What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-11-07 compared with 2024-08-07 · 253 added, 206 removed, 270 unchanged (63% of the section changed)

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and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” All statements other than

statements of historical fact contained in this Quarterly Report, including statements regarding future events, our future financial performance,

business strategy and plans and objectives of management for future operations, are forward-looking statements.

We have attempted to identify

forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,”

“could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,”

“predicts,” “should,” or “will” or the negative of these terms or other comparable terminology.

we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy.

These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined

under “Risk Factors” or elsewhere in this Quarterly Report, which may cause our or our industry’s actual results, levels

of activity, performance or achievements expressed or implied by these forward-looking statements.

Moreover, we operate in a very competitive

and rapidly changing environment.

New risks emerge from time to time and it is not possible for us to predict all risk factors, nor can

we address the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause our actual

results to differ materially from those contained in any forward-looking statements.

All forward-looking statements included in this document

are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements.

statements of historical fact contained in this Quarterly Report, including statements regarding future events, our future financial

performance, business strategy and plans and objectives of management for future operations, are forward-looking statements.

attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,”

“continue,” “could,” “estimates,” “expects,” “intends,” “may,”

“plans,” “potential,” “predicts,” “should,” or “will” or the negative of

these terms or other comparable terminology.

Although we do not make forward-looking statements unless we believe we have a reasonable

basis for doing so, we cannot guarantee their accuracy.

These statements are only predictions and involve known and unknown risks, uncertainties

and other factors, including the risks outlined under “Risk Factors” or elsewhere in this Quarterly Report, which may cause

our or our industry’s actual results, levels of activity, performance or achievements expressed or implied by these forward-looking

Moreover, we operate in a very competitive and rapidly changing environment.

New risks emerge from time to time and it is

not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which

any factor, or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking

All forward-looking statements included in this document are based on information available to us on the date hereof, and

we assume no obligation to update any such forward-looking statements.

You should not place undue reliance on any forward-looking

statement, each of which applies only as of the date of this Quarterly Report on Form-10-Q.

Before you invest in our securities, you should

be aware that the occurrence of the events described in the section entitled “Risk Factors” and elsewhere in this Quarterly

Report could negatively affect our business, operating results, financial condition and stock price.

Except as required by law, we undertake

no obligation to update or revise publicly any of the forward-looking statements after the date of this Quarterly Report on Form-10-Q

to conform our statements to actual results or changed expectations.

Before you invest in our securities, you

should be aware that the occurrence of the events described in the section entitled “Risk Factors” and elsewhere in this

Quarterly Report could negatively affect our business, operating results, financial condition and stock price.

Except as required by

law, we undertake no obligation to update or revise publicly any of the forward-looking statements after the date of this Quarterly Report

on Form-10-Q to conform our statements to actual results or changed expectations.

Business Overview

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Phase 2 Clinical Trial

In the REL-1017-202 study, 62 subjects, with an

average age of 49.2 years, with an average Hamilton Depression Rating Scale score of 25.3 and an average Montgomery-Asberg Depression

In the REL-1017-202 study, 62 subjects, with

an average age of 49.2 years, with an average Hamilton Depression Rating Scale score of 25.3 and an average Montgomery-Asberg Depression

Rating Scale (MADRS) score of 34.0 (severe depression), were randomized.

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Phase 3 Program

On December 20, 2020, Relmada announced that the

first patient had been enrolled in the first Phase 3 clinical trial (RELIANCE I) for the Company’s lead product candidate, REL-1017,

as an adjunctive treatment for MDD.

On December 20, 2020, Relmada announced that

the first patient had been enrolled in the first Phase 3 clinical trial (RELIANCE I) for the Company’s lead product candidate,

REL-1017, as an adjunctive treatment for MDD.

On April 1, 2021, Relmada announced the initiation

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In addition, on October 4, 2021, Relmada announced

that in order to support potential regulatory submissions seeking approval for REL-1017 as adjunctive and monotherapy treatment, the Food

and Drug Administration (FDA) confirmed that, based on what was known at the time, Relmada would not be required to conduct a two-year

that in order to support potential regulatory submissions seeking approval for REL-1017 as adjunctive and monotherapy treatment, the

Food and Drug Administration (FDA) confirmed that, based on what was known at the time, Relmada would not be required to conduct a two-year

carcinogenicity study of REL-1017, as sufficient clinical data had been generated to date.

The FDA also confirmed that Relmada would not

need to conduct a TQT cardiac study in humans to support cardiac safety in potential regulatory submissions for REL-1017, as the data

already provided and the data to be generated by the Phase 3 program would be adequate to evaluate the cardiac safety profile of REL-1017.

The FDA also confirmed that Relmada would

not need to conduct a TQT cardiac study in humans to support cardiac safety in potential regulatory submissions for REL-1017, as the

data already provided and the data to be generated by the Phase 3 program would be adequate to evaluate the cardiac safety profile of

On August 9, 2022, Relmada announced that the

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Top-line Results -Oxycodone:

On July 27, 2021, Relmada announced top-line results

that showed that all three doses of REL-1017 (25 mg, 75 mg and 150 mg, the therapeutic, supratherapeutic and maximum tolerated doses (MTD),

respectively) tested in recreational opioid users, demonstrated a highly statistically significant difference vs.

the active control drug,

oxycodone 40 mg.

The study’s primary endpoint was a measure of “likability” with the subjects rating the maximum effect

(or Emax) for Drug Liking “at the moment”, using a 1=100 bipolar rating scale (known as a visual analog scale or VAS), with

100 as the highest likability, 50 as neutral (placebo-like), and 0 the highest dislike.

In summary, all tested doses of REL-1017, including

the 150 mg MTD, showed a highly statistically significant difference in abuse potential versus oxycodone with p-values less than 0.05.

On July 27, 2021, Relmada announced top-line

results that showed that all three doses of REL-1017 (25 mg, 75 mg and 150 mg, the therapeutic, supratherapeutic and maximum tolerated

doses (MTD), respectively) tested in recreational opioid users, demonstrated a highly statistically significant difference vs.

control drug, oxycodone 40 mg.

The study’s primary endpoint was a measure of “likability” with the subjects rating

the maximum effect (or Emax) for Drug Liking “at the moment”, using a 1=100 bipolar rating scale (known as a visual analog

scale or VAS), with 100 as the highest likability, 50 as neutral (placebo-like), and 0 the highest dislike.

In summary, all tested doses

of REL-1017, including the 150 mg MTD, showed a highly statistically significant difference in abuse potential versus oxycodone with

p-values less than 0.05.

Consistent results were seen for the secondary endpoints.

Additionally, all REL-1017 doses including 150 mg (6 times the therapeutic dose

and MTD) were statistically equivalent to placebo (p<0.05).

These results support the lack of opioid effects of REL-1017.

Additionally, all REL-1017 doses including 150 mg

(6 times the therapeutic dose and MTD) were statistically equivalent to placebo (p<0.05).

These results support the lack of opioid

effects of REL-1017.

Top-line Results -Ketamine:

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endpoint was a measure of “likability” with the subjects rating the maximum effect (or Emax) for Drug Liking “at this

moment”, using a 1-100 bipolar rating scale (known as a visual analog scale or VAS), with 100 as the highest likability, 50 as neutral

(placebo-like), and 0 the highest dislike.

moment”, using a 1-100 bipolar rating scale (known as a visual analog scale or VAS), with 100 as the highest likability, 50 as

neutral (placebo-like), and 0 the highest dislike.

Consistent results are seen for the secondary endpoints.

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On October 11, 2023, Relmada announced that it

intends to enter human studies of its proprietary, modified-release formulation of psilocybin (REL-P11) for metabolic indications in doses

that we believe are lower than those associates with psychedelic effects.

The Company plans to commence a single-ascending dose Phase

1 trial in obese subjects in 2024 to define the pharmacokinetic, safety and tolerability profile of Relmada's modified-release psilocybin

formulation (REL-P11) in this population, followed by a Phase 2a trial to establish clinical proof-of-concept.

intends to enter human studies of its proprietary, modified-release formulation of psilocybin (REL-P11) for metabolic indications in

doses that we believe are lower than those associates with psychedelic effects.

The Company plans to commence a single-ascending dose

Phase 1 trial in obese subjects in 2024 to define the pharmacokinetic, safety and tolerability profile of Relmada's modified-release

psilocybin formulation (REL-P11) in this population, followed by a Phase 2a trial to establish clinical proof-of-concept.

Pre-clinical data in a rodent model of metabolic

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These include:

a formal interim analysis, with futility and sample size re-estimation analyses, of RELIANCE

II study by year-end 2024.

enrollment in the ongoing RELIANCE II study by year-end 2024.

Initiate Phase 1 trial

in obese subjects with the modified-release formulation of psilocybin (REL-P11) in 2024.

Conduct a formal interim analysis, with futility and

sample size re-estimation analyses, of RELIANCE II study by year-end 2024.

Outcome of RELIANCE II interim analysis expected before year-end 2024.

Initiate Phase 1 trial in obese subjects with the

modified-release formulation of psilocybin (REL-P11) in 2024.

Our Development Program

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(STAR*D) trial published in the American Journal of Psychiatry.

addition to the high failure rate, only two of the marketed products for depression, esketamine (marketed by Johnson and Johnson as

Spravato®), an in-clinic nasal spray treatment, and dextromethorphan-bupropion (marketed by Axsome as Auvelity ä ),

can demonstrate rapid antidepressant effects, while the other currently approved products can take two to eight weeks to show

The urgent need for improved, faster acting antidepressant treatments is underscored by the fact that severe depression

can be life-threatening, due to heightened risk of suicide.

In addition to the high failure rate, only two

of the marketed products for depression, esketamine (marketed by Johnson and Johnson as Spravato®), an in-clinic nasal spray treatment,

and dextromethorphan-bupropion (marketed by Axsome as Auvelity ä ), can demonstrate rapid

antidepressant effects, while the other currently approved products can take two to eight weeks to show activity.

The urgent need for

improved, faster acting antidepressant treatments is underscored by the fact that severe depression can be life-threatening, due to heightened

risk of suicide.

Esmethadone Overview and Mechanism of Action

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as well as all atypical antipsychotics used adjunctively with standard, FDA-approved antidepressants.

Working through the same brain mechanisms

as ketamine and esketamine but potentially lacking their adverse side effects, esmethadone is being developed as a rapidly acting, oral

agent for the treatment of depression and potentially other CNS conditions.

In chemistry an enantiomer, also known as an optical

isomer, is one of two stereoisomers that are mirror images of each other that are non-superimposable (not identical), much as one’s

left and right hands are the same except for being reversed along one axis.

A racemic compound, or racemate, is one that has equal amounts

of left- and right-handed enantiomers of a chiral molecule.

For racemic drugs, often only one of a drug’s enantiomers is responsible

for the desired physiologic effects, while the other enantiomer is less active or inactive.

Working through the same brain

mechanisms as ketamine and esketamine but potentially lacking their adverse side effects, esmethadone is being developed as a rapidly

acting, oral agent for the treatment of depression and potentially other CNS conditions.

In chemistry an enantiomer, also known as an

optical isomer, is one of two stereoisomers that are mirror images of each other that are non-superimposable (not identical), much as

one’s left and right hands are the same except for being reversed along one axis.

A racemic compound, or racemate, is one that

has equal amounts of left- and right-handed enantiomers of a chiral molecule.

For racemic drugs, often only one of a drug’s enantiomers

is responsible for the desired physiologic effects, while the other enantiomer is less active or inactive.

As a single isomer of racemic methadone, esmethadone

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of depression and other CNS diseases.

We are also developing a novel modified release formulation of psilocybin for the treatment of metabolic

We are also developing a novel modified release formulation of psilocybin for the treatment of

metabolic indications.

Currently, none of our product candidates have

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generating revenues for the foreseeable future.

We had a net loss of $39,596,248 for the six months ended June 30, 2024.

At June 30, 2024,

We had a net loss of $61,322,218 for the nine months ended September 30, 2024.

30, 2024, we had an accumulated deficit of $622,224,899.

Business Strategy

Our strategy is to leverage our considerable industry

experience, understanding of CNS markets and development expertise to identify, develop and commercialize product candidates with significant

market potential that can fulfill unmet medical needs in the treatment of CNS diseases.

We have assembled a management team along with

both scientific advisors, including recognized experts in the fields of depression, and business advisors with significant industry and

regulatory experience to lead and execute the development and commercialization of esmethadone.

Our strategy is to leverage our considerable

industry experience, understanding of CNS markets and development expertise to identify, develop and commercialize product candidates

with significant market potential that can fulfill unmet medical needs in the treatment of CNS diseases.

We have assembled a management

team along with both scientific advisors, including recognized experts in the fields of depression, and business advisors with significant

industry and regulatory experience to lead and execute the development and commercialization of esmethadone.

We plan to further develop esmethadone as our

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13% for cancer and 12% for cardiovascular disease.

depression treatment market is segmented on the basis of antidepressants drugs, devices, and therapies.

Antidepressants are the largest

and most popular market segment.

The antidepressants segment consists of large pharmaceutical and generic companies, such as Eli Lilly,

Pfizer, GlaxoSmithKline, Allergan, Sage Therapeutics and Johnson & Johnson.

Some of the notable drugs produced by these companies

are Cymbalta® (Eli Lilly), Effexor® (Pfizer), Pristiq® (Pfizer), ZURZUVANE TM (Sage),

Spravato® (Johnson & Johnson) and Auvelity ä (Axsome).

The depression treatment market is segmented on

the basis of antidepressants drugs, devices, and therapies.

Antidepressants are the largest and most popular market segment.

The antidepressants

segment consists of large pharmaceutical and generic companies, such as Eli Lilly, Pfizer, GlaxoSmithKline, Allergan, Sage Therapeutics

and Johnson & Johnson.

Some of the notable drugs produced by these companies are Cymbalta® (Eli Lilly), Effexor® (Pfizer),

Pristiq® (Pfizer), ZURZUVAE TM (Sage), Spravato® (Johnson & Johnson) and Auvelity™ (Axsome).

Intellectual Property Portfolio and Market

We have over 50 issued patents and pending patent

applications related to REL-1017 for multiple uses, including psychological and neurological conditions, potentially provide coverage

applications related to REL-1017 for multiple uses, including psychological and neurological conditions, potentially providing coverage

We have also secured an Orphan Drug Designation from the FDA for d-methadone for “the treatment of postherpetic neuralgia”

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We believe that the key elements for our market success include:

Compelling lead product opportunity, REL-1017 currently in two Phase 3 trials for the adjunctive treatment of MDD (RELIANCE II and RELIGHT) that build on the knowledge obtained from RELIANCE I, which did not meet its primary endpoint.

Robust and highly statistically significant, efficacy seen with esmethadone in a randomized Phase 2 trial with the primary endpoint at 7 days, with onset of action seen at 4 days, and the effect carrying through to 14 days (7 days post-treatment).

Successful Phase 1 safety studies of esmethadone and strong clinical activity signal in depression established in three independent animal models in preclinical studies.

Potential in additional multiple indications in underserved markets with large patient population in other affective disorders, and cognitive disorders.

Compelling lead product opportunity, REL-1017 currently in two Phase

3 trials for the adjunctive treatment of MDD (RELIANCE II and RELIGHT) that build on the knowledge obtained from RELIANCE I, which

did not meet its primary endpoint.

Robust and highly statistically significant, efficacy seen with esmethadone

in a randomized Phase 2 trial with the primary endpoint at 7 days, with onset of action seen at 4 days, and the effect carrying through

to 14 days (7 days post-treatment).

Successful Phase 1 safety studies of esmethadone and strong clinical

activity signal in depression established in three independent animal models in preclinical studies.

Potential in additional multiple indications in underserved markets

with large patient population in other affective disorders, and cognitive disorders.

Substantial esmethadone IP Portfolio and market protection:

approved and filed patent applications provide coverage beyond 2033.

Portfolio diversification with the development of a novel psilocybine (REL-P11) for the treatment of metabolic indications.

and filed patent applications provide coverage beyond 2033.

Portfolio diversification with the development of a novel psilocybin (REL-P11) for the treatment of metabolic indications.

This program is expected to enter human studies, to define its pharmacokinetic, safety and tolerability profile, in 2024.

Scientific support of leading experts:

Our scientific advisors include clinicians and scientists who are affiliated with a number of highly regarded medical institutions such as Harvard, Cornell, Yale, and University of Pennsylvania.

support of leading experts:

Our scientific advisors include clinicians and scientists who

are affiliated with a number of highly regarded medical institutions such as Harvard, Cornell,

Yale, and University of Pennsylvania.

Available Information

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Results of Operations

For the Three Months Ended June 30, 2024 versus June 30, 2023:

For the Three Months Ended September 30, 2024 versus September

September 30,

Operating Expenses

Research and development

$ (3,019,116 )

General and administrative

$ (7,207,942 )

Research and Development Expense

Research and development expense for the three

months ended June 30, 2024, was approximately $10,721,100 compared to $13,740,200 for the three months ended June 30, 2023, a decrease

of approximately $3,019,100.

The decrease was primarily due to:

in study costs of $3,423,900 associated with the completion of the long-term, open-label study, Study 310 in the 3 rd Quarter

2023, as well as RELIANCE I and III in late 2022;

in compensation expense of $208,200 due to an decrease in research and development employees and their related bonuses;

months ended September 30, 2024, was approximately $11,149,100 compared to $10,454,100 for the three months ended September 30, 2023,

an increase of approximately $695,000.

The increase was due to:

● Decrease in study costs of

$842,900 associated with the completion of the long-term, open-label study, Study 310 in the 3 rd Quarter 2023, as well as

RELIANCE I and III in late 2022;

● Decrease in manufacturing and drug storage costs of $256,900;

in compensation expense of $115,100 due to a decrease in research and development employees and their related bonuses;

in stock-based compensation expense of $18,200 related to options granted to employees;

Increase in manufacturing and drug storage costs of $380,700;

Increase in other research expenses of $375,000 primarily associated with the ramp-up of the 302 and 304 studies in 2024.

● Increase in other research

expenses of $1,915,500 primarily associated with the ramp-up of the 302 and 304 studies in 2024;

● Increase in stock appreciation rights expense of $12,600

related to stock appreciation rights granted to employees.

General and Administrative Expense

General and administrative expense for the three months ended June

30, 2024, was approximately $8,097,700 compared to $12,286,500 for the three months ended June 30, 2023, a decrease of approximately $4,188,800.

The decrease was primarily due to:

in stock-based compensation expense of 3,813,500 related to option grants to employees and key consultants;

in other general and administrative expenses of $288,100 primarily due to a decrease in consulting services;

in compensation expense of $87,200 related to a decrease of general and administrative employees.

General and administrative expense for the three months ended September

30, 2024, was approximately $11,859,700 compared to $12,238,600 for the three months ended September 30, 2023, a decrease of approximately

The decrease was due to:

Decrease in stock-based compensation of $3,425,600 which can be attributed to two key factors.

First, equity grants from four years ago have dropped off the amortization schedule, as they reached the end of their vesting period.

Second, the Company granted significantly fewer options this past year due to the lack of shareholder approval to increase the 2021 Equity Incentive Plan.

Without this approval, the company was unable to issue a substantial number of new stock options, further contributing to the reduction in stock-based compensation expenses for the current period.

These two factors combined have led to the notable decrease in these expenses;

Increase in cash compensation expense of $2,060,100 related to retention bonuses.

These bonuses were designed to help offset the absence

of equity-based compensation, ensuring that the Company's leadership remained incentivized and aligned with the organization's long-term

Increase in other general and administrative expenses of $986,600 primarily due to an increase in consulting services.

Other Income (Expense)

Interest / investment income was approximately $963,000 and $1,363,400

for the three months ended June 30, 2024 and 2023, respectively.

The decrease was due to lower interest rates and investment yields.

gain on short-term investments was approximately $133,100 and $0 for the three months ended June 30, 2024 and 2023, respectively.

loss on short-term investments was approximately $45,500 and $639,600 for the three months ended June 30, 2024 and 2023, respectively.

The net loss for the Company for the three months ended June 30, 2024

Interest / investment income was approximately

$856,500 and $1,321,400 for the three months ended September 30, 2024 and 2023, respectively.

The decrease was due to lower interest

rates and investment yields.

Realized gain on short-term investments was approximately $147,800 and realized loss on short-term investments

was approximately $51,700 for the three months ended September 30, 2024 and 2023, respectively.

Unrealized gain on short-term investments

was approximately $278,600 and unrealized loss on short-term investments was approximately $579,100 for the three months ended September

30, 2024 and 2023, respectively.

The net loss for the Company for the three months ended September 30,

2024 and 2023 was approximately $21,726,000 and $22,002,100, respectively.

The Company had loss per share basic and diluted of $0.72 and

for the three months ended June 30, 2024 and 2023, respectively.

The Company did not provide for income taxes for

the three months ended June 30, 2024 and 2023, since there was a loss and a full valuation allowance against all deferred tax assets.

$0.73 for the three months ended September 30, 2024 and 2023, respectively.

The Company did not provide for income taxes

for the three months ended September 30, 2024 and 2023, since there was a loss and a full valuation allowance against all deferred tax

Results of Operations

For the Six Months Ended June 30, 2024 versus June 30, 2023

For the Nine Months Ended September 30, 2024 versus September 30,

September 30,

Operating Expenses

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Research and Development Expense

Research and development expense for the six months ended June 30,

2024 was approximately $ 24,026,400 compared to $29,601,200 for the six months ended June 30, 2023, a decrease of approximately $5,574,800.

The decrease was primarily due to:

Decrease in study costs of $7,082,800 associated with the completion of the long-term, open-label study, Study 310 in the 3 rd Quarter 2023, as well as RELIANCE I and III in late 2022

Decrease in stock-based compensation expense of $437,500;

Decrease in compensation expense of $146,800 due to a decrease in research and development employees and their related bonuses;

Increase in other research expenses of $1,672,000 primarily associated with the ramp-up of the 302 and 304 studies in 2024;

Increase in manufacturing and drug storage costs of $386,600;

Increase in pre-clinical and toxicology expenses of $33,700.

Research and development expense for the nine

months ended September 30, 2024 was approximately $35,175,500 compared to $40,055,300 for the nine months ended September 30, 2023, a

decrease of approximately $4,879,800.

The decrease was due to:

in study costs of $7,925,700 associated with the completion of the long-term, open-label study, Study 310 in the 3 rd Quarter

2023, as well as RELIANCE I and III in late 2022

● Decrease in

stock-based compensation expense of $455,700;

in compensation expense of $261,900 due to a decrease in research and development employees and their related bonuses;

in other research expenses of $3,587,500 primarily associated with the ramp-up of the 302 and 304 studies in 2024;

in manufacturing and drug storage costs of $129,700;

in pre-clinical and toxicology expenses of $33,700;

● Increase in stock appreciation right expenses of $12,600.

General and Administrative Expense

General and administrative expense for the six months ended June 30,

2024 was approximately $17,780,200 compared to $24,579,100 for the six months ended June 30, 2023, a decrease of approximately $6,798,900.

The decrease was primarily due to:

Decrease in stock-based compensation expense of $6,577,500 related to option grants to employees and key consultants;

Decrease in other general and administrative expenses of $196,000 primarily due to a decrease in consulting services;

Decrease in compensation expense of $25,400 primarily related an decrease of general and administrative employees and their related bonuses.

General and administrative expense for the nine months ended September

30, 2024 was approximately $29,640,000 compared to $36,817,700 for the nine months ended September 30, 2023, a decrease of approximately

The decrease was due to:

Decrease in stock-based compensation of $10,003,100 which can be attributed to two key factors.

First, equity grants from four years ago have dropped off the amortization schedule, as they reached the end of their vesting period.

Second, the Company granted significantly fewer options this past year due to the lack of shareholder approval to increase the 2021 Equity Incentive Plan.

Without this approval, the company was unable to issue a substantial number of new stock options, further contributing to the reduction in stock-based compensation expenses for the current period.

These two factors combined have led to the notable decrease in these expenses;

● Increase in cash compensation expense of $2,034,700 related to the retention bonuses.

These bonuses were designed to help offset the absence

of equity-based compensation, ensuring that the company's leadership remained incentivized and aligned with the organization's long-term

in other general and administrative expenses of $790,700 primarily due to an increase in consulting services.

Other Income (Expense)

Interest / investment income was approximately $2,875,400 and $3,892,500

for the six months ended June 30, 2024 and 2023, respectively.

for the nine months ended September 30, 2024 and 2023, respectively.

The decrease was due to lower interest rates and investment yields.

gain on short-term investments was approximately $186,200 for the six months ended June 30, 2024 compared to a realized loss of approximately

$666,700 for the six months ended June 30, 2023.

Unrealized gain on short-term investments was approximately $5,200 and $651,500 for the

six months ended June 30, 2024 and 2023, respectively.

The net loss for the Company for the six months ended June 30, 2024

Realized gain on short-term investments was approximately $334,100 and realized loss on short term investments was approximately $718,400

for the nine months ended September 30, 2024 and 2023, respectively.

Unrealized gain on short-term investments was approximately $283,800

and $72,300 for the nine months ended September 30, 2024 and 2023, respectively.

The net loss for the Company for the nine months ended September 30,

2024 and 2023 was approximately $61,322,200 and $73,626,600, respectively.

The Company had loss per share basic and diluted of $2.03 and

for the six months ended June 30, 2024 and 2023, respectively.

The Company did not provide for income taxes for

the six months ended June 30, 2024 and 2023, since there was a loss and a full valuation allowance against all deferred tax assets.

As shown in the accompanying unaudited condensed consolidated financial

statements, the Company incurred negative operating cash flows of $26,299,773 for the six months ended June 30, 2024 and has an accumulated

deficit of $600,498,929 from inception through June 30, 2024.

At June 30, 2024, the Company had cash and cash equivalents and short term

investments of $70,437,329.

Management believes that the Company’s

existing cash and cash equivalents and short-term investments will enable it to fund operating expenses and capital expenditure requirements

for at least 12 months from the issuance of these unaudited condensed consolidated financial statements.

Beyond that point management

will evaluate the size and scope of any subsequent operations and clinical trials that will affect the timing of additional financings

through public or private sales of equity or debt securities or from bank or other loans or through strategic collaboration and/or licensing

Further, additional financing does not affect the Company’s conclusion that based on the cash on hand and the budgeted

cash flow requirements, the Company has sufficient funds to maintain operations for at least 12 months from the issuance of these unaudited

condensed consolidated financial statements.

$2.45 for the nine months ended September 30, 2024 and 2023, respectively.

The Company did not provide for income taxes

for the nine months ended September 30, 2024 and 2023, since there was a loss and a full valuation allowance against all deferred tax

As shown in the accompanying unaudited condensed

consolidated financial statements, the Company has incurred losses and negative cash flows from operations since inception and expects

to incur additional losses until such time that it can generate significant revenue from the commercialization of its product candidates.

During the nine months ended September 30, 2024, the Company incurred a net loss of $61,322,218 and had negative operating cash flows

of $42,956,164.

Given the Company’s projected operating requirements and its existing cash and cash equivalents and short-term investments,

the Company is projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements

These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern.

In response to these conditions, management is currently evaluating

the size and scope of any subsequent operations and clinical trials that will affect the timing to obtain the required funding of future

Financing strategies may include, but are not limited to, the public or private sale of equity or debt securities or from

bank or other loans or through strategic collaboration and/or licensing agreements.

There can be no assurances that the Company will be

able to secure additional financing, or if available, that it will be sufficient to meet its needs or on favorable terms.

Because management’s

plans have not yet been finalized and are not within the Company’s control, the implementation of such plans cannot be considered

As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s

ability to continue as a going concern.

The following table sets forth selected cash flow information for

the periods indicated below:

September 30,

Cash used in operating activities

5 unchanged sentences

$ (2,607,779 )

For the six months ended June 30, 2024, cash used in operating activities

was $26,299,773 primarily due to the net loss of $39,596,248 offset by non-cash stock-based compensation charges of $15,508,887.

were realized and unrealized gains on short-term investments of $186,247 and $5,248, respectively.

In addition, there was a decrease in

operating assets and liabilities of $2,020,917.

For the six months ended June 30, 2023, cash

used in operating activities was $29,778,363 primarily due to the net loss of $51,624,530 offset by non-cash stock-based compensation

charges of $22,523,983.

For the nine months ended September 30, 2024,

cash used in operating activities was $42,956,164 due to the net loss of $61,322,218 offset by non-cash stock-based compensation charges

of $23,458,012.

There were realized and unrealized gains on short-term investments of $334,082 and $283,803, respectively.

there was a decrease in operating assets and liabilities of $4,474,073.

For the nine months ended September 30, 2023,

cash used in operating activities was $41,409,492 due to the net loss of $73,626,588 offset by non-cash stock-based compensation charges

of $33,916,921.

There were realized losses and unrealized gains on short-term investments of $718,422 and $72,329, respectively.

In addition, there was a decrease in operating assets and liabilities of $693,048.

For the six months ended June 30, 2024, cash provided

by investing activities was $24,072,718, due to $8,313,312 of purchases of short-term investments offset by $32,386,030 of sales of short-term

For the six months ended June 30, 2023, cash

provided by investing activities was $38,851,812, due to $45,577,832 of purchases of short-term investments offset by $84,429,644 of

sales of short-term investments.

For the six months ended June 30, 2024, cash provided by financing

activities was $221,747 due to proceeds from options exercised for common stock of $246,747 offset by ATM fees of $25,000.

There was no cash provided by financing activities for the six months

ended June 30, 2023.

there was a decrease in operating assets and liabilities of $2,345,918.

For the nine months ended September 30, 2024, cash provided by investing

activities was $40,216,239, due to $11,424,986 of purchases of short-term investments offset by $51,641,225 of sales of short-term investments.

For the nine months ended September 30, 2023,

cash provided by investing activities was $42,712,186, due to $57,151,963 of purchases of short-term investments offset by $99,864,149

of sales of short-term investments.

Net cash provided by financing activities for

the nine months ended September 30, 2024 was $132,146, due to proceeds from options exercised for common stock of $246,747 offset by ATM

fees of $114,601.

Net cash provided by financing activities for

the nine months ended September 30, 2023 was $0.

Effects of Inflation

15 unchanged sentences

subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.

Our unaudited condensed consolidated financial statements are presented

in accordance with U.S.

Our unaudited condensed consolidated financial

statements are presented in accordance with U.S.

GAAP, and all applicable U.S.

GAAP accounting standards effective as of June 30, 2024 have been taken into consideration

in preparing the unaudited condensed consolidated financial statements.

The preparation of unaudited condensed consolidated financial

statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and disclosure

of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts

of revenues and expenses for the reporting period.

Management bases its estimates on historical experience and on various assumptions

that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying

value of assets and liabilities that are not readily apparent from other sources.

On a continual basis, management reviews its estimates

utilizing currently available information, changes in facts and circumstances, historical experience, and reasonable assumptions.

such reviews, and if deemed appropriate, management’s estimates are adjusted accordingly.

Actual results could differ from those

estimates and assumptions under different and/or future circumstances.

Management considers an accounting estimate to be critical if:

it requires assumptions to be made that were uncertain at the time the estimate was made;

changes in the estimate, or the use of different estimating methods that could have been selected, could have a material impact on results of operations or financial condition.

We evaluate our estimates and assumptions on an

ongoing basis and none of the Company’s estimates and assumptions used within the unaudited condensed consolidated financial statements

involve a high level of estimation uncertainty.

For additional discussion regarding the application of the significant accounting policies,

see Note 2 to the Company’s unaudited condensed consolidated financial statements included in this report.

GAAP accounting standards effective as of September 30,

2024 have been taken into consideration in preparing the unaudited condensed consolidated financial statements.

The preparation of unaudited

condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of

assets, liabilities, and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial

statements and the reported amounts of revenues and expenses for the reporting period.

Management bases its estimates on historical experience

and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making

judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.

On a continual basis,

management reviews its estimates utilizing currently available information, changes in facts and circumstances, historical experience,

and reasonable assumptions.

After such reviews, and if deemed appropriate, management’s estimates are adjusted accordingly.

results could differ from those estimates and assumptions under different and/or future circumstances.

Management considers an accounting

estimate to be critical if:

it requires assumptions to be made that were uncertain at the time

the estimate was made;

changes in the estimate, or the use of different estimating methods

that could have been selected, could have a material impact on results of operations or financial condition.

We evaluate our estimates and assumptions on

an ongoing basis and none of the Company’s estimates and assumptions used within the unaudited condensed consolidated financial

statements involve a high level of estimation uncertainty.

For additional discussion regarding the application of the significant accounting

policies, see Note 3 to the Company’s unaudited condensed consolidated financial statements included in this report.

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