What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2025-03-27 compared with 2024-03-19 · 182 added, 137 removed, 69 unchanged (82% of the section changed)

MANAGEMENT’S DISCUSSION AND

ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The information and financial data discussed

below is derived from the consolidated financial statements of Relmada for the years ended December 31, 2023 and 2022.

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

information and financial data discussed below is derived from the consolidated financial statements of Relmada for the years ended December

31, 2024 and 2023.

The consolidated financial statements of Relmada were prepared and presented in accordance with generally accepted

accounting principles in the United States.

The information and financial data discussed below is only a summary and should be read in

conjunction with the historical financial statements and related notes of Relmada contained elsewhere in this Annual Report.

The consolidated

financial statements of Relmada were prepared and presented in accordance with generally accepted accounting principles in the United

The information and financial data discussed below is only a summary and should be read in conjunction with the historical financial

statements and related notes of Relmada contained elsewhere in this Report.

The consolidated financial statements contained elsewhere

in this Report fully represent Relmada’s financial condition and operations;

however, they are not indicative of the Company’s

future performance.

See “Cautionary Note Regarding Forward Looking Statements” above for a discussion of forward-looking

statements and the significance of such statements in the context of this Annual Report.

This discussion contains forward-looking statements

reflecting our current expectations that involve risks and uncertainties.

Actual results may differ materially from those discussed in

these forward-looking statements due to a number of factors, including those set forth in the section entitled “ Risk Factors ”

and elsewhere herein.

The information and financial data discussed below is only a summary and should be read in conjunction with the

historical financial statements and related notes of Relmada Therapeutics, Inc.

financial statements contained elsewhere in this Report fully represent Relmada’s financial condition and operations;

they are not indicative of the Company’s future performance.

See “Cautionary Note Regarding Forward Looking Statements”

above for a discussion of forward-looking statements and the significance of such statements in the context of this Annual Report.

discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties.

Actual results

may differ materially from those discussed in these forward-looking statements due to a number of factors, including those set forth

in the section entitled “ Risk Factors ” and elsewhere herein.

The information and financial data discussed below is

only a summary and should be read in conjunction with the historical financial statements and related notes of Relmada Therapeutics,

contained elsewhere in this document.

current consolidated financial position and consolidated results of operations;

are not necessarily indicative of the Company’s

future performance.

See “Cautionary Note Regarding Forward Looking Statements” above for a discussion of forward-looking

statements and the significance of such statements in the context of this document.

Our Corporate History and Background

Relmada’s current consolidated financial position and consolidated results of operations;

are not necessarily indicative of the Company’s future performance.

See “Cautionary Note Regarding Forward Looking Statements”

above for a discussion of forward-looking statements and the significance of such statements in the context of this document.

Corporate History and Background

Relmada Therapeutics, Inc.

is a clinical-stage,

publicly traded biotechnology company developing NCEs that potentially address areas of high unmet medical need in the treatment of depression

and other CNS diseases.

The Company’s lead product candidate, esmethadone,

is being developed as a rapidly acting, oral agent for the treatment of depression and other potential indications.

On October 15, 2019, we reported top-line data

from study REL-1017-202.

This was a double-blind, placebo-controlled Phase 2 clinical trial evaluating the safety, tolerability and efficacy

of two doses of REL-1017, 25 mg once a day and 50 mg once a day, as an adjunctive treatment in patients with MDD, who experienced an

inadequate response to 1 to 3 treatments with an antidepressant medication.

On December 20, 2020, the Company announced that

the first patient had been enrolled in the first Phase 3 clinical trial (RELIANCE I) of REL-1017, as an adjunctive treatment for MDD.

On April 1, 2021, Relmada announced the initiation of RELIANCE II,

the second of two sister pivotal Phase 3 clinical trials (RELIANCE I and RELIANCE II) of REL-1017, as an adjunctive treatment for MDD.

On October 4, 2021, Relmada announced the initiation

of the RELIANCE III study, the 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 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.

On October 13, 2022, Relmada announced that the

RELIANCE III study, evaluating REL-1017 in the monotherapy setting for MDD, did not achieve its primary endpoint, which was a statistically

significant improvement in depression symptoms compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)

On December 7, 2022, Relmada announced that the

RELIANCE I, evaluating REL-1017 as an adjunctive treatment for MDD, did not achieve its primary endpoint, which was a statistically significant

improvement in depression symptoms compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) on Day 28

Patients who completed the RELIANCE trials were eligible to rollover

into a long-term, open-label study (Study 310), which also included subjects who had not previously participated in a REL-1017 clinical

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, safety 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.

No new safety signals were detected.

(Relmada, the Company,

we or us) (a Nevada corporation), is a publicly traded, clinical-stage biotechnology company.

We substantially redesigned our development

programs following a comprehensive strategic review occasioned by disappointing interim analysis results in December 2024 indicating that

our then lead development candidate, esmethadone (d-methadone, dextromethadone, or REL-1017) for the adjunctive treatment of Major Depressive

Disorder (MDD), was unlikely to succeed in its pivotal trial.

We concluded in our review that the most promising path to create shareholder

value was to lever our extensive drug development expertise and clinical operations capabilities by acquiring new development candidates,

while pausing further work on REL-1017.

Hence we accelerated ongoing efforts to augment our development pipeline while diversifying its

risk, which culminated in the recently announced licensing of NDV-01, a novel delivery formulation of a widely used chemotheraphy

regimen used to treat non muscle-invasive bladder cancer (NMIBC) that is currently in Phase 2, and the acquisition of Sepranolone, a Phase

2b-ready neurosteroid with potential applications in Prader-Willi syndrome (PWS), Tourette Syndrome (TS), essential tremor and other diseases

related to excessive GABAergic activity.

We also had been developing REL-P11, a modified-release

formulation of psilocybin, as an investigational agent for the treatment of metabolic disease.

The REL-P11 program has successfully completed

a Phase 1 safety study.

However, in light of an ongoing strategic review of this business opportunity, the changing regulatory landscape

for psychedelics, its early stage of development and the acquisition of new, more advanced product candidates, this program has also been

REL-1017 Program Update

Since 2013, we had been developing esmethadone

as our lead product candidate as an oral agent for the treatment of depression and other potential indications.

In December 2024,

we reported that the pre-planned interim analysis, conducted by the Independent Data Monitoring Committee (DMC), of Reliance II, our Phase

3 study of esmethadone as a potential adjunctive treatment for MDD, indicated that the study was futile and unlikely to meet the primary

efficacy endpoint with statistical significance, and that we would pause the Reliance II and Relight Phase 3 studies of esmethadone.

Following this 2024 REL-1017 setback, which we believe most likely

resulted from an overwhelming placebo response—a trend that has become more common than exceptional in central nervous system (CNS)

clinical trials—the program has been paused pending a comprehensive data review, after which we will make a decision regarding the

future of this program.

Strategic Business Review and New Approach

Following a comprehensive evaluation of the Company’s

business strategy and growth opportunities, management and the Board of Directors have implemented a revised approach aimed at maximizing

shareholder value.

This refined strategy remains focused on:

– Advancing novel and differentiated therapeutic solutions

Unmet Medical Needs – Targeting areas with significant gaps in treatment

Market Opportunities – Prioritizing programs with substantial commercial potential

● Intellectual

Property Protection – Strengthen and extending patent coverage to safeguard long-term value

Key Strategic Priorities

Under this updated approach, we will continue

to emphasize:

Development Expertise – Focusing on high-value therapeutic areas while rigorously assessing development risks, market viability,

and success probabilities

Diversification – Expanding and balancing our portfolio to mitigate risk and enhance growth potential

● Prioritizing

Mid- to Late-Stage Programs – Concentrating resources on assets with clear path to commercialization

● Accelerating

Market Entry – Streamline development timelines to bring therapies to patients faster

Cost-Effective Development Paths – Optimizing resource allocation and strategic partnerships

Commercialization Strategy – Focusing on opportunities that require minimal sales and marketing infrastructure

This strategic framework positions the Company for long-term growth

while maintaining execution and financial prudence.

Progress in Strategic Execution

We commenced a strategic review in December 2024

of our then existing development pipeline and the opportunities open to us given our core strengths in every aspect of drug development,

with particular expertise in CNS.

That process recently resulted in a series of transactions that have considerably expanded and strengthened

Relmada’s potential to create shareholder value.

Over the past three months, we have successfully closed two important transactions,

NDV-01 in-licensing and Sepranolone acquisition, which align with our new strategy.

On February 6, 2025, Relmada announced the acquisition

from Asarina Pharma AB (Asarina) of Sepranolone, a Phase 2b ready neurosteroid being developed for the potential treatment of PWS, TS,

essential tremor and other diseases related to the excessive GABAergic activity.

On March 25, 2025, Relmada announced the in-license

agreement from Trigone Pharma Ltd.

(Trigone) of NDV-01, a novel delivery formulation of a widely used chemotherapeutic regimen used to

We have not generated revenues and do not anticipate

9 unchanged sentences

The decrease in research and development expense was primarily due to:

Decrease in study costs of $45,506,500 associated with the completion

execution of two Phase 3 trials and the long-term, open-label, safety study (Study 310);

Decrease in other research

Decrease in study costs

of $8,667,500 associated with the completion of two Phase 3 trials and the long-term, open-label, safety study (Study 310) during

Decrease in stock-based

compensation expense of $1,286,400;

Decrease in compensation

expense of $280,700 due to lower employee-related costs;

Increase in other research

expenses of $1,248,700 primarily associated with additional consultants contracted to assist in the execution of our Phase 3 trials;

Decrease in manufacturing

Increase in pre-clinical

and toxicology expenses of $328,900;

Increase in manufacturing

and drug storage costs of $25,100 related to materials needed to complete the Phase 3 program.

Decrease in stock-based compensation expense of $658,700;

Decrease in pre-clinical and toxicology expenses of $131,000;

Increase in compensation expense of $1,624,500 due to higher employee-related costs.

General and Administrative Expense

Total general and administrative expense for the year ended December

31, 2023 was approximately $48,894,900, as compared to $47,926,100 for the same period of 2022, an increase of $968,800.

in general and administrative expenses was primarily due to:

Increase in compensation expense of $2,242,000 due to higher employee-related costs;

Increase in stock-based

compensation expense of $275,000 primarily related to options granted to employees and the board of directors during 2023;

Decrease in other general and administrative expenses

of $1,548,200 due to decreases in professional fees and consulting expenses during 2023.

Total general and administrative expense for

the year ended December 31, 2024 was approximately $37,715,500, as compared to $48,894,900 for the same period of 2023, a decrease of

The decrease in general and administrative expenses was primarily due to:

Decrease in stock-based compensation

expense of $12,335,900 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 other general

and administrative expenses of $1,006,000 due to increases in professional fees and consulting expenses during 2024;

Increase in compensation

expense of $150,500 due to higher employee-related costs.

Other Income, Net

Gain on settlement fees was approximately $6,351,600

received from a settlement during 2022.

There was no gain on settlement of fees during 2023.

Interest/investment income was approximately

for the year ended December 31, 2023 compared to approximately $2,659,400 for the same period of 2022, an increase of $2,492,300.

increase was primarily related to higher returns from higher interest rates, offset by lower average investment balance during 2023 as

compared to 2022.

Realized loss on short-term investments was approximately

$4,064,400 compared to approximately $585,500 for the same period of 2022, an increase of $3,478,900.

The increase was related to the

timing of the sales of short-term investments along with market conditions.

$3,530,000 for the year ended December 31, 2024 compared to approximately $5,151,700 for the same period of 2023, a decrease of $1,621,700.

The decrease was primarily related to lower average investment balance during 2024 as compared to 2023.

Realized gain on short-term investments was approximately

$374,900 compared to a realized loss of approximately $4,064,400 for the same period of 2023, an increase of $4,439,300.

was related to the timing of the sales of short-term investments along with market conditions.

Unrealized gain on short-term investments was

approximately $3,823,200 compared to an unrealized loss of approximately $4,220,300 for the same period of 2022, an increase of $8,043,500.

The increase was related to the market conditions.

approximately $6,700 compared to approximately $3,823,200 for the same period of 2023, a decrease of $3,816,500.

The decrease was related

to the market conditions.

The Company did not provide for income taxes

3 unchanged sentences

respectively, based on the factors described above.

As shown in the accompanying financial statements, the Company incurred

negative operating cash flows of $51,659,206 for the year ended December 31, 2023 and has an accumulated deficit of $560,902,681 from

inception through December 31, 2023.

Relmada has funded its past operations through

equity raises and warrant and stock option exercises.

believes that due to previous equity raises completed and exercises of options and warrants and the resulting cash position on its balance

sheet, it has sufficient funding, based on its budgeted cash flow requirements, to continue ongoing operations for at least 12 months

from the filing of this annual report.

shown in the accompanying audited 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 twelve months ended December 31, 2024, the Company

incurred a net loss of $79,979,354 and had negative operating cash flows of $51,755,798.

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 operations.

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

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 probable.

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.

Cash Flows from Operating, Investing and Financing Activities

The following table sets forth selected cash flow information for

4 unchanged sentences

Cash provided by investing activities

Cash provided by (used in) financing activities

Cash used in financing activities

Net decrease in cash and cash equivalents

$ (1,304,337 )

$ (39,047,534 )

For the year ended December 31, 2023, cash used in operating activities

was $51,659,206 primarily due to the net loss of $98,791,746.

This was offset by non-cash expenses which primarily consisted of stock-based

compensation of $43,811,149.

There were realized losses and unrealized gains on short term investments of $4,064,391 and $3,823,234, respectively.

In addition, there were increases in operating assets and liabilities for the year ended December 31, 2023 of $3,080,234.

For the year ended December 31, 2022, cash used

in operating activities was $103,801,617 primarily due to the net loss of $157,043,823.

This was offset by non-cash expenses which primarily

consisted of stock-based compensation of $44,194,765 and a gain on settlement of $6,351,606.

There were realized and unrealized losses

on short term investments of $585,522 and $4,220,255, respectively.

In addition, there were increases in operating assets and liabilities

for the year ended December 31, 2022 of $10,593,270.

For the year ended December 31, 2023, cash provided by investing activities

was $50,453,332, due to $90,463,532 of purchases of short term investments offset by $140,916,864 of sales of short term investments.

For the year ended December 31, 2022, cash provided

by investing activities was $19,733,609, due to $47,293,763 of purchases of short term investments offset by $67,027,372 of sales of

short term investments.

For the year ended December 31, 2024, net cash

used in operating activities was $51,755,798 primarily due to the net loss of $79,979,354.

This was offset by non-cash expenses which

primarily consisted of stock-based compensation of $30,184,414 and stock appreciation rights compensation of $4,467.

There were realized

and unrealized gains on short term investments of $374,926 and $6,735, respectively.

In addition, there were decreases in operating assets

and liabilities for the year ended December 31, 2024 of $1,583,664.

For the year ended December 31, 2023, net cash

used in operating activities was $51,659,206 primarily due to the net loss of $98,791,746.

This was offset by non-cash expenses which

primarily consisted of stock-based compensation of $43,811,149.

There were realized losses and unrealized gains on short term investments

of $4,064,391 and $3,823,234, respectively.

In addition, there were increases in operating assets and liabilities for the year ended

December 31, 2023 of $3,080,234.

For the year ended December 31, 2024, net cash

provided by investing activities was $51,561,597, due to $12,079,628 of purchases of short term investments offset by $63,641,225 of

sales of short term investments.

For the year ended December 31, 2023, net cash

provided by investing activities was $50,453,332, due to $90,463,532 of purchases of short term investments offset by $140,916,864 of

sales of short term investments.

cash used in financing activities for the year ended December 31, 2024, was $40,341 due to

proceeds from cash exercises of options of $246,747 offset by ATM reactivation fees of $287,088.

Net cash used in financing activities for the

year ended December 31, 2023, was $98,463 due to ATM reactivation fees.

Net cash provided by financing activities for

the year ended December 31, 2022, was $45,020,474 due to proceeds from issuance of common stock of $42,728,599, proceeds from warrants

exercised for common stock of $1,264,523, proceeds from options exercised for common stock of $703,720, proceeds from Section 16b short

swing profit of $373,632 offset by the payment of fees for warrants issued for common stock of $50,000.

Effects of Inflation

Our assets are primarily monetary, consisting

of cash and cash equivalents.

of cash and cash equivalents and short-term investments.

Because of their liquidity, these assets are not directly affected by inflation.

Because we intend to retain

and continue to use our equipment, we believe that the incremental inflation related to replacement costs of such items will not materially

affect our operations.

However, the rate of inflation affects our expenses, such as those for employee compensation and contract services,

which could increase our level of expenses and the rate at which we use our resources.

However, the rate of inflation affects our expenses, such as those for employee compensation and contract services, which could increase

our level of expenses and the rate at which we use our resources.

Lease Obligations

The Company is obligated to pay approximately

$171,800 under 2 leases for office space over the next year.

Company is obligated to pay approximately $105,000 under 2 leases for office space over the

We do not have a seasonal business cycle.

Critical Accounting Policies and Use of Estimates

A critical accounting policy is one that is both

important to the portrayal of a company’s financial condition and results of operations and requires management’s most difficult,

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

The preparation of financial statements in conformity

27 unchanged sentences

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-K

Item 7. Management’s Discussion and Analysis