What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-08-07 compared with 2024-05-08 · 217 added, 204 removed, 259 unchanged (62% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL

CONDITION AND RESULTS OF OPERATION

MANAGEMENT’S DISCUSSION

AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

FORWARD-LOOKING STATEMENT NOTICE

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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.

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.

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.

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

Relmada Therapeutics, Inc.

(Relmada, the Company,

(Relmada or the Company,

we or us) (a Nevada corporation), is a clinical-stage biotechnology company focused on the development of esmethadone (d-methadone, dextromethadone,

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top-line data from study REL-1017-202.

During late 2022, we announced RELIANCE I and III, both Phase 3 trials, did not achieve their

primary endpoints.

Relmada has completed its long term, open label study and plans to complete two additional ongoing adjunctive Phase

3 trials (RELIANCE II and RELIGHT).

During late 2022, we announced RELIANCE I and III, both Phase 3 trials, did not achieve their primary

Relmada has completed its long term open label study and plans to complete two additional ongoing adjunctive Phase 3 trials

(RELIANCE II and RELIGHT).

Relmada also intends, in 2024, to enter human

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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

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.

On August 9, 2022, Relmada announced that the

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In the study, the REL-1017 treatment

arm (n= 113) showed a MADRS reduction of 15.1 points at Day 28 versus 12.9 points for the placebo arm (n=114), which is a clinically

meaningful difference of 2.3 points on the MADRS.

The study also showed a nominally statistically significant difference in the response

rate, with a response rate of 39.8% in the REL-1017 arm vs 27.2% in the placebo arm (p<0.05).

Additionally, in a prespecified per

protocol population analysis, the REL-1017 treatment arm (n=101) showed a MADRS reduction of 15.6 points at Day 28 versus 12.5 points

for the placebo arm (n=97), a difference of 3.1 points, with nominal p=0.051.

arm (n= 113) showed a MADRS reduction of 15.1 points at Day 28 versus 12.9 points for the placebo arm (n=114), which is a clinically meaningful

difference of 2.3 points on the MADRS.

The study also showed a nominally statistically significant difference in the response rate, with

a response rate of 39.8% in the REL-1017 arm vs 27.2% in the placebo arm (p<0.05).

Additionally, in a prespecified protocol population

analysis, the REL-1017 treatment arm (n=101) showed a MADRS reduction of 15.6 points at Day 28 versus 12.5 points for the placebo arm

(n+97), a difference of 3.1 points, with nominal p=0.051.

Patients who completed the RELIANCE trials were

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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.

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.

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.

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 patients in the first half of 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:

Complete enrollment in the ongoing RELIANCE II study,

which is planned to enroll approximately 300 patients, with top-line data in the second half of 2024.

Initiate Phase 1 trial in obese patients with the

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

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.

Our Development Program

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

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.

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.

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 indications.

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

Currently, none of our product candidates have

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generating revenues for the foreseeable future.

We had a net loss of $21,828,126 for the three months ended March 31, 2024.

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

At June 30, 2024,

we had an accumulated deficit of $600,498,929.

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.

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), ZURZUVANE TM (Sage), Spravato® (Johnson & Johnson) and (Auvelity ä (Axsome).

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).

Intellectual Property Portfolio and Market

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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.

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).

Phase 1 safety studies of esmethadone and strong clinical activity signal in depression established

in three independent animal models in preclinical studies.

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 psilocybin (REL-P11) for the treatment of metabolic indicati ons.

This program is expected to enter human studies, to define its pharmacokinetic, safety and tolerability profile, in first half of

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.

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.

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 March 31, 2024 versus March 31, 2023

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

Operating Expenses

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Research and development expense for the three

months ended March 31, 2024 was approximately $13,305,300 compared to $15,861,000 for the three months ended March 31, 2023, a decrease

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 change was primarily driven by:

● Decrease in study costs of $3,658,900 associated with the completion

of the long-term, open-label study, Study 310 in 3rd Quarter 2023, as well as RELIANCE I and III in late 2022;

● Decrease in stock-based compensation expense of $294,800;

● Increase in other research expenses of $1,330,800 primarily associated

with the ramp-up of the 302 and 304 studies in 2024;

Increase in compensation expense of $61,300 due to an increase in research and development employees and their related bonus;

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;

in stock-based compensation expense of $142,700 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.

General and Administrative Expense

General and administrative expense for the three

months ended March 31, 2024 was approximately $9,682,600 compared to $12,292,600 for the three months ended March 31, 2023, a decrease

of approximately $2,610,000.

The change was primarily due to:

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.

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

and 2023 was approximately $17,768,100 and $25,303,000, respectively.

The Company had loss per share basic and diluted of $0.59 and $0.84

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.

Results of Operations

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

Operating Expenses

Research and development

$ (5,574,820 )

General and administrative

$ (12,373,691 )

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;

● Increase in other general and administrative expenses of $92,100 primarily

due to an increase in consulting services;

● Increase in compensation expense of $62,000 related to an increase

of general and administrative employees and their related bonuses.

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.

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.

Other Income (Expense)

Interest/investment income was approximately

$1,055,900 and $1,207,600 for the three months ended March 31, 2024 and 2023, respectively.

The decrease was due to higher interest rates

and investment yields.

Realized gain on short-term investments was approximately $53,100 and realized loss was $666,700 for the three

months ended March 31, 2024 and 2023, respectively.

Unrealized gain on short-term investments for the three months ended March 31, 2024

was approximately $50,700 compared to approximately $1,291,100 for the three months ended March 31, 2023.

The net loss for the Company for the three months

ended March 31, 2024 and 2023 was approximately $21,828,100 and $26,351,600 respectively.

The Company had loss per share, basic and diluted

of $0.72 and $0.87 for the three months ended March 31, 2024 and 2023, respectively.

The Company did not provide for income taxes

for the three months ended March 31, 2024 and 2023, since there was a loss and a full valuation allowance against all deferred tax assets.

As shown in the accompanying financial statements,

the Company incurred negative operating cash flows of $13,036,748 for the three months ended March 31, 2024 and has an accumulated deficit

of $582,730,807 from inception through March 31, 2024.

At March 31, 2024 the Company had cash and cash equivalents, and short-term investments

of $83,612,705.

Interest / investment income was approximately $2,018,900 and $2,571,000

for the six 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 $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

and 2023 was approximately $39,596,200 and $51,624,500, respectively.

The Company had loss per share basic and diluted of $1.31 and $1.72

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

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the periods indicated below:

Three Months Ended

Cash used in operating activities

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Cash provided by financing activities

Net increase/(decrease) in cash and cash equivalents

Net (decrease) increase in cash and cash equivalents

$ (2,005,308 )

For the three months ended March 31, 2024, cash

used in operating activities was $13,036,748 primarily due to the net loss of $21,828,126 offset by non-cash stock-based compensation

charges of $8,295,468.

There were realized gains and unrealized gains on short-term investments of $53,133 and $50,713, respectively.

In addition, there was a decrease in operating assets and liabilities of $599,756.

For the three months ended March 31, 2023, cash

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

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

For the three months ended March 31, 2024, cash provided by investing activities was $10,058,451 due to $7,013,933 of purchases of short-term

investments offset by $17,072,384 of sales of short-term investments.

For the three months ended March 31, 2023, cash

provided by investing activities was $40,003,549 related to the purchase of $34,767,288 and the sale of $74,770,836 short-term investments.

Net cash provided by financing activities for

the three months ended March 31, 2024 was $221,747 due to proceeds from options exercised for common stock of $246,747 offset by ATM fees

There was no cash provided by financing activities

for the three months ended March 31, 2023.

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.

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 March 31, 2024

have been taken into consideration in preparing the unaudited 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 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.

Actual results could differ from those estimates and assumptions

under different and/or future circumstances.

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.

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.

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