fatigue Associated with Disordered Sleep Using Very Low Dose Cyclobenzaprine

– Agitation in Neurodegenerative Condition

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

CBP/Amitriptyline

Eutectic Formulations

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

ZL201480024011.1

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

ZL.201580050140.2

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Taiwan R.O.C.

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Taiwan R.O.C.

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

(1211591 in Austria, CZ2014-762323 in Czechia, 602014058260.5 in Germany,

E018723 in Estonia, P20200055 in Croatia, 201361792757 P in Ireland, 2020.67 in Monaco, P-2020/0094 in Serbia, 201431487 in Slovenia,

33269 in Slovakia, 2020000045 in San Marino, AL/P/2019/906 in Albania, MK/P/2020/67 in Republic of North Macedonia, 3102655 in Greece,

502020000007756 in Italy)

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

European Patent Office - Albania, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Republic of North Macedonia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Methods of Producing Same

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Methods of Producing Same

September 18, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

in Austria, CZ2014-762323 in Czechia, 602014058260.5 in Germany, E018723 in Estonia, P20200055 in Croatia, 201361792757

P in Ireland, 2020.67 in Monaco, P-2020/0094 in Serbia, 201431487 in Slovenia, 33269 in Slovakia, 2020000045 in San Marino,

AL/P/2019/906 in Albania, MK/P/2020/67 in Republic of North Macedonia, 3102655 in Greece, 502020000007756 in Italy)

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Patent Office - Albania, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Republic

of North Macedonia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands,

Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Patent Office - Albania, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Republic

of North Macedonia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands,

Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Methods of Producing Same

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

BR112015022095-9

Pharmaceutical Composition, Method of Fabrication, Eutectic Composition and Use of Compositions Containing Cyclobenzaprine HCl and Mannitol

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Pharmaceutical

Composition, Method of Fabrication, Eutectic Composition and Use of Compositions Containing Cyclobenzaprine HCl and Mannitol

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

ZL201910263541.6

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

ZL202011576351.9

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Analogs of CBP

Country / Region

Expiration Date

Analogs of Cyclobenzaprine and Amitryptilene

July 13, 2038

Analogs of Cyclobenzaprine and Amitryptilene

July 13, 2038

Analogs of Cyclobenzaprine and Amitryptilene

July 13, 2038

Oxytocin therapeutics

Country / Region

Expiration Date

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

of Cyclobenzaprine and Amitryptilene

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

ZL201680013809.5

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

(P20231438 in Croatia;

Magnesium-Containing

Oxytocin Formulations and Methods of Use

602016083177.5 in Germany;

3114323 in Greece;

HU/E065385 in Hungary;

65034 in Serbia;

SM-T-202400020 in San Marino;

SM-T-202400020 in San

and 2023-GE-778438 in Turkey)

Magnesium-Containing Oxytocin Formulations and Methods of Use

Europe – (Albania, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, North Macedonia, Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom)

January 7, 2036

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing Oxytocin Formulations and Methods of Use

Republic of Korea

January 7, 2036

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing

Oxytocin Formulations and Methods of Use

– (Albania, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece,

Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, North Macedonia, Norway, Poland,

Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom)

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

BR112017014545-6

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Labeled Oxytocin and Method of Manufacture and Use

March 1, 2039

Magnesium-Containing Oxytocin Formulations and Methods of Use

April 12, 2037

Magnesium-Containing Oxytocin Formulations and Methods of Use

April 12, 2037

Magnesium-Containing

Oxytocin Formulations and Methods of Use

BR122024008322-1

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Oxytocin and Method of Manufacture and Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

ZL201780036185.3

Magnesium-Containing Oxytocin Formulations and Methods of Use

April 12, 2037

Magnesium-Containing Oxytocin Formulations and Methods of Use

April 12, 2037

Magnesium-Containing Oxytocin Formulations and Methods of Use

April 12, 2037

Magnesium-Containing Oxytocin Formulations and Methods of Use

April 12, 2037

(602017086259.2 in Germany;

and SM/T/2025/000041 in

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing Oxytocin Formulations and Methods of Use

April 12, 2037

(2595251 in Spain)

Methods and Pharmaceutical Composition for the Treatment of a Feeding Disorder with Early-Onset in a Patient

Europe – (Spain, France, and United Kingdom)

Methods for the Treatment of a Feeding Disorder with Onset During Neonate Development Using an Agonist of the Oxytocin Receptor

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

(2526672 in Spain)

New Uses of Oxytocin-like Molecules and Related Methods

Europe – (Switzerland, Spain, France, United Kingdom, and Ireland)

Methods for the Treatment of Insulin Resistance

June 22, 2031

Nociceptin/Orphanin FQ therapeutics

Country / Region

Expiration Date

Methods for treatment of pain

August 11, 2031

Methods for treatment of pain

October 12, 2030

Methods for treatment of pain

July 27, 2030

ZL 201080042858.4

Methods for treatment of pain

July 27, 2030

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

(602017086259.2

and SM/T/2025/000041 in San Marino)

Magnesium-Containing

Oxytocin Formulations and Methods of Use

– (Albania, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece,

Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, North Macedonia, Norway, Poland,

Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom)

and Pharmaceutical Composition for the Treatment of a Feeding Disorder with Early-Onset in a Patient

– (Spain, France, Germany, Italy, and United Kingdom)

for the Treatment of a Feeding Disorder with Onset During Neonate Development Using an Agonist of the Oxytocin Receptor

for the Treatment of Prader-Willi-like Syndrome or Non-Organic Failure to Thrive (NOFITT) Feeding Disorder Using an Agonist

of the Oxytocin Receptor

Uses of Oxytocin-like Molecules and Related Methods

– (Switzerland, Spain, France, Germany, Italy, United Kingdom, and Ireland)

for the Treatment of Insulin Resistance

Nociceptin/Orphanin

FQ therapeutics

for treatment of pain

201080042858.4

for treatment of pain

(602010028120.5 in Germany)

Methods for treatment of pain

Europe – (Switzerland, Germany, Denmark, France, and United Kingdom)

July 27, 2030

Methods for treatment of pain

July 27, 2030

Methods for treatment of pain

July 27, 2030

Methods for treatment of pain

July 27, 2030

Methods for treatment of pain

July 27, 2030

Methods for treatment of pain

July 27, 2030

Methods for treatment of pain

July 27, 2030

Methods for treatment of pain

July 27, 2030

Tianeptine – Neurocognitive

Country / Region

Expiration Date

Method for Treating Neurocognitive Dysfunction

September 24, 2030

Method for Treating Neurodegenerative Dysfunction

April 30, 2029

for treatment of pain

– (Switzerland, Germany, Denmark, France, and United Kingdom)

for treatment of pain

– Neurocognitive Dysfunction

for Treating Neurocognitive Dysfunction

for Treating Neurodegenerative Dysfunction

(602009047361.1 in Germany;

1 unchanged sentence

and E911827 in Austria)

Method for Treating Neurodegenerative Dysfunction

European Patent Office – Austria, Belgium, Switzerland, Germany, Spain, France, United Kingdom, Ireland, Luxembourg, Monaco, and Portugal

April 30, 2029

for Treating Neurodegenerative Dysfunction

Patent Office – Austria, Belgium, Switzerland, Germany, Spain, France, United Kingdom, Ireland, Luxembourg, Monaco,

(602009057284.9 in Germany;

1 unchanged sentence

and E1100344 in Austria)

Method for Treating Neurocognitive Dysfunction

European Patent Office – Austria, Belgium, Switzerland, Germany, Spain, France, United Kingdom, Ireland, Luxembourg, Monaco, and Portugal

April 30, 2029

TFF2 therapeutics

Country / Region

Expiration Date

Trefoil family factor proteins and uses thereof

April 2, 2033

Trefoil family factor proteins and uses thereof

April 2, 2033

Synthetic Chimeric Poxviruses

Country / Region

Expiration Date

Synthetic Chimeric Poxviruses

November 2, 2037

Synthetic Chimeric Poxviruses

November 2, 2037

Synthetic Chimeric Poxviruses

November 2, 2037

Synthetic Chimeric Poxviruses

November 2, 2037

Synthetic Chimeric Poxviruses

November 2, 2037

for Treating Neurocognitive Dysfunction

Patent Office – Austria, Belgium, Switzerland, Germany, Spain, France, United Kingdom, Ireland, Luxembourg, Monaco,

family factor proteins and uses thereof

Chimeric Poxviruses

ZL201780078546.0

Synthetic Chimeric Poxviruses

November 2, 2037

Synthetic Chimeric Poxviruses

November 2, 2037

Chimeric Poxviruses

Synthetic Chimeric Poxviruses

November 2, 2037

Triptan Compound – Formulations

Country / Region

Expiration Date

Formulations Comprising Triptan Compounds

July 19, 2031

Formulations Comprising Triptan Compounds

June 16, 2030

Formulations Comprising Triptan Compounds

June 16, 2030

Formulations Comprising Triptan Compounds

June 16, 2030

Formulations Comprising Triptan Compounds

June 16, 2030

Formulations Comprising Triptan Compounds

June 16, 2030

Formulations Comprising Triptan Compounds

June 17, 2030

Formulations Comprising Triptan Compounds

June 17, 2030

(E760080 in Austria;

Vaccinia Virus

Chimeric Vaccinia Virus

ZL201980029677.9

Chimeric Vaccinia Virus

vaccine against COVID-19

Poxvirus Based Vaccine against SARS-CoV-2 virus

Compound – Formulations

Comprising Triptan Compounds

502016000000073 in Italy;

602010028995.8

602010028995.8 in Germany;

and 2553862 in Spain)

Formulations Comprising Triptan Compounds

European Patent Office - Austria, Belgium, Czechia, Denmark, France, Germany, Italy, Spain, Switzerland, and United Kingdom

June 17, 2030

Formulations Comprising Triptan Compounds

June 17, 2030

Formulations Comprising Triptan Compounds

Republic of Korea

June 17, 2030

Formulations Comprising Triptan Compounds

June 17, 2030

Formulations Comprising Triptan Compounds

June 17, 2030

Formulations Comprising Triptan Compounds

June 17, 2030

Triptan Compound – Migraine

Country / Region

Expiration Date

Pharmaceutical Composition for Treating Migraine

January 29, 2036

Pharmaceutical Composition for Treating Migraine

January 29, 2036

Pharmaceutical Composition for Treating Migraine

January 29, 2036

Comprising Triptan Compounds

Patent Office - Austria, Belgium, Czechia, Denmark, France, Germany, Italy, Spain, Switzerland, and United Kingdom

Comprising Triptan Compounds

Compound – Migraine

Pharmaceutical

Composition for Treating Migraine

Pharmaceutical

Composition for Treating Migraine

Pharmaceutical

Composition for Treating Migraine

Pharmaceutical

Composition Comprising Sumatriptan for Treating Migraine

Pharmaceutical Composition Comprising Sumatriptan for Treating Migraine

February 1, 2036

Pharmaceutical Composition Comprising Sumatripan for Treating Migraine

February 1, 2036

CD40 and anti-CD154 Therapeutics

Country / Region

Expiration Date

(E1717312 in Austria;

and anti-CD154 Therapeutics

P20241602 in Croatia;

602020036714.4

602020036714.4 in Germany;

3116977 in Greece;

HU/E069680 in Hungary;

502024000056334 in Italy;

66218 in Serbia;

2994684 in Spain;

and SM-T-202400527

in San Marino)

Anti-CD154 antibodies and uses thereof

Europe – (Albania, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, North Macedonia, Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovenia, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom)

CBP - ASD and PTSD

Country / Region

Expiration Date

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

August 20, 2039

Pending Patent Applications

Our current pending patent applications

are as follows:

CD40 and anti-CD154 Therapeutics

Application No.

Country / Region

Anti-CD154 antibodies and uses thereof

and SM-T-202400527 in San Marino)

antibodies and uses thereof

– (Albania, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany,

Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, North Macedonia, Norway,

Poland, Portugal, Romania, San Marino, Serbia, Slovenia, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom)

ZL202080059891.1

antibodies and uses thereof

- ASD and PTSD

of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

– Sexual dysfunction

ZL202180040673.8

Cyclobenzaprine

Treatment for Sexual Dysfunction

Cyclobenzaprine

Treatment for Sexual Dysfunction

Cyclobenzaprine

Treatment for Sexual Dysfunction

Patent Applications

current pending patent applications are as follows:

and anti-CD154 Therapeutics

antibodies and uses thereof

BR112021026410-8

Anti-CD154 antibodies and uses thereof

antibodies and uses thereof

BR122024022801-7

Anti-CD154 antibodies and uses thereof

antibodies and uses thereof

202510443183.2

Anti-CD154 antibodies and uses thereof (Allowed)

Anti-CD154 antibodies and uses thereof

European Patent Office

Anti-CD154 antibodies and uses thereof

PI 2021007835

Anti-CD154 antibodies and uses thereof

PI 2024006778

Anti-CD154 antibodies and uses thereof

antibodies and uses thereof

Patent Office

antibodies and uses thereof

MX/a/2022/000133

Anti-CD154 antibodies and uses thereof

62022063693.5

Anti-CD154 antibodies and uses thereof (Allowed)

antibodies and uses thereof

42025108505.6

Anti-CD154 antibodies and uses thereof

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

antibodies and uses thereof

of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

BR112023013285-1

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

202280019221.6

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

European Patent Office

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

PI 2023003993

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

Patent Office

of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

MX/a/2023/008055

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

62024090562.5

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

62024090562.5

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

Inhibitors of CD40-CD154 Binding

of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

62024091450.2

Inhibitors of CD40-CD154 Binding

CBP/Amitriptyline Eutectic Formulations

Application No.

Country / Region

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

PCT/EP2025/065085

Methods Comprising Administration of Modified CD154 Antibodies

CBP/Amitriptyline

Eutectic Formulations

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

BR112017005231-8

Eutectic Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

BR122020020968-2

Eutectic Formulations of Cyclobenzaprine Hydrochloride

European Patent Office

Eutectic Formulations of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

Application No.

Country / Region

PI 2023000078

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Sublingual CBP/Amitriptyline

Application No.

Country / Region

Compositions and Methods for Transmucosal Absorption

Formulations of Cyclobenzaprine Hydrochloride

Patent Office

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride (Allowed)

Formulations of Cyclobenzaprine Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

CBP/Amitriptyline

and Methods for Transmucosal Absorption

202010024102.2

Compositions and Methods for Transmucosal Absorption

Gulf Cooperation

Compositions and Methods for Transmucosal Absorption

Gulf Cooperation

Compositions and Methods for Transmucosal Absorption

Gulf Cooperation

and Methods for Transmucosal Absorption

Cooperation Council

and Methods for Transmucosal Absorption

Cooperation Council

and Methods for Transmucosal Absorption

Cooperation Council

42020020336.2

Compositions and Methods for Transmucosal Absorption

P-00 2021 01421

Compositions and Methods for Transmucosal Absorption

CBP – Agitation in Neurodegenerative

Application No.

Country / Region

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions (Allowed)

and Methods for Transmucosal Absorption

– Agitation in Neurodegenerative Condition

BR112020011345-0

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

201880079917.1

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

European Patent Office

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Patent Office

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

62020022462.9

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

62021029558.5

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

42024101171.7

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

202410396685.X

Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

Analogs of CBP

Application No.

Country / Region

Cyclobenzaprine

Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

of Cyclobenzaprine and Amitriptyline

201880050758.2

Analogs of Cyclobenzaprine and Amitriptyline

European Patent Office

Analogs of Cyclobenzaprine and Amitriptyline

CBP – ASD and PTSD

Application No.

Country / Region

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

Gulf Cooperation Council

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

Taiwan R.O.C.

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

of Cyclobenzaprine and Amitriptyline

Patent Office

of Cyclobenzaprine and Amitriptyline

– ASD and PTSD

of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

Cooperation Council

of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

BR112021003107-3

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

201980062283.3

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

202510112547.9

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

European Patent Office

of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

Patent Office

62021045278.0

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

62022046260.5

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

Cyclobenzaprine or Amitriptyline Containing Compositions for Use in Treating Stress Disorders

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

42025114696.5

of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

Cyclobenzaprine

or Amitriptyline Containing Compositions for Use in Treating Stress Disorders

of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

10-2024-02502Q

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

CBP – Fibromyalgia

Application No.

Country / Region

Cyclobenzaprine Treatment for Fibromyalgia

of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

– Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

202180089897.8

Cyclobenzaprine Treatment for Fibromyalgia

European Patent Office

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Patent Office

62024089847.3

Cyclobenzaprine Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

62024090216.8

Cyclobenzaprine Treatment for Fibromyalgia

PI 2023003286

Cyclobenzaprine Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

MX/a/2023/006720

Cyclobenzaprine Treatment for Fibromyalgia

CBP – Fibromyalgia (Early Onset Response, Favorable

Tolerability, and Side Effect Profile)

Application No.

Country / Region

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

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

PCT/US2024/061125

Early Onset Response, Favorable Tolerability, and Side Effect Profile in the Treatment of Fibromyalgia

CBP – Acute Stress Reaction or Acute Stress Disorder

Application No.

Country / Region

Onset Response, Favorable Tolerability, and Side Effect Profile in the Treatment of Fibromyalgia

– Acute Stress Reaction or Acute Stress Disorder

PCT/US2025/012803

Cyclobenzaprine Treatment for Acute Stress Reaction or Acute Stress Disorder

CBP – Alcohol Use Disorder

Application No.

Country / Region

Cyclobenzaprine Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Acute Stress Reaction or Acute Stress Disorder

– Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

112023009731-2

Cyclobenzaprine Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

202180088339.X

Cyclobenzaprine Treatment for Alcohol Use Disorder

European Patent Office

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Patent Office

62024087606.5

Cyclobenzaprine Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

62024089500.8

Cyclobenzaprine Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

MX/a/2023/005899

Cyclobenzaprine Treatment for Alcohol Use Disorder

CBP – Sexual dysfunction

Application No.

Country / Region

Cyclobenzaprine Treatment for Sexual Dysfunction

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

– Sexual dysfunction

Cyclobenzaprine

Treatment for Sexual Dysfunction

Cyclobenzaprine

Treatment for Sexual Dysfunction

Cyclobenzaprine

Treatment for Sexual Dysfunction

Cyclobenzaprine

Treatment for Sexual Dysfunction (Allowed)

Patent Office

Cyclobenzaprine

Treatment for Sexual Dysfunction

62023077251.4

Cyclobenzaprine Treatment for Sexual Dysfunction (Allowed)

Cyclobenzaprine Treatment for Sexual Dysfunction

European Patent Office

Cyclobenzaprine Treatment for Sexual Dysfunction

Cyclobenzaprine

Treatment for Sexual Dysfunction

62025103395.2

Cyclobenzaprine Treatment for Sexual Dysfunction

Cyclobenzaprine

Treatment for Sexual Dysfunction

Cyclobenzaprine

for Treatment or Prevention of Sexual Dysfunction Associated with Mental Health Conditions in Female Patients

Cyclobenzaprine

for Treatment or Prevention of Sexual Dysfunction Associated with Mental Health Conditions in Female Patients

Patent Office

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

Cyclobenzaprine

Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

Cyclobenzaprine

Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

Cyclobenzaprine

Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

202380055899.4

Cyclobenzaprine Treatment for Sexual Dysfunction

Cyclobenzaprine

Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

Cyclobenzaprine

Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

Patent Office

62025114250.6

Cyclobenzaprine Treatment for Sexual Dysfunction

Cyclobenzaprine for Treatment or Prevention of Sexual Dysfunction Associated with Mental Health Conditions in Female Patients

European Patent Office

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

Application No.

Country / Region

Cyclobenzaprine Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

Not Yet Assigned

Cyclobenzaprine Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

European Patent Office

Cyclobenzaprine Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

Cyclobenzaprine

Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

62025114926.1

Cyclobenzaprine

Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

Cyclobenzaprine

Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

Cyclobenzaprine

Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

MX/a/2025/000142

Cyclobenzaprine Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

Oxytocin therapeutics

Application No.

Country / Region

Magnesium-Containing Oxytocin Formulations and Methods of Use

BR122024008322-1

Magnesium-Containing Oxytocin Formulations and Methods of Use

Cyclobenzaprine

Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

Cyclobenzaprine

Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

Cyclobenzaprine

Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use (Allowed)

42024096348.8

Magnesium-Containing Oxytocin Formulations and Methods of Use

European Patent Office

Magnesium-Containing Oxytocin Formulations and Methods of Use

Labeled Oxytocin and Method of Manufacture and Use

European Patent Office

Labeled Oxytocin and Method of Manufacture and Use

Magnesium-Containing Oxytocin Formulations and Methods of Use

Magnesium-Containing Oxytocin Formulations and Methods of Use (Allowed)

Magnesium-Containing Oxytocin Formulations and Methods of Use

European Patent Office

Magnesium-Containing Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Patent Office

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Oxytocin and Method of Manufacture and Use

Patent Office

Oxytocin and Method of Manufacture and Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Patent Office

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

42023079422.4

Magnesium-Containing Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

42025113914.3

Magnesium-Containing

Oxytocin Formulations and Methods of Use

MX/a/2023/008840

Magnesium-Containing Oxytocin Formulations and Methods of Use

Nociceptin/Orphanin FQ therapeutics

Application No.

Country / Region

Magnesium-Containing

Oxytocin Formulations and Methods of Use

PCT/US2025/020483

Peptide Analogs

Nociceptin/Orphanin

FQ therapeutics

BR122021007932-3

Methods for Treatment of Pain

Synthetic Chimeric Poxviruses

Application No.

Country / Region

Synthetic Chimeric Poxviruses

P 20170103043

Synthetic Chimeric Poxviruses

Gulf Cooperation Council

for Treatment of Pain

Chimeric Poxviruses

Synthetic Chimeric Poxviruses

Gulf Cooperation Council

Synthetic Chimeric Poxviruses (Allowed)

Taiwan R.O.C.

Chimeric Poxviruses

Cooperation Council

Chimeric Poxviruses

Cooperation Council

BR112019008781-8

Synthetic Chimeric Poxviruses

European Patent Office

Synthetic Chimeric Poxviruses

Synthetic Chimeric Poxviruses (Allowed)

Synthetic Chimeric Poxviruses

Chimeric Poxviruses

BR112019008781-9

Synthetic Chimeric Poxviruses

Chimeric Poxviruses

Patent Office

Chimeric Poxviruses

Chimeric Poxviruses (Allowed)

Chimeric Poxviruses

62020003684.1

Synthetic Chimeric Poxviruses

Synthetic Vaccinia Virus

Application No.

Country / Region

Synthetic Chimeric Vaccinia Virus

Gulf Cooperation Council

Synthetic Chimeric Vaccinia Virus

Gulf Cooperation Council

Synthetic Chimeric Vaccinia Virus

Taiwan R.O.C.

Synthetic Chimeric Vaccinia Virus

Chimeric Poxviruses

Vaccinia Virus

Chimeric Vaccinia Virus

Cooperation Council

Chimeric Vaccinia Virus

Cooperation Council

Chimeric Vaccinia Virus

BR112020022181-3

Synthetic Chimeric Vaccinia Virus

201980029677.9

Synthetic Chimeric Vaccinia Virus

European Patent Office

Synthetic Chimeric Vaccinia Virus

PI 2020005696

Synthetic Chimeric Vaccinia Virus

MX/a/2020/011586

Synthetic Chimeric Vaccinia Virus

Chimeric Vaccinia Virus

202510639606.8

Synthetic Chimeric Vaccinia Virus

Chimeric Vaccinia Virus

Patent Office

Chimeric Vaccinia Virus

62021038254.0

Synthetic Chimeric Vaccinia Virus

PI 2024003859

Synthetic Chimeric Vaccinia Virus

Poxvirus vaccine against COVID-19

Application No.

Country / Region

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

African Intellectual Property Organization

Chimeric Vaccinia Virus

vaccine against COVID-19

Poxvirus Based Vaccine against SARS-CoV-2 virus

Intellectual Property Organization

AP/P/2022/014318

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

African Regional Intellectual Property Organization

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

Poxvirus Based Vaccine against SARS-CoV-2 virus

Regional Intellectual Property Organization

Poxvirus Based Vaccine against SARS-CoV-2 virus

BR112022016992-2

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

Poxvirus Based Vaccine against SARS-CoV-2 virus

202180027983.6

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

Eurasian Patent Office

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

European Patent Office

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

PI 2022004613

Poxvirus Based Vaccine against SARS-CoV-2 virus

Patent Office

Poxvirus Based Vaccine against SARS-CoV-2 virus

Patent Office

Poxvirus Based Vaccine against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

Poxvirus Based Vaccine against SARS-CoV-2 virus

MX/a/2022/010588

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

Poxvirus Based Vaccine against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

10-2022-7033014

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

Republic of Korea

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

Poxvirus Based Vaccine against SARS-CoV-2 virus

62023075022.1

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

Poxvirus Based Vaccine against SARS-CoV-2 virus

62023083678.0

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

TFF2 therapeutics

Application No.

Country / Region

Modified TFF2 polypeptides

Poxvirus Based Vaccine against SARS-CoV-2 virus

TFF2 polypeptides

202080071768.1

Modified TFF2 polypeptides

European Patent Office

Modified TFF2 polypeptides

TFF2 polypeptides

Patent Office

TFF2 polypeptides

TFF2 polypeptides Containing Compositions and Methods of Use Thereof

TFF2 polypeptides

MX/a/2022/002337

Modified TFF2 polypeptides

TFF2 polypeptides

62023066535.3

Modified TFF2 polypeptides

TFF2 polypeptides

62023066928.0

Modified TFF2 polypeptides

Antiviral Drugs – Cathepsin Inhibitors

Application No.

Country / Region

Compositions and Methods for Increasing Efficacy of a Drug

TFF2 polypeptides

Compound – Formulations

Comprising Triptan Compounds

Compound – Migraine

of Treating Migraine

Pharmaceutical

Composition for Treating Migraine

– Conditions Associated with Peroxisome Proliferator-Activated Receptor

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

BR112025020808-0

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

202480032955.7

Compositions and Methods for Increasing Efficacy of a Drug

Triptan Compound – Formulations

Application No.

Country / Region

Formulations Comprising Triptan Compounds

Triptan Compound – Migraine

Application No.

Country / Region

Methods of Treating Migraine

Pharmaceutical Composition for Treating Migraine

Tianeptine – Conditions Associated with Peroxisome

Proliferator-Activated Receptor

Application No.

Country / Region

PCT/US2024/021799

(S)-Tianeptine and Use in Treating Disorders and 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.

owner of the following U.S.

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

Patent Office

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

MX/a/2025/011371

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

(S)-Tianeptine

and Use in Treating Disorders and Conditions Associated with Peroxisome Proliferator-Activated Receptor

and Service Marks

Pharmaceuticals, Inc.

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:

1 unchanged sentence

4656463, issued December 16,

We are the owner of the following

marks for which applications for U.S.

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.

97/424052, filed May 23, 2022), RAPONTIS (Serial No.

97/424058, filed May 23, 2022), PROTECTIC (Serial No.

filed May 23, 2022), TONIX PHARMACEUTICALS (Serial No.

FYMRALIN (Serial

98/327953, filed December 22, 2023), MODALTIN (Serial No.

99/562722, filed December 23, 2025), RAPONTIS (Serial No.

filed December 23, 2025), PROTECTIC (Serial No.

99/562746, filed December 23, 2025), TONIX PHARMACEUTICALS (Serial No.

filed May 31, 2024), ANGSTRO-TECHNOLOGY (Serial No.

98/006538, filed

May 22, 2023) and TNX-102 SL (Serial No.

97/185424, filed December 22, 2021).

Tonix Medicines, 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.

98/006538, filed May 22, 2023) ).

Medicines, Inc.

are the owner of the following U.S.

federally registered marks:

5 unchanged sentences

5981221, issued February 11, 2020);

TOSYMRA & DROPLET Design (Reg.

TOSYMRA & DROPLET

6124333, issued August 11, 2020);

ZEMBRACE (Reg.

5186989, issued

April 18, 2017);

5186989, issued April 18, 2017);

ZEMBRACE SYMTOUCH (Reg.

2 unchanged sentences

6117797, issued August 4, 2020);

ONE LOGO Design (Serial No.

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:

We are the owner of the following International Registrations under the Madrid Protocol:

TOSYMRA (Reg.

1501060, issued October 16, 2019 – Extensions of Protection to:

Canada, European Union, Japan,

Republic of Korea, United Kingdom);

Canada, European Union, Japan, Republic

ZEMBRACE (Reg.

1683288, issued August 17, 2022 – Extensions of Protection to:

Canada (still

pending), China, European Union, Israel, Mexico, United Kingdom);

Canada, China, European Union,

Israel, Mexico, United Kingdom);

DROPLET Design (Reg.

1545038, issued June 29, 2020 – Extensions

of Protection to:

Canada, European Union, Israel, Japan, Norway, Republic of Korea, Switzerland, Turkey, United Kingdom);

1545038, issued June 29, 2020 – Extensions of Protection to:

European Union, Israel, Japan, Norway, Republic of Korea, Switzerland, Turkey, United Kingdom);

European Union:

TONIX ONE LOGO Design (Application No.

19151272, filed March 4, 2025).

Research and Development

We have approximately

45 employees dedicated to research and development.

Our research and development operations are located in Chatham, 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.

We have nine employees

supporting sales administration and marketing initiatives.

We also have three sales employees who are focused

on customer service requests and top-tier headache specialists.

We utilize third party vendors to support trade, managed

markets, marketing initiatives, and promotional compliance programs.

TONIX ONE LOGO

Design (Registration No.

019151272, issued July 9, 2025);

United Kingdom:

TOSYMRA, Reg.

UK00801501060.

Pharma Limited

are the owner of the mark TONMYA for which U.S.

Application Serial Number:

97/185424, filed December 22, 2021, is currently pending.

and Development

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.

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.

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

2 unchanged sentences

It was designed for the manufacture of nonclinical and clinical investigational products for our Infectious Disease portfolio.

focus of which is TNX-801 a Smallpox and Mpox Preventing Vaccine and TNX-1800 a COVID vaccine selected by NIH/NIAID Project NextGen for

Inclusion in Clinical Trials.

This facility was decommissioned in 2024 but Tonix has the ability to reactivate it should we choose to

Our two 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

The FDA and other federal,

state, local and foreign regulatory agencies impose substantial requirements upon the clinical development, approval, labeling,

manufacture, marketing and distribution of drug products.

These agencies regulate, among other things, research and development

activities and the testing, approval, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, advertising

and promotion of our product candidates.

The regulatory approval process is generally lengthy and expensive, with no guarantee

of a positive result.

Moreover, failure to comply with applicable requirements by the FDA or other requirements may result in civil

or criminal penalties, recall or seizure of products, injunctive relief including partial or total suspension of production, or

withdrawal of a product from the market.

The FDA regulates,

among other things, the research, manufacture, promotion and distribution of drugs in the U.S.

under the FDCA and other statutes

and implementing regulations.

The process required by the FDA before prescription drug product candidates may be marketed in the

generally involves the following:

completion of extensive nonclinical laboratory tests, animal studies and formulation studies, all performed in accordance with the FDA’s Good Laboratory Practice regulations;

submission to the FDA of an IND, which must become effective before human clinical trials may begin;

performance of adequate and well-controlled human clinical trials in accordance with the FDA’s regulations, including Good Clinical Practices, to establish the safety and efficacy of the product candidate for each proposed indication;

submission to the FDA of an NDA for drug products, or a Biologics License Application, or BLA, for biologic products;

satisfactory completion of a preapproval inspection by the FDA of the manufacturing facilities at which the product is produced to assess compliance with cGMP regulations;

the FDA’s review and approval of the NDA or BLA prior to any commercial marketing, sale or shipment of the drug.

The testing and approval

process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product

candidates will be granted on a timely basis, if at all.

Nonclinical tests include

laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animals and

other animal studies.

The results of nonclinical tests, together with manufacturing information and analytical data, are submitted

as part of an IND to the FDA.

Some nonclinical testing may continue even after an IND is submitted.

The IND also includes one or

more protocols for the initial clinical trial or trials and an investigator’s brochure.

An IND automatically becomes effective

30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions relating to the proposed

clinical trials as outlined in the IND and places the clinical trial on a clinical hold.

In such cases, the IND sponsor and the

FDA must resolve any outstanding concerns or questions before any clinical trials can begin.

Clinical trial holds also may be imposed

at any time before or during studies due to safety concerns or non-compliance with regulatory requirements.

An independent Institutional

Review Board, or IRB, at each of the clinical centers proposing to conduct the clinical trial must review and approve the plan

for any clinical trial before it commences at that center.

An IRB considers, among other things, whether the risks to individuals

participating in the trials are minimized and are reasonable in relation to anticipated benefits.

The IRB also approves the consent

form signed by the trial participants and must monitor the study until completed.

Clinical Trials

Clinical trials involve

the administration of the product candidate to human subjects under the supervision of qualified medical investigators according

to approved protocols that detail the objectives of the study, dosing procedures, subject selection and exclusion criteria, and

the parameters to be used to monitor participant safety.

Each protocol for a U.S.

study is submitted to the FDA as part of the

Human clinical trials

are typically conducted in three sequential phases, but the phases may overlap, or be combined.

Phase 1 clinical trials typically involve the initial introduction of the product candidate into healthy human volunteers.

In Phase 1 clinical trials, the product candidate is typically tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and pharmacodynamics.

Phase 2 clinical trials are generally conducted in a limited patient population to gather evidence about the efficacy of the product candidate for specific, targeted indications;

to determine dosage tolerance and optimal dosage;

and to identify possible adverse effects and safety risks.

Phase 2 clinical trials, in particular Phase 2b trials, can be undertaken to evaluate clinical efficacy and to test for safety in an expanded patient population at geographically dispersed clinical trial sites.

Phase 3 clinical trials are undertaken to evaluate clinical efficacy and to test for safety in an expanded patient population at geographically dispersed clinical trial sites.

The size of Phase 3 clinical trials depends upon clinical and statistical considerations for the product candidate and disease.

Phase 3 clinical trials are intended to establish the overall risk-benefit ratio of the product candidate and provide an adequate basis for product labeling.

Post-approval clinical

trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial approval.

These clinical trials are used

to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term

safety follow-up.

Clinical testing must

satisfy the extensive regulations of the FDA.

Reports detailing the results of the clinical trials must be submitted at least annually

to the FDA and safety reports must be submitted for serious and unexpected adverse events.

Success in early-stage clinical trials

does not assure success in later-stage clinical trials.

The FDA, an IRB or we may suspend a clinical trial at any time on various

grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.

New Drug Applications

Assuming successful

completion of the required clinical trials, the results of product development, nonclinical studies and clinical trials are submitted

to the FDA as part of an NDA (or BLA, in the case of a biologic product).

An NDA or BLA also must contain extensive manufacturing

information, as well as proposed labeling for the finished product.

An NDA or BLA applicant must develop information about the

chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in accordance with cGMP.

The manufacturing process must be capable of consistently producing quality product within specifications approved by the FDA.

The manufacturer must develop methods for testing the quality, purity and potency of the final product.

In addition, appropriate

packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product does not undergo

unacceptable deterioration over its shelf life.

Prior to approval, the FDA will conduct an inspection of the manufacturing facilities

to assess compliance with cGMP.

The FDA reviews all

NDAs and BLAs submitted before it accepts them for filing.

The FDA may request additional information rather than accept an NDA

In this event, the NDA or BLA must be resubmitted with the additional information and is subject to review before the

FDA accepts it for filing.

After an application is filed, the FDA may refer the NDA or BLA to an advisory committee for review,

evaluation and recommendation as to whether the application should be approved and under what conditions.

The FDA is not bound

by the recommendations of an advisory committee, but it considers them carefully when making decisions.

The FDA may deny approval

of an NDA or BLA if the applicable regulatory criteria are not satisfied.

Data obtained from clinical trials are not always conclusive

and the FDA may interpret data differently than we interpret the same data.

The FDA may issue a

complete response letter, which may require additional clinical or other data or impose other conditions that must be met in order

to secure final approval of the NDA or BLA.

If a product receives regulatory approval, the approval may be significantly limited

to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value

of the product.

In addition, the FDA may require us to conduct Phase 4 testing which involves clinical trials designed to further

assess a drug’s safety and effectiveness after NDA or BLA approval, and may require surveillance programs to monitor the

safety of approved products which have been commercialized.

Once issued, the FDA may withdraw product approval if ongoing regulatory

requirements are not met or if safety or efficacy questions are raised after the product reaches the market.

Section 505(b)

There are two types of NDAs:

the Section 505(b)(1) NDA, or full NDA, and

the Section 505(b)(2) NDA.

A full NDA is submitted under Section 505(b)(1) of the FDCA, and must contain full reports of investigations

conducted by the applicant to demonstrate the safety and effectiveness of the drug.

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.

Our drug approval strategy for our new formulations of approved chemical

entities is to submit Section 505(b)(2) NDAs to the FDA.

We submitted NDA under Section 505(b)(2) for TNX-102 SL for FM, and plan to submit

an 505(b)(2)for TNX-2900 for Prader Willi Syndrome.

The FDA may not agree that these product candidates are approvable as a Section 505(b)(2)

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 Protections

An applicant submitting

a Section 505(b)(2) NDA must certify to the FDA with respect to the patent status of the reference drug upon which the applicant

relies in support of approval of its drug.

With respect to every patent listed in the FDA’s Orange Book, which is the FDA’s

list of approved drug products, as claiming the reference drug or an approved method of use of the reference drug, the Section

505(b)(2) applicant must certify that:

(1) there is no patent information listed in the orange book for the reference drug;

the listed patent has expired;

(3) the listed patent has not expired, but will expire on a particular date;

(4) the listed patent

is invalid or will not be infringed by the manufacture, use, or sale of the product in the Section 505(b)(2) NDA;

or (5) if the

patent is a use patent, that the applicant does not seek approval for a use claimed by the patent.

If the applicant files a certification

to the effect of clause (1), (2) or (5), FDA approval of the Section 505(b)(2) NDA may be made effective immediately upon successful

FDA review of the application, in the absence of marketing exclusivity delays, which are discussed below.

If the applicant files

a certification to the effect of clause (3), the Section 505(b)(2) NDA approval may not be made effective until the expiration

of the relevant patent and the expiration of any marketing exclusivity delays.

If the Section 505(b)(2)

NDA applicant provides a certification to the effect of clause (4), referred to as a paragraph IV certification, the applicant

also must send notice of the certification to the patent owner and the holder of the NDA for the reference drug.

The filing of

a patent infringement lawsuit within 45 days of the receipt of the notification may prevent the FDA from approving the Section

505(b)(2) NDA for 30 months from the date of the receipt of the notification unless the court determines that a longer or shorter

period is appropriate because either party to the action failed to reasonably cooperate in expediting the action.

FDA may approve the Section 505(b)(2) NDA before the 30 months have expired if a court decides that the patent is invalid or not

infringed, or if a court enters a settlement order or consent decree stating the patent is invalid or not infringed.

Notwithstanding

the approval of many products by the FDA pursuant to Section 505(b)(2), over the last few years certain brand-name pharmaceutical

companies and others have objected to the FDA’s interpretation of Section 505(b)(2).

If the FDA’s interpretation of

Section 505(b)(2) is successfully challenged in court, the FDA may be required to change its interpretation of Section 505(b)(2)

which could delay or even prevent the FDA from approving any Section 505(b)(2) NDA that we submit.

The pharmaceutical industry

is highly competitive, and it is not uncommon for a manufacturer of an approved product to file a citizen petition with the FDA

seeking to delay approval of, or impose additional approval requirements for, pending competing products.

If successful, such petitions

can significantly delay, or even prevent, the approval of the new product.

Moreover, even if the FDA ultimately denies such a petition,

the FDA may substantially delay approval while it considers and responds to the petition.

Marketing Exclusivity

Market exclusivity

provisions under the FDCA can delay the submission or the approval of Section 505(b)(2) NDAs, thereby delaying a Section 505(b)(2)

product from entering the market.

The FDCA provides five-year marketing exclusivity to the first applicant to gain approval of

an NDA for an NCE, meaning that the FDA has not previously approved any other drug containing the same active moiety.

This exclusivity

prohibits the submission of a Section 505(b)(2) NDA for any drug product containing the active ingredient during the five-year

exclusivity period.

However, submission of a Section 505(b)(2) NDA that certifies that a listed patent is invalid, unenforceable,

or will not be infringed, as discussed above, is permitted after four years, but if a patent infringement lawsuit is brought within

45 days after such certification, FDA approval of the Section 505(b)(2) NDA may automatically be stayed until 7½ years after

the NCE approval date.

The FDCA also provides three years of marketing exclusivity for the approval of new and supplemental NDAs

for product changes, including, among other things, new indications, dosage forms, routes of administration or strengths of an

existing drug, or for a new use, if new clinical investigations, other than bioavailability studies, that were conducted or sponsored

by the applicant are deemed by FDA to be essential to the approval of the application.

Five-year and three-year

exclusivity will not delay the submission or approval of another full NDA;

however, as discussed above, an applicant submitting

a full NDA under Section 505(b)(1) would be required to conduct or obtain a right of reference to all of the nonclinical and adequate

and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

Other types of exclusivities

in the United States include orphan drug exclusivity and pediatric exclusivity.

The FDA may grant orphan drug designation to a

drug intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals

in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that

the cost of developing and making available in the United States a drug for this type of disease or condition will be recovered

from sales in the United States for that drug.

Seven-year orphan drug exclusivity is available to a product that has orphan drug

designation and that receives the first FDA approval for the indication for which the drug has such designation.

Orphan drug exclusivity

prevents approval of another application for the same drug for the same orphan indication, for a period of seven years, regardless

of whether the application is a full NDA or a Section 505(b)(2) NDA, except in limited circumstances, such as a showing of clinical

superiority to the product with orphan exclusivity.

Pediatric exclusivity, if granted, provides an additional six months to an

existing exclusivity or statutory delay in approval resulting from a patent certification.

This six-month exclusivity, which runs

from the end of other exclusivity protection or patent delay, may be granted based on the voluntary completion of a pediatric study

in accordance with an FDA-issued “Written Request” for such a study.

Section 505(b)(2) NDAs

are similar to full NDAs filed under Section 505(b)(1) in that they are entitled to any of these forms of exclusivity if they meet

the qualifying criteria.

They also are entitled to the patent protections described above, based on patents that are listed in

the FDA’s Orange Book in the same manner as patents claiming drugs and uses approved for NDAs submitted as full NDAs.

Breakthrough Therapy Designation

The Food and Drug Administration

Safety and Innovation Act, or FDASIA, Section 902 provides for Breakthrough Therapy designation.

A Breakthrough Therapy is a drug:

intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition;

preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

Fast Track Designation

A Fast Track is a designation

by the FDA of an investigational drug which:

intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition;

non-clinical or clinical data demonstrate the potential to address an unmet medical need

track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill

an unmet medical need.

The benefits of a Fast Track designation include rolling submission of portions of the NDA for the drug

candidate and eligibility for priority review of the NDA.

Additionally, more frequent meetings and written communication with the

FDA regarding the development plan and trial design for the drug candidate are encouraged throughout the entire drug development

and review process, with the goal of having earlier drug approval and access for patients.

Material Threat Medical Countermeasures

In 2016, the 21 st

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

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.

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.

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.

Government Regulation

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.

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.

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

of extensive preclinical laboratory tests, preclinical animal studies, and toxicity data, all performed in accordance with the good laboratory

practices, or GLP, regulations;

to the FDA of an IND, which must become effective before human clinical studies may begin;

by an independent IRB or ethics committee representing each clinical site before each clinical study may be initiated;

● performance

of adequate and well-controlled human clinical studies to establish the safety and efficacy, or in the case of a biologic, the safety,

purity and potency, of the drug candidate for each proposed indication;

● preparation

of and submission to the FDA of a new drug application, or NDA, or biologics license application, or BLA, which must include data from

required pre-clinical studies and all pivotal clinical studies and information showing that the product can be manufactured in a controlled

determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review;

of the product application by an FDA advisory committee, where appropriate and if applicable;

● satisfactory

completion of an FDA pre-approval inspection of the manufacturing facilities where the drug candidate is produced to assess compliance

review and approval of an NDA or BLA prior to any commercial marketing or sale of the drug or biologic.

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;

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.

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.

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.

The drug or biologic is initially introduced into healthy human subjects or patients with the target disease or condition.

These studies are designed to evaluate the safety, dosage tolerance, metabolism and pharmacologic actions of the investigational new

drug in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on effectiveness.

The drug or biologic is administered to a limited patient population to evaluate dosage tolerance and optimal dosage, identify

possible adverse side effects and safety risks and preliminarily evaluate efficacy.

The drug or biologic is administered to an expanded patient population, generally at geographically dispersed clinical study

sites to generate enough data to statistically evaluate dosage, clinical effectiveness and safety, to establish the overall benefit-risk

relationship of the investigational product and to provide an adequate basis for product approval.

In some cases, the FDA may condition approval of an NDA or BLA for a drug candidate on the sponsor’s agreement to

conduct additional clinical studies after approval.

In other cases, a sponsor may commit to conducting or voluntarily conduct additional

clinical studies after approval to gain more information about the drug.

Such post-approval studies are typically referred to as Phase

4 clinical studies.

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.

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.

provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the

We may also suspend or terminate a clinical study based on evolving business objectives and/or competitive climate.

Manufacturing and Control Information

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.

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.

of an NDA or BLA to the FDA

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

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.

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.

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.

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.

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.

FDA’s Decision on an NDA or BLA

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

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.

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.

Review and Accelerated Approval Programs

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.

FDA may give a priority review designation to drugs that offer major advances in treatment or provide a treatment where no adequate therapy

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.

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.

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.

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.

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

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.

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.

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.

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.

● restrictions

on the marketing or manufacturing of the product;

withdrawal of the product from the market or product recalls;

warning letters or holds on post-approval clinical studies;

of the FDA to approve pending NDAs or BLAs or supplements to approved NDAs or BLAs, or suspension or revocation of product licenses or

seizure or detention, or refusal to permit the import or export of products;

● injunctions

or the imposition of civil or criminal penalties.

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.

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.

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.

Designation and Exclusivity

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.

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.

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.

and Exclusivity

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.

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

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.

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.

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.

Amendments, 505(b)(2) NDAs and Exclusivity

505 of the FDCA describes three types of marketing applications that may be submitted to the FDA to request marketing authorization for

A Section 505(b)(1) NDA is an application that contains full reports of investigations of safety and efficacy.

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

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.

in the Orange Book can, in turn, be cited by potential competitors in support of approval of an ANDA or 505(b)(2) NDA.

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.

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.

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

An “active moiety” is defined as the molecule responsible for the drug substance’s physiological or pharmacologic

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.

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.

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

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.

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.

cases, extensive, time-consuming, and costly clinical and nonclinical studies may still be required for approval of a Section 505(b)(2)

drug approval strategy for our new formulations of approved chemical entities is to submit Section 505(b)(2) NDAs to the FDA.

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).

Term Restoration and Extension

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.

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.

Threat Medical Countermeasures

2016, the 21 st 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.

1 unchanged sentence

tularemia, botulinum toxin, and pandemic influenza, which includes SARS-CoV-2.

Other Regulatory Requirements

Maintaining substantial

compliance with appropriate federal, state and local statutes and regulations requires the expenditure of substantial time and

financial resources.

Drug manufacturers are required to register their establishments with the FDA and certain state agencies,

and after approval, the FDA and these state agencies conduct periodic unannounced inspections to ensure continued compliance with

ongoing regulatory requirements, including cGMPs.

In addition, after approval, some types of changes to the approved product, such

as adding new indications, manufacturing changes and additional labeling claims, are subject to further FDA review and approval.

The FDA may require post-approval testing and surveillance programs to monitor safety and the effectiveness of approved products

that have been commercialized.

Any drug products manufactured or distributed by us pursuant to FDA approvals are subject to continuing

regulation by the FDA, including:

record-keeping requirements;

reporting of adverse experiences with the drug;

providing the FDA with updated safety and efficacy information;

reporting on advertisements and promotional labeling;

drug sampling and distribution requirements;

complying with electronic record and signature requirements.

In addition, the FDA

strictly regulates labeling, advertising, promotion and other types of information on products that are placed on the market.

are numerous regulations and policies that govern various means for disseminating information to health-care professionals as well

as consumers, including to industry sponsored scientific and educational activities, information provided to the media and information

provided over the Internet.

Drugs may be promoted only for the approved indications and in accordance with the provisions of the

approved label.

The FDA has very broad

enforcement authority and the failure to comply with applicable regulatory requirements can result in administrative or judicial

sanctions being imposed on us or on the manufacturers and distributors of our approved products, including warning letters, refusals

of government contracts, clinical holds, civil penalties, injunctions, restitution and disgorgement of profits, recall or seizure

of products, total or partial suspension of production or distribution, withdrawal of approvals, refusal to approve pending applications,

and criminal prosecution resulting in fines and incarceration.

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.

In addition, even after regulatory approval is obtained, later discovery of previously unknown problems

with a product may result in restrictions on the product or even complete withdrawal of the product from the market.

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.

and Reimbursement

of our product candidates, if approved, will depend, in part, on the extent to which such products will be covered by third-party

payors, such as government health care programs, commercial insurance and managed healthcare organizations.

These third-party payors

are increasingly limiting coverage or reducing reimbursements for medical products and services.

In addition, the U.S.

state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions

on reimbursement and requirements for substitution of generic products.

Third-party payors decide which therapies they will pay

for and establish reimbursement levels.

Third-party payors often rely upon Medicare coverage policy and payment limitations in

setting their own coverage and reimbursement policies.

However, decisions regarding the extent of coverage and amount of reimbursement

to be provided for any drug candidates that we develop will be made on a payor-by-payor basis.

Each payor determines

whether or not it will provide coverage for a therapy, what amount it will pay the manufacturer for the therapy, and on what tier

of its formulary it will be placed.

The position on a payor’s list of covered drugs, or formulary, generally determines the co-payment that

a patient will need to make to obtain the therapy and can strongly influence the adoption of such therapy by patients and physicians.

Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing

controls and measures, could further limit our net revenue and results.

Decreases in third-party reimbursement for our product

candidates or a decision by a third-party payor to not cover our product candidates could reduce physician usage of our product

candidates, once approved, and have a material adverse effect on our sales, results of operations and financial condition.

Healthcare Laws

of our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party

payors, we will also be subject to healthcare regulation and enforcement by the federal government and the states and foreign governments

in which we will conduct our business, including our clinical research, proposed sales, marketing and educational programs.

to comply with these laws, where applicable, can result in the imposition of significant civil penalties, criminal penalties, or

laws that may affect our ability to operate, among others, include:

the federal Health Insurance Portability and Accountability

Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the

conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;

state laws governing the privacy and security of health information in certain circumstances, some of which are more stringent

than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance

the federal healthcare programs’ Anti-Kickback Statute, which prohibits, among other things, persons from knowingly

and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either

the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made

under federal healthcare programs such as the Medicare and Medicaid programs;

federal false claims laws which prohibit, among other

things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid,

or other third-party payors that are false or fraudulent;

federal criminal laws that prohibit executing a scheme to defraud any

healthcare benefit program or making false statements relating to healthcare matters;

the Physician Payments Sunshine Act, which

requires manufacturers of drugs, devices, biologics, and medical supplies to report annually to the U.S.

Department of Health and

Human Services information related to payments and other transfers of value to physicians (defined to include doctors, dentists,

optometrists, podiatrists and chiropractors) and teaching hospitals, and ownership and investment interests held by physicians

and their immediate family members;

and state law equivalents of each of the above federal laws, such as anti-kickback and false

claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.

In addition, many states

have similar laws and regulations, such as anti-kickback and false claims laws that may be broader in scope and may apply regardless

of payor, in addition to items and services reimbursed under Medicaid and other state programs.

Additionally, to the extent that

our product is sold in a foreign country, we may be subject to similar foreign laws.

The Impact of New Legislation and Amendments to Existing

The FDCA is subject

to routine legislative amendments with a broad range of downstream effects.

In addition to new legislation, such as the FDA Reauthorization

Act of 2017 or the FDASIA in 2012, Congress introduces amendments to reauthorize drug user fees and address emerging concerns every

We cannot predict the impact of these new legislative acts and their implementation of regulations on our business.

The programs established or to be established under the legislation may have adverse effects upon us, including increased regulation

of our industry.

Compliance with such regulation may increase our costs and limit our ability to pursue business opportunities.

In addition, the FDA’s regulations, policies and guidance are often revised or reinterpreted by the agency or the courts

in ways that may significantly affect our business and our products.

expect that additional federal and state, as well as foreign, healthcare reform measures will be adopted in the future, any of

which could result in reduced demand for our products or additional pricing pressure.

Human Capital Resources

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.

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.

after FDA approves a product, failure to have the product covered by third-party payors may have material adverse effect on sales.

and state governments continue to promulgate new policies and regulations;

such policies and regulations may have material adverse effect

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.

and Regulatory Changes, Including Health Care Reform

laws and regulation that affect our business are subject to change from time to time, and entirely new laws and regulations are sometimes

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.

Corrupt Practices Act

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.

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

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.

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.

Union Drug Development

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.

to the United States, the various phases of preclinical and clinical research in the European Union are subject to significant regulatory

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.

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.

improve the current system, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use was adopted in 2014.

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.

Union Drug Review and Approval

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).

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

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.

MAs are issued nationally by the competent authorities of the Member States of the EEA and only cover their respective territory.

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.

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.

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.

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;

may still require the applicant to withdraw its marketing authorization application and to conduct additional non-clinical and clinical

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.

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:

product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition;

prevalence of the conditions is not more than five in ten thousand persons in the European Union when the application is made, or that

it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition

in the European Union and that without incentives it is unlikely that the marketing of the drug in the European Union would generate

sufficient return to justify the necessary investment;

there is no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in the European

Union or, if such method exists, that the drug will be of significant benefit to those affected by that condition.

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.

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

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.

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:

holder of the MA for the original orphan drug has given its consent to the second applicant;

holder of the MA for the original orphan drug is unable to supply sufficient quantities of

second applicant can establish in the application that the second drug, although similar

to the orphan drug already authorized, is safer, more effective or otherwise clinically superior.

abovementioned Regulation (EC) No.

141/2000 provides for other incentives regarding orphan medicinal products.

Post-Approval

holder of a MA must comply with EU requirements applicable to manufacturing, marketing, promotion and sale of medicinal products.

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.

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

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.

Capital Resources

As of March 12, 2026, we had 142 full-time employees, of whom 29 hold M.D.

We have 70 employees dedicated to research and development.

We have two employees supporting sales administration and

marketing initiatives and three sales employees who are focused on customer service requests and top-tier headache specialists.

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 Chatham, 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 26 Main Street, Suite 101, Chatham, New Jersey 07928, and our telephone

number is (862) 799 8599.

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.

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

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

successfully.

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.

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.

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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business