What changed in this filing

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Item 1. Business

2025-03-18 compared with 2024-04-01 · 2455 added, 2442 removed, 870 unchanged (85% of the section changed)

28 unchanged sentences

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

● Our prospects are dependent on the success of Tonmya TM

and progressing our pipeline through development stages.

To the extent regulatory approval of Tonmya is delayed or not granted or, if

approved, Tonmya 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 managers;

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® which we recently acquired from Upsher Smith Laboratories,

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

and operating this new commercial business;

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, which relies on single-source suppliers;

ability to raise additional capital or refinance or pay-off our debt, 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.

We are a fully-integrated

biopharmaceutical company focused on developing and commercializing therapeutics to treat and prevent human disease and alleviate suffering.

Our near-term priority is

to submit a New Drug Application (“NDA”) to the U.S.

Food and Drug Administration (“FDA”) for Tonmya™* (also

known as TNX-102 SL, cyclobenzaprine HCl sublingual tablet) for the management of fibromyalgia (“FM”).

FM is a chronic pain

disorder characterized by chronic widespread pain, non-restorative sleep, fatigue and impaired cognition.

Tonmya is a non-opioid analgesic

designed for long-term bedtime use and has completed two positive Phase 3 studies.

Tonix announced the positive results of the second

Phase 3 study in December of 2023.

Tonmya treatment resulted in highly statistically significant improvement in the primary endpoint of

pain reduction (p=0.00005) and statistical significance in all six of the key secondary endpoints.

Tonmya was well tolerated.

adverse events were similar between Tonmya and placebo.

No serious adverse events were reported.

The FDA conditionally accepted Tonmya

as the trade name for TNX-102 SL for the management of fibromyalgia in January 2024.

We have scheduled a type B pre-NDA meeting with the

FDA in the first half of 2024, plan to submit an NDA for the approval of Tonmya in the second half of 2024 and expect an FDA decision

on the NDA in the second half of 2025.

We are preparing for a commercial launch of Tonmya conditional on FDA approval.

Tonmya is a proprietary sublingual

tablet formulation of cyclobenzaprine (“CBP”) designed for bedtime administration.

In December 2020, we reported positive

results from the Phase 3 RELIEF study of Tonmya 5.6 mg for the management of FM.

In July 2021, we had disappointing results from a second

Phase 3 study, RALLY.

In December 2023, we reported positive results from the third Phase 3 RESILIENT study, which met its pre-specified

endpoint by significantly reducing daily pain compared to placebo in patients with fibromyalgia.

In preparation for the launch

of Tonmya, we have built a team of professionals to market and distribute our products.

Our commercial portfolio consists of two FDA-approved

prescription products for the treatment of migraine which were acquired from Upsher-Smith Laboratories (“Upsher Smith”) in June 2023:

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.

Our commercial team is engaged in marketing and distributing

our products, and also engaged in planning the launch of Tonmya.

In addition to Tonmya and

our marketed products, we have a pipeline of products in development that include therapeutics and vaccines which are based on small molecules

and biologics.

Our pipeline has been generated from internal discovery, as well as licenses, acquisitions and collaborations with academic

institutions and non-profit organizations.

Our portfolio is focused on

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

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

Our immunology portfolio

includes TNX-1500*, a biologic to address organ transplant rejection and autoimmune diseases.

Finally, our infectious disease portfolio

includes a vaccine in development to prevent smallpox and mpox (formerly known as monkeypox), TNX-801*.

TNX-801 also serves as the live

virus vaccine platform or recombinant pox vaccine (“RPV”) platform for vaccines to protect against other infectious diseases,

including TNX-1800* and TNX-1850* for COVID-19.

In addition to fibromyalgia,

TNX-102 SL* is being developed as a potential treatment for a type of Long COVID, the symptoms of which overlap with fibromyalgia, that

we term fibromyalgia-type Long COVID.

TNX-102 SL has completed a Phase 2 proof-of-concept study.

Long COVID is also known as PASC, (“post-acute

sequelae of SARS-CoV-2 infection”) is a chronic post-acute COVID-19 condition.

We initiated enrollment in the Phase 2 PREVAIL study, in

August 2022, and topline results were reported in September 2023.

The study did not meet the primary endpoint of change in mean pain from

baseline but did show activity in improving fatigue, a hallmark symptom of Long COVID.

TNX-102 SL also is being

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

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

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

Phase 2 OASIS study at UNC is supported by the U.S.

Department of Defense (“DoD”).

We expect enrollment in the OASIS

study to begin in the second quarter of 2024.

The UNC-led OASIS study will build upon the existing AURORA initiative, a major

national research initiative to improve the understanding, prevention, and recovery of individuals who have experienced a traumatic

In addition, TNX-102 SL has

active INDs for PTSD, agitation in Alzheimer’s disease (“AAD”), and alcohol use disorder (“AUD”).

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

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).

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.

Another CNS candidate in

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

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.)

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.

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.

We expect to initiate enrollment in a potentially pivotal Phase 2 study of TNX-1300 in emergency rooms in the second

quarter of 2024.

Our rare disease

portfolio includes TNX-2900* (intranasal potentiated oxytocin) for Prader-Willi syndrome (“PWS”), a genetic disorder characterized by

complex symptoms.

The formulation technology for TNX-2900 was acquired from Trigemina, Inc.

and licensed from Stanford University in

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

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 genes.

We are developing a different intranasal

oxytocin product, TNX-1900* (intranasal potentiated oxytocin with magnesium) for several CNS disorders through investigator-initiated

TNX-1900 is in development through investigator-initiated studies for the treatment of binge eating disorder (“BED”),

adolescent obesity, social anxiety disorder (“SAD”), and bone health in pediatric autism.

We received IND clearance from the

FDA in the fourth quarter of 2021 to study TNX-1900 in chronic migraine and we initiated the Phase 2 PREVENTION study for the prevention

of migraine headaches in chronic migraineurs in the first quarter of 2023.

Topline results from the study, reported in December 2023,

showed that TNX-1900 did not meet the primary endpoint as measured by a reduction from 28-day run-in baseline in the mean number of migraine

headache days during the last 28 days of the treatment phase.

PREVENTION was a small proof-of-concept study with 88 patients enrolled

across three arms (TNX-1900 30 IU QD, TNX-1900 30 IU BID, and placebo), and was not powered to result in a statistically significant outcome.

In the trial, TNX-1900 was generally well-tolerated with no treatment-emergent serious or severe adverse events.

We have discontinued

development of TNX-1900 in chronic migraine.

Our lead candidate in the immunology pipeline

is TNX-1500, an Fc-modified humanized mAb, directed against CD40-ligand (CD40L, also known as CD154).

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.

TNX-1500 is being developed as a prophylaxis against organ transplant rejection as well as to treat autoimmune

The IND was cleared and a Phase 1 study of TNX-1500 in healthy volunteers was initiated in the second quarter of 2023 and

completed the clinical phase in the first quarter of 2024.

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

in allogeneic and xenogeneic organ transplants in non-human primates at Massachusetts General Hospital, a teaching hospital of Harvard

Medical School (“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

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 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

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.

In March of 2024, MGH announced the first GE pig kidney transplant into a living

recipient supported in part by the pre-clinical work with TNX-1500.

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

Our immunology pipeline also includes

TNX-1700*, a recombinant Trefoil Factor Family 2 (“rTFF2”) fusion protein that was licensed from Columbia University in 2019.

TNX-1700 consists of TFF2 fused to human serum albumin (HAS) 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.

Our infectious disease

portfolio includes vaccines based on our live virus vaccine or 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

attenuated vaccine based on synthesized horsepox, is in the pre-IND stage of development to protect against smallpox and mpox.

has become endemic in the U.S.

since it spread in the U.S.

and other countries outside of Africa, mostly in populations of men who

have sex with men.

Non-human primates vaccinated with TNX-801 were protected from mpox in studies reported in the first quarter of

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

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 attenuated than older

vaccinia-based smallpox vaccines in both human primary cell lines and immunocompromised mice.

That work has been posted on

BioRxiv, which is not peer-reviewed.

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.

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 the third quarter of 2023, TNX-1800 was selected by the U.S.

National Institute of Allergy and

Infectious Diseases (“NIAID”), a part of the NIH, to be included in their Project NextGen initiative,

an initiative to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19.

The COVID-19 vaccines approved for

use in the U.S.

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.

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.

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

Tonix has three pre-clinical research

and development programs developing broad spectrum antivirals.

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.

TNX-3900* are broad-spectrum small molecule oral antivirals which inhibit essential cathepsins required by viruses

such as coronaviruses and filoviruses to infect cells.

TNX-4200* are orally available CD45 antagonists in preclinical development.

believe that partial inhibition of CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations and

a lower dose, and therefore will have a higher safety window.

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.

TNX-4000* are viral glycan-targeted

engineered biologics.

These antivirals are currently in preclinical development.

Relating to our development programs,

we own and operate the Research and Development Center (“RDC”) in Frederick, Maryland consisting of one building totaling

approximately 48,000 square feet.

The RDC conducts research on central nervous system, immunology, and infectious disease candidates.

The RDC facility is mostly biosafety level 2 (BSL-2), with some components designated BSL-3.

We also own and operate 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 and clinical scale manufacturing of live-virus vaccines and biologics to support

clinical trials.

We have engaged CBRE, an international real estate brokerage firm, to find a strategic partner for, or buyer of, ADC.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

are led by a management team with significant industry experience in drug development.

We complement our management team with

a network of scientific, clinical, and regulatory advisors that includes recognized experts in their respective fields.

strategy is to use our integrated development engine to advance innovative programs across multiple therapeutic areas through

the drug development process, with the ultimate objectives of FDA approval and commercialization.

The principal components of

our strategy are to:

● Pursue CNS, rare disease, immunology, and infectious disease indications with high unmet medical need and significant commercial potential.

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

Disease Pipeline

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

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

The formulation technology

for TNX-2900 was acquired from Trigemina, Inc.

and licensed from Stanford University in 2020.

The potentiated formulation includes magnesium,

which has been shown in animal studies to potentiate binding of oxytocin to the oxytocin receptor.

The therapeutic technology was licensed

from Inserm, the French National Institute of Health and Medical Research.

TNX-2900 was granted Orphan-Drug Designation by the FDA in

the second half of 2023 and the IND was cleared by the FDA in the fourth quarter of 2023 and received Rare Pediatric Disease Designation

on March 21, 2024.

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

appetite beginning in childhood with complications of obesity and diabetes.

We have sponsored a research program at Inserm to study oxytocin

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

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.

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

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

The principal

components of our strategy are to:

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.

One of our latest stage product candidates is Tonmya for the management of FM, a condition which affects between 6-12 million adults in the U.S.

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.

are also pursuing a treatment using TNX-102 SL for FM-type Long COVID, a condition for which there is no currently approved therapy.

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 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 bone loss associated with autism.

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 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 currently focusing on

the development of TNX-801 to prevent smallpox and mpox, and TNX-1800 to protect against COVID-19.

While there are FDA-approved vaccines

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

While 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.

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.

We believe 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 Tonmya 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.

determine that such a strategy would be more favorable than developing our own sales capabilities, we would seek to enter into collaborations

with pharmaceutical or biotechnology companies for commercialization.

Pursue 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 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.

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 plan to opportunistically

apply for new patents to protect our product candidates.

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

additional indications and commercial opportunities for our product candidates.

We will seek to maximize the value of our other

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

For example, we own rights related

to the development and commercialization of TNX-102 SL for generalized anxiety disorder, depression, and fatigue related to disordered

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

Finally, our live virus platform

using our RPV technology may be developed as vaccines for future pandemics, infectious diseases generally and oncology, in addition to

smallpox and mpox.

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

4 unchanged sentences

Nervous System

is a chronic syndrome characterized by widespread pain accompanied by fatigue, non-restorative sleep, cognitive dysfunction or

“brain fog” and mood issues.

The peak incidence of FM occurs between 20-50 years of age, and the majority of diagnosed

patients are female.

FM may have a substantial negative impact on social and occupational function, including disrupted relationships

with family and friends, social isolation, reduced activities of daily living and leisure activities, avoidance of physical activity,

and loss of career or inability to advance in career or education.

According to the American Chronic Pain Association, an estimated

six to twelve million adults in the U.S.

to a report by Frost and Sullivan that we commissioned, despite the availability of approved medications, the majority of patients

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

Prescription pain and sleep medications are frequently

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

therapeutic benefit, and many of these medications carry significant safety risks and risk of dependence.

For example, approximately

30% of patients diagnosed with FM take chronic opioids, despite the lack of evidence for their effectiveness and the risk of addiction

and toxicity, including overdose.

Fibromyalgia-type

Long COVID, or PASC, is a

condition that some survivors of COVID-19 infection experience in varying degrees of severity.

It is a chronic disabling condition that

is expected to result in a significant global health and economic burden.

We are focusing the development of TNX-102 SL specifically on

fibromyalgia-type Long COVID, the symptoms of which include intense fatigue, sleep problems, multi-site pain, and cognitive issues (“brain

The proposed indication is for the management of multi-site pain associated with PASC.

infection, many patients experience one or many of the symptoms of Long COVID:

some patients have initial symptoms that become prolonged;

others manifest entirely new syndromes that impact more than one system or organ.

According to a 2021 publication in the Journal of

American Medical Association , over 1 in 10 healthcare workers who had recovered from COVID-19 were still coping with at least one

moderate to severe symptom eight months later.

Research shows that Long COVID occurs in approximately 19% of recovered COVID-19 patients.

There is currently no approved drug for the treatment of Long COVID.

is a primary headache disorder characterized by recurrent headaches that are moderate to severe.

Typically, episodes affect one

side of the head, are pulsating in nature, and last from a few hours to three days.

Associated symptoms may include nausea, vomiting,

and sensitivity to light, sound, or smell.

The pain is generally made worse by physical activity, although regular exercise may

have prophylactic effects.

Up to one-third of people affected have aura, typically a short period of visual disturbance that signals

that the headache will soon occur.

Occasionally, aura can occur with little or no headache following it.

Approximately one billion

individuals worldwide suffer from migraine (~14% of the population).

Migraine is the second leading cause of years lived with

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

system, called central sensitization.

Brain imaging studies have localized the functional disorder to the brain’s insular

and anterior cingulate cortex.

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

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

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

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

Physicians and patients report common dissatisfaction with currently marketed products.

Fibromyalgia is now recognized as the

prototypic nociplastic syndrome.

Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic

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

Nociplastic syndromes

can involve components of both central and peripheral sensitization.

Fibromyalgia can occur without any identifiable precipitating

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

chronic nociceptive or neuropathic

recovery from an infectious illness;

a cancer diagnosis or cancer treatment;

a metabolic or endocrine stress;

a traumatic event.

In the cases 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.

National Academies of Sciences,

Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable condition that occurs after recovery from COVID-19

in the context of Long COVID.

Fibromyalgia is also recognized as a Chronic Overlapping Pain Condition, due to shared symptoms

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

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

We believe that diagnosing fibromyalgia in Long COVID patients will increase

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

Tonix has previously

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

with a constellation of symptoms that overlap with fibromyalgia.

According to reports by Frost

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

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

Prescription pain and sleep medications are frequently prescribed off-label

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

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

For example, based on U.S.

claims data, approximately 50%

of patients diagnosed with FM are prescribed opioids within 18 months of diagnosis, despite the lack of evidence for their effectiveness

and the risk of addiction and toxicity, including overdose.

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

15 unchanged sentences

Stress Disorder (ASD)

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.

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.

veterans, 87% reported exposure to at

least one potentially traumatic event during their service.

No medications are currently available at or near the point of care to treat

patients suffering from acute traumatic events and to support long-term health.

Syndrome (PWS)

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

with equal frequency and all races and ethnicities.

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

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

with significant morbidity and mortality.

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

currently no approved treatment for obesity and hyperphagia in adults and older children associated with PWS.

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

14 unchanged sentences

the tumor grows.

per the National Cancer Institute, the 5-year relative survival for stomach cancer is 33.3%.

According to 2017-2019 data, approximately

0.8 percent of men and women will be diagnosed with stomach cancer during their lifetime.

In 2019, there were an estimated 123,920

people living with stomach cancer in the U.S.

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.

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

5 unchanged sentences

turn malignant with time.

Similar to gastric cancer, the malignancy begins in the mucosal layer and spreads outwards.

5-year relative survival rate is 65.1%, per the National Cancer Institute.

According to 2017-2019 data, approximately 4.1 percent

of men and women will be diagnosed with colorectal cancer during their lifetime.

In 2019, there were an estimated 1,369,005 people

living with colorectal cancer in the United States.

Smallpox is an acute contagious disease

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

Smallpox was declared eradicated in 1980 following

a global immunization campaign.

Smallpox is transmitted from person to person by infective droplets during close contact with infected

symptomatic people.

Mpox is an acute contagious disease caused by the monkeypox virus or MPXV, which is also a member of the orthopoxvirus

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 2 cases spread rapidly in the U.S.

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.

and other countries.

More than 30,000

cases in the U.S.

have been reported according to the U.S.

Centers for Disease Control and Prevention.

An outbreak of Clade 1 mpox in

the Democratic Republic of the Congo is raising concerns by the U.S.

Bipartisan Commission on Biodefense.

Smallpox was eradicated by a World Health

Organization program that vaccinated individuals with live replicating vaccinia vaccines wherever smallpox appeared.

In the 1970s, vaccination

of civilians to protect against smallpox was discontinued in the U.S.;

however, smallpox remains a material threat to national security

and a proportion of military personnel, including members of the Global Response Force continue to be vaccinated.

Vaccines for smallpox

and mpox are stockpiled by the U.S.

government in the strategic national stockpile and for potential widespread immunization in the event

of malicious reintroduction of VARV.

National Academy of Sciences has recently issued a consensus report raising concerns about

the state of new mpox vaccines in development.

is a contagious virus causing the disease COVID-19 that became a global pandemic in 2019 and has resulted in more than three million

While the infection and mortality rates have slowed in regions of the world with high vaccination rates, the struggle

with the pathogen is ongoing and evolving since SARS-CoV-2 is mutating into new variants.

COVID-19 is characterized by fever,

sore throat, acute shortness of breath, cough, and oxygen desaturation in the blood.

At least three major variants have swept

across the world in successive waves and overwhelmed healthcare systems during these waves.

With new variants of the virus emerging,

therapeutic research is addressing the challenge of keeping up with this rapidly mutating virus.

The early vaccines have been

effective in limiting the severity of disease in vaccinated individuals.

Vaccines that elicit strong T cell responses are believed

to have the potential to provide long-term or durable protection.

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.

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

smallpox appeared.

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

however, smallpox

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

Force continue to be vaccinated.

Vaccines for smallpox and mpox are stockpiled by the U.S.

government in the strategic national

stockpile and for potential widespread immunization in the event of malicious reintroduction of VARV.

National Academy

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

4 unchanged sentences

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

These products collectively generated combined gross retail product

sales of approximately $28.5 million for the twelve months ended December 31, 2023.

Zembrace SymTouch is the only

actively promoted brand of sumatriptan autoinjector in the United States.

It has a unique low dose and has demonstrated onset of migraine

pain relief in as few as 10 minutes (17% of patients vs.

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

It has a unique low dose and has

demonstrated onset of migraine pain relief in as few as 10 minutes (17% of patients vs.

5% for placebo).

Zembrace SymTouch also demonstrated migraine pain freedom for

46% of patients (vs 27% for placebo) at 2 hours in a single-attack, double-blind study (N=230).

Zembrace SymTouch currently has patent

protection to 2036.

Tosymra employs Intravail® permeation enhancer technology and is pharmacokinetically equivalent to 4 mg subcutaneous

Tosymra delivers migraine pain relief in as little as 10 minutes with just one spray for some patients (13% vs.

Zembrace SymTouch also

demonstrated migraine pain freedom for 46% of patients (vs 27% for placebo) at 2 hours in a single-attack, double-blind study

Zembrace SymTouch currently has patent protection to 2036.

Tosymra employs Intravail® permeation enhancer technology

and is pharmacokinetically equivalent to 4 mg subcutaneous sumatriptan.

Tosymra delivers migraine pain relief in as little as

10 minutes with just one spray for some patients (13% vs.

5% for placebo).

7 unchanged sentences

of Development

Phase 3 studies completed, preparing NDA submission

Fibromyalgia-type

2 study completed

submitted and accepted by FDA for review;

PDUFA goal date of August 15, 2025

Stress Reaction

2 ready* – investigator-initiated IND

2, targeted 2Q 2024 start

2 ready, IND cleared

Obesity, Binge Eating Disorder, Bone Health in Pediatric Autism, Social Anxiety Disorder, *

2 completed for chronic migraine and currently enrolling for other indications*

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

Social Anxiety Disorder

Phase 2 currently enrolling*

Phase 2 clinical phase completed*

Transplant Rejection

1 study ongoing

1 topline reported 1Q’25

and Mpox vaccine

Treatment or Prevention of Viral Disease

Gastric and colorectal Cancer

*Investigator

Initiated Studies

TNX-102 SL is a proprietary

sublingual tablet formulation of 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, fibromyalgia-type Long

COVID, AAD and AUD.

The University of North Carolina has an investigator-initiated IND for ASD that references our

We own all rights to TNX-102 SL in all geographies, and we bear no obligations to third parties for any future development or commercialization.

Excipients used in TNX-102 SL are approved for pharmaceutical use.

Some of the excipients were specially selected to promote a local oral

environment that facilitates mucosal absorption of CBP.

current TNX-102 SL sublingual tablets each contain 2.8 mg of CBP.

TNX-102 SL 5.6 mg (two 2.8 mg tablets) at

bedtime has completed two positive Phase 3 studies for the management of fibromyalgia.

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.

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.

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

and histaminergic H1 receptors.

is the active ingredient of two products that are approved in the U.S.

for the treatment of muscle spasm:

Flexeril® (5 mg

and 10 mg oral immediate-release, or IR, tablet) and Amrix ® (15 mg and 30 mg oral extended-release capsule).

Flexeril brand of CBP IR tablet has been discontinued since May 2013.

There are numerous generic versions of CBP IR tablets on

CBP-containing products are approved for short term use (two to three weeks) only as an adjunct to rest and physical

therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

CBP IR tablets are recommended for

three times per day dosing, which results in relatively stable blood levels of CBP after several days of treatment.

Extended-release

CBP capsules taken once a day mimic, and flatten, the pharmacokinetic profile of three times per day CBP IR tablets.

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

for the treatment

of muscle spasm:

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

mg oral extended-release capsule or ER capsule).

The Flexeril brand of CBP IR tablet has been discontinued since May 2013.

are numerous generic versions of CBP IR tablets on the market.

CBP-containing products are approved for short term use (two to

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

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

CBP after several days of treatment.

Extended-release (ER) CBP capsules taken once a day mimic, and flatten, the pharmacokinetic

profile of three times per day CBP IR tablets.

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

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

NorCBP is a secondary

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

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 largely bypasses the “first pass”

hepatic metabolism that swallowed medications undergo, results in a higher plasma ratio of CBP to its main active metabolite,

norcyclobenzaprine.

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.

Some subjects experienced transient numbness of the tongue after

TNX-102 SL administration.

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 reference listed drug (RLD).

In general, the

development timeline for a 505(b)(2) NDA is shorter and less expensive than an NDA developed under Section 505(b)(1), which is for new

chemical entities, or NCEs, that have never been approved in the U.S.

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

to oral IR CBP tablets.

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

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

during sleeping hours when taken at bedtime.

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

during chronic use contribute to its activity in treating fibromyalgia.

We believe this is the first drug designed to

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

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

adverse reactions reported in these studies.

The most common adverse event was transient numbness in the mouth after TNX-102 SL

administration.

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 to fibromyalgia, fibromyalgia-type Long COVID, and PTSD patients and possibly other CNS (central nervous system) indications that

are underserved by currently marketed products or have no approved treatment.

We have also successfully

completed a bridging pharmacokinetic study in ethnic Japanese and Chinese volunteers that shows similar characteristics to our historical

data in Caucasian volunteers.

We believe this will satisfy one of the criteria for approval in Japan and China and will allow us to reference

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) – FM program

are developing Tonmya as a bedtime treatment for FM under an active IND application.

The potential approval of Tonmya for FM is

expected to be under Section 505(b)(2) of the FDCA.

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

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

Development Plan

Positive Phase 3 RESILIENT Study (F307)

The first patient was enrolled

in the pivotal Phase 3 RESILIENT study in April 2022.

The RESILIENT study was a double-blind, randomized, placebo-controlled adaptive

design trial designed to evaluate the efficacy and safety of Tonmya in FM.

The two-arm trial enrolled 457 participants in the U.S.

first two weeks of treatment consist of a run-in period in which participants start on Tonmya 2.8 mg (1 tablet) or placebo.

all participants increase their dose to Tonmya 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 Tonmya 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:

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.

Tonmya was well tolerated and consistent with prior trials, with no new safety

signals observed.

Among participants randomized to the Tonmya and placebo arms, 81.0% and 79.2%, respectively, completed the 14-week dosing

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

higher in the Tonmya 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.

events resulted in premature study discontinuation in 6.1% of those who received Tonmya compared with 3.5% of placebo recipients.

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 Tonmya arm.

Of the two in the Tonmya 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.

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 Tonmya 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 Tonmya 2.8 mg (1 tablet) or placebo.

After the first two weeks, all patients had the dose increased to Tonmya

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.

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.

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.

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,

Tonmya did not achieve statistical significance over placebo on the primary endpoint of reduction in daily pain, and 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.

Positive Phase 3 RELIEF Study (F304)

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 Tonmya in 503 participants with FM, which we refer to as the RELIEF 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 Tonmya to treat FM at a dose of 5.6 mg, administered sublingually once daily at bedtime

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.

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change from baseline in the weekly

average of daily diary pain severity numerical rating scale (NRS) scores for Tonmya 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:

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).

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;

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];

Consistent with the proposed mechanism that Tonmya

acts in fibromyalgia through improving sleep quality, Tonmya showed nominal improvement of sleep by several measures.

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:

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, Tonmya was also nominally significant

over placebo on T-scores (LS mean difference:

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 ratings and

PROMIS Sleep Disturbance instrument were 0.31 and 0.32, respectively.

In the RELIEF study, Tonmya

was similarly well tolerated as in the Phase 2 BESTFIT and Phase 3 AFFIRM studies, which both studied Tonmya at a lower dose of 2.8 mg

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

Among participants randomized to the Tonmya

and placebo arms, 82.3% and 83.5%, respectively, completed the 14-week dosing period.

As expected, based on prior studies, administration

site reactions are the most commonly reported adverse events and were higher in the Tonmya treatment group, including rates of hypoaesthesia

oral (17.3% vs.

0.8%), oral pain/discomfort (11.7% v.

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 almost all 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 Tonmya 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 Tonmya compared with 3.9% of placebo recipients.

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 Tonmya arm.

in the Tonmya arm, one was a motor vehicle accident with multiple bone fractures, and the other was a case of pneumonia secondary to an

Phase 3 AFFIRM Study (F301)

the third quarter of 2016, we announced the results of a randomized, double-blind, placebo-controlled, 12-week Phase 3 study of

Tonmya 2.8 mg in 519 participants with FM, which we refer to as the AFFIRM study.

The primary objective of this study was to evaluate

the potential clinical benefit of using Tonmya to treat FM at a dose of 2.8 mg, administered sublingually once daily at bedtime

for 12 weeks.

The primary endpoint of the AFFIRM trial was the 30% pain responder analysis in which a responder is defined as

a subject for whom pain intensity was reduced by at least 30% at Week 12 as compared to baseline.

AFFIRM did not achieve statistical

significance at the primary endpoint (p=0.095).

Yet, statistical significance was achieved when pain was analyzed instead as a

continuous variable, either by mixed model for repeated measure (“MMRM”0 (p<0.001) or by MMRM with multiple imputation

for missing data (p=0.005), a generally accepted approach to pain data.

Tonmya also showed statistically significant improvements

in the declared secondary analyses of the Patient Global Impression of Change, or PGIC (p=0.038) and the Fibromyalgia Impact Questionnaire-Revised,

or FIQ-R (p<0.001).

The study also showed statistically significant improvement with Tonmya on measures of sleep quality, including

the Patient-Reported Outcomes Measurement Information System, or PROMIS, Sleep Disturbance instrument (p<0.001).

was well tolerated in the AFFIRM trial.

Among patients randomized to the active and control arms, 78% and 86%, respectively, completed

the 12-week dosing period.

The most common adverse events were local in nature, with transient hypoaesthesia oral occurring

in 40% of participants on Tonmya vs.

1% on placebo.

These local adverse events did not appear to affect either rates of retention

of study participants or their compliance with taking Tonmya.

Systemic adverse events were similar between Tonmya and placebo.

No serious adverse events were reported.

NDA Requirements

An Agreed Initial Pediatric

Study Plan (“Agreed iPSP”) is required for the initial NDA submission.

The Agreed iPSP was accepted by the FDA in September

We submitted an amended iPSP in the third quarter of 2021 and received comments from the FDA in the fourth quarter of 2021.

submitted a second amended iPSP in first quarter 2024 and plan to come to an Agreed PSP by the time of NDA submission.

An acceptable

Pediatric Study Plan will be determined at the time of the NDA approval.

on our discussions with the FDA and the FDA official meeting minutes, we will not have to conduct special populations, such as

geriatric and renal/hepatic impaired patients, drug-drug interaction or cardiovascular safety studies to support the Tonmya NDA

filing since the pivotal systemic exposure bridging study using Amrix as the reference listed drug (RLD) has been successfully

Due to the well-established safety profile of CBP at much higher doses than we proposed for FM and the long-term safety

data in PTSD, up to 15 months, on Tonmya 5.6 mg, the FDA has not requested a risk management plan or medication guide for this

NDA Requirements

1 Bioequivalence, Bridging PK, Food-Effect and Dose-Proportionality Studies

have completed the required Phase 1 bioequivalence, multi-dose bridging pharmacokinetic, and food effect and dose-proportionality

Cyclobenzaprine

Hydrochloride Nonclinical Development

October 2016, we completed the six-month repeated-dose toxicology study of the active ingredient, CBP, in rats and a nine-month

repeated-dose toxicology study in dogs required for the NDA filing.

These chronic toxicity studies were requested by the FDA to

augment the nonclinical information in the AMRIX prescribing information, or labeling, which is necessary to support the TNX-102

SL labeling for long-term use.

Due to the lack of evidence of potential abuse in clinical studies of TNX-102 SL, the FDA agreed

that nonclinical study to assess CBP abuse potential is not required to support the TNX-102 SL NDA filing.

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.

In 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.

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.

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.

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

have initiated nonclinical safety, pharmacology and embryo-fetal development toxicology studies as part of the agreed IND-enabling

nonclinical data package to support clinical studies of Tonmya in Japan.

TNX 102 SL – Fibromyalgia-type Long COVID Program

We are developing TNX-102

SL as a bedtime treatment for fibromyalgia-type Long COVID.

The potential approval of TNX-102 SL for Long COVID is expected to be under

Section 505(b)(2) of the FDCA.

Phase 2 PREVAIL Study (TNX-CY-PA201)

We initiated a Phase 2 study

of TNX-102 SL as a treatment for fibromyalgia-type Long COVID, in August 2022.

The study is a randomized, double-blind, placebo-controlled

study designed to evaluate the efficacy and safety of TNX-102 SL for fibromyalgia-type Long COVID.

In the study, 63 subjects were enrolled

and randomized 1:1 across approximately 30 U.S.

sites to receive either TNX-102 SL or placebo daily at bedtime for 14 weeks.

started with one TNX-102 SL 2.8 mg tablet or one placebo tablet for the first 2 weeks and then increased to TNX-102 SL 5.6 mg (2 x 2.8

mg tablets) or two placebo tablets for the remaining 12 weeks of the treatment period.

Given the lack of Long COVID treatments and the

size of the current proof-of-concept study, an effect size (“ES”) ≥ 0.2 was the pre-specified threshold for declaring the

primary endpoint positive.

The study trended towards a benefit but did not achieve statistical significance on the primary efficacy endpoint

of change from baseline in the diary numerical rating scale (NRS) weekly average of daily self-reported worst Long COVID pain intensity

scores for TNX-102 SL at the Week 14 endpoint versus placebo ES = 0.08)

The change from baseline to

the Week 14 endpoint for the daily sleep quality diary, PROMIS Sleep Disturbance, PROMIS Fatigue, PROMIS Cognitive function, the Insomnia

Severity Index (ISI) and Sheehan Disability Scale showed numerical improvements in (MMRM, ES ≥ 0.2):

sleep diary (MMRM, ES =0.23), PROMIS sleep Disturbance (MMRM, ES=0.32), PROMIS fatigue (MMRM, ES=0.50), PROMIS Cognitive Function –

Abilities, (MMRM, ES=0.21), the ISI (ANCOVA, ES=0.24) and the Sheehan Disability Scale (ANCOVA, ES=0.26).

Moreover, robust activity was

observed in the PGIC responder (very much improved or much improved) rate for TNX-102 SL compared to placebo:

week 6 (31.3%

9.7%, difference=21.6%), week 10 (28.1% vs.

12.9%, difference=15.2%), week 14 (34.4% vs.

16.1%, difference=18.2%).

TNX-102 SL was

generally well tolerated with an adverse event (“AE”) profile comparable to prior studies with TNX-102 SL.

AE-related discontinuations

were similar in drug and placebo arms.

No new safety signals were observed.

We intend to request an End-of-Phase

2 meeting with the FDA to discuss a potential Phase 3 program based on a proposed primary outcome measure using the PROMIS Fatigue scale.

Fatigue is the symptom of Long COVID that principally overlaps with chronic fatigue syndrome/myalgic encephalomyelitis and fibromyalgia.

In the NIH funded RECOVER study analysis, fatigue was the top featured symptom and is common in each of the four clusters.

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 – Acute Stress Disorder Program

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2 OASIS Study

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.

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 after a motor vehicle collision.

The trial will enroll approximately 180 individuals who acutely experienced

trauma at study sites across the U.S.

and participants will be randomized in the emergency department to receive a two-week course

of either TNX-102 SL or placebo.

The OASIS trial will build upon a foundation of knowledge and infrastructure developed

through the University of North Carolina-led, $40 million AURORA initiative.

The AURORA study is a major national research initiative

to improve the understanding, prevention, and recovery of individuals who have experienced a traumatic event.

AURORA is supported by funding

from the NIH, leading brain health nonprofit One Mind, private foundations, and partnerships with leading tech companies such as Mindstrong

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

Initiation of patient enrollment

in the proposed investigator sponsored OASIS trial is anticipated in the second quarter of 2024.

The FDA granted IND clearance in the

first quarter of 2024.

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 OLE

studies of the PTSD program.

Based on the FDA’s guidance, the long-term safety exposure studies in PTSD are also expected

to support an NDA for the management of fibromyalgia.

Manufacturing

Tonmya 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 process.

Tonix is ready to manufacture TNX-102

SL commercial product for the forecasted fibromyalgia market.

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.

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

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

$40 million AURORA initiative.

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

and recovery of individuals who have experienced a traumatic event.

AURORA is supported by funding from the NIH, leading brain

health nonprofit One Mind, private foundations, and partnerships with leading tech companies such as Mindstrong Health and Verily

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

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.

– Cocaine Intoxication

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of Michigan, and in-licensed by Tonix from Columbia University in 2019.

In a Phase 2 randomized,

double-blind, placebo-controlled clinical study, TNX-1300 at 100 mg or 200 mg i.v .

doses was well tolerated and interrupted cocaine

effects after cocaine 50 mg i.v .

August 2022, we announced that we received a Cooperative Agreement grant from NIDA, part

of NIH, to support development of TNX-1300.

A positive Phase 2a study of volunteer cocaine users in a controlled

laboratory setting has been previously completed.

TNX-1300 has been granted Breakthrough Therapy designation by the FDA.

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 is in the process of manufacturing Phase 2/3 drug product clinical supply.

expect to initiate a Phase 2 clinical trial of TNX-1300 in the second quarter of 2024.

The Phase 2 trial is a single-blind, open-label, placebo-controlled, randomized 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.

– 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 the French National Institute of Health and Medical Research (Inserm).

The licensing

agreement has been negotiated and signed by Inserm Transfert, the private subsidiary of Inserm, on behalf of Inserm (the French National

Institute of Health and Medical Research), Aix-Marseille Université and Centre Hospitalier Universitaire of Toulouse.

PWS is recognized

as the most common genetic cause of life-threatening childhood obesity and affects males and females with equal frequency and all races

and ethnicities.

There is currently no approved treatment for either the suckling deficit in infants or the obesity and hyperphagia in

older children associated with PWS.

Since PWS is an orphan disease that occurs in approximately one in 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.

In 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.

a Phase 2 randomized, double-blind, placebo-controlled clinical study, TNX-1300 at 100 mg or 200 mg i.v .

doses was well

tolerated and interrupted cocaine effects after cocaine 50 mg i.v .

August 2022, we announced that we received a Cooperative Agreement grant from NIDA, part of NIH, to support development of TNX-1300.

A positive Phase 2a study of volunteer cocaine users in a controlled laboratory setting has been previously completed.

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.

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.

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

Oxytocin has no recognized addiction potential.

It has been observed that low oxytocin levels in the body can lead to an increase in migraine headache frequency, and that increased

oxytocin levels can relieve migraine headaches.

Certain other chronic pain conditions are also associated with decreased oxytocin

TNX-1900, the addition of magnesium to the oxytocin formula enhances oxytocin receptor binding as well as its effects on trigeminal

neurons and craniofacial analgesic effects in animal models.

Intranasal oxytocin has been well tolerated in several clinical trials

in both adults and children.

There are 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

TNX-1500 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.

Phase 1 study of TNX-1500 in healthy volunteers was initiated in the second quarter of 2023 and has completed the clinical phase.

results are expected in the third quarter of 2024.

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 non-human primates.

The data demonstrates that TNX-1500 showed activity in preventing organ rejection

and was well tolerated in non-human primates.

Blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic

alloimmunity in non-human primate models of cardiac and kidney allograft model without clinical thrombosis.

Furthermore, pre-clinical

research supports TNX-1500’s activity in preventing pig xenograft organ rejection.

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.

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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

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

Tonix completed a pre-IND meeting with

the FDA in October 2022 to discuss the most efficient and appropriate investigational plan to establish the safety and effectiveness

evidence to support the licensure of TNX-1500.

The IND was cleared and a Phase 1 study of TNX-1500 in healthy volunteers was initiated

in the second quarter of 2023 and completed the clinical phase in the first quarter of 2024.

and Simponi® are trademarks of Janssen;

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

– Potential Smallpox and Mpox Vaccine

TNX-801 is a novel potential

smallpox- and mpox-preventing vaccine based on a synthetic version of live horsepox virus, grown in cell culture.

Though it shares structural

characteristics with vaccinia-based vaccines, TNX-801 has unique properties that we believe indicate potential safety advantages over

existing live replicating vaccinia virus vaccines, which have been associated with adverse side effects such as myopericarditis in some

Emergent BioSolutions’ ACAM2000® is the only replicating vaccinia virus vaccine currently approved by the

FDA to protect against smallpox.

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® is the only non-replicating virus vaccine

currently approved by the FDA to protect against smallpox and mpox.

Jynneos® requires two-doses, with an efficacy of approximately

35% after one dose.

During the most recent mpox outbreak in the United States, dropout between doses was 24%.

We believe TNX-801 has

the potential to have improved tolerability relative to replicating vaccinia vaccines and the potential to have improved efficacy relative

to non-replicating vaccinia vaccines.

We also believe that TNX-801 would require only one dose.

Smallpox was eradicated by

a World Health Organization program that vaccinated individuals with live replicating vaccinia vaccines wherever smallpox appeared.

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

however, smallpox remains a material threat

to national security and a proportion of military personnel, including members of the Global Response Force, continue to be vaccinated.

The Bipartisan Commission on Biodefense (2024) noted that “Smallpox and other orthopoxviruses pose significant threats to the United

States and the world due to their potential for weaponization, accidental release, and vulnerability of populations who stopped routinely

vaccinating against smallpox in the 1970s” (Bipartisan Commission on Biodefense.

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.

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

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

Though it shares structural characteristics with vaccinia-based vaccines, TNX-801 has unique properties that we believe

indicate potential safety advantages over existing live replicating vaccinia virus vaccines, which have been associated with adverse

side effects such as myopericarditis in some individuals.

Emergent BioSolutions’ ACAM2000® is the only replicating

vaccinia virus vaccine currently approved by the FDA to protect against smallpox and mpox.

We believe replicating virus vaccines have potential

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

Bavarian Nordic’s

Jynneos®, the only non-replicating virus vaccine, is currently approved by the FDA to protect against smallpox and mpox.

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.

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

smallpox appeared.

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

however, smallpox

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

Force, continue to be vaccinated.

The Bipartisan Commission on Biodefense (2024) noted that “Smallpox and other orthopoxviruses

pose significant threats to the United States and the world due to their potential for weaponization, accidental release, and

vulnerability of populations who stopped routinely vaccinating against smallpox in the 1970s” (Bipartisan Commission on

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

1 unchanged sentence

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

Mpox remains a growing epidemic threat

in certain regions of Africa and beyond.

Starting in May of 2022, cases of mpox have been reported outside of Africa in patients who had

not been infected while in Africa.

More than 93,000 cases have been reported as of Feb.

2024 with 32,000 reported in the U.S.

Centers for Disease Control and Prevention.

In 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 challenge.

Mpox 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.

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.

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.

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.

results were published in the peer-reviewed journal Viruses in 2023.

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

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

in both human primary cell lines and immunocompromised mice and that work has been posted on BioRxiv, which is not peer-reviewed.

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.

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.

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 that meeting cGMP quality to support a clinical study.

– Potential COVID-19 Vaccine

TNX-1800 is an attenuated, 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.

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 and is being configured

for simplified delivery by using a microneedle patch to increase accessibility and acceptability.

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.

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

The COVID-19 vaccines that are

approved for use in the U.S.

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 (“AP3”) 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 a non-human

primate 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.

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 attenuated than older VACV-based smallpox vaccines in human

primary cell lines and immunocompromised mice (Trefry, SV et al.

Recombinant chimeric Horsepox Virus (TNX-801) is attenuated relative

to Vaccinia Virus Strains in Human Primary Cell Lines and in Immunocompromised Mice.

We 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.

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.

At 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 attenuated than older VACV-based smallpox vaccines in human primary

cell lines and immunocompromised mice.

–Adolescent Obesity, Binge Eating Disorder and Social Anxiety

(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.

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.

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

Oxytocin has no recognized addiction potential.

It has been observed that low oxytocin levels in the body can lead to an increase in migraine headache frequency, and that increased

oxytocin levels can relieve migraine headaches.

Certain other chronic pain conditions are also associated with decreased oxytocin

TNX-1900, the addition of magnesium to the oxytocin formula enhances oxytocin receptor binding as well as its effects on trigeminal

neurons and craniofacial analgesic effects in animal models.

Intranasal oxytocin has been well tolerated in several clinical trials

in both adults and children.

initiated a Phase 2 study of TNX-1900 for the prevention of migraine headaches in chronic migraineurs in the first quarter of

Topline results from the study, reported in December 2023, showed that TNX-1900 did not meet the primary endpoint of reducing

migraine days.

We discontinued the program.

TNX-1900 was generally well-tolerated with no treatment-emergent serious or severe

adverse events.

are three ongoing Phase 2 investigator-led studies enrolling at MGH:

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.

to the studies at MGH, Tonix is conducting an investigator-initiated study of TNX-1900 for the treatment of SAD at the University

of Washington.

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.

– 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.

Facilities Overview

to our COVID-19 and other infectious disease development programs, we seek to be a leader in the movement to re-build domestic

research, development and manufacturing capabilities.

Because this movement follows a protracted period when domestic research,

development and manufacturing were moved out of the U.S., or “off-shore” by other companies to save on labor and other

costs, the movement to reverse that trend has been described as “on-shoring” or “re-domestication”.

COVID-19 pandemic demonstrated that national borders may close during a health emergency.

Therefore, domestic capabilities are

essential for the health security of the U.S., which has also been described as pandemic preparedness and biodefense.

As articulated

in the American Pandemic Preparedness Plan, or AP3 released by the U.S.

Office of Science and Technology Policy, this 100-day

goal for vaccines is a key component of preparedness for future pandemics.

Our goal is to establish the infrastructure necessary

to support the pandemic preparedness goals established in the AP3, specifically with respect to our RPV vaccine platform and potentially

to other vaccine and therapeutic platforms.

Research & Development Center (RDC)

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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

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Advanced Development Center (ADC)

ADC located in the New Bedford business park in Dartmouth, Massachusetts is operational and intended to accelerate development

and clinical scale manufacturing of live-virus vaccines and biologics to support Phase 1 and Phase 2 clinical trials.

single-use bioreactors and purification suites with equipment for Good Manufacturing Practice (GMP) production of vaccines for

and biologics clinical trials, including the capability of producing sterile vaccines in glass bottles.

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.

We have engaged

CBRE, an international real estate brokerage firm, to find a strategic partner for, or buyer of, 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

Sales and Distribution

Marketing activity for Zembrace

Symtouch and Tosymra in the United States will be conducted by our wholly-owned subsidiary, Tonix Medicines, Inc.

We focus our sales and

marketing efforts on physicians in private practice and in public treatment systems.

We employ standard pharmaceutical marketing practices

to promote our products, encompassing advertisements, professional symposia, sales initiatives, and educational outreach aimed at physicians,

nurses, social workers, counselors, and other stakeholders involved in treating 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.

intend to implement patient access programs and expand distribution channels in our marketing efforts for our migraine drugs.

activity for 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.

We employ standard

pharmaceutical marketing practices to promote our products, encompassing advertisements, professional symposia, sales initiatives,

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

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.

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

17 unchanged sentences

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

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.

Zembrace and 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.

Tonix is developing TNX-102

SL for the treatment of fibromyalgia.

Products approved for the treatment of fibromyalgia include Lyrica® (pregabalin), developed

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

and duloxetine are available as generics, while Savella still enjoys exclusivity.

Tonix is aware of several other companies developing

treatments for fibromyalgia.

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

the first half of 2024.

is developing Rystiggo® (rozanolixizumab), a monoclonal antibody targeting the neonatal Fc receptor

(FcRn) blocker in a Phase 2 trial to treat adults with severe fibromyalgia syndrome.

Scilex Pharmaceuticals, Inc.

have a Phase 1, open

label, randomized, single-dose, 3-period, 3-treatment crossover study to evaluate the pharmacokinetics of SP-104 under fasting and fed

conditions and to compare to Naltrexone Hydrochloride Tablets USP in healthy adult subjects in New Zealand.

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.

is investigating IMC-1 for the treatment of fibromyalgia.

In September 2023, Tryp Therapeutics, Inc.

initiated a Phase IIa, open-label,

pilot study to assess the safety and efficacy of Psilocybin (TRP-8802) administration in concert with psychotherapy among adult patients

with fibromyalgia.

In the first quarter of 2024, Silo Pharma announced preclinical data on SP-26, its novel time-released, dose-controlled

formulation of ketamine initially targeted for fibromyalgia.

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)

currently are no approved products for the treatment of long COVID/PASC.

Tonix is aware of several companies developing therapeutics

for long COVID including, but not limited to, Direct Biologics, LLC (DB-001 in Phase III), American CryoStem Corporation, Ampio

Pharmaceuticals, Inc.

(AMPE), Pieris Pharmaceuticals, Inc., Resolve Therapeutics, LLC, GeNeuro, Organicell Regenerative Medicine,

Inc., Berlin Cures Holding AG (Phase II currently enrolling in Europe) and Statera BioPharma, Inc.

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-19.

Virios Therapeutics, Inc.

that it is targeting the initiation of a phase II program for IMC-2 (combination of valacyclovir and celecoxib) as a treatment for the

fatigue, orthostatic intolerance and other symptoms associated with Long COVID in second half of 2024.

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

Stress Reaction/Acute Stress Disorder (ASR/ASD)

There are no approved drugs

for treating ASR or for the prevention of ASD or PTSD.

There are no approved antidotes

for the treatment of cocaine intoxication.

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.

Patients generally receive supportive care.

We are not aware of any drugs in development for

the treatment of cocaine intoxication.

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

Anti-CD40-ligand

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 several companies

developing biologics that target the CD40L molecule and block its interaction with CD40 including Sanofi, UCB, Eledon Pharmaceuticals,

and Amgen (which acquired Horizon Therapeutics plc).

In February 2024, Sanofi published their Phase II clinical trial of frexalimab in

people with relapsing multiple sclerosis in The New England Journal of Medicine .

The phase II trial involving participants with

multiple sclerosis, inhibition of CD40L with frexalimab had an effect that generally favored a greater reduction in the number of new

gadolinium-enhancing T1-weighted lesions at week 12 as compared with placebo.

In August 2023, H.Lundbeck A/S (in partnership with AprilBio)

completed their phase I, 2-part, single ascending dose, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability,

pharmacokinetics, and pharmacodynamics of Lu AG22515 (APB-A1) in healthy adult subjects.

There are multiple companies in the process

of developing antagonistic anti-CD40 mAbs, including Novartis, Boehringer Ingelheim GmbH, Kiniska Pharmaceuticals, Boston Immune Therapies,

and NapaJen Pharma Inc.

Syndrome (PWS)

Somatropin, which targets the Growth Hormone

Receptor is approved in the U.S.

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 Europe.

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

Patients generally receive care to best manage individual

symptom presentation.

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.

Soleno is developing diazoxide chloride controlled release (DCCR) which had positive results

in a randomized withdrawal study of PWS and based on which Soleno expects to file an NDA.

Tonix is aware of several companies that are

focused on developing a therapeutic for the treatment of PWS including, but not limited to, Aadvark Therapeutics, ConSynance Therapeutics,

Lipidio Pharma, Helsinn, Inversago Pharma, Saniona, 9 Meters Biopharma, Neuren Pharmaceuticals, Neuracle Science, Harmony Biosciences

Holding Inc., and Notitia Biotechnologies.

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.

Harmony Biosciences Holdings, Inc.

just 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.

Neuren Pharmaceuticals Limited initiated their Phase II in August 2023.

and Colorectal Cancer

The effectiveness of KEYTRUDA®

has sparked a surge of activity in the field of oncology and immunotherapy, driving a multitude of research endeavors focused on enhancing

cancer treatment results and prolonging patient survival.

GRANITE for colorectal

cancer is in Phase III for Gritstone bio, Inc.

Last year, Amgen Inc.

announced topline results for the global Phase III CodeBreaK

300 study evaluating LUMAKRAS combined with Vectibix vs current standard of care in chemorefractory metastatic KRAS G12C-mutated

colorectal cancer.

Again in 2023, Bexion Pharmaceuticals announced that the first adult patient has been dosed in the Phase Ib/II

placebo controlled, double blinded study on the efficacy and safety of BXQ-350 in combination with mFOLFOX7 and Bevacizumab in newly

diagnosed metastatic colorectal carcinoma.

Several other companies developing biologics for the treatment of gastric and colorectal cancer

include Medivir AB (Birinapant), PDS Biotechnology Corporation, GSK plc (Jemperli) in partnership with AnaptysBio, Inc.

Vaccines for COVID-19 granted full FDA regulatory approval include Comirnaty®

(BNT162b2), marketed by Pfizer-BioNTech, Spikevax® (mRNA-1273), marketed by Moderna, Inc.

and Covovax® (NVX-CoV2373) marketed

Other vaccines have received emergency use authorization (“EUA”) in international markets.

Other companies developing

COVID-19 vaccines include Ocugen Inc., Invivyd, Inc.

and Vaxxinity, Inc..

Ocugen’s OCU500 was selected by NIH/NIAID Project NextGen

for clinical trials.

and Mpox Vaccines and Antivirals

Vaccines approved

for the prevention of smallpox include ACAM2000®, marketed by Emergent BioSolutions and JYNNEOS®, marketed by Bavarian Nordic.

JYNNEOS® is also approved for the prevention of mpox.

Approved antivirals for smallpox include TPOXX®, marketed by SIGA and TEMBEXA®,

marketed by Chimerix.

These antivirals are not FDA approved for the treatment of mpox.

Tonix is aware of other companies developing treatments

for smallpox and mpox including Moderna, EpiVax, Inc., Emergex Vaccines Holding Ltd., BioFactura, Blue Water Vaccines, NightHawk Biosciences,

Ascletis Pharma, Inc., and Hyundai Bioscience Co., Ltd.

believe that we have an extensive patent portfolio and substantial know-how relating to Tonmya/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 8, 2024, the patents we are either the owner of record of or own the contractual right to include 42 issued U.S.

and 337 issued non-U.S.

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 actively pursuing an additional 23 U.S.

non-provisional patent applications, 4 international

patent applications, and 237 non-U.S./non-international patent applications.

non-provisional patent applications, 3 international patent applications,

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

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

36 unchanged sentences

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 March 8, 2024 are summarized

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

summarized below.

SL — Central Nervous System Conditions

patent portfolio for TNX-102 SL includes patents and patent applications directed to compositions of matter of CBP, formulations containing CBP, and methods for treating CNS conditions, such as TNX-102 SL for PTSD, for acute stress disorder,

for pain, fatigue and sleep disturbances in fibromyalgia, for alcohol abuse, for disordered sleep, for sexual dysfunction, for

depression in fibromyalgia, fatigue, e.g., CAP rates, post-acute sequelae of SARS-CoV-2 infection, and for agitation in neurodegenerative

conditions, e.g., AAD.

patent portfolio for TNX-102 SL includes patents and patent applications directed to compositions of matter of CBP, formulations

containing CBP, and methods for treating CNS conditions, such as TNX-102 SL for PTSD, for pain, fatigue and sleep disturbances

in fibromyalgia, for treating or managing fibromyalgia (early onset response, favorable tolerability, or side effect profile),

for alcohol abuse, for disordered sleep, for sexual dysfunction, for depression in fibromyalgia, for fatigue and disordered sleep

(e.g., CAP rates), for post-acute sequelae of SARS-CoV-2 infection, for acute stress reaction/acute stress disorder, and for agitation

in neurodegenerative conditions, e.g., AD.

eutectic compositions were discovered by development partners and are termed the “Eutectic Technology.” The patent

45 unchanged sentences

The claims recite a method of using TNX-102 SL’s active ingredient cyclobenzaprine

to treat PTSD and provides TNX-102 SL with US market exclusivity until 2030, excluding any patent term extensions.

to treat PTSD and provides US market exclusivity until 2030, excluding any patent term extensions.

March 23, 2018, Japanese Patent No.

18 unchanged sentences

hydrochloride and mannitol and methods of making those compositions.

August 4, 2023, Chinese Patent No.

ZL201910263541.6, entitled “Eutectic Formulations of Cyclobenzaprine Hydrochloride and

Amitriptyline Hydrochloride,” issued.

The claims recite a eutectics of cyclobenzaprine hydrochloride and beta-mannitol and

methods of making those eutectics.

July 23, 2019, U.S.

4 unchanged sentences

In response to an opposition filed in September 2020 by Hexal AG, the European Patent Office’s Opposition Division

upheld the patent in unamended form in the January 2022 oral proceedings.

upheld the patent in unamended form after the January 2022 oral proceedings.

Hexal AG did not appeal that decision.

6 unchanged sentences

The European Patent

Office’s Opposition Division upheld the patent claims in unamended form at the February 2022 oral proceedings.

did not appeal that decision.

Office’s Opposition Division upheld the patent claims in unamended form after the February 2022 oral proceedings.

AG did not appeal that decision.

June 4, 2024, U.S.

11,998,516, entitled “Methods and Compositions for Treating Depression Using Cyclobenzaprine,”

The claims recite methods for treating major depressive disorder in a fibromyalgia patient using a composition comprising

cyclobenzaprine or its salts.

December 15, 2020, U.S.

19 unchanged sentences

On October 5, 2022, International Patent Application No.

PCT/US2022/045791, entitled “Cyclobenzaprine Treatment for Sexual Dysfunction” was filed.

The claims of these applications

are directed to methods using pharmaceutical compositions and combinations for treating sexual dysfunction with cyclobenzaprine

or pharmaceutically acceptable salts of cyclobenzaprine.

PCT/US2022/045791, entitled “Cyclobenzaprine Treatment for Sexual Dysfunction,” was filed and is now nationalized

in European Patent Office and U.S.

Patent Application No.

The claims of these applications are directed to

methods using pharmaceutical compositions and combinations for treating sexual dysfunction with cyclobenzaprine or pharmaceutically

acceptable salts of cyclobenzaprine.

October 25, 2016 and July 28, 2020, U.S.

43 unchanged sentences

entitled “Cyclobenzaprine Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC),” were filed.

are directed to methods of treating PASC or one or more associated symptoms comprising administering cyclobenzaprine or a pharmaceutically

acceptable salts of cyclobenzaprine.

is now nationalized in 9 countries.

The claims are directed to methods of treating PASC or one or more associated symptoms comprising

administering cyclobenzaprine or a pharmaceutically acceptable salts of cyclobenzaprine.

December 19, 2024, U.S.

non-provisional Patent Application No.

18/988,194 and International Patent Application No.

PCT/US2024/061125,

entitled “Early Onset Response, Favorable Tolerability, and Side Effect Profile in the Treatment of Fibromyalgia,”

The claims are directed to methods for treating or managing fibromyalgia and its associated symptoms in subjects characterized

by an early onset of one or more of:

(1) a reduction in widespread pain;

(2) a reduction in sleep disturbance;

(3) a reduction

or (4) an improved sleep quality.

The claims are also directed to methods for preventing or avoiding clinically meaningful

changes in mean weight, in mean systolic blood pressure or mean diastolic blood pressure, or a decline in sexual functioning.

January 23, 2025, International Patent Application No.

PCT/US2025/012803, entitled Cyclobenzaprine Treatment for Acute Stress

Reaction or Acute Stress Disorder,” was filed.

The claims are directed to methods for treating or preventing acute stress

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

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

12 unchanged sentences

Oxytocin Formulations and Methods of Use,” issued.

also acquired International Patent Application No.

PCT/US2017/027265, filed April 12, 2017, entitled “Magnesium-Containing

Oxytocin Formulations and Methods of Use” (nationalized in 9 countries).

On December 3, 2024, U.S.

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

The patent, which claims methods

for treating autism spectrum disorder, social anxiety disorder, or a social communication disorder, will expire in April 2037,

excluding any patent term extensions.

also have rights to International Patent Application No.

1 unchanged sentence

and Method of Manufacture and Use” (nationalized in the U.S., European Patent Office and Japan).

On April 30, 2024, U.S.

11,970,554, 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

10 unchanged sentences

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

have licensed technology using oxytocin-based therapeutics for the treatment of PWS and non-organic failure

to thrive disease from the French National Institute of Health and Medical Research (INSERM).

The co-exclusive license relates

to TNX-2900, an intranasal potentiated oxytocin, for the treatment of Prader-Willi syndrome and other feeding disorders.

the license, we have rights to European Patent No.

EP2575853B1, entitled “Methods and Pharmaceutical Composition for the

Treatment of a Feeding Disorder with Early-Onset in a Patient”;

8,853,158, entitled “Methods for the

Treatment of a Feeding Disorder with Onset During Neonate Development Using an Agonist of the Oxytocin Receptor”;

9,125,862, entitled “Methods for the Treatment of Prader-Willi-like Syndrome or Non-Organic Failure to Thrive

(NOFITT) Feeding Disorder Using an Agonist of the Oxytocin Receptor.” The U.S.

patents expire in May 2031,

excluding any patent term extensions.

have licensed technology using oxytocin-based therapeutics for the treatment of PWS and non-organic failure to thrive disease

from the French National Institute of Health and Medical Research (INSERM).

The co-exclusive license relates to TNX-2900, an intranasal

potentiated oxytocin, for the treatment of Prader-Willi syndrome and other feeding disorders.

Under the license, we have rights

to European Patent No.

EP2575853B1, entitled “Methods and Pharmaceutical Composition for the Treatment of a Feeding Disorder

with Early-Onset in a Patient”;

8,853,158, entitled “Methods for the Treatment of a Feeding Disorder

with Onset During Neonate Development Using an Agonist of the Oxytocin Receptor”;

9,125,862, entitled

“Methods for the Treatment of Prader-Willi-like Syndrome or Non-Organic Failure to Thrive (NOFITT) Feeding Disorder Using

an Agonist of the Oxytocin Receptor.” The U.S.

patents expire in May 2031, excluding any patent term extensions.

— Cocaine Intoxication Treatment

20 unchanged sentences

with Modified Anti-CD154 Antibodies” on January 6, 2022 (nationalized in 14 countries).

August 28, 2024, European Patent No.

3993876, entitled “Anti-CD154 Antibodies and Uses Thereof,” issued (validated

in 37 countries).

The claims recite an isolated antibody that binds CD154, compositions comprising the antibody, and use of the

compositions for treating or preventing a transplant rejection.

— Live Horsepox Vaccine for Prevention of Smallpox and Mpox

22 unchanged sentences

and TNX-1850 — Live Modified Horsepox Vaccine for Prevention of COVID-19

are developing TNX-1800 and TNX-1850, live attenuated modified HPXVs, as a COVID-19 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

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.

Application No.

The PCT application is not 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.

March 1, 2023, we filed International Patent Application No.

PCT/US2023/063503, entitled “Recombinant Poxvirus Based Vaccine

Against the Omicron Strain of SARS-CoV-2 Virus and Variants Thereof.” This application is directed to synthetic poxviruses

comprising a SARS-CoV-2 virus protein of an omicron strain, poxvirus delivery vectors for SARS-CoV-2 virus proteins of an omicron

strain and methods of using these modified poxviruses to protect individuals against the SARS-CoV-2 virus of an omicron strain.

— Recombinant Trefoil Family Factor 2 (rTFF2) to Treat Gastric and Pancreatic 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 pancreatic cancers.

The licensed patents are directed to rTFF2 compositions and methods of treatment.

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.

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.

— Triple Reuptake Inhibitor to Treat PTSD

have licensed rights from Wayne State University to develop a potential product, TNX-1600, for PTSD treatment.

The licensed patents

directed to pyran-based derivatives and analogues.

7,915,433, 8,017,791, 8,519,159, 8,841,464, and 8,937,189, entitled “Tri-substituted 2-benzhydryl

5-benzlamino-tetrahydro-pyran-4-OL and 6-benzhydryl-4-benzylamino-tetrahydro-pyran-3-OL analogues, and novel 3,6 disubstituted

pyran derivatives” and U.S.

9,458,124, entitled “Substituted Pyran Derivatives”.

These patents provide

TNX-1600 with US market exclusivity between April 2024 and February 2034, respectively, subject to any patent term extensions.

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

7 unchanged sentences

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

and Tosymra — Sumatriptan

We have acquired the intellectual

property rights of Zembrace SymTouch and Tosymra and their uses in treating migraine from Upsher-Smith Laboratories, LLC.

9,211, 282, U.S.

— 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,

These rights include U.S.

9,211, 282, U.S.

3 unchanged sentences

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).

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:

Anti-Cocaine Compositions

and Treatment

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

Anti-Cocaine Compositions and Treatment

December 30, 2027

Anti-Cocaine Compositions

and Treatment

Anti-Cocaine Compositions and Treatment

July 10, 2027

Anti-Cocaine Compositions

and Treatment

Anti-Cocaine Compositions and Treatment

July 10, 2027

Anti-Cocaine Compositions

and Treatment

Anti-Cocaine Compositions and Treatment

July 10, 2027

Anti-Cocaine Compositions

and Treatment

Anti-Cocaine Compositions and Treatment

July 10, 2027

2046368 (602007045044.6

2046368 (602007045044.6 in Germany;

502016000056543 in Italy)

Anti-Cocaine Compositions

and Treatment

European Patent

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

Anti-Cocaine Compositions and Treatment

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

July 10, 2027

Anti-Cocaine Compositions

and Treatment

Anti-Cocaine Compositions and Treatment

July 10, 2027

Anti-Cocaine Compositions

and Treatment

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

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

July 10, 2027

CBP/Amitriptyline

Compositions and

Methods for Transmucosal Absorption

Sublingual CBP/Amitriptyline

Country / Region

Expiration Date

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

Taiwan R.O.C.

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

Taiwan R.O.C.

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

Taiwan R.O.C.

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

June 14, 2033

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

(AL/P/2022/458 in Albania;

P20221325T in Croatia;

602013082236.0

3111421 in Greece;

502022000069474 in Italy;

P912561 in North Macedonia;

SM-T-202200436 in San Marino;

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

Compositions for Transmucosal Delivery and Uses Thereof

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

June 14, 2033

BR112014031394-6

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Compositions and

Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

June 14, 2033

Methods and Compositions

for Treating Depression Using Cyclobenzaprine

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

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

Methods and Compositions

for Treating Depression Using Cyclobenzaprine

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

Methods and Compositions

for Treating Depression Using Cyclobenzaprine

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

Methods and Compositions

for Treating Depression Using Cyclobenzaprine

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

Methods and Compositions

for Treating Depression Using Cyclobenzaprine

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

Methods and Compositions

for Treating Depression Using Cyclobenzaprine

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

(AL/P/2020/15

MK/P/2020/68 in North Macedonia;

Methods and Compositions for Treating Depression Using Cyclobenzaprine

March 6, 2032

(AL/P/2020/15 in Albania;

P20200142 in Croatia;

in North Macedonia;

602012066717.6 in Germany;

3103147 in Greece;

HU/E048596 in Hungary;

502020000014740 in Italy;

SM-T-202000083

in San Marino;

10476 in North

SM-T-202000083 in San Marino;

60240 in Serbia;

202000139T4 in Turkey)

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,

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

Methods and Compositions

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

Country / Region

Expiration Date

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

November 18, 2030

Methods and Compositions

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

Methods 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

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

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

December 11, 2038

CBP/Amitriptyline

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

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

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride

and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride

and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

3 unchanged sentences

September 18, 2035

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

ZL201480024011.1

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

ZL.201580050140.2

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Taiwan R.O.C.

March 14, 2034

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

and Amitriptyline Hydrochloride

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

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

3 unchanged sentences

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

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

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

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Methods of Producing Same

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

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Methods of Producing Same

September 18, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

BR112015022095-9

Pharmaceutical Composition,

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

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

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

ZL201910263541.6

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

March 14, 2034

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

ZL202011576351.9

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations of Cyclobenzaprine Hydrochloride

September 18, 2035

Analogs of Cyclobenzaprine

and Amitryptilene

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

Magnesium-Containing

Oxytocin Formulations and Methods of Use

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

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

ZL201680013809.5

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

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)

(P20231438 in Croatia;

602016083177.5 in Germany;

HU/E065385 in Hungary;

65034 in Serbia;

SM-T-202400020 in San Marino;

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

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing Oxytocin Formulations and Methods of Use

January 7, 2036

Magnesium-Containing

Oxytocin Formulations and Methods of Use

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

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

Magnesium-Containing Oxytocin Formulations and Methods of Use

April 12, 2037

ZL201780036185.3

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing Oxytocin Formulations and Methods of Use

April 12, 2037

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing Oxytocin Formulations and Methods of Use

April 12, 2037

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

New Uses of Oxytocin-like

Molecules and Related Methods

Europe – (Switzerland,

Spain, France, United Kingdom, and Ireland)

Methods for the

Treatment of Insulin Resistance

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

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

Methods for treatment

Nociceptin/Orphanin FQ therapeutics

Country / Region

Expiration Date

Methods for treatment of pain

August 11, 2031

Methods for treatment

Methods for treatment of pain

October 12, 2030

Methods for treatment

Methods for treatment of pain

July 27, 2030

ZL 201080042858.4

Methods for treatment

Methods for treatment of pain

July 27, 2030

2459183 (602010028120.5

Methods for treatment

Europe – (Switzerland,

Germany, Denmark, France, and United Kingdom)

2459183 (602010028120.5 in Germany)

Methods for treatment of pain

Europe – (Switzerland, Germany, Denmark, France, and United Kingdom)

July 27, 2030

Methods for treatment

Methods for treatment of pain

July 27, 2030

Methods for treatment

Methods for treatment of pain

July 27, 2030

Methods for treatment

Methods for treatment of pain

July 27, 2030

Methods for treatment

Methods for treatment of pain

July 27, 2030

Methods for treatment

Methods for treatment of pain

July 27, 2030

Methods for treatment

Methods for treatment of pain

July 27, 2030

Methods for treatment

Methods for treatment of pain

July 27, 2030

– Neurocognitive Dysfunction

Method for Treating

Neurocognitive Dysfunction

Tianeptine – Neurocognitive

Country / Region

Expiration Date

Method for Treating Neurocognitive Dysfunction

September 24, 2030

Method for Treating

Neurodegenerative Dysfunction

April 30, 2029

2299822 (602009047361.1

in Germany 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

3246031 (602009057284.9

Method for Treating

Neurocognitive Dysfunction

European Patent

Office – Austria, Belgium, Switzerland, Germany, Spain, France, United Kingdom, Ireland, Luxembourg, Monaco, and Portugal

Method for Treating Neurodegenerative Dysfunction

April 30, 2029

reuptake inhibitor therapeutics

Tri-substituted

2-benzhydryl 5-benzlamino-tetrahydro-pyran-4-OL and 6-benzhydryl-4-benzylamino-tetrahydro-pyran-3-OL analogues, and novel

3,6 disubstituted pyran derivatives

Tri-substituted

2-benzhydryl 5-benzlamino-tetrahydro-pyran-4-OL and 6-benzhydryl-4-benzylamino-tetrahydro-pyran-3-OL analogues, and novel

3,6 disubstituted pyran derivatives

2299822 (602009047361.1 in Germany;

2644511 in Spain;

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

Tri-substituted

2-benzhydryl 5-benzlamino-tetrahydro-pyran-4-OL and 6-benzhydryl-4-benzylamino-tetrahydro-pyran-3-OL analogues, and novel

3,6 disubstituted pyran derivatives

December 7, 2025

Tri-substituted

2-benzhydryl 5-benzlamino-tetrahydro-pyran-4-OL and 6-benzhydryl-4-benzylamino-tetrahydro-pyran-3-OL analogues, and novel

3,6 disubstituted pyran derivatives

3246031 (602009057284.9 in Germany;

2727851 in Spain;

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

Tri-substituted

2-benzhydryl 5-benzlamino-tetrahydro-pyran-4-OL and 6-benzhydryl-4-benzylamino-tetrahydro-pyran-3-OL analogues, and novel

3,6 disubstituted pyran derivatives

January 12, 2027

Substituted Pyran Derivatives

February 6, 2034

Trefoil family factor

proteins and uses thereof

TFF2 therapeutics

Country / Region

Expiration Date

Trefoil family factor proteins and uses thereof

April 2, 2033

Trefoil family factor

proteins and uses thereof

Trefoil family factor proteins and uses thereof

April 2, 2033

Chimeric Poxviruses

Synthetic Chimeric

Synthetic Chimeric Poxviruses

Country / Region

Expiration Date

Synthetic Chimeric Poxviruses

November 2, 2037

Synthetic Chimeric

Synthetic Chimeric Poxviruses

November 2, 2037

Synthetic Chimeric

Synthetic Chimeric Poxviruses

November 2, 2037

Synthetic Chimeric

Synthetic Chimeric Poxviruses

November 2, 2037

Compound – Formulations

Formulations Comprising

Triptan Compounds

Synthetic Chimeric Poxviruses

November 2, 2037

ZL201780078546.0

Synthetic Chimeric Poxviruses

November 2, 2037

Synthetic Chimeric Poxviruses

November 2, 2037

Synthetic Chimeric Poxviruses

November 2, 2037

Triptan Compound – Formulations

Country / Region

Expiration Date

Formulations Comprising Triptan Compounds

July 19, 2031

Formulations Comprising

Triptan Compounds

Formulations Comprising Triptan Compounds

June 16, 2030

Formulations Comprising

Triptan Compounds

Formulations Comprising Triptan Compounds

June 16, 2030

Formulations Comprising

Triptan Compounds

Formulations Comprising Triptan Compounds

June 16, 2030

Formulations Comprising

Triptan Compounds

Formulations Comprising Triptan Compounds

June 16, 2030

Formulations Comprising

Triptan Compounds

Formulations Comprising Triptan Compounds

June 16, 2030

Formulations Comprising

Triptan Compounds

Formulations Comprising Triptan Compounds

June 17, 2030

Formulations Comprising Triptan Compounds

June 17, 2030

(E760080 in Austria;

502016000000073 in Italy;

602010028995.8

Formulations Comprising

Triptan Compounds

European Patent

Office - Austria, Belgium, Czechia, Denmark, France, Germany, Italy, Spain, Switzerland, and United Kingdom

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

Formulations Comprising Triptan Compounds

June 17, 2030

Formulations Comprising

Triptan Compounds

Formulations Comprising Triptan Compounds

Republic of Korea

June 17, 2030

Formulations Comprising

Triptan Compounds

Formulations Comprising Triptan Compounds

June 17, 2030

Formulations Comprising

Triptan Compounds

Formulations Comprising Triptan Compounds

June 17, 2030

Formulations Comprising

Triptan Compounds

Formulations Comprising Triptan Compounds

June 17, 2030

Compound – Migraine

Pharmaceutical Composition

for Treating Migraine

Triptan Compound – Migraine

Country / Region

Expiration Date

Pharmaceutical Composition for Treating Migraine

January 29, 2036

Pharmaceutical Composition

for Treating Migraine

Pharmaceutical Composition for Treating Migraine

January 29, 2036

Pharmaceutical Composition

Comprising Sumatriptan for Treating Migraine

Pharmaceutical Composition for Treating Migraine

January 29, 2036

Pharmaceutical Composition Comprising Sumatriptan for Treating Migraine

February 1, 2036

Pharmaceutical Composition

Comprising Sumatripan for Treating Migraine

Pharmaceutical Composition Comprising Sumatripan for Treating Migraine

February 1, 2036

Patent Applications

current pending patent applications are as follows:

and anti-CD154 Therapeutics

Anti-CD154 antibodies

and uses thereof

Anti-CD154 antibodies

and uses thereof

CD40 and anti-CD154 Therapeutics

Country / Region

Expiration Date

(E1717312 in Austria;

P20241602 in Croatia;

602020036714.4

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

BR112021026410-8

Anti-CD154 antibodies

and uses thereof

Anti-CD154 antibodies

and uses thereof

Anti-CD154 antibodies and uses thereof

BR122024022801-7

Anti-CD154 antibodies and uses thereof

202080059891.1

Anti-CD154 antibodies

and uses thereof

Anti-CD154 antibodies

and uses thereof (Allowed)

European Patent

Anti-CD154 antibodies

and uses thereof

Anti-CD154 antibodies

and uses thereof

Anti-CD154 antibodies

and uses thereof

Anti-CD154 antibodies

and uses thereof

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

Anti-CD154 antibodies and uses thereof

PI 2024006778

Anti-CD154 antibodies and uses thereof

MX/a/2022/000133

Anti-CD154 antibodies

and uses thereof

Anti-CD154 antibodies

and uses thereof

Anti-CD154 antibodies

and uses thereof

Anti-CD154 antibodies

and uses thereof

Anti-CD154 antibodies and uses thereof

62022063693.5

Anti-CD154 antibodies

and uses thereof

Anti-CD154 antibodies and uses thereof (Allowed)

62022062573.0

Anti-CD154 antibodies

and uses thereof

Methods of Inducing

Immune Tolerance with Modified Anti-CD154 Antibodies

Methods of Inducing

Immune Tolerance with Modified Anti-CD154 Antibodies

Anti-CD154 antibodies and uses thereof

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

BR112023013285-1

Methods of Inducing

Immune Tolerance with Modified Anti-CD154 Antibodies

Methods of Inducing

Immune Tolerance with Modified Anti-CD154 Antibodies

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

202280019221.6

Methods of Inducing

Immune Tolerance with Modified Anti-CD154 Antibodies

Methods of Inducing

Immune Tolerance with Modified Anti-CD154 Antibodies

European Patent

Methods of Inducing

Immune Tolerance with Modified Anti-CD154 Antibodies

Methods of Inducing

Immune Tolerance with Modified Anti-CD154 Antibodies

Methods of Inducing

Immune Tolerance with Modified Anti-CD154 Antibodies

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

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

MX/a/2023/008055

Methods of Inducing

Immune Tolerance with Modified Anti-CD154 Antibodies

Methods of Inducing

Immune Tolerance with Modified Anti-CD154 Antibodies

Methods of Inducing

Immune Tolerance with Modified Anti-CD154 Antibodies

Methods of Inducing

Immune Tolerance with Modified Anti-CD154 Antibodies

Inhibitors of CD40-CD154

European Patent

Inhibitors of CD40-CD154

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

62024090562.5

Inhibitors of CD40-CD154

CBP/Amitriptyline

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

BR112017005231-8

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

BR122020020968-2

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride (Allowed)

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

European Patent

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

62024091450.2

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride (Allowed)

Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies

Inhibitors of CD40-CD154 Binding

202080033531.4

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Eutectic Formulations

of Cyclobenzaprine Hydrochloride

Inhibitors of CD40-CD154 Binding

CBP/Amitriptyline Eutectic Formulations

Application No.

Country / Region

Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

BR112017005231-8

Eutectic 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

Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

Formulations of Cyclobenzaprine Hydrochloride

Eutectic Formulations

of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

CBP/Amitriptyline

and Methods for Transmucosal Absorption

and Methods for Transmucosal Absorption (Allowed)

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

202010024102.2

and Methods for Transmucosal Absorption

Compositions and Methods for Transmucosal Absorption

Gulf Cooperation

Compositions and Methods for Transmucosal Absorption

Gulf Cooperation

Compositions and Methods for Transmucosal Absorption

Gulf Cooperation

42020020336.2

and Methods for Transmucosal Absorption

– 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

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)

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 (Allowed)

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

Cyclobenzaprine

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

European Patent

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

MX/a/2020/006140

Cyclobenzaprine

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

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

European Patent Office

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

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

Methods and Compositions

for Treating Depression Using Cyclobenzaprine (Allowed)

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

62021029558.5

of Cyclobenzaprine and Amitriptyline

Patent Office

Analogs of Cyclobenzaprine

and Amitriptyline

– ASD and PTSD

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

Gulf Cooperation

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

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

202410396685.X

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

Analogs of CBP

Application No.

Country / Region

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

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

BR112021003107-3

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

201980062283.3

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

European Patent

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

202510112547.9

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

European Patent Office

62021045278.0

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

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

MX/a/2021/002012

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

Methods of Treating

Acute Stress Disorder and Posttraumatic Stress Disorder

– Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

62022046260.5

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

European Patent

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

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

10-2024-02502Q

Methods of Treating Acute Stress Disorder and Posttraumatic Stress Disorder

CBP – Fibromyalgia

Application No.

Country / Region

Cyclobenzaprine Treatment for Fibromyalgia

202180089897.8

Cyclobenzaprine Treatment for Fibromyalgia

European Patent Office

62024089847.3

Cyclobenzaprine Treatment for Fibromyalgia

62024090216.8

Cyclobenzaprine Treatment for Fibromyalgia

PI 2023003286

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine Treatment for Fibromyalgia

MX/a/2023/006720

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

Cyclobenzaprine

Treatment for Fibromyalgia

– Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine Treatment for Fibromyalgia

CBP – Fibromyalgia (Early Onset Response, Favorable

Tolerability, and Side Effect Profile)

Application No.

Country / Region

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

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

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

Cyclobenzaprine

Treatment for Alcohol Use Disorder

European Patent

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine

Treatment for Alcohol Use Disorder

Cyclobenzaprine Treatment for Alcohol Use Disorder

European Patent Office

62024087606.5

Cyclobenzaprine Treatment for Alcohol Use Disorder

62024089500.8

Cyclobenzaprine Treatment for Alcohol Use Disorder

MX/a/2023/005899

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

PCT/US2022/045791

Cyclobenzaprine

Treatment for Sexual Dysfunction

Cyclobenzaprine

Treatment for Sexual Dysfunction

Cyclobenzaprine

Treatment for Sexual Dysfunction

Cyclobenzaprine

Treatment for Sexual Dysfunction

Cyclobenzaprine Treatment for Alcohol Use Disorder

CBP – Sexual dysfunction

Application No.

Country / Region

Cyclobenzaprine Treatment for Sexual Dysfunction

202180040673.8

Cyclobenzaprine

Treatment for Sexual Dysfunction

Cyclobenzaprine

Treatment for Sexual Dysfunction

European Patent

Cyclobenzaprine

Treatment for Sexual Dysfunction

Cyclobenzaprine Treatment for Sexual Dysfunction (Allowed)

Cyclobenzaprine Treatment for Sexual Dysfunction

European Patent Office

Cyclobenzaprine Treatment for Sexual Dysfunction

62023077251.4

Cyclobenzaprine

Treatment for Sexual Dysfunction

Cyclobenzaprine Treatment for Sexual Dysfunction

62023078964.1

Cyclobenzaprine

Treatment for Sexual Dysfunction

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

PCT/US2023/025895

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

BR1120170145456

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

European Patent

Magnesium-Containing

Oxytocin Formulations and Methods of Use (Allowed)

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Republic of Korea

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Labeled Oxytocin

and Method of Manufacture and Use (Allowed)

Labeled Oxytocin

and Method of Manufacture and Use

European Patent

Labeled 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

Magnesium-Containing

Oxytocin Formulations and Methods of Use

European Patent

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Cyclobenzaprine Treatment for Sexual Dysfunction

62025103395.2

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)

MX/a/2025/000142

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

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

42024096348.8

Magnesium-Containing

Oxytocin Formulations and Methods of Use

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

42023079422.4

Magnesium-Containing Oxytocin Formulations and Methods of Use

MX/a/2023/008840

Magnesium-Containing

Oxytocin Formulations and Methods of Use

Nociceptin/Orphanin

FQ therapeutics

Magnesium-Containing Oxytocin Formulations and Methods of Use

Nociceptin/Orphanin FQ therapeutics

Application No.

Country / Region

BR122021007932-3

Methods for Treatment

Chimeric Poxviruses

Synthetic Chimeric

Methods for Treatment of Pain

Synthetic Chimeric Poxviruses

Application No.

Country / Region

Synthetic Chimeric Poxviruses

P 20170103043

Synthetic Chimeric

Gulf Cooperation

Synthetic Chimeric

Gulf Cooperation

Synthetic Chimeric

Synthetic Chimeric Poxviruses

Gulf Cooperation Council

Synthetic Chimeric Poxviruses

Gulf Cooperation Council

Synthetic Chimeric Poxviruses (Allowed)

Taiwan R.O.C.

Synthetic Chimeric

BR112019008781-8

Synthetic Chimeric

BR122023000373-0

Synthetic Chimeric

201780078546.0

Synthetic Chimeric

Poxviruses (Allowed)

Synthetic Chimeric

European Patent

Chimeric Poxviruses

Synthetic Chimeric

Chimeric Poxviruses

Synthetic Chimeric

62020003684.1

Synthetic Chimeric

Synthetic Chimeric Poxviruses

European Patent Office

Synthetic Chimeric Poxviruses

Synthetic Chimeric Poxviruses (Allowed)

Synthetic Chimeric Poxviruses

62020003684.1

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric

Vaccinia Virus

Gulf Cooperation

Synthetic Chimeric

Vaccinia Virus

Gulf Cooperation

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric

Vaccinia Virus

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

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric Vaccinia Virus

BR112020022181-3

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric Vaccinia Virus

201980029677.9

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric

Vaccinia Virus

European Patent

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric Vaccinia Virus

European Patent Office

Synthetic Chimeric Vaccinia Virus

PI 2020005696

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric Vaccinia Virus

MX/a/2020/011586

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric Vaccinia Virus

62021036744.2

Synthetic Chimeric

Vaccinia Virus

Synthetic Chimeric Vaccinia Virus

62021038254.0

Synthetic Chimeric

Vaccinia Virus

vaccine against COVID-19

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

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

AP/P/2022/014318

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

African Regional Intellectual Property Organization

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

BR112022016992-2

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

202180027983.6

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

Eurasian Patent Office

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

European Patent Office

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

PI 2022004613

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

MX/a/2022/010588

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant 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

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

Republic of Korea

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine

against SARS-CoV-2 virus

Recombinant Poxvirus

Based Vaccine against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

62023075022.1

Recombinant Poxvirus

Based Vaccine against SARS-CoV-2 virus

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

62023083678.0

Recombinant Poxvirus

Based Vaccine against SARS-CoV-2 virus

PCT/US2023/063503

Recombinant Poxvirus

Based Vaccine Against the Omicron Strain of SARS-CoV-2 Virus and Variants Thereof

Recombinant Poxvirus Based Vaccine against SARS-CoV-2 virus

TFF2 therapeutics

Application No.

Country / Region

Modified TFF2 polypeptides

4 unchanged sentences

Modified TFF2 polypeptides

European Patent

European Patent Office

Modified TFF2 polypeptides

9 unchanged sentences

Modified TFF2 polypeptides

Drugs – Cathepsin Inhibitors

Compositions and

Methods for Increasing Efficacy of a Drug

Compositions and

Methods for Increasing Efficacy of a Drug

Compositions and

Methods for Increasing Efficacy of a Drug

European Patent

Compositions and

Methods for Increasing Efficacy of a Drug

Compositions and

Methods for Increasing Efficacy of a Drug

202180060848.1

Compositions and

Methods for Increasing Efficacy of a Drug

62023079383.3

Compositions and

Methods for Increasing Efficacy of a Drug

Antiviral Drugs – Cathepsin Inhibitors

Application No.

Country / Region

Compositions and Methods for Increasing Efficacy of a Drug

62023079383.3

Compositions and

Methods for Increasing Efficacy of a Drug

Compound – Formulations

Formulations Comprising

Triptan Compounds

Compound – Migraine

Methods of Treating

Pharmaceutical Composition

for Treating Migraine

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.

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.

federally registered mark:

1 unchanged sentence

4656463, issued December 16, 2014).

are the owner of the following marks for which applications for U.S.

We are the owner of the following

marks for which applications for U.S.

federal registration are currently pending:

FYMRALIN (Serial

98/327953, filed December 22, 2023), MODALTIN (Serial No.

FYMRALIN (Serial No.

98/327953, filed December 22, 2023),

MODALTIN (Serial No.

97/424052, filed May 23, 2022), RAPONTIS (Serial No.

1 unchanged sentence

filed May 23, 2022), TONIX PHARMACEUTICALS (Serial No.

98/577945, filed May 31, 2024), ANGSTRO-TECHNOLOGY (Serial No.

98/006538, filed

April 30, 2020), ANGSTRO-TECHNOLOGY (Serial No.

98/006538, filed May 22, 2023) and TONMYA (Serial No.

May 22, 2023) and TNX-102 SL (Serial No.

97/185424, filed December 22, 2021).

Medicines, Inc.

seek trademark and service mark protection in the United States and outside of the United States where available and when appropriate.

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.

6 unchanged sentences

issued February 11, 2020);

TOSYMRA & DROPLET

TOSYMRA & DROPLET Design (Reg.

6142333, 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);

We are the owner of the following

International Registrations under the Madrid Protocol:

ONE LOGO Design (Serial No.

99/057051, filed February 26, 2025).

We are the owner of the following International Registrations under the

Madrid Protocol:

TOSYMRA (Reg.

1501060, issued October 16, 2019 – Extensions of

Protection to:

Canada, European Union, Japan, Republic of Korea, United Kingdom);

1501060, issued October 16, 2019 – Extensions of Protection to:

Canada, European Union, Japan,

Republic of Korea, United Kingdom);

ZEMBRACE (Reg.

1683288, issued August 17,

2022 – Extensions of Protection to:

Canada (still pending), China, European Union, Israel, Mexico, United Kingdom);

1545038, issued June 29, 2020 – Extensions of Protection to:

Canada, European Union, Israel, Japan, Norway,

Republic of Korea, Switzerland, Turkey, United Kingdom).

and Development

have approximately 71 employees dedicated to research and development.

Our research and development operations are located in

Chatham, NJ, Dartmouth, MA, 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 acquired the RDC in Frederick, Maryland consisting of two

buildings totaling approximately 48,000 square feet.

The acquisition closed in October 2021 and is operational.

We have two 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.

1683288, issued August 17, 2022 – Extensions of Protection to:

Canada (still

pending), 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);

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.

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.

of our small molecules drug candidates are synthesized using industry standard processes, and our drug products are formulated

using commercially available pharmaceutical grade excipients.

own a 45,000 square foot facility in Massachusetts, to house our new Advanced Development Center for accelerated development and manufacturing

of vaccines and biologics.

As of October 1, 2022, the facility was ready for its intended use and is operational.

This facility, in addition

to contract CMOs, is currently used for the manufacture of nonclinical and clinical investigational products for our Immunology and Infectious

Disease portfolio.

The current focus of which is TNX-1500 for Organ Transplant Rejection/Autoimmune Disorders, TNX-01 a Smallpox and

Monkeypox Preventing Vaccine and TNX-1800 a COVID vaccine selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials.

own an approximately 44-acre site in Hamilton, Montana, for the construction of a vaccine development and commercial scale manufacturing

As of December 31, 2023, the facility was not ready for its intended use.

We have contracted

with third-party cGMP-compliant contract manufacturer organizations(“CMOs”), for the manufacture of TNX-102 SL drug

substance and drug products for clinical and commercial supply.

Our manufacturing operations are managed and controlled out of

our Dublin, Ireland offices.

All of our small molecules

drug candidates are synthesized using industry standard processes, and our drug products are formulated using commercially available

pharmaceutical grade excipients.

We own a 45,000 square foot facility in Massachusetts, to house our new

Advanced Development Center for accelerated development and manufacturing of vaccines and biologics.

This facility is currently decommissioned.

It was designed for the manufacture of nonclinical and clinical investigational products for our Infectious Disease portfolio.

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

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.

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 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:

of extensive nonclinical laboratory tests, animal studies and formulation studies, all performed in accordance with the FDA’s

Good Laboratory Practice regulations;

to the FDA of an IND, which must become effective before human clinical trials may begin;

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;

to the FDA of an NDA for drug products, or a Biologics License Application, or BLA, for biologic products;

completion of a preapproval inspection by the FDA of the manufacturing facilities at which the product is produced to assess

compliance with cGMP regulations;

FDA’s review and approval of the NDA or BLA prior to any commercial marketing, sale or shipment of the drug.

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.

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.

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.

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.

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

The IRB also approves the consent form signed by the trial participants and must monitor the study until completed.

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.

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

clinical trials are typically conducted in three sequential phases, but the phases may overlap, or be combined.

1 clinical trials typically involve the initial introduction of the product candidate into healthy human volunteers.

1 clinical trials, the product candidate is typically tested for safety, dosage tolerance, absorption, metabolism, distribution,

excretion and pharmacodynamics.

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;

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.

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.

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

Drug Applications

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

The manufacturing process must be capable of consistently producing quality product within specifications approved

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.

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.

FDA reviews all NDAs and BLAs submitted before it accepts them for filing.

The FDA may request additional information rather than

accept an NDA for filing.

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.

is not bound by the recommendations of an advisory committee, but it considers them carefully when making decisions.

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.

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.

are two types of NDAs:

the Section 505(b)(1) NDA, or full NDA, and the Section 505(b)(2) NDA.

We intend to file Section 505(b)(2)

NDAs for TNX-102 SL for FM, and FM-type Long COVID, and TNX-2900 for Prader Willi Syndrome and for certain other

products, that might, if accepted by the FDA, save time and expense in the development and testing of our product candidates.

need to file a Section 505(b)(1) NDA for certain other products in the future.

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

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 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.

drug approval strategy for our new formulations of approved chemical entities is to submit Section 505(b)(2) NDAs to the FDA.

As such, we plan to submit an NDA under Section 505(b)(2) for TNX-102 SL for FM, FM-type Long COVID, and TNX-2900

for Prader Willi Syndrome.

The FDA may not agree that these product candidates are approvable as a Section 505(b)(2) NDA.

FDA determines that a Section 505(b)(2) NDA is not appropriate and that a full NDA is required, the time and financial resources

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).

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;

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)

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

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.

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.

the 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.

(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

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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.

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.

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.

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.

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.

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.

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

Therapy Designation

Food and Drug Administration Safety and Innovation Act, or FDASIA, Section 902 provides for Breakthrough Therapy designation.

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:

alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition;

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.

Track Designation

Fast Track is a designation by the FDA of an investigational drug which:

alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition;

or clinical data demonstrate the potential to address an unmet medical need

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

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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

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.

Threat Medical Countermeasures

2016, the 21 st Century Cures Act, or Act, was signed into law to support ongoing biomedical innovation.

the Act, Section 3086, is aimed at “Encouraging Treatments for Agents that Present a National Security Threat.” The

Act created a new priority review voucher program for approved “material threat medical countermeasure applications.”

The Act defines such countermeasures as drug or biological products, including vaccines intended to treat biological, chemical,

radiological, or nuclear agents that present a national security threat or to treat harm from a condition that may be caused by

administering a drug or biological product against such an agent.

The Department of Homeland Security has identified 13 such threats,

including anthrax, smallpox, Ebola/Marburg, tularemia, botulinum toxin, and pandemic influenza, which includes the SARS coronavirus

2, known as SARS-CoV-2.

Regulatory Requirements

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.

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

against such an agent.

The Department of Homeland Security has identified 13 such threats, including anthrax, smallpox, Ebola/Marburg,

tularemia, botulinum toxin, and pandemic influenza, which includes SARS-CoV-2.

Other 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

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regulation by the FDA, including:

record-keeping

requirements;

of adverse experiences with the drug;

the FDA with updated safety and efficacy information;

on advertisements and promotional labeling;

sampling and distribution requirements;

with electronic record and signature requirements.

addition, the FDA strictly regulates labeling, advertising, promotion and other types of information on products that are placed

on the market.

There 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.

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.

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.

and Reimbursement

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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.

These third-party payors

are increasingly limiting coverage or reducing reimbursements for medical products and services.

In addition, the U.S.

government, 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.

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

Failure to comply with these laws, where applicable, can result in the imposition of significant civil penalties, criminal

penalties, or both.

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:

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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.

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.

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.

Impact of New Legislation and Amendments to Existing Laws

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 five years.

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.

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.

Capital Resources

of April 1, 2024, we had 103 full-time employees, of whom 16 hold M.D.

We have 71 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.

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 Chatham, NJ, Dartmouth, MA, 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 26 Main Street, Suite 101, Chatham, New Jersey 07928,

and our telephone number is (862) 799 8599.

Human Capital Resources

As of March 17, 2025, we had 81 full-time employees, of whom 12 hold M.D.

We have 45 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.

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.

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.

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.

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