What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2024-11-13 compared with 2024-08-13 · 344 added, 336 removed, 38 unchanged (95% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations

should read the following discussion and analysis of financial condition and operating results together with our financial statements

and the related notes and other financial information included elsewhere in this quarterly report on Form 10-Q, as well as our audited

consolidated financial statements and related notes as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023,

as filed on March 29, 2024.

This discussion contains forward-looking statements that involve risks and uncertainties.

As a result of

many factors, such as those set forth in the section of this report captioned “Risk Factors” and elsewhere in this Quarterly

Report on Form 10-Q as well as the risk factors set forth in the section titled “Risk Factors” included in our Annual Report

on Form 10-K, our actual results may differ materially from those anticipated in these forward-looking statements.

For convenience of

presentation some of the numbers have been rounded in the text below.

this report, the terms “our,” “we,” “us,” and the “Company” refer to Pasithea Therapeutics

and its subsidiaries, Pasithea Therapeutics Limited (U.K.), Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, Pasithea

Clinics Inc., Alpha-5 Integrin, LLC (“Alpha-5”), and AlloMek Therapeutics, LLC (“AlloMek”).

Pasithea Therapeutics

Limited (U.K.), legally dissolved as of January 2, 2024 was a private limited Company, registered in the United Kingdom (U.K.).

Therapeutics Portugal, Sociedade Unipessoal Lda, is a private limited Company registered in Portugal.

Management’s Discussion and Analysis

of Financial Condition and Results of Operations

You should read the following discussion and

analysis of financial condition and operating results together with our financial statements and the related notes and other financial

information included elsewhere in this quarterly report on Form 10-Q, as well as our audited consolidated financial statements and related

notes as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023, as filed on March 29, 2024.

This discussion

contains forward-looking statements that involve risks and uncertainties.

As a result of many factors, such as those set forth in the

section of this report captioned “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q as well as the risk factors

set forth in the section titled “Risk Factors” included in our Annual Report on Form 10-K, our actual results may differ materially

from those anticipated in these forward-looking statements.

For convenience of presentation some of the numbers have been rounded in the

Throughout this report, the terms “our,”

“we,” “us,” and the “Company” refer to Pasithea Therapeutics Corp.

and its subsidiaries, Pasithea

Therapeutics Limited (U.K.), Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, Pasithea Clinics Inc., Alpha-5 Integrin, LLC (“Alpha-5”),

and AlloMek Therapeutics, LLC (“AlloMek”).

Pasithea Therapeutics Limited (U.K.), legally dissolved as of January 2, 2024,

was a private limited Company, registered in the United Kingdom (U.K.).

Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, is a

private limited Company registered in Portugal.

Pasithea Clinics Inc.

is incorporated

Alpha-5 and AlloMek, are both Delaware limited liability companies.

The operations of Pasithea Therapeutics Limited (U.K.),

Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, and Pasithea Clinics Inc.

is incorporated in Delaware.

Alpha-5 and AlloMek, are both Delaware

limited liability companies.

The operations of Pasithea Therapeutics Limited (U.K.), Pasithea Therapeutics Portugal, Sociedade Unipessoal

Lda, and Pasithea Clinics Inc.

have been discontinued.

NOTE REGARDING FORWARD-LOOKING STATEMENTS

Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as

amended, and Section 21E of the Securities Exchange Act of 1934, as amended.

These statements are generally identified by the use of

such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,”

“forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,”

“outlook,” “will,” “potential” and similar statements of a future or forward-looking nature.

forward-looking statements speak only as of the date of filing this Quarterly Report with the SEC, and include, without limitation, statements

about the following:

our lack of operating history;

the expectation that we

will incur significant operating losses for the foreseeable future and will need significant additional capital;

the period over which we

estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure

requirements;

our estimates regarding

expenses, future revenue, capital requirements and needs for additional financing;

our plans to develop and

commercialize our product candidates involves a lengthy and expensive process, with an uncertain outcome;

the initiation, enrollment,

timing, progress, results, and cost of our research and development programs and our current and future preclinical studies and clinical

trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work,

the period during which the results of the trials will become available;

the timing of interim data

and final results from our clinical trials for PAS-004;

the potential safety and

efficacy of our product candidates and the therapeutic implications of clinical and preclinical data;

the timing and focus of

our future preclinical studies and clinical trials, and the reporting of data from those studies and trials;

the size of the market

opportunity for our future product candidates, including our estimates of the number of patients who suffer from the diseases we

are targeting;

the success of competing

therapies that are or may become available;

the beneficial characteristics,

safety, efficacy and therapeutic effects of our future product candidates;

our ability to obtain and

maintain regulatory approval of our future product candidates;

our plans relating to the

further development of our future product candidates, including additional disease states or indications we may pursue;

existing regulations and

regulatory developments in the United States and other jurisdictions;

our dependence on third

the need to hire additional

personnel and our ability to attract and retain such personnel;

our plans and ability to

obtain or protect intellectual property rights, including extensions of patent terms where available and our ability to avoid infringing

the intellectual property rights of others;

our financial performance

and sustaining an active trading market for our Common Stock and Public Warrants;

our ability to restructure

our operations to comply with any potential future changes in government regulation;

disruptions to the development

of our product candidates due to public health crises, such as epidemics and pandemics, including the COVID-19 global pandemic;

the impact of global economic

and market conditions and political developments on our business, including, among others, rising inflation and capital market disruptions,

economic sanctions, bank failures, regional conflicts around the world, and economic slowdowns or recessions that may result from

such developments which could harm our research and development efforts as well as the value of our Common Stock and our ability

to access capital markets;

business interruptions

resulting from geopolitical actions and global events, including political instability, natural disasters and events of terrorism

and wars such as the war between Ukraine and Russia, and the corresponding tensions created from such conflict between Russia, the

United States and countries in Europe as well as other countries such as China, and the conflict between Hamas and Israel;

our reliance on foreign contract research organizations (CROs) and

contract manufacturing organizations (CMOs), including WuXi AppTec, that may be subject to U.S.

legislation, including the proposed BIOSECURE

bill, trade restrictions and other foreign regulatory requirements which could increase the cost or reduce the supply of material available

to us, delay the procurement or supply of such material or have an adverse effect on our ability to secure significant commitments from

governments to purchase our potential therapies

forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some

of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events.

and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially

from those projected in the forward-looking statements.

You should refer to the “ Risk Factors ” section of this Quarterly

Report for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by

our forward-looking statements.

We operate in an evolving environment and new risk factors and uncertainties may emerge from time to

It is not possible for management to predict all risk factors and uncertainties.

As a result of these factors, we cannot assure

you that the forward-looking statements in this Quarterly Report will prove to be accurate.

Except as required by applicable law, we

do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information,

future events, changed circumstances or otherwise.

You should review the factors and risks and other information we describe in the reports

we will file from time to time with the SEC.

are a clinical-stage biotechnology company primarily focused on the discovery, research and development of innovative treatments for

CNS disorders and other diseases, including RASopathies.

Our primary operations, the Therapeutics segment, are focused on developing

our lead therapeutic candidate, PAS-004, a next-generation macrocyclic mitogen-activated protein kinase, or MEK inhibitor that we believe

may address the limitations and liabilities associated with existing drugs with a similar mechanism of action.

PAS-004 is a small molecule

allosteric inhibitor of MEK 1 and MEK 2 for potential use in the treatment of a range of RASopathies, including neurofibromatosis type

1 (“NF1”)- associated neurofibromas and a number of oncology indications, among others that we acquired from AlloMek Therapeutics,

LLC in October 2022.

In December 2023, the FDA cleared our IND for PAS-004 and the Company received a study may proceed letter from the

FDA for the Company’s Phase 1 multicenter, open-label, dose escalation trial of PAS-004 in patients with MAPK pathway-driven advanced

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report

on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section

21E of the Securities Exchange Act of 1934, as amended.

These statements are generally identified by the use of such words as “may,”

“could,” “should,” “would,” “believe,” “anticipate,” “forecast,”

“estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,”

“will,” “potential” and similar statements of a future or forward-looking nature.

These forward-looking statements

speak only as of the date of filing this Quarterly Report with the SEC, and include, without limitation, statements about the following:

lack of operating history;

expectation that we will incur significant operating losses for the foreseeable future and will need significant additional capital;

period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital

expenditure requirements;

estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

plans to develop and commercialize our product candidates involves a lengthy and expensive process, with an uncertain outcome;

initiation, enrollment, timing, progress, results, and cost of our research and development programs and our current and future preclinical

studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related

preparatory work, the period during which the results of the trials will become available;

timing of interim data and final results from our clinical trials for PAS-004;

potential safety and efficacy of our product candidates and the therapeutic implications of clinical and preclinical data;

timing and focus of our future preclinical studies and clinical trials, and the reporting of data from those studies and trials;

the size of the market opportunity for our future product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;

success of competing therapies that are or may become available;

beneficial characteristics, safety, efficacy and therapeutic effects of our future product candidates;

ability to obtain and maintain regulatory approval of our future product candidates;

plans relating to the further development of our future product candidates, including additional disease states or indications we may

regulations and regulatory developments in the United States and other jurisdictions;

dependence on third parties;

need to hire additional personnel and our ability to attract and retain such personnel;

plans and ability to obtain or protect intellectual property rights, including extensions of patent terms where available and our ability

to avoid infringing the intellectual property rights of others;

financial performance and sustaining an active trading market for our Common Stock and Public Warrants;

ability to restructure our operations to comply with any potential future changes in government regulation;

● disruptions

to the development of our product candidates due to public health crises, such as epidemics and pandemics, including the COVID-19 global

impact of global economic and market conditions and political developments on our business, including, among others, rising inflation

and capital market disruptions, economic sanctions, bank failures, regional conflicts around the world, and economic slowdowns or recessions

that may result from such developments which could harm our research and development efforts as well as the value of our Common Stock

and our ability to access capital markets;

interruptions resulting from geopolitical actions and global events, including political instability, natural disasters and events of

terrorism and wars such as the war between Ukraine and Russia, and the corresponding tensions created from such conflict between Russia,

the United States and countries in Europe as well as other countries such as China, and the conflict between Hamas and Israel;

reliance on foreign contract research organizations (CROs) and contract manufacturing organizations (CMOs), including WuXi AppTec, that

may be subject to U.S.

legislation, including the proposed BIOSECURE bill, trade restrictions and other foreign regulatory requirements

which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material or have

an adverse effect on our ability to secure significant commitments from governments to purchase our potential therapies

Because forward-looking

statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond

our control, you should not rely on these forward-looking statements as predictions of future events.

The events and circumstances reflected

in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the

forward-looking statements.

You should refer to the “ Risk Factors ” section of this Quarterly Report for a discussion

of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements.

We operate in an evolving environment and new risk factors and uncertainties may emerge from time to time.

It is not possible for management

to predict all risk factors and uncertainties.

As a result of these factors, we cannot assure you that the forward-looking statements

in this Quarterly Report will prove to be accurate.

Except as required by applicable law, we do not plan to publicly update or revise

any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise.

You should review the factors and risks and other information we describe in the reports we will file from time to time with the SEC.

Company Summary

We are a clinical-stage biotechnology company

primarily focused on the discovery, research and development of innovative treatments for CNS disorders and other diseases, including

Our primary operations, the Therapeutics segment,

are focused on developing our lead therapeutic candidate, PAS-004, a next-generation macrocyclic mitogen-activated protein kinase, or

MEK inhibitor that we believe may address the limitations and liabilities associated with existing drugs with a similar mechanism of action.

PAS-004 is a small molecule allosteric inhibitor of MEK 1 and MEK 2 for potential use in the treatment of a range of RASopathies, including

neurofibromatosis type 1 (“NF1”)- associated neurofibromas and a number of oncology indications, among others that we acquired

from AlloMek Therapeutics, LLC in October 2022.

In December 2023, the FDA cleared our IND for PAS-004 and we received a study may proceed

letter from the FDA for our Phase 1 multicenter, open-label, dose escalation trial of PAS-004 in patients with MAPK pathway-driven advanced

tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition.

The Company is currently conducting

the Phase 1 clinical trial at four clinical sites in the United States and plans to open an additional three sites in Eastern Europe in

the third quarter of 2024.

The Company’s clinical development plan for PAS-004 is to begin a Phase 1 clinical trial in adult and

pediatric NF1-associated plexiform and/or cutaneous neurofibroma and ultimately seek FDA marketing approval in these patient populations.

Additionally,

the Company has two programs that are in the discovery stage, which the Company believes address limitations in the treatment paradigm

of the indications the Company plans to address with these programs, which are currently ALS for PAS-003 and schizophrenia for PAS-001.

During the year ended December 31, 2023, we determined to cease further development of our PAS-002 program for multiple sclerosis due

to several factors including the significant capital, resources and time required to develop the program, and the current and projected

availability of effective treatment options for MS patients, among others.

ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of

one or more of our product candidates.

Until such time as we can generate significant revenue from product sales, if ever, we expect

to finance our operations through the sale of equity, debt financings, or other capital sources, including potential collaborations with

other companies or other strategic transactions.

We are currently conducting the Phase 1 clinical

trial at four clinical sites in the United States and plan to open an additional three sites in Eastern Europe in the fourth quarter of

Our clinical development plan for PAS-004 is to begin a Phase 1/2a clinical trial in adult patients with NF1-associated plexiform

and/or cutaneous neurofibromas followed by pediatric patients and ultimately seek FDA marketing approval in these patient populations.

Additionally, we have two programs that are in

the discovery stage, which we believe address limitations in the treatment paradigm of the indications we plan to address with these programs,

which are currently ALS for PAS-003 and schizophrenia for PAS-001.

During the year ended December 31, 2023, we determined to cease further

development of our PAS-002 program for multiple sclerosis due to several factors including the significant capital, resources and time

required to develop the program, and the current and projected availability of effective treatment options for MS patients, among others.

Our ability to generate

product revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of our product

Until such time we can generate significant revenue from product sales, if ever, we expect to finance our operations through

the sale of equity, debt financings, or other capital sources, including potential collaborations with other companies or other strategic

transactions.

Adequate funding may not be available to us on acceptable terms, or at all.

to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the

development and commercialization of our product candidates.

expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates

through all stages of development and clinical trials and, ultimately, seek regulatory approval.

In addition, if we obtain marketing

approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing,

marketing, sales and distribution.

We expect our expenses and capital requirements will increase significantly in connection with our

ongoing activities as we:

continue our ongoing and

planned research and development of our product candidates;

initiate nonclinical studies

and clinical trials for any additional product candidates that we may pursue;

scale up external manufacturing

capacity with the aim of securing sufficient quantities to meet our capacity requirements for clinical trials and potential commercialization;

establish a sales, marketing

and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing

develop, maintain, expand,

protect and enforce our intellectual property portfolio;

acquire or in-license product

candidates and technologies;

add clinical, operational,

financial and management information systems and personnel, including personnel to support our product development and planned future

commercialization efforts.

December 28, 2023, we filed a Certificate of Amendment to our Second Amended and Restated Certificate of Incorporation reflecting a one-for-20

reverse stock split (the “Reverse Stock Split”) of our issued and outstanding shares of Common Stock which became effective

at 12:01 a.m.

If we fail to raise capital or enter into such

agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of

our product candidates.

We expect to continue to incur significant expenses

and operating losses for the foreseeable future as we advance our product candidates through all stages of development and clinical trials

and, ultimately, seek regulatory approval.

In addition, if we obtain marketing approval for any of our product candidates, we expect to

incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution.

We expect our expenses

and capital requirements will increase significantly in connection with our ongoing activities as we:

our ongoing and planned research and development of our product candidates;

nonclinical studies and clinical trials for any additional product candidates that we may pursue;

up external manufacturing capacity with the aim of securing sufficient quantities to meet our capacity requirements for clinical trials

and potential commercialization;

a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial

manufacturing costs;

develop, maintain, expand, protect and enforce our intellectual property portfolio;

or in-license product candidates and technologies;

clinical, operational, financial and management information systems and personnel, including personnel to support our product development

and planned future commercialization efforts.

Recent Developments

Clinical Updates

On September 9, 2024, we announced the successful

completion of long-term chronic toxicity studies for our lead candidate PAS-004.

On September 26, 2024, we announced safety, tolerability,

pharmacokinetic (PK) and preliminary efficacy data from the first two cohorts of patients in our Phase 1 clinical trial of PAS-004.

2024 Offering

On September 26, 2024, we entered into a securities

purchase agreement (the “ September 2024 Offering”) with an institutional investor,

pursuant to which we agreed to sell pre-funded warrants (“Pre-Funded Warrants”) to purchase up to an aggregate of 1,219,513

shares of Common Stock at an exercise price of $0.001 per share, Series A warrants to purchase up to an aggregate of 1,219,513 shares

of Common Stock at an exercise price of $3.85 per share, and Series B warrants (together with the Series A Warrants, the “September

2024 PIPE Warrants”) to purchase up to an aggregate of 1,219,513 shares of Common Stock with an exercise price of $3.85 per share.

The combined purchase price per Pre-Funded Warrant and accompanying September 2024 PIPE Warrants was $4.099.

Aggregate gross proceeds

from the September 2024 Offering were approximately $4.5 million and the September 2024 Offering closed on September 30, 2024.

Scientific Advisory Board

On September 3, 2024, we announced that Rebecca

Brown, M.D., Ph.D., was appointed as a member of our Scientific Advisory Board.

Brown is currently Director of the Neurofibromatosis

Clinic at The Mount Sinai Hospital and Assistant Professor in the Department of Neurology (Division of Neuro-Oncology), Internal Medicine,

and Neurosurgery at the institution.

Reverse Stock Split

On December 28, 2023,

we filed a Certificate of Amendment to our Second Amended and Restated Certificate of Incorporation reflecting a one-for-20 reverse stock

split (the “Reverse Stock Split”) of our issued and outstanding shares of Common Stock which became effective at 12:01 a.m.

Eastern Time on January 2, 2024.

As a result of the Reverse Stock Split, every 20

shares of Common Stock issued and outstanding were converted into one share of Common Stock, with a corresponding reduction in the number

of authorized shares of Common Stock from 495,000,000 to 100,000,000.

The Reverse Stock Split affected all stockholders uniformly and

did not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the Reverse Stock

Split resulted in some stockholders owning a fractional share.

No fractional shares were issued in connection with the Reverse Stock

Stockholders who were otherwise entitled to receive a fractional share instead received a cash payment (without interest) equal

to such fraction multiplied by the average of the closing sales prices of Common Stock on The Nasdaq Capital Market for the five consecutive

trading days immediately preceding the effective date of the Reverse Stock Split (with such average closing sales prices adjusted to

give effect to the Reverse Stock Split).

All outstanding securities entitling their holders to purchase shares of Common Stock or acquire

shares of Common Stock, including stock options, convertible debt and warrants, were adjusted as a result of the Reverse Stock Split,

as required by the terms of those securities.

accompanying condensed consolidated financial statements reflect the Reverse Stock Split.

All share and per share information data

herein that relates to our Common Stock prior to the effective date has been retroactively restated to reflect the Reverse Stock Split.

have recently experienced higher costs across our business as a result of inflation, including higher costs related to employee compensation

and outside services.

We expect inflation to continue to have a negative impact throughout 2024, and it is uncertain whether we will

be able to offset the impact of inflationary pressures in the near term.

of Operations

of the Three and Six Months Ended June 30, 2024 and 2023

financial results for the three and six months ended June 30, 2024 and 2023 are summarized

For the Three Months

Ended June 30,

As a result of the Reverse Stock Split, every 20 shares of Common

Stock issued and outstanding were converted into one share of Common Stock, with a corresponding reduction in the number of authorized

shares of Common Stock from 495,000,000 to 100,000,000.

The Reverse Stock Split affected all stockholders uniformly and did not alter

any stockholder’s percentage interest in our equity, except to the extent that the Reverse Stock Split resulted in some stockholders

owning a fractional share.

No fractional shares were issued in connection with the Reverse Stock Split.

Stockholders who were otherwise

entitled to receive a fractional share instead received a cash payment (without interest) equal to such a fraction multiplied by the

average of the closing sales prices of Common Stock on The Nasdaq Capital Market for the five consecutive trading days immediately preceding

the effective date of the Reverse Stock Split (with such average closing sales prices adjusted to give effect to the Reverse Stock Split).

All outstanding securities entitling their holders to purchase shares of Common Stock or acquire shares of Common Stock, including stock

options, convertible debt and warrants, were adjusted as a result of the Reverse Stock Split, as required by the terms of those securities.

The accompanying condensed

consolidated financial statements reflect the Reverse Stock Split.

All share and per share information data herein that relates to

our Common Stock prior to the effective date has been retroactively restated to reflect the Reverse Stock Split.

Impact of Inflation

We have recently experienced

higher costs across our business as a result of inflation, including higher costs related to employee compensation and outside services.

We expect inflation to continue to have a negative impact throughout 2024, and it is uncertain whether we will be able to offset the impact

of inflationary pressures in the near term.

Results of Operations

Comparison of the Three and Nine Months Ended

September 30, 2024 and 2023

Our financial results for the three and nine months

ended September 30, 2024 and 2023 are summarized as follows:

For the Three Months Ended

September 30,

General and administrative

1 unchanged sentence

Loss from operations

Other income (expense), net

Other income, net

Net loss from continuing operations

2 unchanged sentences

$ (3,612,590 )

For the Six Months

Ended June 30,

For the Nine Months Ended

September 30,

General and administrative

1 unchanged sentence

Loss from operations

Other income (expense), net

(10,990,412 )

(10,830,579 )

Other income, net

Net loss from continuing operations

(10,726,923 )

(10,476,484 )

Net loss from discontinued operations, net of tax

1 unchanged sentence

$ (10,913,499 )

and administrative

and administrative expenses consist primarily of personnel expenses, including salaries, benefits, and stock-based compensation expense,

for employees and consultants in executive, finance and accounting, legal, operations support, information technology and human resource

General and administrative expenses also include corporate facility costs not otherwise included in research and development

expense, including rent, utilities, depreciation, amortization, and maintenance, as well as legal fees related to intellectual property

and corporate matters, fees for accounting and consulting services and other expenses, including insurance, public company and corporate

communications, information technology, and board fees.

and administrative expenses decreased by approximately $213,000, or 12%, for the three months ended June 30, 2024 compared to the three

months ended June 30, 2023.

The decrease was primarily driven by decreases in (i) accounting and business development of approximately

$27,000 (ii) non-cash amortization and depreciation and stock-based compensation of approximately $184,000, (iii) personnel related expenses

of approximately $67,000, (iv) legal expenses of approximately $48,000, (v) public company and corporate communications expenses of approximately

$25,000 and (vi) other expenses of approximately $104,000, offset by increases in (i) office expenses of approximately $204,000 and (ii)

consulting costs of approximately $38,000.

and administrative expenses decreased by approximately $38,000, or 1%, for the six months ended June 30, 2024 compared to the six months

ended June 30, 2023.

The decrease was primarily driven by decreases in (i) personnel costs of approximately $324,000, (ii) accounting

and business development of approximately $95,000 and (iii) other expenses of approximately $104,000, offset by increases in (i) legal

expenses of approximately $171,000, (ii) office expenses, including franchise taxes and insurance of approximately $145,000, (iii) public

company and corporate communications expenses of approximately $80,000, (iv) non-cash amortization and depreciation and stock-based compensation

of approximately $52,000 and (v) consulting costs of approximately $37,000.

expect general and administrative expenses to continue at lower levels in fiscal year 2024 as compared to fiscal year 2023 due to the

non-recurring expenses that were incurred in 2023 related to the unsolicited, non-binding proposal to acquire all outstanding shares

of the Company from a third party and the tender offer we completed in September 2023.

and Development

Research and development expenses relate to activities primarily focused

on the development of PAS-004 for the three and six months ended June 30, 2024, and PAS-004, PAS-003, and PAS-001 for the three and six

months ended June 30, 2023.

Research and development expenses increased by approximately $307,000,

or 15%, for the three months ended June 30, 2024 compared to the three months ended June 30, 2023.

The increase was primarily driven by

increases in (i) clinical trial costs of approximately $844,000 related to the initiation of the Phase 1 clinical trial of PAS-004, (ii)

personnel expenses, including salaries, benefits and severance payments of approximately $279,000 related to the closure of our research

laboratory and reduction in related workforce, and (iii) general expenses of approximately $74,000, offset by decreases in (i) manufacturing

and CMC expenses of approximately $323,000, (ii) preclinical research and development expenses related to our discovery programs of approximately

$ 460,000, (iii) consulting costs of approximately $53,000 and (iv) non-cash stock-based compensation of approximately $54,000.

Research and development expenses increased by approximately $982,000,

or 31%, for the six months ended June 30, 2024 compared to the six months ended June 30, 2023.

The increase was primarily driven by increases

in (i) clinical trial costs of approximately $1,527,000 related to the initiation of the Phase 1 clinical trial of PAS-004, (ii) personnel

expenses, including salaries, benefits and severance payments of approximately $257,000 related to the closure of our research laboratory

and reduction in related workforce, (iii) consulting costs of approximately $102,000, iv) general expenses of approximately $65,000 and

(v) non-cash stock-based compensation of approximately $61,000, offset by decreases in (i) preclinical research and development expenses

related to our discovery programs of approximately $893,000 and (ii) manufacturing and CMC expenses of approximately $137,000.

General and administrative

General and administrative expenses consist primarily

of personnel expenses, including salaries, benefits, and stock-based compensation expense, for employees and consultants in executive,

finance and accounting, legal, operations support, information technology and human resource functions.

General and administrative expenses

also include corporate facility costs not otherwise included in research and development expenses, including rent, utilities, depreciation,

amortization, and maintenance, as well as legal fees related to intellectual property and corporate matters, fees for accounting and consulting

services and other expenses, including insurance, public company and corporate communications, information technology, and board fees.

General and administrative expenses decreased

by approximately $741,000, or 34%, for the three months ended September 30, 2024 compared to the three months ended September 30, 2023.

The decrease was primarily driven by decreases in (i) legal expenses of approximately $493,000, (ii) public company and corporate communications

expenses of approximately $217,000, (iii) accounting and business development of approximately $115,000, and (iv) personnel, other income

and gain on payable of approximately $43,000 offset by an increase in (i) consulting costs of approximately $78,000, (ii) non-cash stock

based expense of approximately $28,000, and (iii) other expense and gain on disposal of assets of $21,000.

General and administrative expenses decreased

by approximately $779,000, or 13%, for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023.

The decrease was primarily driven by decreases in (i) personnel costs of approximately $326,000, (ii) legal expenses of approximately

$322,000, (iii) accounting and business development of approximately $210,000, (iv) public company and corporate communications expenses

of approximately $137,000, (v) other income of approximately $117,000, and (vi) gain on payable of $18,000, offset by an increases in

(i) office expenses, including franchise taxes and insurance of approximately $152,000, (ii) consulting costs of approximately $114,000,

(iii) non-cash amortization and depreciation, stock-based compensation of approximately $80,000, and (iv) other expense of approximately

We expect general and administrative expenses

to continue at lower levels in fiscal year 2024 as compared to fiscal year 2023 due to the non-recurring expenses that were incurred in

2023 related to the unsolicited, non-binding proposal to acquire all our outstanding shares from a third party and the tender offer we

completed in September 2023.

Research and Development

Research and development expenses relate to

activities primarily focused on the development of PAS-004 for the three and nine months ended September 30, 2024, and PAS-004,

PAS-003, and PAS-001 for the three and nine months ended September 30, 2023.

Research and development

expenses decreased by approximately $44,000, or 3%, for the three months ended September 30, 2024 compared to the three months ended September

The decrease was primarily driven by decreases in (i) preclinical research and development expenses related to our discovery

programs of approximately $403,000 and (ii) personnel expenses and stock compensation expense of approximately $137,000 related to the

closure of our research laboratory and reduction in related workforce, offset by increases in (i) consulting expenses of approximately

$35,000, (ii) general research and development expenses of approximately $181,000, (iii) manufacturing and CMC expenses of approximately

$160,000 and (iv) clinical trial costs of approximately $120,000 related to the initiation of the Phase 1 clinical trial of PAS-004.

Research and development expenses increased by

approximately $939,000, or 20%, for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023.

increase was primarily driven by increases in (i) clinical trial costs of approximately $1,647,000 related to the initiation of the Phase

1 clinical trial of PAS-004, (ii) general research and development expenses of approximately $246,000, (iii) consulting costs of approximately

$137,000, (iv) stock compensation and personnel cost of approximately $182,000 and (v) manufacturing and CMC expenses of approximately

$22,000 offset by (i) preclinical research and development related to our discovery programs of approximately $1,295,000.

We expect research and

1 unchanged sentence

as well as PAS-004 CMC activities, offset by decreases in preclinical research and development related to the closure of our research

income (expense), net

the three months ended June 30, 2024, other income (expense), net decreased by approximately $152,000, or 66%, compared to the three

months ended June 30, 2023.

The decrease in other income (expense), net is due primarily to a decrease in the fair value of the Public

Warrants and the Representative Warrants (as such terms are defined in “Note 2 – Summary of Significant Accounting Policies”

in the Notes to Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this Form 10-Q) that occurred during the three

months ended June 30, 2024, compared to a larger increase in the fair value of the Public Warrants and the Representative Warrants that

occurred during the three months ended June 30, 2023.

the six months ended June 30, 2024, other income (expense), net increased by approximately $81,000, or 46%, compared to the six months

ended June 30, 2023.

The increase in other income (expense), net is due primarily to dividend income of $268,000 during the six months

ended June 30, 2024 compared to approximately $111,000 of dividend income during the six months ended June 30, 2023.

This increase was

partially offset related to the decrease in the fair value of warrant liabilities.

See “Note 2 – Summary of Significant Accounting

Policies” in the Notes to Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this Form 10-Q for more information

on the accounting treatment of the Public Warrants and the Representative Warrants.

the year ended December 31, 2023, we discontinued our support services to anti-depression clinics in the U.K.

and related at-home services

in New York, NY.

We also discontinued our clinical operations in Los Angeles, CA and disposed of the related property.

Accordingly, we

discontinued the operations of our Clinics segment provided by our subsidiaries, and currently have one reportable segment, the Therapeutics

segment, related to the research and development of our therapeutic product candidates.

As of June 30, 2023, all activity related to

our discontinued subsidiaries is included in Net loss from discontinued operations, net of tax in the condensed consolidated statements

of operations and comprehensive loss.

Other income,

For the three months ended September 30, 2024,

other income, net decreased by approximately $172,000, or 97%, compared to the three months ended September 30, 2023.

The decrease in

other income, net is due primarily to a decrease in the fair value of the Public Warrants and the Representative Warrants (as such terms

are defined in “Note 2 – Summary of Significant Accounting Policies” in the Notes to Unaudited Condensed Consolidated

Financial Statements in Part I, Item 1 of this Form 10-Q) that occurred during the three months ended September 30, 2024, compared to

a larger increase in the fair value of the Public Warrants and the Representative Warrants that occurred during the three months ended

September 30, 2023.

For the nine months ended September 30, 2024,

other income, net decreased by approximately $91,000, or 26%, compared to the nine months ended September 30, 2023.

The increase in other

income, net is due primarily to an increase in the fair value of warrant liabilities of approximately $191,000, offset by dividend income

of $343,000 during the nine months ended September 30, 2024 compared to approximately $254,000 of dividend income during the nine months

ended September 30, 2023.

See “Note 2 – Summary of Significant Accounting Policies” in the Notes to Unaudited Condensed

Consolidated Financial Statements in Part I, Item 1 of this Form 10-Q for more information on the accounting treatment of the Public Warrants

and the Representative Warrants.

Discontinued Operations

During the year ended December 31, 2023, we discontinued

our support services to anti-depression clinics in the U.K.

and related at-home services in New York, NY.

We also discontinued our clinical

operations in Los Angeles, CA and disposed of the related property.

Accordingly, we discontinued the operations of our Clinics segment

provided by our subsidiaries, and currently have one reportable segment, the Therapeutics segment, related to the research and development

of our therapeutic product candidates.

As of June 30, 2023, all activity related to our discontinued subsidiaries is included in Net loss

from discontinued operations, net of tax in the condensed consolidated statements of operations and comprehensive loss.

Working Capital

September 30,

Current assets

1 unchanged sentence

Working capital

Working capital decreased by approximately $6.8 million between December

31, 2023 and June 30, 2024 due primarily to cash used to fund operations for the six months ended June 30, 2024.

and Financial Condition

Six Months Ended

Working capital decreased by approximately $5.0

million between December 31, 2023 and September 30, 2024 primarily due to cash used to fund operations for the nine months ended September

Liquidity and Financial Condition

Nine Months Ended

September 30,

Net loss from continuing operations

4 unchanged sentences

$ (9,519,789 )

Net cash used in investing activities

Net cash provided by financing activities

Net cash provided by investing activities

Net cash provided by (used in) financing activities

Effect of foreign currency translation

3 unchanged sentences

$ (13,503,174 )

and cash equivalents decreased by approximately $8.4 million for the six months ended June 30, 2024, compared to a decrease of approximately

$6.4 million for the six months ended June 30, 2023, which was primarily attributable to cash used to fund operations and an increase

in prepaid expenses.

& Capital Resources Outlook

As of June 30, 2024, we had approximately $8.0 million in operating

bank accounts and money market funds, with working capital of approximately $7.2 million.

We have incurred significant operating losses

and negative cash flows from operations.

On June 30, 2024, we had an accumulated deficit of approximately $43.0 million.

We have incurred

recurring losses, have experienced recurring negative operating cash flows, and require significant cash resources to execute our business

Historically, our major sources of cash have been comprised of proceeds from various public and private offerings of our capital

We are dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue

to execute our development plans and continue operations.

Subsequent to the consummation of the Initial Public Offering, our liquidity

was and continues to be satisfied through the net proceeds from the Initial Public Offering, the private placement we consummated in November

2021 and the receipt of cash upon the prior exercise of our outstanding warrants.

Based on the foregoing, management believes that we

will not have sufficient working capital to meet our needs through twelve months from the issuance date of the condensed consolidated

financial statements, without raising additional capital.

& Capital Resources Outlook

primary use of cash is to fund operating expenses, primarily general and administrative and research and development expenditures.

used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding

accounts payable, accrued expenses and prepaid expenses.

of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are

unable to estimate the exact amount of our operating capital requirements.

Our future funding requirements will depend on many factors,

including, but not limited to:

the scope, timing, progress

and results of discovery, preclinical development, laboratory testing and clinical trials for our product candidates;

the costs of manufacturing

our product candidates for clinical trials and in preparation for marketing approval and commercialization;

the extent to which we

enter into collaborations or other arrangements with third parties in order to further develop our product candidates;

the costs of preparing,

filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual

property-related claims;

the costs and fees associated

with the discovery, acquisition or in-license of additional product candidates or technologies;

expenses needed to attract

and retain skilled personnel;

the costs required to scale

up our clinical, regulatory and manufacturing capabilities;

the costs of future commercialization

activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities, for any of our product

candidates for which we receive marketing approval;

revenue, if any, received

from commercial sales of our product candidates, should any of our product candidates receive marketing approval.

will need significant additional funds to meet operational needs and capital requirements for clinical trials, other research and development

expenditures, and business development activities.

Cash and cash equivalents decreased by approximately

$7.0 million for the nine months ended September 30, 2024 compared to a decrease of approximately $13.5 million for the nine months ended

September 30, 2023, which was primarily attributable to cash used to fund operations and an increase in prepaid expenses.

Liquidity & Capital Resources Outlook

As of September 30, 2024, we had approximately

$9.4 million in operating bank accounts and money market funds, with working capital of approximately $9.1 million.

We have incurred significant

operating losses and negative cash flows from operations.

On September 30, 2024, we had an accumulated deficit of approximately $46.4

We have incurred recurring losses, have experienced recurring negative operating cash flows, and require significant cash resources

to execute our business plans.

Historically, our major sources of cash have been comprised of proceeds from various public and private

offerings of our capital stock.

We received aggregate gross proceeds of approximately $4.5 million as a result of the September 2024 Offering.

We are dependent on obtaining additional working capital funding from the sale of equity and/or debt securities to continue to execute

our development plans and continue operations.

Based on the foregoing, management believes that we will not have

sufficient working capital to meet our needs through twelve months from the issuance date of the condensed consolidated financial statements,

without raising additional capital.

Liquidity & Capital Resources Outlook

Our primary use of cash is to fund operating expenses,

primarily general and administrative and research and development expenditures.

Cash used to fund operating expenses is impacted by the

timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses.

Because of the numerous risks and uncertainties

associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of

our operating capital requirements.

Our future funding requirements will depend on many factors, including, but not limited to:

scope, timing, progress and results of discovery, preclinical development, laboratory testing and clinical trials for our product candidates;

costs of manufacturing our product candidates for clinical trials and in preparation for marketing approval and commercialization;

extent to which we enter into collaborations or other arrangements with third parties in order to further develop our product candidates;

costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending

intellectual property-related claims;

costs and fees associated with the discovery, acquisition or in-license of additional product candidates or technologies;

needed to attract and retain skilled personnel;

costs required to scale up our clinical, regulatory and manufacturing capabilities;

costs of future commercialization activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities,

for any of our product candidates for which we receive marketing approval;

if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval.

We will need significant additional funds to meet

operational needs and capital requirements for clinical trials, other research and development expenditures, and business development

We currently have no credit facility or committed sources of capital.

Because of the

numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate

the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical studies.

Note 9 – Commitments and Contingencies in the Notes to Unaudited Condensed Consolidated Financial Statements in Part I, Item 1

of this Form 10-Q for a summary of our contractual obligations.

Sheet Arrangements

the periods presented, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K promulgated

under the Exchange Act.

Accounting Estimates

critical accounting estimates, which include (1) revenue recognition, (2) stock-based compensation and (3) fair value measurements, are

more fully described in the Notes to our Consolidated Financial Statements included in our Form 10-K for the fiscal year ended December

31, 2023, as filed on March 29, 2024.

During the six months ended June 30, 2024, there were no material changes to our critical accounting

policies and estimates from those described in our Form 10-K.

Accounting Pronouncements

Note 2 – Summary of Significant Accounting Policies in the Notes to our Unaudited Condensed Consolidated Financial Statements in

Part I, Item 1 of this Form 10-Q for a description of recent accounting pronouncements applicable to our financial statements.

Because of the numerous risks and uncertainties associated

with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays

and operating expenditures associated with our current and anticipated clinical studies.

Contractual Obligations

See Note 9 – Commitments and Contingencies

in the Notes to Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this Form 10-Q for a summary of our contractual

Off-Balance Sheet Arrangements

During the periods presented, we did not have

any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K promulgated under the Exchange Act.

Critical Accounting Estimates

Our critical accounting estimates, which include

(1) revenue recognition, (2) stock-based compensation and (3) fair value measurements, are more fully described in the Notes to our Consolidated

Financial Statements included in our Form 10-K for the fiscal year ended December 31, 2023, as filed on March 29, 2024.

During the nine

months ended September 30, 2024, there were no material changes to our critical accounting policies and estimates from those described

in our Form 10-K.

Recent Accounting Pronouncements

See Note 2 – Summary of Significant Accounting

Policies in the Notes to our Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this Form 10-Q for a description

of recent accounting pronouncements applicable to our financial statements.

Quantitative and Qualitative Disclosures about Market Risk

As a smaller reporting company, we are not required to provide the information required by this Item.

Not Applicable.

As a smaller reporting company, we are not required

to provide the information required by this Item.

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