What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-13 compared with 2025-08-07 · 282 added, 266 removed, 142 unchanged (79% of the section changed)

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FORWARD-LOOKING STATEMENT NOTICE

This Quarterly Report on Form 10-Q (this Report)

contains forward looking statements that involve risks and uncertainties, principally in the sections entitled “Risk Factors,”

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.

This Quarterly Report on Form 10-Q (this Report) contains forward looking

statements that involve risks and uncertainties, principally in the sections entitled “Risk Factors,” and “Management’s

Discussion and Analysis of Financial Condition and Results of Operations.” All statements other than statements of historical fact

contained in this Quarterly Report, including statements regarding future events, our future financial performance, business strategy

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

We have attempted to identify forward-looking

statements by terminology including “anticipates,” “believes,” “can,” “continue,” “could,”

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

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

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

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

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

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

Moreover, we operate in a very competitive

and rapidly changing environment.

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

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

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

All forward-looking statements included in this document

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

You should not place undue reliance on any forward-looking

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(TS), essential tremor and other diseases related to excessive GABAergic activity.

Following the 2024 REL-1017 setback and subsequent

post hoc analyses, the program has been terminated effective July 7, 2025.

Following the 2024 REL-1017 setback and subsequent post hoc analyses,

the program was terminated effective July 7, 2025.

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

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

Effective May 12, 2025, this program has been terminated.

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 on an enhanced approach aimed at maximizing

shareholder value.

This refined strategy remains focus on:

Innovation – Advancing

novel and differentiated therapeutic solutions

Addressing Unmet Medical

Needs – Targeting areas with significant gaps in treatment

Large 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 approach, we will continue to emphasize:

Leveraging Development

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

probabilities

Pipeline 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

Pursuing Cost-Effective

Development Paths – Optimizing resource allocation and strategic partnerships

Targeted 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.

Effective May 12, 2025, this program was terminated.

Currently, our lead product, NDV-01 is a novel, controlled-release

intravesical formulation of gemcitabine and docetaxel.

NDV-01 is currently in a Phase 2 clinical trial to assess its safety and efficacy

in patients with aggressive forms of non-muscle invasive bladder cancer (NMIBC).

We intend to develop NDV-01 for the treatment of high-risk,

2nd line Bacillus Calmette-Guérin (BCG)*-unresponsive NMIBC and also in intermediate risk patients in the adjuvant setting.

expect to initiate Phase III programs for each indication in the first-half of 2026.

Our second product, Sepranolone is a novel neurosteroid

epimer of allopregnanolone.

Sepranolone is being developed for the potential treatment of Prader-Willi Syndrome, Tourette Syndrome, excessive

tremor and other diseases related to excessive GABAergic activity.

We expect to initiate a Phase IIb study in Prader-Willi Syndrome in

the first-half of 2026.

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.

Since January 1, 2025, we have successfully closed two important transactions,

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

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.

March 25, 2025 , Relmada announced the in-license agreement from Trigone

(Trigone) of NDV-01, a novel delivery formulation of a widely

used chemotherapeutic regimen used to treat NMIBC.

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

Key Upcoming Anticipated Milestones

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These include:

NDV-01 Nine-month data

from ongoing Phase 2 NMBIC Study – 2 nd Half 2025

NDV-01 Twelve-month data

from ongoing Phase 2 NMBIC Study – Year end 2025

NDV-01 United States Investigative

New Drug clearance – 1st Half 2026

Sepranolone - Initiation

of clinical trial in PWS – 1st Half 2026

NDV-01 Twelve-month data from ongoing Phase 2 NMBIC Study – Early 2026

NDV-01 United States Investigative New Drug clearance – 1st Half 2026

NDV-01 High-risk, 2nd line BCG-unresponsive NMIBC Phase III Trial Initiation - 1st Half 2026

NDV-01 Intermediate Risk in the Adjuvant Setting Phase III Trial Initiation – 1 st Half 2026

Sepranolone - Initiation of clinical trial in PWS – 1st Half 2026

Our Development Programs

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a naturally occurring neurosteroid that counteracts the effects of Allopregnanolone.

Sepranolone is designed to normalize GABA A

receptor activity by targeting two specific receptor subtypes (alpha-2 and alpha-4) without directly interfering with GABA signaling,

making it a novel and selective treatment approach for diseases such as PWS and TS and other disorders that feature compulsive behavior.

Sepranolone is designed to normalize GABA A receptor

activity by targeting two specific receptor subtypes (alpha-2 and alpha-4) without directly interfering with GABA signaling, making it

a novel and selective treatment approach for diseases such as PWS and TS and other disorders that feature compulsive behavior.

Data from an open-label Phase 2a randomized study

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standard of care:

69% greater increase of

Quality of Life (using the Gilles de la Tourette Syndrome Quality of Life total score (GTS-QOL)

50% greater reduction in

impairment (YGTSS)

44% greater reduction of

the premonitory urge to tic (PUTS – the Premonitory Urge to Tic scale)

69% greater increase of Quality of Life (using the Gilles de la Tourette Syndrome Quality of Life total score (GTS-QOL)

50% greater reduction in impairment (YGTSS)

44% greater reduction of the premonitory urge to tic (PUTS – the Premonitory Urge to Tic scale)

Importantly, no off-target CNS effects or systemic

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over 335 participants and has demonstrated a favorable safety profile.

Relmada is currently evaluating the nonclinical

and clinical strategy for the development of Sepranolone.

Relmada expects to initiate a Phase II pilot study of Sepranolone

in Prader Willi Syndrome in the 1 st half of 2026.

NDV-01 Program

Our second program , in-licensed on March 24,

2025, NDV-01, is a novel intravesicular delivery technology designed for the long-acting, controlled release of gemcitabine and docetaxel.

This combination therapy has gained significant interest as an alternative to Bacillus Calmette-Guérin (BCG) for treating NMIBC,

especially given the global BCG shortage since 2019.

Clinical studies have shown that gemcitabine and docetaxel achieve response rates

and Recurrence-Free Survival comparable to or better than BCG.

However, conventional administration is cumbersome, requiring sequential

drug delivery over three to four hours, with limited tumor exposure time.

NDV-01, our lead program, was in-licensed on March 24, 2025, NDV-01,

is a novel intravesicular delivery technology designed for the long-acting, controlled release of gemcitabine and docetaxel.

This combination

therapy has gained significant interest as an alternative to BCG for treating NMIBC, especially given the global BCG shortage since 2019.

Clinical studies have shown that gemcitabine and docetaxel achieve response rates and Recurrence-Free Survival comparable to or better

However, conventional administration is cumbersome, requiring sequential drug delivery over three to four hours, with limited

tumor exposure time.

NDV-01 potentially addresses these limitations

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exposure enhances the therapeutic effect while improving patient convenience.

NDV-01 is formulated as a controlled-release

intravesical therapy containing gemcitabine and docetaxel.

By maintaining continuous drug exposure within the bladder, NDV-01 may optimize

local efficacy while minimizing systemic absorption and associated side effects.

Unlike conventional intravesical instillations, which

result in fluctuating drug levels, NDV-01 provides a continuous release of both agents over 10 days.

This sustained delivery may improve

cancer cell eradication and reduce recurrence risk while lowering the frequency of administration.

NDV-01 is formulated as a controlled-release intravesical

therapy containing gemcitabine and docetaxel.

By maintaining continuous drug exposure within the bladder, NDV-01 may optimize local efficacy

while minimizing systemic absorption and associated side effects.

Unlike conventional intravesical instillations, which result in fluctuating

drug levels, NDV-01 provides a continuous release of both agents over 10 days.

This sustained delivery may improve cancer cell eradication

and reduce recurrence risk while lowering the frequency of administration.

NDV-01 is currently in a Phase 2 clinical trial

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the safety and efficacy of NDV-01 in patients with High Grade-NMIBC.

Patients are treated with NDV-01 in a biweekly induction phase,

follow by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated.

efficacy endpoints are safety and complete response rate (Complete Response Rate at 12 months), and secondary efficacy endpoints are

duration of response (DOR) and event free survival (EFS).

On April 28, 2025, the Company announced positive

initial data from the Phase 2 study.

As of the latest cut-off, a total of 26 patients had been enrolled:

20 patients had reached the

3-month assessment with 7 reaching the 6-month assessment.

On August 7, 2025, the Company announced positive 6-month follow-up

data from the Phase 2 study.

Highlights of the 6-month follow-up data from the Phase 2 study:

Baseline characteristics (n=29)

Median Age (years) (range)

Median BCG Doses (range)

● BCG-naïve (n (%))

● BCG exposed (n (%))

● BCG unresponsive (n (%))

Stage (n (%))

Patients are treated with NDV-01 in a biweekly induction phase, follow

by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated.

The primary efficacy

endpoints are safety and complete response rate (Complete Response Rate at 12 months), and secondary efficacy endpoints are duration of

response (DOR) and event free survival (EFS).

Nine-Month Safety and Efficacy Data

We obtained nine-month safety and efficacy data

for our Phase II study of NDV-01 in high-risk NMIBC.

Among 36 enrolled patients who received at least one dose, no new safety signals

were observed with respect to the type, frequency or severity of adverse events.

No patients experienced Grade ≥3 treatment-related

adverse events, and no patients discontinued treatment due to adverse events.

Of the 36 patients, 22 (61%) experienced a treatment-related

adverse event.

Among treatment-related adverse events, 62% were transient uncomfortable urination (dysuria), 9% were asymptomatic positive

urine culture and 7% were hematuria.

The below table summarizes the efficacy data from the study.

Complete Response (CR)

* One subject has reached the 9-month assessment and had a

No patient had progression to muscle invasive disease.

No patient underwent a radical cystectomy.

No patient had >= Grade 3 treatment

related adverse events and no patients discontinued treatment due to adverse events.

Includes patients with CR after re-induction.

60% CR rate after re-induction.

Two patients have reached the 12-month assessment,

and both have a CR.

No patient has progressed to muscle-invasive disease and no patient has undergone radical cystectomy.

are awaiting the three-month response assessment.

The Company also recently announced the successful completion and receipt

of written minutes from a Type B pre-IND meeting with the U.S.

Food and Drug Administration (FDA) regarding the planned Phase 3 program

for NDV-01 in non-muscle invasive bladder cancer (NMIBC) patients.

Relmada secured FDA alignment on certain key elements of the planned

Phase 3 pivotal program for NDV-01, expected to begin in H1 2026, and incorporating two studies in:

High-risk, 2nd line BCG-unresponsive NMIBC patients

● Intermediate risk NMIBC in the adjuvant setting

Following are the key outcomes from the FDA

Type B pre-IND meeting (specific study design details to be further discussed with the agency):

FDA Feedback on proposed NDV-01 Phase III

The FDA indicated that

in the BCG-unresponsive setting, a single arm trial may be acceptable in a patient population refractory to other therapies, with the

details of such a design to be discussed further with the FDA.

The FDA also indicated that, a randomized, post-transurethral resection

of the bladder tumor (“TURBT”) adjuvant study comparing NDV-01 to observation in intermediate risk NMIBC patients with a time-to-event

primary endpoint is generally acceptable, subject to submission of the intended trial design and endpoint definition to the FDA in a meeting

In addition, the FDA agreed with our proposal to rely on FDA’s prior findings of safety for Gemzar and Taxotere and published

literature for the nonclinical safety assessment of NDV-01 because this is a proposed 505(b)(2) approval.

Based on this feedback, we requested Type B meetings with the FDA for

the randomized intermediate-risk NMIBC trial and for the BCG-unresponsive trial.

We have protocols in active development for both the

single-arm study in BCG-unresponsive NMIBC with carcinoma in situ (CIS) who are refractory to other therapies, which would enroll approximately

100 patients, and the randomized intermediate-risk NMIBC trial, which would enroll approximately 266 patients.

We intend to develop NDV-01 for the treatment

of high-risk, 2nd line BCG-unresponsive NMIBC and also in intermediate risk patients in the adjuvant setting.

We expect to initiate

Phase III programs for each indication in the first-half of 2026.

Our Corporate History and Background

We are a clinical-stage, publicly traded biotechnology

company developing NCEs and novel versions of drug products that potentially address areas of high unmet medical need in the treatment

of cancer, neurological disorders, depression and other diseases.

We are a clinical-stage, publicly traded biotechnology company developing

NCEs and novel versions of drug products that potentially address areas of high unmet medical need in the treatment of cancer, neurological

disorders, and other diseases.

Currently, none of our product candidates has

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for the foreseeable future.

We had a net loss of approximately $27,425,900 for the six months ended June 30, 2025.

At June 30, 2025, we

had an accumulated deficit of approximately $668,308,000.

We had a net loss of approximately $37,517,400 for the nine months ended September 30, 2025.

30, 2025, we had an accumulated deficit of approximately $678,399,400.

Business Strategy

Our strategy is to leverage our considerable

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

candidates with significant market potential that can fulfill unmet medical needs.

We have assembled a management team along with both

scientific advisors, and business advisors with significant industry and regulatory experience to lead and execute the development and

commercialization of our product candidates.

Our strategy is to leverage our considerable industry

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

with significant market potential that can fulfill unmet medical needs.

We have assembled a management team along with both scientific

advisors, and business advisors with significant industry and regulatory experience to lead and execute the development and commercialization

of our product candidates.

Intellectual Property Portfolio and Market

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PWS, TS, obsessive-compulsive disorder, and gambling disorder, potentially providing coverage beyond 2030.

more than 10 issued patents and pending patent applications related to NDV-01 for multiple uses, including formulations and methods for

controlled release of therapeutics for treatment of diseases such as bladder cancer, potentially providing coverage beyond 2038.

We have more than 10 issued patents and pending

patent applications related to NDV-01 for multiple uses, including formulations and methods for controlled release of therapeutics for

treatment of diseases such as bladder cancer, potentially providing coverage beyond 2038.

Key Strengths

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

Compelling lead product

opportunities in NDV-01 and Sepranolone.

Experienced management

team with considerable drug development expertise;

Multiple potential bladder

cancer related indications for NDV-01.

Extensive safety database

for Sepranolone as well as promising signal of efficacy in Tourette Syndrome

Substantial and growing

IP portfolio for both Sepranolone and NDV-01

Scientific support of leading

Compelling lead product opportunities in NDV-01 and Sepranolone.

Experienced management team with considerable drug development expertise;

Multiple potential bladder cancer related indications for NDV-01.

Extensive safety database for Sepranolone as well as promising signal of efficacy in Tourette Syndrome

Substantial and growing IP portfolio for both Sepranolone and NDV-01

Scientific support of leading experts:

Our scientific advisors include clinicians and scientists who are affiliated with a number of highly regarded medical institutions.

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Results of Operations

For the Three Months Ended June 30, 2025 versus June 30, 2024

For the Three Months Ended September 30, 2025 versus September 30,

September 30,

Operating Expenses

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Research and Development Expense

and development expense for the three months ended June 30, 2025 was approximately $2,819,400 compared to $10,721,100 for the three months

ended June 30, 2024, a decrease of approximately $7,901,700.

Research and development expense for the three months ended September

30, 2025 was approximately $4,036,300 compared to $11,149,100 for the three months ended September 30, 2024, a decrease of approximately

The change was primarily driven by:

Decrease in other research expenses of $5,537,300 primarily associated with the winding down of the REL-1017 302 and 304 studies in 2025;

Decrease in other research expenses of $5,103,600 primarily associated

with the winding down of the REL-1017 302 and 304 studies in 2025;

Decrease in stock-based compensation expense of $1,382,700;

Decrease in study costs of $807,900 associated with the winding down of the REL-1017 studies;

Decrease in manufacturing and drug storage costs of $599,900;

Increase in compensation expense of $430,100 due to a increase in research and development employees and their related bonus.

Decrease in study costs of $1,262,200 associated with the winding down

of the REL-1017 studies;

Increase in manufacturing and drug storage costs of $450,600;

Increase in compensation expense of $185,100 due to an increase in

research and development employees and their related bonus.

General and Administrative Expense

and administrative expense for the three months ended June 30, 2025 was approximately $7,401,900 compared to $8,097,700 for the three

months ended June 30, 2024, a decrease of approximately $695,800.

General and administrative expense for the three months ended September

30, 2025 was approximately $6,291,100 compared to $11,859,700 for the three months ended September 30, 2024, a decrease of approximately

The change was primarily due to:

Decrease in stock-based compensation expense of $2,782,500;

Increase in compensation expense of $1,652,000 due to an increase of general and administrative employees and their related bonuses;

Increase in other general

and administrative expenses of $5,900 primarily due to an increase in consulting services.

Decrease in compensation expense of $1,850,800 due to an decrease of

general and administrative employees and their related bonuses;

Decrease in other general and administrative expenses of $935,300 primarily

due to an decrease in consulting services.

Interest/investment income was approximately $247,000

and $963,000 for the three months ended June 30, 2025 and 2024, respectively.

and $856,500 for the three months ended September 30, 2025 and 2024, respectively.

The decrease was due to lower average investment balance.

Realized gain on short-term investments was approximately $47,200 and $133,100 for the three months ended June 30, 2025 and 2024, respectively.

Unrealized loss on short-term investments was approximately $13,800 and $45,500 for the three months ended June 30, 2025 and 2024.

The net loss for the Company for the three months

ended June 30, 2025 and 2024 was approximately $9,866,400 and $17,768,100, respectively.

The Company had loss per share basic and diluted

of $0.30 and $0.59 for the three months ended June 30, 2025 and 2024, respectively.

The Company did not provide for income taxes for

the three months ended June 30, 2025 and 2024, since there was a loss and a full valuation allowance against all deferred tax assets.

Realized loss on short-term investments was approximately $81,400 for the three months ended September 30, 2025 compared to a realized

gain on short term investments of approximately $147,800 for the three months ended September 30, 2024.

Unrealized gain on short-term

investments was approximately $70,300 and $278,600 for the three months ended September 30, 2025 and 2024.

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

2025 and 2024 was approximately $10,091,500 and $21,726,000, respectively.

The Company had loss per share basic and diluted of $0.30 and

$0.72 for the three months ended September 30, 2025 and 2024, respectively.

The Company did not provide for income taxes

for the three months ended September 30, 2025 and 2024, since there was a loss and a full valuation allowance against all deferred tax

Results of Operations

For the Six Months Ended June 30, 2025 versus June 30, 2024

For the Nine Months Ended September 30, 2025 versus September 30, 2024:

September 30,

Operating Expenses

Research and development

$ (16,368,864 )

General and administrative

$ (26,048,394 )

Research and Development Expense

Research and development expense for the six months

ended June 30, 2025 was approximately $14,770,400 compared to $24,026,400 for the six months ended June 30, 2024, a decrease of approximately

Research and development expense for the nine months ended September

30, 2025 was approximately $18,806,700 compared to $35,175,500 for the nine months ended September 30, 2024, a decrease of approximately

The decrease was primarily due to:

Decrease in other research expenses of $10,773,100 primarily associated with the wind-down of the 302 and 304 studies in 2025;

Decrease in other research expenses of $15,910,400 primarily associated

with the wind-down of the 302 and 304 studies in 2025;

Decrease in stock-based compensation expense of $3,398,300;

Decrease in manufacturing and drug storage costs of $286,200;

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

Increase in costs of $2,717,900 associated with the acquisitions of

Sepranolone and NDV-01 in the first quarter of 2025 offset with a decrease of 302 and 304 study expenses due to the wind-down of these

Increase in compensation expense of $323,100 due to an increase in research and development employees and their related bonuses.

Increase in compensation expense of $508,200 due to an increase in

research and development employees and their related bonuses.

General and Administrative Expense

General and administrative expense for the six

months ended June 30, 2025 was approximately $13,669,300 compared to $17,780,200 for the six months ended June 30, 2024, a decrease of

approximately $4,110,900.

General and administrative expense for the nine months ended September

30, 2025 was approximately $19,960,400 compared to $29,640,000 for the nine months ended September 30, 2024, a decrease of approximately

The decrease was primarily due to:

Decrease in stock-based compensation expense of $5,539,100 related to option grants to employees and key consultants;

Decrease in other general and administrative expenses of $281,600 primarily due to a decrease in consulting services;

Increase in compensation expense of $1,709,800 primarily related an increase of general and administrative employees and their related bonuses.

Interest / investment income was approximately $761,700 and $2,018,900

for the six months ended June 30, 2025 and 2024, respectively.

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

gain on short-term investments was approximately $110,200 for the six months ended June 30, 2024 compared to a realized gain of approximately

$186,200 for the six months ended June 30, 2024.

Unrealized gain on short-term investments was approximately $141,900 and $5,200 for the

six months ended June 30, 2025 and 2024, respectively.

The net loss for the Company for the six months ended June 30, 2025

Decrease in stock-based compensation expense of $8,321,700 related

to option grants to employees and key consultants;

Decrease in other general and administrative expenses of $1,216,900

primarily due to a decrease in consulting services;

Decrease in compensation expense of $141,000 primarily related an decrease

of general and administrative employees and their related bonuses.

Interest / investment income was approximately

$1,008,800 and $2,875,500 for the nine months ended September 30, 2025 and 2024, respectively.

The decrease was due to lower interest

rates and investment yields and a lower average balance.

Realized gain on short-term investments was approximately $28,700 and $334,100

for the nine months ended September 30, 2025 and 2024, respectively.

Unrealized gain on short-term investments was approximately $212,200

and $283,800 for the nine months ended September 30, 2025 and 2024, respectively.

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

2025 and 2024 was approximately $37,517,400 and $61,322,200 respectively.

The Company had loss per share, basic and diluted of $1.16 and

for the six months ended June 30, 2025 and 2024, respectively.

$2.03 for the nine months ended September 30, 2025 and 2024, respectively.

The Company did not provide for income taxes for

the six months ended June 30, 2025 and 2024, since there was a loss and a full valuation allowance against all deferred tax assets.

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 six months ended June 30, 2025, the Company incurred a net loss of $27,425,907 and had negative

operating cash flows of $24,468,909.

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 are issued.

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 terms.

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 concluded that management’s plans do not alleviate substantial doubt about

the Company’s ability to continue as a going concern.

The following table sets forth selected cash flow information for

the periods indicated below:

Six Months Ended

the nine months ended September 30, 2025 and 2024, since there was a loss and a full valuation allowance against all deferred tax assets.

As shown in the accompanying unaudited consolidated financial statements,

the Company has incurred losses and negative cash flows from operations since inception and expects to incur additional losses until such

time that it can generate significant revenue from the commercialization of its product candidates.

During the nine months ended September

30, 2025, the Company incurred a net loss of $37,517,403 and had negative operating cash flows of $31,190,765.

At September 30, 2025,

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

On November 5, 2025 the Company announced the

closing of its underwritten offering of 40,142,000 shares of its common stock and, in lieu of common stock to certain investors, pre-funded

warrants to purchase up to 5,315,000 shares of common stock.

The shares of common stock were sold at an offering price of $2.20 per share,

and the pre-funded warrants were sold at an offering price of $2.199 per pre-funded warrant, which represents the per share offering price

for the common stock less the $0.001 per share exercise price for each such pre-funded warrant.

The net proceeds to Relmada from the offering,

before deducting other expenses payable by Relmada, and excluding the exercise of any pre-funded warrants, are approximately $94 million.

As of the date of this report, Management believes

that the Company’s existing cash and cash equivalents and short-term investments will enable it to fund operating expenses and capital

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

Beyond that point management will evaluate the size and scope of any subsequent trials that will affect the timing of additional financings

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

Any such expenditures related to any subsequent clinical trials will not be incurred until such additional financing is raised.

As a result, the Company concluded that management’s plans alleviated substantial doubt about the Company’s ability to continue

as a going concern as of September 30, 2025 and the Company has sufficient funds to maintain operations for at least 12 months from the

issuance of these unaudited condensed consolidated financial statements.

The following table sets forth selected cash flow information for the

periods indicated below:

Nine Months Ended

September 30,

Nine Months Ended

September 30,

Cash used in operating activities

5 unchanged sentences

$ (2,472,542 )

the six months ended June 30, 2025, cash used in operating activities was $24,468,909 primarily due to the net loss of $27,425,907 offset

by non-cash stock-based compensation charges of $7,926,448.

There were realized gains and unrealized gains on short-term investments

of $110,156 and $141,934, respectively.

In addition, there was an increase in operating assets and liabilities of $4,717,360.

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 $4,477,995.

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

respectively.

In addition, there was an increase in operating assets and liabilities of $4,766,880.

For the six months ended June 30, 2025, cash provided

by investing activities was $22,038,255, due to $809,375 of purchases of short-term investments offset by $22,847,630 of sales of short-term

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 nine months ended September 30, 2025,

cash used in operating activities was $31,190,765 primarily due to the net loss of $37,517,403 offset by non-cash stock-based compensation

charges of $11,534,002 and fair value changes on stock appreciation rights of $216,640.

There were realized gains and unrealized gains

on short-term investments of $28,717 and $212,210, respectively.

In addition, there was a decrease in operating assets and liabilities

of $5,183,077.

For the nine months ended September 30, 2024,

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

of $23,458,012 and fair value changes on stock appreciation rights of $12,562.

There were realized and unrealized gains on short-term

investments of $334,082 and $283,803, respectively.

In addition, there was a decrease in operating assets and liabilities of $4,486,635.

For the nine months ended September 30, 2025, cash provided by investing

activities was $28,791,244, due to $1,043,307 of purchases of short-term investments offset by $29,834,551 of sales of short-term investments.

For the nine months ended September 30, 2024,

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

of sales of short-term investments.

Net cash used by financing activities for the

six months ended June 30, 2025 was $73,021 related to ATM expenses.

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 expenses of $25,000.

nine months ended September 30, 2025 was $73,021 related to ATM expenses.

Net cash provided by financing activities for the nine months ended

September 30, 2024 was $132,146, due to proceeds from options exercised for common stock of $246,747 offset by ATM expenses of $114,601.

Effects of Inflation

5 unchanged sentences

Commitments and Contingencies

Please refer to Note 10 in our Annual Report

on Form 10-K for the year ended December 31, 2024 under the heading Commitments and Contingencies.

To our knowledge there have been no

material changes to the risk factors that were previously disclosed in the Company’s Annual Report on Form 10-K for the year ended

December 31, 2024.

Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also

may materially adversely affect our business, financial condition and/or operating results.

Please refer to Note 10 in our Annual Report on

Form 10-K for the year ended December 31, 2024 under the heading Commitments and Contingencies.

To our knowledge there have been no material

changes to the risk factors that were previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December

Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially

adversely affect our business, financial condition and/or operating results.

Critical Accounting Policies and Estimates

2 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.

unaudited condensed consolidated financial statements are presented in accordance with U.S.

Our unaudited condensed consolidated financial

statements are presented in accordance with U.S.

GAAP, and all applicable U.S.

GAAP accounting

standards effective as of June 30, 2025 have been taken into consideration in preparing the unaudited condensed consolidated

financial statements.

The preparation of unaudited condensed consolidated financial statements requires management to make estimates

and assumptions that affect the reported amounts of assets, liabilities, and disclosure of contingent assets and liabilities at the date

of the unaudited condensed consolidated financial statements and the reported amounts of revenues and expenses for the reporting period.

Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances,

the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent

from other sources.

On a continual basis, management reviews its estimates utilizing currently available information, changes in facts

and circumstances, historical experience, and reasonable assumptions.

After such reviews, and if deemed appropriate, management’s

estimates are adjusted accordingly.

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

Management considers an accounting estimate to be critical if:

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

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

operations or financial condition.

We evaluate our estimates and assumptions on

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

statements involve a high level of estimation uncertainty.

For additional discussion regarding the application of the significant accounting

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

GAAP accounting standards effective as of September 30,

2025 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

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.

Management considers an accounting estimate to

be critical if:

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

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

We evaluate our estimates and assumptions on an ongoing basis and none

of the Company’s estimates and assumptions used within the unaudited condensed consolidated financial statements involve a high

level of estimation uncertainty.

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

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

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis