What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-05-08 compared with 2023-11-08 · 152 added, 201 removed, 311 unchanged (53% 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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Relmada Therapeutics, Inc.

(Relmada or the Company,

(Relmada, 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 did not achieve their primary endpoints.

has completed its long term, open label study and plans to complete two additional 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 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).

Relmada also intends, in 2024, to enter human

studies of its proprietary, non-psychedelic/low dose modified-release formulation of psilocybin for metabolic indications.

studies of its proprietary, modified-release formulation of psilocybin (REL-P11) in doses that we believe are lower than those associated

with psychedelic effects for metabolic indications.

Esmethadone (d-Methadone, dextromethadone,

Phase 2 Clinical Trial

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of RELIANCE II, the second of two sister pivotal Phase 3 clinical trials (RELIANCE I and RELIANCE II) for the Company’s lead product

candidate, REL-1017, as an adjunctive treatment for MDD.

candidate, REL-1017, as an adjunctive treatment for Major Depressive Disorder (MDD).

On October 4, 2021, Relmada announced the initiation

of RELIANCE III study, a monotherapy trial for the Company’s lead product candidate, REL-1017.

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

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

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 2.2 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 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 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 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.

Patients who completed the RELIANCE trials were

eligible to rollover into the long-term, open-label study, which also included subjects who had not previously participated in a REL-1017

clinical trial.

eligible to rollover into the long-term, open-label study, Study 310, which also included subjects who had not previously participated

in a REL-1017 clinical trial.

This rollover study completed subject visits on July 11, 2023.

On August 23, 2023, Relmada announced the dosing

of the first patient in RELIGHT, a Phase 3 clinical trial for REL-1017, as an adjunctive treatment for MDD.

On September 20, 2023, Relmada announced efficacy

results for the de novo (or new to treatment) patients (204 patients) and safety results for all subjects (627 patients) from the Phase

3, long-term, open-label, registrational trial (Study 310) of REL-1017 in patients with Major Depressive Disorder (MDD).

Patients treated

daily with REL-1017 for up to one year experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and

associated functional impairment.

REL-1017 was well-tolerated with long-term dosing, showing low rates of adverse events and discontinuations

due to adverse events.

results for the de novo (or new to treatment) patients (204 patients) and safety results for all subjects (627 patients) from Study 310

of REL-1017 in patients with MDD.

Patients treated daily with REL-1017 for up to one year experienced rapid, clinically meaningful, and

sustained improvements in depressive symptoms and associated functional impairment.

REL-1017 was well-tolerated with long-term dosing,

showing low rates of adverse events and discontinuations due to adverse events.

The most commonly reported adverse events deemed to be

treatment-related all occurred included headache, nausea and dizziness.

No new safety signals were detected.

In addition, in order to support potential regulatory

submissions seeking approval for REL-1017 as monotherapy and adjunctive treatment, the FDA confirmed that, based on what is known at

this time, Relmada will not be required to conduct a two-year carcinogenicity study of REL-1017, as sufficient clinical data have been

generated to date.

The FDA also confirmed that Relmada does not need to conduct a Thorough QT analysis (TQT) cardiac study in humans

to support cardiac safety in potential regulatory submissions for REL-1017, as the data provided so far and the data generated by the

Phase 3 program will be adequate to evaluate the cardiac safety profile of REL-1017.

On August 23, 2023, Relmada announced the dosing

of the first patient in RELIGHT, a Phase 3 clinical trial for REL-1017, as an adjunctive treatment for MDD.

Human Abuse Potential (HAP) Studies

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Top-line Results - Ketamine:

On February 23, 2022,

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 MTD, respectively) tested in recreational drug users, demonstrated a substantial (30+ points) and statistically significant difference

the active control drug, intravenous ketamine 0.5 mg/kg over 40 minutes, and, importantly, were statistically equivalent to placebo.

The study’s primary 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.

On February 23, 2022, 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 MTD, respectively)

tested in recreational drug users, demonstrated a substantial (30+ points) and statistically significant difference vs.

the active control

drug, intravenous ketamine 0.5 mg/kg over 40 minutes, and, importantly, were statistically equivalent to placebo.

The study’s primary

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.

Consistent results are seen for the secondary endpoints.

Psilocybin Program:

On October 11, 2023,

Relmada announced that it intends to enter human studies of its proprietary, non-psychedelic/low dose modified-release formulation of

psilocybin for metabolic indications.

The Company plans to commence a single-ascending dose Phase 1 trial in obese patients with steatotic

liver disease in early 2024 to define the pharmacokinetic, safety and tolerability profile of Relmada's modified-release psilocybin formulation

in this population, followed by a Phase 2a trial in the same patient population to establish clinical proof-of-concept.

Pre-clinical data in

a rodent model of metabolic dysfunction-associated steatotic liver disease (MASLD) demonstrated beneficial effects of non-psychedelic/low

dose psilocybin on multiple metabolic parameters, including reduced hepatic steatosis, reduced body weight gain, and fasting blood glucose

Psilocybin Program (REL-P11):

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.

Pre-clinical data in a rodent model of metabolic

dysfunction-associated steatotic liver disease (MASLD) demonstrated beneficial effects of psilocybin on multiple metabolic parameters,

including reduced hepatic steatosis, reduced body weight gain, and fasting blood glucose levels.

Key Upcoming Anticipated Milestones

We expect multiple key milestones over the next

12-18 months.

These include:

● Complete enrollment in ongoing RELIANCE II, which is planned to enroll

approximately 300 patients, in the first half of 2024.

● Complete enrollment in new Relight study, which is planned to enroll

approximately 300 patients, in the second half of 2024.

Initiate Phase I trial of non-psychedelic/low dose modified-release formulation of psilocybin in early 2024.

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.

Our Development Program

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(NIMH) estimated that 21.0 million adults aged 18 or older in the United States had at least one major depressive episode in the past

According to data from nationally representative surveys supported by NIMH, only about half of Americans diagnosed with major depression

in a given year receive treatment.

According to data from nationally representative surveys supported by NIMH, about 61% of adult Americans diagnosed with major depression

received treatment in 2021.

Of those receiving treatment with as many as four different standard antidepressants, 33% of drug-treated

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REL-1017) in other indications

While our current strategy is to focus on the

further development of esmethadone as an adjunctive treatment of MDD, we may in the future re-commence testing of esmethadone as a monotherapy

In addition, we are evaluating other indications that Relmada may explore in the future, including restless leg syndrome and

other glutamatergic system activation related diseases.

While our current strategy is currently to focus

on the further development of esmethadone as an adjunctive treatment for MDD, we are evaluating other indications that Relmada may explore

in the future, including restless leg syndrome and other glutamatergic system activation related diseases.

Psilocybin Program

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Specifically,

in a rodent model of metabolic dysfunction-associated steatotic liver disease (MASLD), beneficial effects of non-psychedelic/low dose

psilocybin were observed on multiple metabolic parameters, including reduced hepatic steatosis, reduced body weight gain, and fasting

blood glucose levels.

in a rodent model of metabolic dysfunction-associated steatotic liver disease (MASLD), beneficial effects of psilocybin were observed

on multiple metabolic parameters, including reduced hepatic steatosis, reduced body weight gain, and fasting blood glucose levels.

Our Corporate History and Background

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of depression and other CNS diseases.

We are also developing a novel non-psychedelic/low dose 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 net loss of $73,626,588 for the nine months ended September 30, 2023.

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

2024, we had an accumulated deficit of $582,730,807.

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

Pristiq® (Pfizer), Zulresso® (Sage), Spravato® (Johnson & Johnson) and Auvelity ä (Axsome).

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

Intellectual Property Portfolio and Market

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

(postherpetic neuralgia is lasting pain in areas of skin affected by previous outbreaks of shingles, caused by the varicella zoster,

or herpes zoster, virus) which, upon potential NDA approval, carries 7-year FDA Orphan Drug marketing exclusivity.

(postherpetic neuralgia is lasting pain in areas of skin affected by previous outbreaks of shingles, caused by the varicella zoster, or

herpes zoster, virus) which, upon potential NDA approval, carries 7-year FDA Orphan Drug marketing exclusivity.

In the European Union,

some of our actual and prospective products may be eligible up to 10 years of market exclusivity, which includes 8 years data exclusivity

and 2 years market exclusivity.

In addition to any granted patents, REL-1017 will be eligible for market exclusivity to run concurrently

with the term of the patent for 5 years in the U.S.

(Hatch Waxman Act) plus an additional 6 months of pediatric exclusivity and up to

10 years of exclusivity in the European Union.

We believe an extensive intellectual property estate of US and foreign patents and applications,

once approved, will protect our technology and products.

some of our prospective products may be eligible up to 10 years of market exclusivity, which includes 8 years data exclusivity and 2 years

market exclusivity.

In addition to any granted patents, REL-1017 will be eligible for market exclusivity to run concurrently with the

term of the patent for 5 years in the U.S.

(Hatch Waxman Act) and may be eligible for an additional 6 months of pediatric exclusivity

and up to 10 years of exclusivity in the European Union.

We believe an extensive intellectual property estate of US and foreign patents

and applications, once approved, will protect our technology and products.

Key Strengths

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

Compelling lead product opportunity, REL-1017 currently in the second

of three Phase 3 trials for the adjunctive treatment of MDD.

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 for esmethadone 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 non-psychedelic/low

dose psilocybin for the treatment of metabolic indications.

This program is expected to enter human studies, to define its pharmacokinetic,

safety and tolerability profile, in early 2024.

● 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

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.

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 September 30, 2023 versus September

September 30,

For the Three Months Ended March 31, 2024 versus March 31, 2023

Operating Expenses

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Research and development expense for the three

months ended September 30, 2023 was approximately $10,454,100 compared to $30,529,100 for the three months ended September 30, 2022, a

decrease of approximately $20,075,000.

The decrease was primarily due to:

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

of approximately $2,555,700.

The change was primarily driven by:

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

of the RELIANCE I and III in late 2022;

Decrease in other research expenses of $6,137,200 primarily associated

with the reduction of consultants contracted to assist in RELIANCE I and III that concluded in late 2022;

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 compensation expense of $208,300 due to an increase in

research and development employees and their related bonus;

● 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;

● Increase in manufacturing and drug storage costs of $5,900.

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General and administrative expense for the three

months ended September 30, 2023 was approximately $12,238,600 compared to $8,208,100 for the three months ended September 30, 2022, an

increase of approximately $4,030,500.

The increase was primarily due to:

Increase in stock-based compensation expense of $4,483,200;

Increase in compensation expense of $29,100 related to an increase of general and administrative employees and their related bonuses;

Decrease in other general and administrative expenses of $481,800 primarily due to a decrease in consulting services.

Other Income (Expense)

Interest / investment income was approximately

$1,321,400 and $827,600 for the three months ended September 30, 2023 and 2022, respectively.

The increase was due to higher interest

rates and investment yields.

Realized loss on short-term investments was approximately $51,700 and $561,600 for the three months ended

September 30, 2023 and 2022, respectively.

Unrealized loss on short-term investments was approximately $579,100 and $947,500 for the

three months ended September 30, 2023 and 2022, respectively.

Gain on settlement of fees was $6,351,600 for the three months ended September

The net loss for the Company for the three months

ended September 30, 2023 and 2022 was approximately $22,002,100 and $39,418,700 respectively.

The Company had loss per share, basic and

diluted of $0.73 and $1.31 for the three months ended September 30, 2023 and 2022, respectively.

The Company did not provide for income taxes

for the three months ended September 30, 2023 and 2022, since there was a loss and a full valuation allowance against all deferred tax

Results of Operations

For the Nine Months Ended September 30, 2023 versus September 30,

September 30,

Operating Expenses

Research and development

$ (46,399,345 )

General and administrative

$ 122,546,656

$ (45,673,683 )

Research and Development Expense

Research and development expense for the nine

months ended September 30, 2023 was approximately $40,055,300 compared to $86,454,600 for the nine months ended September 30, 2022, a

decrease of approximately $46,399,300.

The decrease was primarily driven by:

Decrease in study costs of $35,273,800 associated with the completion

of RELIANCE I and III in late 2022;

Decrease in other research expenses of $11,640,300 primarily associated

with the reduction of consultants contracted to assist in the execution of RELIANCE I and III that concluded in late 2022;

Decrease in manufacturing and drug storage costs of $414,700;

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:

● Decrease in stock-based compensation expense of $2,764,100;

Increase in compensation expense of $1,141,000 due to an increase in research and development employees and their related bonuses.

General and Administrative Expense

General and administrative expense for the nine

months ended September 30, 2023 was approximately $36,817,700 compared to $36,092,000 for the nine months ended September 30, 2022, an

increase of approximately $725,700.

The increase was primarily due to:

Increase in stock-based compensation expense of $1,559,500 primarily related to options granted to employees and key consultants;

Increase in compensation expense of $415,800 related to an increase of general and administrative employees and their related bonuses;

Decrease in other general and administrative expenses of $1,249,600 primarily due to a decrease in consulting services.

● 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.

Other Income (Expense)

Interest/investment income was approximately

$3,892,500 and $1,544,900 for the nine months ended September 30, 2023 and 2022, respectively.

Realized loss on short-term investments

was approximately $718,400 and $552,200 for the nine months ended September 30, 2023 and 2022, respectively.

Unrealized gain on short-term

investments was approximately $72,300 and unrealized loss on short-term investments was approximately $3,897,100 for the nine months

ended September 30, 2023 and 2022, respectively.

Gain on settlement fees was $6,351,600 for the nine months ended September 30, 2022.

The net loss for the Company for the nine months

ended September 30, 2023 and 2022 was approximately $73,626,600 and $119,099,500 respectively.

The Company had loss per share, basic and

diluted of $2.45 and $4.04 for the nine months ended September 30, 2023 and 2022, respectively.

$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 nine months ended September 30, 2023 and 2022, since there was a loss and a full valuation allowance against all deferred tax

As shown in the accompanying financial statements, the Company incurred

negative operating cash flows of $41,409,492 for the nine months ended September 30, 2023 and has an accumulated deficit of $535,737,523

from inception through September 30, 2023.

At September 30, 2023 the Company had cash and cash equivalents, and short-term investments

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.

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the periods indicated below:

Nine Months Ended

September 30,

Nine Months Ended

September 30,

Three Months Ended

Cash used in operating activities

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Net increase/(decrease) in cash and cash equivalents

For the nine months ended September 30, 2023,

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

$ (2,756,550 )

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

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 nine months ended September 30, 2022,

cash used in operating activities was $67,918,717 primarily due to the net loss of $119,099,458 offset by non-cash stock-based compensation

For the three months ended March 31, 2023, cash

used in operating activities was $16,505,094 primarily due to the net loss of $26,321,576 offset by non-cash stock-based compensation

charges of $11,354,466.

There were realized and unrealized losses on short-term investments of $552,171 and $3,897,135, respectively.

In addition, there was an increase in operating assets and liabilities of $14,162,599.

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.

For the nine months ended September 30, 2022,

cash provided by investing activities was $21,389,056 due to $38,996,173 of purchases of short-term investments offset by $60,382,229

of sales of short-term investments.

Net cash provided by financing activities for

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

There were realized losses and unrealized gains on short-term investments of $666,708 and $1,291,110, respectively.

In addition, there was a decrease in operating assets and liabilities of $913,582.

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 nine months ended September 30, 2022 was $44,610,591 due to sales of common stock of $42,728,599, proceeds from warrants exercised

for common stock of $1,228,272, and proceeds from options exercised for common stock of $703,720.

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.

Effects of Inflation

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GAAP, and all applicable U.S.

GAAP accounting standards effective as of September 30,

GAAP accounting standards effective as of March 31, 2024

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

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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.

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

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

QUANTITATIVE AND QUALITATIVE

DISCLOSURES ABOUT MARKET RISK.

There have been no material changes to our exposures

to market risks as disclosed under the heading “Quantitative and Qualitative Disclosures About Market Risks” in the annual

MD&A contained in our Form 10-K for the year ended December 31, 2022.

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