What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-11-09 compared with 2023-08-10 · 472 added, 693 removed, 120 unchanged (91% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS

OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This Management’s

Discussion and Analysis of Financial Condition and Results of Operations includes a number of forward-looking statements that reflect

Management’s current views with respect to future events and financial performance.

You can identify these statements by

forward-looking words such as “may” “will,” “expect,” “anticipate,” “believe,”

“estimate” and “continue,” or similar words.

Those statements include statements regarding the intent,

belief or current expectations of us and members of its management team as well as the assumptions on which such statements are

Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and

involve risk and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Management’s Discussion and Analysis of Financial Condition and Results of Operations includes a number of forward-looking statements

that reflect Management’s current views with respect to future events and financial performance.

You can identify these statements

by forward-looking words such as “may” “will,” “expect,” “anticipate,” “believe,”

“estimate” “continue,” or similar words.

Those statements include statements regarding the intent, belief

or current expectations of us and members of its management team as well as the assumptions on which such statements are based.

investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risk and uncertainties,

and that actual results may differ materially from those contemplated by such forward-looking statements.

Readers are urged

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differences include, but are not limited to:

the COVID-19 pandemic, including its impact on the Company, substantial competition;

our possible need for additional financing;

risks related to our ability to successfully commercialize our products, failure to

obtain clearances or approvals from the United States Food and Drug Administration, or FDA, and noncompliance with FDA regulations;

our need for additional financing;

substantial competition;

uncertainties of patent protection and litigation;

uncertainties of government or third

party payor reimbursement;

limited research and development efforts and dependence upon third parties;

and risks related to failure

to obtain clearances or approvals from the United States Food and Drug Administration, or FDA, and noncompliance with FDA regulations.

Business Overview

Tonix is a biopharmaceutical

company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and

alleviate suffering.

Tonix Medicines, our commercial subsidiary markets Zembrace® SymTouch® (sumatriptan injection)

3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories

from whom the products were acquired on June 30, 2023.

Zembrace SymTouch and Tosymra are each indicated for the treatment of acute

migraine with or without aura in adults.

Tonix’s development portfolio is composed of central nervous system (CNS), rare

disease, immunology and infectious disease product candidates.

Tonix’s CNS development portfolio includes both small molecules

and biologics to treat pain, neurologic, psychiatric and addiction conditions.

Tonix’s lead development CNS candidate, TNX-102

SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed

enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth

quarter of 2023.

TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition.

Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results are expected in the third quarter of 2023.

TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for

major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with

topline results expected in the fourth quarter of 2023.

TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule

oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease.

tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition

test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture.

TNX-1900 (intranasal

potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase

2 proof-of-concept study with topline data expected in the fourth quarter of 2023.

TNX-1900 is also being studied in binge eating

disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs.

(cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation

A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023.

Tonix’s rare disease development

portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome.

TNX-2900 has been granted

Orphan Drug designation by the FDA.

Tonix’s immunology development portfolio includes biologics to address organ transplant

rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L

or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases.

A Phase 1 study

of TNX-1500 is expected to be initiated in the third quarter of 2023.

Tonix’s infectious disease pipeline includes TNX-801,

a vaccine in development to prevent smallpox and mpox.

TNX-801 also serves as the live virus vaccine platform or recombinant pox

vaccine platform for other infectious diseases.

The infectious disease development portfolio also includes TNX-3900 and TNX-4000,

which are classes of broad-spectrum small molecule oral antivirals.

Tonix’s product

development candidates are investigational new drugs or biologics and have not been approved for any indication.

Tonix Medicines has contracted to acquire the Zembrace SymTouch and Tosymra registered trademarks.

Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc.

Results of Operations

We anticipate that

our results of operations will fluctuate for the foreseeable future due to several factors, such as the sales of Zembrace® and Tosymra®, the progress of our research

and development efforts and the timing and outcome of regulatory submissions.

uncertainties of

government or third party payor reimbursement;

limited research and development efforts and dependence upon third parties and those

discussed in the section titled “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended

December 31, 2022 and in our other SEC filings, as may be amended, supplemented or superseded from time to time by other reports

we file with the SEC.

is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent

human disease and alleviate suffering.

Tonix Medicines, our commercial subsidiary, markets

Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a

transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023.

SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults.

development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product

Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic,

psychiatric and addiction conditions.

Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual

tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory

Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023.

TNX-102 SL is also being developed to

treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results were reported in the third quarter

TNX-1900 (intranasal potentiated oxytocin), is in development as a

preventive treatment in chronic migraine, and the clinical phase of a Phase 2 proof-of-concept study is now completed with topline

data expected in early December 2023.

TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety

disorder by academic collaborators under investigator-initiated INDs.

TNX-1300 (cocaine esterase) is a biologic designed to treat

cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA.

A Phase 2 study of TNX-1300 is expected to be

initiated in the fourth quarter of 2023.

Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated

oxytocin) for the treatment of Prader-Willi syndrome.

TNX-2900 has been granted Orphan Drug designation by the FDA.

immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including

TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of

allograft rejection and for the treatment of autoimmune diseases.

A Phase 1 study of TNX-1500 was initiated in the third quarter of

Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox.

also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including

TNX-1800, in development as a vaccine to protect against COVID-19.

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

National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials.

The infectious disease development portfolio also includes

TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

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

of Operations

anticipate that our results of operations will fluctuate for the foreseeable future due to several factors, such as the progress of our

research and development efforts and the timing and outcome of regulatory submissions.

Due to these uncertainties, accurate predictions

of future operations are difficult or impossible to make.

Three Months Ended June 30, 2023

Compared to Three Months Ended June 30, 2022

Research and Development

Research and development expenses for the three months ended June 30, 2023 were $22.0 million, an increase of $5.4

million, or 33%, from $16.6 million for the three months ended June 30, 2022.

This increase is predominately due to increased clinical

expenses of $1.4 million, employee-related expenses of $1.3 million, lab supplies of $0.6 million, building-related expenses of $1.4 million

and professional fees of $0.3 million.

The table below summarizes

our direct research and development expenses for our product candidates and development platform for the three months ended June

30, 2023, and 2022.

Three Months Ended June 30,

Months Ended September 30, 2023 Compared to Three Months Ended September 30, 2022

Company recognized revenue from customers beginning in the three months period ended September 30, 2023 as a result of the Upsher

Smith acquisition.

See discussion at Note 10 to our interim condensed financial statements appearing in this Quarterly Report on

Revenue recognized for the three months ended September 30, 2023 was $4.0 million.

Company’s net product revenues are summarized below:

Three Months Ended September 30,

Zembrace® Symtouch®

Total product revenues

Cost of Sales .

Company recognized cost of sales beginning in the three months period ended September 30, 2023 as a result of the Upsher Smith

See discussion at Note 10 to our interim condensed financial statements appearing in this Quarterly Report on Form

Cost of sales recognized for the three months ended September 30, 2023 was $2.4 million.

and Development Expenses .

Research and development expenses for the three months ended September 30, 2023 were $21.1 million,

a decrease of $1.1 million, or 5%, from $22.2 million for the three months ended September 30, 2022.

This decrease is predominately due

to decreased non-clinical expenses of $1.6 million, manufacturing expenses of $2.9 million, offset by an increase in clinical expenses

of $1.5 million, an increase in employee-related expenses and professional fees of $1.0 million, office-related expenses of $0.7 million

and lab supplies of $0.2 million.

table below summarizes our direct research and development expenses for our product candidates and development platform for the three

months ended September 30, 2023, and 2022.

Three months ended September 30,

(in thousands)

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Direct expenses – TNX - 1900

Direct expenses – TNX – 1900

Direct expenses – TNX – 3900

Direct expenses – Other programs

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and development expenses consist principally of external costs for clinical, nonclinical and manufacturing, such as fees paid to

contractors, consultants and CROs in connection with our development work.

Included in “Internal Staffing, Overhead and Other”

is overhead, supplies, research and development employee costs (including stock option expenses), travel, regulatory and legal.

General and Administrative

General and administrative expenses for the three months ended June 30, 2023 were $7.0 million, an increase of

$0.2 million, or 3%, from $6.8 million incurred in the three months ended June 30, 2022.

The increase in primarily due to an increase

in legal expenses of $0.4 million, offset by a decrease in employee-related expenses of $0.2 million.

a result of the forgoing, the net loss for the three months ended June 30, 2023 was $28.4 million, an increase of $5.3 million, or 23%, compared to a net loss of $23.1

million for the three months ended June 30, 2022.

Six Months Ended June 30, 2023 Compared

to Six Months Ended June 30, 2022

Research and Development

Research and development expenses for the six months ended June 30, 2023 were $48.5 million, an increase of $13.5

million, or 39%, from $35.0 million for the six months ended June 30, 2022.

This increase is predominately due to increased clinical expenses

of $5.4 million, non-clinical expenses of $1.3 million employee-related expenses of $3.2 million, office-related expenses of $2.9 million,

professional fees of $0.7 million and lab supplies of $2.5 million offset by a decrease in manufacturing expenses of $3.2 million.

The table below summarizes

our direct research and development expenses for our product candidates and development platform for the six months ended June

30, 2023, and 2022.

Six Months Ended June 30,

contractors, consultants and contract research organizations in connection with our development work.

Included in “Internal

Staffing, Overhead and Other” is overhead, supplies, research and development employee costs (including stock option expenses),

travel, regulatory and legal.

and Administrative Expenses .

General and administrative expenses for the three months ended September 30, 2023 were

$8.7 million, an increase of $1.3 million, or 18%, from $7.4 million incurred in the three months ended September 30, 2022.

increase is primarily due to sales and marketing of $1.3 million, transition services agreement fees payable to Upsher-Smith Laboratories,

LLC (“USL”) of $0.7 million, an increase in amortization expenses of $0.2 million, offset by a decrease in financial

reporting expenses of $0.6 million and payroll-related expenses of $0.4 million.

As a result of the foregoing, the net loss for the three months ended September 30, 2023 was $28.0 million, compared to

a net loss of $29.0 million for the three months ended September 30, 2022.

Months Ended September 30, 2023 Compared to Nine Months Ended September 30, 2022

Company recognized revenue from Customers beginning in the nine months period ended September 30, 2023 as a result of the Upsher

Smith acquisition.

See discussion at Note 10 to our interim condensed financial statements appearing in this Quarterly Report on

Revenue recognized for the nine months ended September 30, 2023 was $4.0 million.

The Company’s net product revenues are summarized below:

Nine Months Ended September 30,

Zembrace® Symtouch®

Total product revenues

Cost of Sales .

Company recognized cost of sales beginning in the nine months period ended September 30, 2023 as a result of the Upsher Smith acquisition.

See discussion at Note 10 to our interim condensed financial statements appearing in this Quarterly Report on Form 10-Q.

sales recognized for the nine months ended September 30, 2023 was $2.4 million

and Development Expenses .

Research and development expenses for the nine months ended September 30, 2023 were $69.5 million,

an increase of $12.3 million, or 22%, from $57.2 million for the nine months ended September 30, 2022.

This increase is predominately

due to increased clinical expenses of $6.9 million, employee-related expenses of $3.7 million, office-related expenses of $3.5 million

and lab supplies of $2.7 million, offset by a decrease in manufacturing costs of $6.1 million and non-clinical expenses of $0.2 million.

table below summarizes our direct research and development expenses for our product candidates and development platform for the nine

months ended September 30, 2023, and 2022.

Nine months ended September 30,

(in thousands)

6 unchanged sentences

Direct expenses – TNX - 1900

Direct expenses – TNX - 3900

Direct expenses – Other programs

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Total research & development

Our direct research

and development expenses consist principally of external costs for clinical, nonclinical and manufacturing, such as fees paid to

contractors, consultants and contract research organizations in connection with our development work.

Included in “Internal Staffing, Overhead and Other”

is overhead, supplies, research and development employee costs (including stock option expenses), travel, regulatory and legal.

General and Administrative

General and administrative expenses for the six months ended June 30, 2023 were $14.4 million, a decrease of $0.4

million, or 3%, from $14.8 million incurred in the six months ended June 30, 2022.

The decrease is primarily due to a decrease in financial

reporting expenses of $1.1 million, offset by an increase in legal fees of $0.3 million, increased accounting fees of $0.3 million and

employee-related expenses of $0.1 million.

As a result of the foregoing, the net loss for the six months ended June 30, 2023 was $61.4 million, an increase of $11.8 million, or 24%, compared to a net loss of

$49.6 million for the six months ended June 30, 2022.

License Agreements

direct research and development expenses consist principally of external costs for clinical, nonclinical and manufacturing, such as fees

paid to contractors, consultants and CROs in connection with our development work.

Included in “Internal Staffing, Overhead and

Other” is overhead, supplies, research and development employee costs (including stock option expenses), travel, regulatory and

and Administrative Expenses .

General and administrative expenses for the nine months ended September 30, 2023 were $23.1

million, an increase of $0.9 million, or 4%, from $22.2 million incurred in the nine months ended September 30, 2022.

The increase is

primarily due to sales and marketing of $1.3 million, and transition services agreement fees payable to USL of $0.7 million, depreciation

expenses of $0.3 million and accounting-related expenses of $0.3 million, offset by a decrease in financial reporting expenses of $1.8

million and compensation-related expenses of $0.2 million.

As a result of the foregoing, the net loss for the nine months ended September 30, 2023 was $89.3 million, compared to

a net loss of $78.5 million for the nine months ended September 30, 2022.

On February 13, 2023,

we exercised an option to obtain an exclusive license from Columbia for the development of a portfolio of both fully human and

murine mAbs for the treatment or prophylaxis of SARS-CoV-2 infection, including our TNX-3600 and TNX-4100 product candidates, respectively.

we exercised an option to obtain an exclusive license from Columbia for the development of a portfolio of fully human and murine

mAbs for the treatment or prophylaxis of SARS-CoV-2 infection, including our TNX-3600 and TNX-4100 product candidates, respectively.

The licensed mAbs were developed as part of a research collaboration and option agreement between us and Columbia.

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or prophylaxis of SARS-CoV-2 infection.

We believe that the licensing of these mAbs strengthens our pipeline of next-generation

therapeutics to treat COVID-19, which is caused by SARS-CoV-2.

As consideration for entering into the License Agreement, we paid

a license fee of approximately $0.4 million to Curia.

The License Agreement also provides for single-digit royalties and contingent

milestone payments.

As of June 30, 2023, other than the upfront fee, no payments have been accrued or paid in relation to this

As consideration for entering into the License Agreement, we paid a license fee of approximately

$0.4 million to Curia.

The license agreement also provides for single-digit royalties and contingent milestone payments.

September 30, 2023, other than the upfront fee, no payments have been accrued or paid in relation to this agreement.

On May 18, 2022, we

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contingent milestone payments.

As of June 30, 2023, other than the upfront fee, no payments have been accrued or paid in relation

As of September 30, 2023, other than the upfront fee, no payments have been accrued or paid in relation

to this agreement.

On February 11, 2021,

we entered into a license agreement (the “Inserm License Agreement”) pursuant to which we licensed technology using

oxytocin-based therapeutics for the treatment of Prader-Willi syndrome and non-organic failure to thrive disease from Inserm (the

French National Institute of Health and Medical Research), Aix-Marseille Université and Centre Hospitalier Universitaire

The Inserm License Agreement provides for the payment of annual fees and milestone payments upon the occurrence of

specified sales milestones, totaling approximately $0.4 million, as well royalties on net sales of products based on the licensed

technology, and assignment/transfer and sublicense royalties.

As of June 30, 2023, no milestone payments have been accrued or paid

in relation to this agreement.

On September 16, 2019,

we entered into an exclusive License Agreement (the “Columbia License Agreement”) with the Trustees of Columbia University

in the City of New York (“Columbia”), as subsequently amended, pursuant to which Columbia granted to us an exclusive

license, with the right to sublicense, certain patents and technical information (collectively, the “TFF2 Technology”)

related to a recombinant Trefoil Family Factor 2 (TFF2), and to develop and commercialize products thereunder (each, a “TFF2

Pursuant to the terms of the Columbia License Agreement, Columbia has reserved for itself the right to practice

the TFF2 Technology for academic research and educational purposes.

We paid a five-digit

license fee to Columbia as consideration for entering into the Columbia License Agreement, which was previously recorded to research

and development expenses in the statement of operations.

We are obligated to use Commercially Reasonable Efforts, as defined in

the Columbia License Agreement, to develop and commercialize the TFF2 Product, and to achieve specified developmental milestones.

We are obligated to

pay Columbia single-digit royalties on net sales of (i) TFF2 Products sold by us or a sublicensee and (ii) any other products that

involve material or technical information related to the TFF2 Product and transferred to us pursuant to the License Agreement (“Other

Products”) sold by us or a sublicensee.

Royalties on each particular TFF2 Product are payable on a country-by-country and

Product-by-Product basis until the latest of (i) the date of expiration of the last valid claim in the last to expire of the issued

patents covered by the Columbia License Agreement, and (ii) a specified period of time after the first commercial sale of a TFF2

Product in the country in question.

Royalties on each particular Other Product are payable on a country-by-country and product-by-product

basis until a specified period of time after the first commercial sale of such particular Other Product in such country.

payable on net sales of the TFF2 Product and Other Products may be reduced by 50% of the royalties payable by us to any third party

for intellectual property rights which are necessary for the practice of the rights licensed to us under the Columbia License Agreement,

provided that the royalty payable on a TFF2 Product or Other Product may not be reduced by more than 50%.

We are also obligated

to make contingent milestone payments to Columbia totaling $4.1 million on a Product-by-Product basis upon the achievement of

certain development, approval and sales milestones related to a TFF2 Product.

In addition, we shall pay Columbia 5% of consideration,

other than royalty payments and certain other categories of consideration, payable to us by a sublicensee.

As of June 30, 2023,

no milestone payments have been accrued or paid in relation to this agreement.

On May 20, 2019, we

entered into an exclusive License Agreement (the “License Agreement”) with Columbia pursuant to which Columbia, for

itself and on behalf of the University of Kentucky and the University of Michigan (collectively, the “Institutions”)

granted to us an exclusive license, with the right to sublicense, certain patents, technical information and material (collectively,

the “Technology”) related to a double-mutant cocaine esterase, and to develop and commercialize products thereunder

(each, a “Product”).

Pursuant to the terms of the License Agreement, Columbia has reserved for itself and the Institutions

the right to practice the Technology for academic research and educational purposes.

We paid a six-digit

license fee to Columbia as consideration for entering into the License Agreement.

We are obligated to use Commercially Reasonable

Efforts, as defined in the License Agreement, to develop and commercialize the Product, and to achieve specified developmental

We are obligated

to pay Columbia single-digit royalties on net sales of (i) Products sold by us or a sublicensee and (ii) any other products that

involve material or technical information related to the Product and transferred to us pursuant to the License Agreement (“Other

Products”) sold by us or a sublicensee.

Royalties on each particular Product are payable on a country-by-country and Product-by-Product

basis until the latest of (i) the date of expiration of the last valid claim in the last to expire of the issued patents covered

by the License Agreement, (ii) a specified period of time after the first commercial sale of a Product in the country in question,

or (iii) expiration of any market exclusivity period granted by a regulatory agency.

Royalties on each particular Other Product

are payable on a country-by-country and product-by-product basis until the later of (i) a specified period of time after the first

commercial sale of such particular Other Product in such country or (ii) expiration of any market exclusivity period granted by

a regulatory agency.

Royalties payable on net sales of the Product and Other Products may be reduced by 50% of the royalties payable

by us to any third party for intellectual property rights which are necessary for the practice of the rights licensed to us under

the License Agreement, provided that the royalty payable on a Product or Other Product may not be reduced by more than 50%.

We are also obligated

to make contingent milestone payments to Columbia totaling $3 million on a Product-by-Product basis upon the achievement of certain

development, approval and sales milestones related to a Product.

In addition, we shall pay Columbia 5% of consideration, other

than royalty payments and certain other categories of consideration, payable to us by a sublicensee.

As of June 30, 2023, no milestone

payments have been accrued or paid in relation to this agreement.

Asset Purchase Agreements

On June 23, 2023,

we entered into an Asset Purchase Agreement with Upsher-Smith Laboratories, LLC, (“USL”),

for the acquisition of certain assets related to Zembrace® SymTouch® (sumatriptan injection) 3 mg (“Zembrace”)

and Tosymra® (sumatriptan nasal spray) 10 mg (“Tosymra”) products (such businesses collectively, the “Business”)

and certain inventory related to the Business for an aggregate purchase price of approximately $26.5 million, including certain

deferred payments and subject to customary adjustments (such transaction, the “USL Acquisition”).

The transaction closed

on June 30, 2023.

Purchase Agreements

On June 23, 2023, we

entered into an asset purchase agreement with USL for the acquisition of certain assets related to Zembrace® SymTouch®

(sumatriptan injection) 3 mg (“Zembrace”) and Tosymra® (sumatriptan nasal spray) 10 mg (“Tosymra”)

products (such businesses collectively, the “Business”) and certain inventory related to the Business for an aggregate

purchase price of approximately $26.5 million, including certain deferred payments (such transaction, the “USL Acquisition”).

The transaction closed on June 30, 2023.

Additionally, in connection

with the USL Acquisition, we and USL entered into a Transition Services Agreement (the “Transition Services Agreement”),

pursuant to which USL will provide certain transition services to us for base fees equal to $100,000 per month for the first six

months, and $150,000 per month for the seventh through ninth months, plus additional monthly fees for each service category totaling

up to $150,000 per month.

As consideration for

acquisition of the Business and certain product-related inventories, we transferred an aggregate upfront purchase price of approximately

$22.2 million in cash as of the Closing.

The closing cash consideration was later adjusted upwards by approximately $1.3 million

upon the determination of the value of the acquired inventory on hand as of June 30, 2023.

The inventory adjustment payment is

expected to be settled in the third quarter of 2023.

On the earlier of March 2024 or the completion of the transition services

to be provided by USL, as described above, we agreed to pay an additional deferred payment of $3.0 million in cash.

As the assets acquired met the definition of a business under the current accounting guidance, the total purchase

price was allocated to the acquired inventory and other tangible assets, and the developed technology intangible assets related to Zembrace

and Tosymra based on their estimated fair values on the acquisition date.

The excess of the purchase price over the fair value of the

acquired assets was recorded as goodwill.

February 2, 2023, we entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Healion

with the USL Acquisition, we and USL entered into a transition services agreement pursuant to which USL will provide certain transition

services to us for base fees equal to $100,000 per month for the first six months, and $150,000 per month for the seventh through

ninth months, plus additional monthly fees for each service category totaling up to $150,000 per month.

As the assets acquired

met the definition of a business under the current accounting guidance, the total purchase price was allocated to the acquired

inventory and other tangible assets, and the developed technology intangible assets related to Zembrace and Tosymra based on their

estimated fair values on the acquisition date.

The excess of the purchase price over the fair value of the acquired assets was

recorded as goodwill.

have assumed certain obligations of USL, including the payment of quarterly earn-out payments on annual net sales from the Business

for Tosymra, 4% for net sales of $0 to $30 million, 7% of net sales of $30 to $75 million;

9% for net sales

of $75 to $100 million;

12% for net sales of $100 to $150 million;

and 15% for net sales greater than $150 million.

Earn-out payments

with respect to Tosymra are payable until the expiration or termination of the product’s Orange Book listed patent(s) with

respect to the United States or, outside the United States, the expiration of the last valid claim covering the product in the

relevant country of the territory.

For Zembrace, earn-out payments on annual net sales in the U.S.

are 3% for net sales of $0 to

$30 million, 6% of net sales of $30 to $75 million;

12% for net sales of $75 to $100 million;

16% for net sales of greater than

$100 million.

Such earn-out payments are payable until July 19, 2025.

Upon the entry of a generic version of the relevant product,

the applicable earn-out rates shall be reduced by 90% percent with respect to Zembrace, and by 66.7% percent for Tosymra.

addition, we have assumed the obligation to pay an additional 3% royalty on net sales of Tosymra, plus an additional 3% if a patent

containing certain claims related to Tosymra issues in the U.S., for 15 years from the first commercial sale of Tosymra in the

applicable country or for as long as the manufacture, use or sale of Tosymra in such country is covered by a valid claim of a licensed

patent, and up to $15 million per Tosymra product on the achievement of sales milestones.

February 2, 2023, we entered into an asset purchase agreement (the “Healion Purchase Agreement”) with Healion

Bio Inc., pursuant to which we acquired all the pre-clinical infectious disease assets of

Healion, including its portfolio of next-generation antiviral technology assets.

Healion’s drug portfolio includes a class

of broad-spectrum small molecule oral antiviral drug candidates with a novel host-directed mechanism of action, including TNX-3900,

formerly known as HB-121.

As consideration for entering into the Asset Purchase Agreement, we paid $1.2 million to Healion.

Because the Healion intellectual property was acquired prior to FDA approval, the cash consideration totaling $1.2 million, was

expensed as research and development costs since there is no alternative future use and the acquired intellectual property does

not constitute a business.

On December 22, 2020,

we entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Katana Pharmaceuticals, Inc.

pursuant to which we acquired Katana assets related to insulin resistance and related syndromes, including obesity (the “Katana

In connection with the acquisition of the Assets, we assumed Katana’s rights and obligations under that certain

Exclusive License Agreement by and between Katana and The University of Geneva (“Geneva”) (the “Geneva License

“Agreement”) pursuant to an Assignment and Assumption Agreement with Geneva (“Geneva Assignment and Assumption

Agreement”), dated December 22, 2020.

As consideration for entering into the Asset Purchase Agreement, we paid $0.7 million

Because the Katana intellectual property was acquired prior to FDA approval, the cash consideration totaling $0.7 million,

was expensed as research and development costs since there is no alternative future use and the acquired intellectual property

does not constitute a business.

Pursuant to the terms

of the Geneva Assignment and Assumption Agreement, Geneva granted us an exclusive license, with the right to sublicense, certain

patents related to the Katana Assets.

We are obligated to use commercially reasonable efforts to diligently develop, manufacture,

and sell products claimed or covered by the patent and will use commercially reasonable efforts to diligently develop markets for

such products.

The Geneva License Agreement specifies developmental milestones and the period of time during which such milestones

must be completed and provides for an annual maintenance fee payable to Geneva.

As of June 30, 2023, no milestone payments have

been accrued or paid in relation to this agreement.

On June 11, 2020, we

entered into an asset purchase agreement (the “Trigemina Asset Purchase Agreement”) with Trigemina, Inc.

(“Trigemina”)

and certain shareholders named therein (the “Executive Shareholders”) pursuant to which we acquired Trigemina assets

related to migraine and pain treatment technologies (the “Trigemina Assets”).

In connection with the acquisition of

the Trigemina Assets, we assumed Trigemina’s rights and obligations under that certain Amended and Restated Exclusive License

Agreement, dated November 30, 2007, as amended, by and between Trigemina and The Board of Trustees of the Leland Stanford Junior

University (“Stanford”) (the “Stanford License “Agreement”) pursuant to an Assignment and Assumption

Agreement with Stanford (“Assignment and Assumption Agreement”), dated June 11, 2020.

As consideration for

entering into the Trigemina Asset Purchase Agreement, we paid $824,759 to Trigemina and issued to Trigemina 10,000 shares of our

common stock and paid Stanford $250,241 pursuant to the terms of the Assignment and Assumption Agreement.

The common stock is unregistered

and subject to a 12 month lock-up and a Shareholder Voting Agreement, dated June 11, 2020, pursuant to which Trigemina and the

Executive Shareholders have agreed to vote the common stock on any matter put to a vote of our shareholders in accordance with

management’s recommendations.

Both the costs associated with the cash payments and share issuance, totaling $2.4 million,

were previously recorded to research and development in the statement of operations.

Because the Trigemina intellectual property

was acquired prior to FDA approval, the cash and stock consideration was expensed as research and development costs since there

is no alternative future use and the acquired intellectual property does not constitute a business.

Pursuant to the terms of the Assignment and Assumption Agreement, Stanford has granted us an exclusive

license, with the right to sublicense, certain patents related to the Trigemina Assets.

Stanford has reserved for itself the right

to practice under the patents for academic research and educational purposes.

We are obligated to use commercially reasonable efforts

to diligently develop, manufacture, and sell products claimed or covered by the patent and will use commercially reasonable efforts

to diligently develop markets for such products.

The Stanford License Agreement specifies developmental milestones and the period

of time during which such milestones must be completed, and provides for an annual maintenance fee payable to Stanford.

30, 2023, other than the annual maintenance fee, no milestone payments have been accrued or paid in relation to this agreement.

On August 19, 2019,

we entered into an asset purchase agreement (the “TRImaran Asset Purchase Agreement”) with TRImaran Pharma, Inc.

and the selling shareholders named therein (the “Selling Shareholders”) pursuant to which we acquired TRImaran’s

assets related to certain pyran-based compounds (the “TRImaran Assets”).

In connection with the acquisition of the

TRImaran Assets, we entered into a First Amended and Restated Exclusive License Agreement (the “WSU License Agreement”)

with Wayne State University (“WSU”) on August 19, 2019, as subsequently amended.

As consideration for entering into

the TRImaran Asset Purchase Agreement, we paid $100,000 to TRImaran and have assumed certain liabilities of TRImaran totaling $68,500.

The $168,500 was previously recorded to research and development expenses in the statement of operations.

Upon the achievement

of specified development, regulatory and sales milestones, we also agreed to pay TRImaran and the Selling Shareholders, in restricted

stock or cash, at our option, a total of approximately $3.4 million.

Pursuant to the terms of the TRImaran Asset Purchase Agreement,

TRImaran and the Selling Shareholders are prohibited from disclosing confidential information related to the TRImaran Assets and

are restricted from engaging, for a period of three years, in the development or commercialization of any therapeutic containing

any pyran-based drug compound for the treatment of post-traumatic stress disorder, attention deficit hyperactivity disorder or

major depressive disorder.

Also for a period of three years, if TRImaran or any Selling Shareholder engage in the research or development

of any potential therapeutic compound for the treatment of any central nervous system disorder, TRImaran or such Selling Shareholder

is obliged to provide notice and opportunity to Tonix to make an offer to acquire or license rights with respect to such product

As of June 30, 2023, no milestone payments have been accrued or paid in relation to this agreement.

Pursuant to the terms

of the WSU License Agreement, WSU granted us an exclusive license, with the right to sublicense, certain patents, technical information

and material (collectively, the “Technology”) related to the TRImaran Assets.

WSU has reserved for itself the right

to practice the Technology for academic research and educational purposes.

We are obligated to use commercially reasonable efforts

to obtain regulatory approval for one or more products utilizing the Technology (“WSU Products”) and to use commercially

reasonable marketing efforts throughout the term of the WSU License Agreement.

The WSU License Agreement specifies developmental

milestones and the period of time during which such milestones must be completed and provides for an annual maintenance fee payable

We are obligated to substantially manufacture WSU Products in the United States if WSU Products will be sold in the United

Pursuant to the WSU

License Agreement, we paid $75,000 to WSU as reimbursement of certain patent expenses, and, upon the achievement of specified

development, regulatory and sales milestones, we also agreed to pay WSU, milestone payments totaling approximately $3.4 million.

We have also agreed to pay WSU single-digit royalties on net sales of WSU Products sold by us or a sublicensee on a tiered basis

based on net sales, and additional sublicense fees on certain consideration received from sublicensees.

Royalties on each particular

WSU Product are payable on a country-by-country and Product-by-Product basis until the date of expiration of the last valid claim

in the last to expire of the issued patents covered by the WSU License Agreement.

Royalties payable on net sales of WSU Products

may be reduced by 50% of the royalties payable by us to any third party for intellectual property rights which are necessary for

the practice of the rights licensed to us under the WSU License Agreement, provided that the royalty payable on a WSU Product

may not be reduced by more than 50%.

Each party also has the right to terminate the agreement for customary reasons such as material

breach and bankruptcy.

The WSU License Agreement contains provisions relating to termination, indemnification, confidentiality

and other customary matters for an agreement of this kind.

As of June 30, 2023, no milestone payments have been accrued or paid

in relation to this agreement.

Liquidity and Capital Resources

As of June 30, 2023,

we had working capital of $32.9 million, comprised primarily of cash and cash equivalents of $25.6 million, Inventory of $13.7

million and prepaid expenses and other of $12.0 million, offset by $7.7 million of accounts payable, $10.3 million of accrued expenses

and current lease liabilities of $0.4 million.

A significant portion of the accounts payable and accrued expenses are due to work

performed in relation to our clinical programs, the USL Acquisition and the build-out of our facilities.

The following table

provides a summary of operating, investing and financing cash flows for the six months ended June 30, 2023, and 2022, respectively

(in thousands):

As consideration for entering into the Healion Purchase Agreement, we paid $1.2 million to Healion.

Healion intellectual property was acquired prior to FDA approval, the cash consideration totaling $1.2 million, was expensed as

research and development costs since there is no alternative future use and the acquired intellectual property does not constitute

and Capital Resources

of September 30, 2023, we had working capital of $13.6 million, comprised primarily of cash and cash equivalents of $6.9 million, inventory

of $13.3 million, receivables, net of $1.6 million and prepaid expenses and other of $9.5 million, offset by $7.8 million of accounts payable, $9.5 million of accrued

expenses and current lease liabilities of $0.4 million.

A significant portion of the accounts payable and accrued expenses are due to

work performed in relation to our clinical programs, and the USL Acquisition.

following table provides a summary of operating, investing and financing cash flows for the nine months ended September 30, 2023, and

2022, respectively (in thousands):

September 30,

Net cash used in operating activities

Net cash used in investing activities

Net cash (used) provided by financing activities

For the six months

ended June, 2023 and 2022, we used approximately $56.3 million and $52.2 million of cash in operating activities, respectively,

which represents cash outlays for research and development and general and administrative expenses in such periods.

in cash outlays principally resulted from an increase in both research and development and general and administrative activities.

For the six months ended June 30, 2023, net cash used from financing activities was $10.5 million predominately from the repurchase

Net cash (used in) provided by financing activities

the nine months ended September 2023 and 2022, we used approximately $79.7 million and $75.8 million of cash in operating activities,

respectively, which represents cash outlays for research and development and general and administrative expenses in such periods.

increase in cash outlays principally resulted from an increase in both research and development and general and administrative activities.

For the nine months ended September 30, 2023, net cash used from financing activities was $4.2 million predominately from the repurchase

of common stock.

For the six months ended June 30, 2022, net proceeds from financing activities was $85.2 million, predominately

For the nine months ended September 30, 2022, net proceeds in financing activities was $80.6 million, predominately

from the sale of our common and preferred stock.

Cash used in investing activities for the six months ended June 30, 2023 was $27.8

related to the purchase of the USL assets and property and equipment, and $34.7 million for the six months ended June 30, 2022

Cash used in investing activities for the nine months ended September 30, 2023 was $28.6

related to the purchase of the USL assets and property and equipment, and $43.5 million for the nine months ended September 30, 2022

related to the purchase of property and equipment.

We believe that our

cash resources at June 30, 2023, and the proceeds that we raised from equity offerings subsequent to the end of the second quarter

of 2023 will meet our operating and capital expenditure requirements into the fourth quarter of 2023, but not beyond.

We continue to face

significant challenges and uncertainties and, as a result, our available capital resources may be consumed more rapidly than currently

expected due to changes we may make in our research and development spending plans.

These factors raise substantial doubt about

our ability to continue as a going concern for the one year period from the date of filing of this Form 10-Q.

We have the ability

to obtain additional funding through public or private financing or collaborative arrangements with strategic partners to increase

the funds available to fund operations.

Without additional funds, we may be forced to delay, scale back or eliminate some of our

research and development activities, or other operations and potentially delay product development in an effort to provide sufficient

funds to continue our operations.

If any of these events occurs, our ability to achieve our development and commercialization goals

would be adversely affected.

Future Liquidity Requirements

We expect to incur

losses from operations for the near future.

We expect to incur increasing research and development expenses, including expenses

related to additional clinical trials and the buildout of our research and development operations and manufacturing.

have enough resources to meet our operating requirements for the one-year period from filing date of this report.

Our future capital

requirements will depend on a number of factors, including the progress of our research and development of product candidates,

the timing and outcome of regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending and

enforcing patent claims and other intellectual property rights, the status of competitive products, the availability of financing

and our success in developing markets for our product candidates.

We will need to obtain

additional capital in order to fund future research and development activities and future capital expenditures.

Future financing

may include the issuance of equity or debt securities, obtaining credit facilities, or other financing mechanisms.

Even if we are

able to raise the funds required, it is possible that we could incur unexpected costs and expenses, fail to collect significant

believe that our cash resources at September 30, 2023, and the proceeds that we raised from equity offerings subsequent to the end

of the third quarter of 2023 will not meet our operating and capital expenditure requirements through the fourth quarter of 2023.

We continue to face significant challenges and uncertainties and, as a

result, our available capital resources may be consumed more rapidly than currently expected due to changes we may make in our research

and development spending plans.

These factors raise substantial doubt about our ability to continue as a going concern for the one year

period from the date of filing of this Form 10-Q.

We must obtain additional funding through public or private financing or collaborative

arrangements with strategic partners to increase the funds available to fund operations.

Without additional funds, we may be forced to

delay, scale back or eliminate some of our research and development activities, or other operations and potentially delay product development

in an effort to provide sufficient funds to continue our operations.

If any of these events occurs, our ability to achieve our development

and commercialization goals would be adversely affected and we may be forced to cease operations.

Liquidity Requirements

expect to incur losses from operations for the near future.

We expect to incur increasing research and development expenses, including

expenses related to additional clinical trials and the buildout of our research and development operations and manufacturing.

not have enough resources to meet our operating requirements for the one-year period from filing date of this report.

future capital requirements will depend on a number of factors, including the progress of our research and development of product candidates,

the timing and outcome of regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing

patent claims and other intellectual property rights, the status of competitive products, the availability of financing and our success

in developing markets for our product candidates.

will need to obtain additional capital in order to fund future research and development activities and future capital expenditures.

financing may include the issuance of equity or debt securities, obtaining credit facilities, or other financing mechanisms.

we are able to raise the funds required, it is possible that we could incur unexpected costs and expenses, fail to collect significant

amounts owed to us, or experience unexpected cash requirements that would force us to seek alternative financing.

if we issue additional equity or debt securities, shareholders may experience additional dilution or the new equity securities

may have rights, preferences or privileges senior to those of existing holders of our common stock.

If additional financing

is not available or is not available on acceptable terms, we may be required to delay, reduce the scope of or eliminate our research

and development programs, reduce our commercialization efforts or obtain funds through arrangements with collaborative partners

Furthermore, if we

issue additional equity or debt securities, shareholders may experience additional dilution or the new equity securities may have rights,

preferences or privileges senior to those of existing holders of our common stock.

additional financing is not available or is not available on acceptable terms, we may be required to delay, reduce the scope of or eliminate

our research and development programs, reduce our commercialization efforts or obtain funds through arrangements with collaborative partners

or others that may require us to relinquish rights to certain product candidates that we might otherwise seek to develop or commercialize

independently.

Share Repurchase

During the first quarter of 2023, we have repurchased 2,512,044 of our shares of common stock outstanding under the 2022 share repurchase program

for up to $12.5 million at prices ranging from $2.75 to $8.61 per share for a gross aggregate cost of approximately $12.5 million .

In addition, we incurred expenses of $0.3 million.

Repurchase Program

During the first quarter of 2023,

we repurchased 2,512,044 of our shares of common stock outstanding under the 2022 share repurchase program for up to $12.5 million at

prices ranging from $2.75 to $8.61 per share for a gross aggregate cost of approximately $12.5 million .

In addition, we incurred

expenses of $0.3 million.

January 2023, the Board of Directors approved a new 2023 share repurchase program pursuant

to which we may repurchase up to an additional $12.5 million in value of our outstanding common stock from time to time

on the open market and in privately negotiated transactions subject to market conditions, share price and other factors.

During the first quarter of 2023, we have repurchased 160,000 of our shares of common stock outstanding

to which we may repurchase up to an additional $12.5 million in value of our outstanding common stock from time to time on

the open market and in privately negotiated transactions subject to market conditions, share price and other factors.

the first quarter of 2023, we repurchased 160,000 of our shares of common stock outstanding

under the new 2023 share repurchase program at $7.12 per share for a gross aggregate cost of $1.1 million .

Convertible Redeemable Preferred stock

No share repurchases occurred in the third quarter of 2023.

Redeemable Preferred stock

October 26, 2022, we issued 1,400,000 shares of Series A Preferred Stock and 100,000 shares of Series B Preferred Stock to certain

5 unchanged sentences

were convertible into shares of our common stock, upon the occurrence of certain events, at a conversion price of $6.25 per share.

at the option of the holder, and at our option upon the fulfillment of certain conditions and subject to certain limitations.

Company and the holders of the preferred stock also entered into a registration rights agreement to register the resale of the

shares of common stock issuable in the event of the conversion of the preferred stock.

The $14.3 million in gross proceeds of the

offering were held in an escrow account, along with an additional $1.5 million deposited by the Company to cover the aggregate

OID as well as the additional amount that would have been necessary to fund the 105% redemption price until the expiration of the

redemption period for the Preferred Stock.

outstanding shares of the Series A Convertible Redeemable Preferred Stock and Series B Convertible Redeemable Preferred Stock were

redeemed in December 2022 at 105% of the $10.00 stated value of the Preferred Stock, or $15.8 million in the aggregate.

outstanding shares of the Series A Convertible Redeemable Preferred Stock and Series B Convertible Redeemable Preferred Stock were redeemed

in December 2022 at 105% of the $10.00 stated value of the Preferred Stock, or $15.8 million in the aggregate.

June 24, 2022, we issued 2,500,000 shares of Series A Preferred Stock and 500,000 shares of Series B Preferred Stock to certain

5 unchanged sentences

were convertible into shares of our common stock, upon the occurrence of certain events, at a conversion price of $25.00 per share.

at the option of the holder, and at our option upon the fulfillment of certain conditions and subject to certain limitations.

Company and the holders of the preferred stock also entered into a registration rights agreement to register the resale of the

shares of common stock issuable in the event of the conversion of the preferred stock.

The $28.5 million in gross proceeds of the

offering were held in an escrow account, along with an additional $3.0 million deposited by the Company to cover the aggregate

OID as well as the additional amount that would have been necessary to fund the 105% redemption price until the expiration of the

redemption period for the Preferred Stock.

All outstanding shares

of the Series A Convertible Redeemable Preferred Stock and Series B Convertible Redeemable Preferred Stock were redeemed in August

2022 at 105% of the $10.00 stated value of the Preferred Stock, or $31.5 million in the aggregate.

July 2023 Financing

July 27, 2023, we entered into a placement agent agreement (the “Placement Agent Agreement”) with A.G.P./Alliance Global

Partners and Brookline Capital Markets, a division of Arcadia Securities, LLC (the “Placement Agents”), pursuant to

which we sold securities consisting of 2,530,000 shares of common stock;

pre-funded warrants to purchase up to 4,470,000 shares

of common stock and common warrants to purchase up to 7,000,000 shares of common stock.

The offering price per Share and accompanying

Common Warrant is $1.00, and the offering price per Pre-Funded Warrant and accompanying Common Warrant is $0.9999.

The Financing closed

on August 1, 2023, the placement agents purchased the shares at a seven-percent discount to the public offering price, for an aggregate

discount of approximately $0.5 million.

We incurred other offering expenses of approximately $0.3 million.

outstanding shares of the Series A Convertible Redeemable Preferred Stock and Series B Convertible Redeemable Preferred Stock were redeemed

in August 2022 at 105% of the $10.00 stated value of the Preferred Stock, or $31.5 million in the aggregate.

2023 Financing

September 28, 2023, we sold 4,050,000 shares of common stock;

pre-funded warrants

to purchase up to 4,950,000 shares of common stock, and accompanying common warrants to purchase up to 9,000,000 shares of common stock

with an exercise price of $0.50 per share and expiring one year from date of issuance, and common warrants to purchase up to 9,000,000

shares of common stock with an exercise price of $0.50 per share and expiring five years from date of issuance in a public offering which closed on October 3, 2023.

The offering price per

share of common stock and accompanying common warrant was $0.50, and the offering price per share of pre-funded warrant and accompanying

common warrant was $0.4999.

We incurred other offering expenses of approximately $0.5 million, which included a placement agent discount.

We received net proceeds

of approximately $4.0 million, after deducting the underwriting discount and other offering expenses.

2023 Financing

July 27, 2023, we sold securities consisting of 2,530,000 shares of common stock;

pre-funded warrants to purchase up to 4,470,000 shares of common stock

and common warrants to purchase up to 7,000,000 shares of common stock in a public offering that closed on August 1, 2023.

The offering price per Share and accompanying Common Warrant

is $1.00, and the offering price per Pre-Funded Warrant and accompanying Common Warrant is $0.9999.

We incurred other offering expenses of approximately $0.7 million, which included a placement agent discount.

net proceeds of approximately $6.3 million, after deducting the underwriting discount and other offering expenses.

Lincoln Park Transaction

On August 16, 2022,

we entered into a purchase agreement (the “2022 Purchase Agreement”) and a registration rights agreement (the “2022

Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”).

Pursuant to the terms of

the 2022 Purchase Agreement, Lincoln Park has agreed to purchase from us up to $50,000,000 of our common stock (subject to certain

limitations) from time to time during the term of the 2022 Purchase Agreement.

Pursuant to the terms of the 2022 Registration Rights

Agreement, we filed with the SEC a registration statement to register for resale under the Securities Act the shares that have

been or may be issued to Lincoln Park under the 2022 Purchase Agreement.

Pursuant to the terms

of the 2022 Purchase Agreement, at the time we signed the 2022 Purchase Agreement and the 2022 Registration Rights Agreement, we

issued 100,000 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock

under the 2022 Purchase Agreement.

The commitment shares were valued at $1,000,000 and recorded as an addition to equity for the

issuance of the common stock and treated as a reduction to equity as a cost of capital to be raised under the 2022 Purchase Agreement.

During the three and

six months ended June 30, 2023, we sold 0 and 0.1 million shares, respectively, of common stock under the 2022 Purchase Agreement,

for net proceeds of approximately $0 and $0.4 million, respectively.

Purchase Agreement with Lincoln Park

we entered into a purchase agreement (the “2022 Purchase Agreement”) and a registration rights agreement with Lincoln

Park, pursuant to which Lincoln Park agreed to purchase from us up to $50,000,000 of our common stock (subject to certain limitations)

from time to time.

We filed a registration statement to register for resale the shares that have been or may be issued to Lincoln

Park under the 2022 Purchase Agreement.

We issued 100,000 shares

of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock under the 2022 Purchase

The commitment shares were valued at $1,000,000 and recorded as an addition to equity for the issuance of the common

stock and treated as a reduction to equity as a cost of capital to be raised under the 2022 Purchase Agreement.

the three and nine months ended September 30, 2023, we sold 0 and 0.1 million shares, respectively, of common stock under the 2022 Purchase

Agreement, for net proceeds of approximately $0 and $0.4 million, respectively.

During the nine months ended September 30, 2022,

no shares of common stock were sold under the 2022 Purchase Agreement.

2021 Lincoln Park Transaction

On December 3, 2021,

we entered into a purchase agreement (the “Purchase Agreement with Lincoln Park”) and a registration rights agreement

(the “Lincoln Park Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”).

Pursuant to the terms of the Purchase Agreement with Lincoln Park, Lincoln Park has agreed to purchase from us up to $80,000,000

of our common stock (subject to certain limitations) from time to time during the term of the Purchase Agreement.

Pursuant to the

terms of the Lincoln Park Registration Rights Agreement, we filed with the SEC a registration statement to register for resale

under the Securities Act the shares that have been or may be issued to Lincoln Park under the Purchase Agreement with Lincoln Park.

Pursuant to the terms

of the Purchase Agreement with Lincoln Park, at the time we signed the Purchase Agreement with Lincoln Park and the Lincoln Park

Registration Rights Agreement, we issued 14,546 shares of common stock to Lincoln Park as consideration for its commitment to purchase

shares of our common stock under the Purchase Agreement with Lincoln Park.

The commitment shares were valued at $1.6 million and

recorded as an addition to equity for the issuance of the common stock and treated as a reduction to equity as a cost of capital

to be raised under the Purchase Agreement with Lincoln Park.

During the three and

six months ended June 30, 2022, we sold 0.1 million and 0.2 million shares, respectively, of common stock under the Purchase

Agreement with Lincoln Park, for net proceeds of approximately $2.0 million and $6.5 million, respectively.

No sales occurred in

applicable rules of the NASDAQ Global Market, the Company could not issue or sell more than 19.99% of the shares of its common

stock outstanding immediately prior to the execution of the Purchase Agreement (approximately 3 million shares) with Lincoln Park

under the Purchase Agreement without stockholder approval, unless the average price of all applicable sales of its common stock

to Lincoln Park under the Purchase Agreement equals or exceeds a threshold amount.

As we have issued approximately 3,000,000 shares

to Lincoln Park under the Purchase Agreement at less than the threshold amount, we will not sell any additional shares under the

Purchase Agreement without shareholder approval.

At-the-Market Offerings

On April 8, 2020, we

entered into a sales agreement (the “Sales Agreement”) with AGP pursuant to which we may issue and sell, from time

to time, shares of our common stock having an aggregate offering price of up to $320.0 million in at-the-market offerings (“ATM”)

we entered into a purchase agreement (the “2021 Purchase Agreement”) and a registration rights agreement with Lincoln

Park, pursuant to which Lincoln Park has agreed to purchase from us up to $80,000,000 of our common stock (subject to certain limitations)

from time to time.

We filed a registration statement to register for resale the shares that have been or may be issued to Lincoln

Park under the 2021 Purchase Agreement.

We issued 14,546 shares

of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock under the 2021 Purchase

Agreement with Lincoln Park.

The commitment shares were valued at $1.6 million and recorded as an addition to equity for the issuance

of the common stock and treated as a reduction to equity as a cost of capital to be raised under the Purchase Agreement with Lincoln

During the nine months

ended September 30, 2022, we sold 0.5 million shares of common stock under the 2021 Purchase Agreement with Lincoln Park, for net

proceeds of approximately $8.7 million.

No sales occurred in 2023, and we may not sell any additional shares under the 2021 Purchase

At-the-Market

April 8, 2020, we entered into a sales agreement (the “Sales Agreement”) with AGP pursuant to which we may issue and sell,

from time to time, shares of our common stock having an aggregate offering price of up to $320.0 million in at-the-market offerings (“ATM”)

AGP will act as sales agent and will be paid a 3% commission on each sale under the Sales Agreement.

Our common stock will

be sold at prevailing market prices at the time of the sale, and, as a result, prices will vary.

During the three and six months

ended June 30, 2023, we sold approximately 0.4 million and 1.0 million shares, respectively, of common stock under the Sales Agreement,

Our common stock will be

sold at prevailing market prices at the time of the sale, and, as a result, prices will vary.

During the three and nine months ended

September 30, 2023, we sold approximately 0 million and 1.0 million shares, respectively, of common stock under the Sales Agreement,

for net proceeds of approximately $0 million and $3.0 million, respectively.

During the three and six months ended June 30, 2022,

we sold approximately 2.2 million and 2.4 million shares, respectively, of common stock under the Sales Agreement, for net proceeds

of approximately $43.0 million and $51.5 million, respectively.

Stock Compensation

On May 3, 2019, our

stockholders approved the Tonix Pharmaceuticals Holding Corp.

2019 Stock Incentive Plan (the “2019 Plan”).

Plan provided for the issuance of up to 700 shares of our common stock.

With the adoption of the 2020 Plan (as defined below),

no further grants may be made under the 2019 Plan.

On January 16, 2020, our stockholders approved the Tonix Pharmaceuticals Holding

2020 Stock Incentive Plan (the “2020 Plan”).

The 2020 Plan provided for the issuance of up to 3,000 shares of

our common stock.

With the adoption of the Amended and Restated 2020 Plan (as defined below), no further grants may be made under

the 2020 Plan.

On May 1, 2020, our

stockholders approved the Tonix Pharmaceuticals Holding Corp.

Amended and Restated 2020 Stock Incentive Plan (“Amended and

Restated 2020 Plan”), and together with the 2020 Plan and the 2019 Plan, the “Plans”).

During the three and nine months ended September 30, 2022,

we sold approximately 3.1 million and 5.5 million shares, respectively, of common stock under the Sales Agreement, for net proceeds of

approximately $43.0 million and $76.2 million, respectively.

May 1, 2020, our stockholders approved the Tonix Pharmaceuticals Holding Corp.

Amended and Restated 2020 Stock Incentive Plan (“Amended

and Restated 2020 Plan”).

Under the terms of

the Amended and Restated 2020 Plan, we may issue (1) stock options (incentive and nonstatutory), (2) restricted stock, (3) stock

appreciation rights (“SARs”), (4) RSUs, (5) other stock-based awards, and (6) cash-based awards.

The Amended and Restated

2020 Plan initially provided for the issuance of up to 50,000 shares of common stock, which amount will be increased to the

extent that awards granted under the Plans are forfeited, expire or are settled for cash (except as otherwise provided in the Amended

and Restated 2020 Plan).

In addition, the Amended and Restated 2020 Plan contains an “evergreen provision” providing

for an annual increase in the number of shares of our common stock available for issuance under the Amended and Restated 2020 Plan

on January 1 of each year for a period of ten years, commencing on January 1, 2021 and ending on (and including) January 1, 2030,

appreciation rights (“SARs”), (4) restricted stock units, (5) other stock-based awards, and (6) cash-based awards.

The Amended and Restated 2020 Plan initially provided for the issuance of up to 50,000 shares of common stock, which amount will

be increased to the extent that awards granted under the Plans are forfeited, expire or are settled for cash (except as otherwise

provided in the Amended and Restated 2020 Plan).

In addition, the Amended and Restated 2020 Plan contains an “evergreen provision”

providing for an annual increase in the number of shares of our common stock available for issuance under the Amended and Restated

2020 Plan on January 1 of each year for a period of ten years, commencing on January 1, 2021 and ending on (and including) January

1, 2030, in an amount equal to the difference between (x) twenty percent (20%) of the total number of shares of common stock outstanding

11 unchanged sentences

grants under the Amended and Restated 2020 Plan may not be more than ten years.

As of June 30, 2023, 1,057,051 shares were available

for future grants under the Amended and Restated 2020 Plan.

We measure the fair

value of stock options on the date of grant, based on the Black Scholes option pricing model using certain assumptions discussed

below, and the closing market price of the Company’s common stock on the date of the grant.

The fair value of the award is

measured on the grant date.

One-third of most stock options granted pursuant to the Plans vest 12 months from the date of grant

and 1/36 th each month thereafter for 24 months and expire ten years from the date of grant.

In addition, the Company

issues options to directors which vest over a one-year period.

The Company also issues premium options to executive officers which

have an exercise price greater than the grant date fair value and has issued performance-based options which vest when target parameters

are met or probable of being met, subject in each case to a one year minimum service period prior to vesting.

Stock-based compensation

expense related to awards is amortized over the applicable service period using the straight-line method.

The risk-free interest

rate is based on the yield of Daily U.S.

Treasury Yield Curve Rates with terms equal to the expected term of the options as of

the grant date.

As of September 30, 2023, 1,062,874 options were

available for future grants under the Amended and Restated 2020 Plan.

measure the fair value of stock options on the date of grant, based on the Black Scholes option pricing model using certain assumptions

discussed below, and the closing market price of the Company’s common stock on the date of the grant.

The fair value of the award

is measured on the grant date.

One-third of most stock options granted pursuant to the Plans vest 12 months from the date of grant and

1/36 th each month thereafter for 24 months and expire ten years from the date of grant.

In addition, the Company issues options

to directors which vest over a one-year period.

The Company also issues premium options to executive officers which have an exercise

price greater than the grant date fair value and has issued performance-based options which vest when target parameters are met or probable

of being met, subject in each case to a one year minimum service period prior to vesting.

Stock-based compensation expense related to

awards is amortized over the applicable service period using the straight-line method.

risk-free interest rate is based on the yield of Daily U.S.

Treasury Yield Curve Rates with terms equal to the expected term of the options

as of the grant date.

The expected term of options is determined using the simplified method, as provided in an SEC Staff Accounting

Bulletin, and the expected stock price volatility is based on the Company’ historical stock price volatility.

The weighted average

fair value of options granted during the three and six months ended June 2023 was $2.73 per share and $4.01 per share, respectively.

The weighted average fair value of options granted during the three and six months ended June 2022 was $23.63 per share and $32.81

weighted average fair value of options granted during the three and nine months ended September 30, 2023 was $0.84 per share and $3.99

per share, respectively.

Stock-based compensation

expense relating to options granted of $2.4 million, of which $1.6 million and $0.8 million, related to General and Administration

and Research and Development, respectively was recognized for the quarter ended June 30, 2023.

The weighted average fair value of options granted during the three and nine months ended September 30, 2022

was $0 per share and $32.81 per share, respectively.

compensation expense relating to options granted of $2.1 million, of which $1.4 million and $0.7 million, related to General and Administration

and Research and Development, respectively was recognized for the quarter ended September 30, 2023.

Stock-based compensation expense

relating to options granted of $2.8 million, of which $2.0 million and $0.8 million, related to General and Administration and

Research and Development, respectively was recognized for the quarter ended June 30, 2022.

Stock-based compensation

expense relating to options granted of $5.2 million, of which $3.6 million and $1.6 million, related to General and Administration

and Research and Development, respectively was recognized for the six-month period ended June 30, 2023.

relating to options granted of $2.7 million, of which $2.0 million and $0.7 million, related to General and Administration and Research

and Development, respectively was recognized for the quarter ended September 30, 2022.

compensation expense relating to options granted of $7.2 million, of which $5.0 million and $2.2 million, related to General and Administration

and Research and Development, respectively was recognized for the nine-month period ended September 30, 2023.

Stock-based compensation

expense relating to options granted of $5.4 million, of which $3.9 million and $1.5 million, related to General and Administration

and Research and Development, respectively was recognized for the six-month period ended June 30, 2022.

As of June 30, 2023,

the Company had approximately $10.3 million of total unrecognized compensation cost related to non-vested awards granted under

the Plans, which the Company expects to recognize over a weighted average period of 1.87 years.

Employee Stock Purchase Plan

On May 3, 2019, our

stockholders approved the Tonix Pharmaceuticals Holdings Corp.

2019 Employee Stock Purchase Plan (the “2019 ESPP”).

As a result of adoption of the 2020 ESPP, as defined below, by the stockholders, no further grants may be made under the 2019 ESPP

On May 1, 2020, our stockholders approved the Tonix Pharmaceuticals Holdings Corp.

2020 Employee Stock Purchase Plan (the

“2020 ESPP”).

No further grants may be made under the 2020 ESPP Plan.

On May 6, 2022, our stockholders approved the

Tonix Pharmaceuticals Holdings Corp.

2022 Employee Stock Purchase Plan (the “2022 ESPP”, and together with the 2019

ESPP and the 2020 ESPP, the “ESPP Plans”)).

The 2022 ESPP allows

eligible employees to purchase up to an aggregate of 15,000 shares of our common stock.

Under the 2022 ESPP, on the first

day of each offering period, each eligible employee for that offering period has the option to enroll for that offering period,

which allows the eligible employees to purchase shares of our common stock at the end of the offering period.

Each offering period

under the 2022 ESPP is for six months, which can be modified from time-to-time.

Subject to limitations, each participant will be

permitted to purchase a number of shares determined by dividing the employee’s accumulated payroll deductions for the offering

period by the applicable purchase price, which is equal to 85 percent of the fair market value of our common stock at

the beginning or end of each offering period, whichever is less.

A participant must designate in his or her enrollment package

the percentage (if any) of compensation to be deducted during that offering period for the purchase of stock under the 2022 ESPP,

expense relating to options granted of $8.1 million, of which $5.9 million and $2.2 million, related to General and Administration and

Research and Development, respectively was recognized for the nine-month period ended September 30, 2022.

of September 30, 2023, the Company had approximately $8.2 million of total unrecognized compensation cost related to non-vested awards

granted under the Plans, which the Company expects to recognize over a weighted average period of 1.74 years.

Stock Purchase Plan

On May 6, 2022, our stockholders approved

the Tonix Pharmaceuticals Holdings Corp.

2022 Employee Stock Purchase Plan (the “2022 ESPP”), which was replaced by the Tonix

Pharmaceuticals Holdings Corp.

2023 Employee Stock Purchase Plan (the “2023 ESPP”, and together with the 2022 ESPP, the “ESPP

Plans”), which was approved by the Company’s stockholders on May 5, 2023.

2023 ESPP allows eligible employees to purchase up to an aggregate of 800,000 shares of the Company’s common stock.

the 2023 ESPP, on the first day of each offering period, each eligible employee for that offering period has the option to enroll for

that offering period, which allows the eligible employees to purchase shares of the Company’s common stock at the end of the offering

Each offering period under the 2023 ESPP is for six months, which can be modified from time-to-time.

Subject to limitations,

each participant will be permitted to purchase a number of shares determined by dividing the employee’s accumulated payroll

deductions for the offering period by the applicable purchase price, which is equal to 85 percent of the fair market value

of our common stock at the beginning or end of each offering period, whichever is less.

A participant must designate in his or her enrollment

package the percentage (if any) of compensation to be deducted during that offering period for the purchase of stock under the 2023 ESPP,

subject to the statutory limit under the Code.

As of June 30, 2023, 1 share was available for future sales under the 2022 ESPP.

2020 ESPP are considered compensatory plans with the related compensation cost expensed over the six-month offering period.

compensation was expensed during the six months ended June 30, 2023 and 2022.

In January 2022, 646 shares that were purchased as

of December 31, 2021, under the 2020 ESPP, were issued.

Accordingly, during the first quarter of 2022, approximately $40,000 of

employee payroll deductions accumulated at December 31, 2021, related to acquiring such shares, was transferred from accrued expenses

to additional paid in capital.

The remaining $30,000 was returned to the employees.

In January 2023, 14,999 shares that were purchased

as of December 31, 2022, under the 2022 ESPP, were issued.

Accordingly, during the first quarter of 2023, approximately $29,000

of employee payroll deductions accumulated at December 31, 2022, related to acquiring such shares, was transferred from accrued

expenses to additional paid in capital.

As of September 30, 2023, 800,000 shares were available for future sales under the 2023

ESPP Plans are considered compensatory plans with the related compensation cost expensed over the six-month offering period.

For the three months ended September 30, 2023 and 2022, $34,000 and $46,000, respectively, was expensed.

For the nine months ended September

30, 2023 and 2022, $34,000 and $46,000, respectively were expensed.

In January 2022, 646 shares that were purchased as of December 31,

2021, under the 2020 ESPP, were issued.

Accordingly, during the first quarter of 2022, approximately $40,000 of employee payroll deductions

accumulated at December 31, 2021, related to acquiring such shares, was transferred from accrued expenses to additional paid in capital.

The remaining $30,000 was returned to the employees.

Research and Development Contracts

We have entered into

contracts with various contract research organizations with outstanding commitments aggregating approximately $62.8 million at

June 30, 2023 for future work to be performed.

Operating leases

As of June 30, 2023,

future minimum lease payments are as follows (in thousands):

Year Ending December 31,

In January 2023, 14,999 shares that were purchased as of December 31, 2022, under

the 2022 ESPP, were issued.

Accordingly, during the first quarter of 2023, approximately $29,000 of employee payroll deductions accumulated

at December 31, 2022, related to acquiring such shares, was transferred from accrued expenses to additional paid in capital.

The remaining

$14,000 was returned to the employees.

As of September 30, 2023, approximately $32,000 of employee payroll deductions have accumulated

and have been recorded in accrued expenses.

and Development Contracts

have entered into contracts with various contract research organizations with outstanding commitments aggregating approximately $33.4

million at September 30, 2023 for future work to be performed.

of September 30, 2023, future minimum lease payments are as follows (in thousands):

2027 and beyond

Included interest

Critical Accounting Policies and Estimates

Our discussion and

analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which

have been prepared in accordance with accounting principles generally accepted in the United States.

The preparation of these

financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and

We evaluate our estimates and judgments on an ongoing basis.

We base our estimates on historical experience and on

assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about

the carrying values of assets and liabilities that are not readily apparent from other sources.

Actual results may differ from these

We believe the

following critical accounting policies affect our more significant judgments and estimates used in the preparation of our condensed

consolidated financial statements.

Business Combinations.

Accounting Policies and Estimates

discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements,

which have been prepared in accordance with accounting principles generally accepted in the United States.

The preparation of these financial

statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses.

our estimates and judgments on an ongoing basis.

We base our estimates on historical experience and on assumptions that we believe to

be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and

liabilities that are not readily apparent from other sources.

Actual results may differ from these estimates.

believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our

condensed consolidated financial statements.

Combinations.

We apply the acquisition method of accounting for business combinations.

Under the acquisition method, the acquiring entity recognizes

all of the identifiable assets acquired and liabilities assumed at their acquisition date fair values.

Under the acquisition method, the acquiring entity

recognizes all of the identifiable assets acquired and liabilities assumed at their acquisition date fair values.

We use our best estimates

and assumptions to estimate the fair values of these tangible and intangible assets.

Any excess of the purchase price over amounts

allocated to the assets acquired is recorded as goodwill.

The acquired intangible assets are amortized using the straight-line

method over the estimated useful lives of the respective assets.

Goodwill is reviewed for impairment on an annual basis, or more

frequently if events or changes in circumstances indicate that the carrying amount of goodwill may be impaired.

Research and Development.

We outsource certain of our research and development efforts and expense the related costs as incurred, including the cost of manufacturing

product for testing, licensing fees and costs associated with planning and conducting clinical trials.

The value ascribed to patents

and other intellectual property acquired was expensed as research and development costs, as it related to particular research and

development projects and had no alternative future uses.

We estimate our accrued

Our clinical trial accrual process is designed to account for expenses resulting from our obligations under contracts

with vendors, consultants and clinical research organizations and clinical site agreements in connection with conducting clinical

Any excess of the purchase price over amounts allocated

to the assets acquired is recorded as goodwill.

The acquired intangible assets are amortized using the straight-line method over the

estimated useful lives of the respective assets.

Goodwill is reviewed for impairment on an annual basis, or more frequently if events

or changes in circumstances indicate that the carrying amount of goodwill may be impaired.

Our gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in the same

period that the revenues are recognized.

Such variable consideration represents chargebacks, rebates, prompt pay and other sales discounts,

and product returns.

These deductions represent estimates of the related obligations and, as such, knowledge and judgment are required

when estimating the impact of these revenue deductions on gross sales for a reporting period.

We began recognizing revenue following

the completion of the USL Acquisition, beginning in the period ended September 30, 2023, and required variable consideration estimates

are currently primarily based on the acquired products historical results.

Adjustments to these estimates to reflect actual results or

updated expectations will be assessed each period.

If any of our ratios, factors, assessments, experiences, or judgments are not indicative

or accurate estimates of our future experience, our results could be materially affected.

The potential of our estimates to vary differs

by program, product, type of customer and geographic location.

In addition, estimates associated with U.S.

Medicare and Medicaid governmental

rebate programs are at risk for material adjustment because of the extensive time delay.

and Development.

We outsource certain of our research and development efforts and expense the related costs as incurred, including the

cost of manufacturing product for testing, licensing fees and costs associated with planning and conducting clinical trials.

ascribed to patents and other intellectual property acquired was expensed as research and development costs, as it related to particular

research and development projects and had no alternative future uses.

estimate our accrued expenses.

Our clinical trial accrual process is designed to account for expenses resulting from our obligations

under contracts with vendors, consultants and clinical research organizations and clinical site agreements in connection with conducting

clinical trials.

The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result

in payment flows that do not match the periods over which materials or services are provided to us under such contracts.

for trial expenses according to the progress of the trial as measured by participant progression and the timing of various aspects

of the trial.

We determine accrual estimates that take into account discussions with applicable personnel and outside service providers

as to the progress or state of completion of trials, or the services completed.

During the course of a clinical trial, we adjust

our clinical expense recognition if actual results differ from our estimates.

We make estimates of our accrued expenses as of each

balance sheet date based on the facts and circumstances known to us at that time.

Our clinical trial accruals and prepaid assets

are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors.

Stock-Based Compensation.

All stock-based payments to employees and to nonemployee directors for their services as directors consisted of grants of restricted

stock and stock options, which are measured at fair value on the grant date and recognized in the consolidated statements of operations

as compensation expense over the relevant vesting period.

We account for

trial expenses according to the progress of the trial as measured by participant progression and the timing of various aspects of the

We determine accrual estimates that take into account discussions with applicable personnel and outside service providers as to

the progress or state of completion of trials, or the services completed.

During the course of a clinical trial, we adjust our clinical

expense recognition if actual results differ from our estimates.

We make estimates of our accrued expenses as of each balance sheet date

based on the facts and circumstances known to us at that time.

Our clinical trial accruals and prepaid assets are dependent upon the

timely and accurate reporting of contract research organizations and other third-party vendors.

Compensation.

All stock-based payments to employees and to nonemployee directors for their services as directors consisted of grants

of restricted stock and stock options, which are measured at fair value on the grant date and recognized in the consolidated statements

of operations as compensation expense over the relevant vesting period.

In addition, for awards that vest immediately and are nonforfeitable,

the measurement date is the date the award is issued.

Redeemable Convertible

Preferred Stock.

Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair

Convertible Preferred Stock.

Preferred shares subject to mandatory redemption are classified as liability instruments and are measured

at fair value.

The Company classifies conditionally redeemable preferred shares, which includes preferred shares that feature redemption

rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely

within the Company’s control, as temporary equity (“mezzanine”) until such time as the conditions are removed

Other than contractual

obligations incurred in the normal course of business, we do not have any off-balance sheet financing arrangements or liabilities,

guarantee contracts, retain or contingent interests in transferred assets or any obligation arising out of a material variable

rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within

the Company’s control, as temporary equity (“mezzanine”) until such time as the conditions are removed or lapse.

than contractual obligations incurred in the normal course of business, we do not have any off-balance sheet financing arrangements or

liabilities, guarantee contracts, retain or contingent interests in transferred assets or any obligation arising out of a material variable

interest in an unconsolidated entity.

Recently Adopted Accounting Pronouncements

In August 2020, the FASB

issued ASU No.

2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts

in Entity’s Own Equity (Subtopic 815-40):

Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity ,

which simplifies accounting for convertible instruments by removing major separation models required under current GAAP.

removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception, and

it also simplifies the diluted earnings per share calculation in certain areas.

We adopted ASU 2020-06 on January 1, 2023, under the

modified retrospective method of transition.

The adoption of ASU 2020-06 did not impact the Company’s financial position, results

of operations or cash flows.

In June 2016, the FASB

issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments.

The main objective of ASU 2016-13 is to provide

financial statement users with more decision-useful information about an entity's expected credit losses on financial instruments

and other commitments to extend credit at each reporting date.

To achieve this objective, the amendments in this update replace

the incurred loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires

consideration of a broader range of reasonable and supportable information to develop credit loss estimates.

will be effective for us for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years,

using a modified retrospective approach.

Early adoption is permitted.

We adopted ASU 2016-13 and related updates as

of January 1, 2023.

Adopted Accounting Pronouncements

August 2020, the FASB issued ASU No.

2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives

and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40):

Accounting for Convertible Instruments and Contracts in an

Entity’s Own Equity , which simplifies accounting for convertible instruments by removing major separation models required under

current GAAP.

The ASU also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative

scope exception, and it also simplifies the diluted earnings per share calculation in certain areas.

We adopted ASU 2020-06 on January

1, 2023, under the modified retrospective method of transition.

The adoption of ASU 2020-06 did not impact the Company’s financial

position, results of operations or cash flows.

ITEM 3 – QUANTITATIVE AND QUALITATIVE

DISCLOSURES ABOUT MARKET RISK

Not applicable.

June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments.

The main objective of ASU 2016-13

is to provide financial statement users with more decision-useful information about an entity's expected credit losses on financial instruments

and other commitments to extend credit at each reporting date.

To achieve this objective, the amendments in this update replace the incurred

loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires consideration of

a broader range of reasonable and supportable information to develop credit loss estimates.

ASU 2016-13 will be effective for

us for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years, using a modified retrospective

Early adoption is permitted.

We adopted ASU 2016-13 and related updates as of January 1, 2023.

of ASU 2016-13 did not impact the Company’s financial position, results of operations or cash flows.

3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

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-Q

Item 2. Management’s Discussion and Analysis