What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-07 compared with 2025-05-12 · 290 added, 303 removed, 118 unchanged (83% of the section changed)

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

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

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

We have attempted to identify

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

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

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

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

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

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

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

Moreover, we operate in a very competitive

and rapidly changing environment.

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

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

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

All forward-looking statements included in this document

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

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

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

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

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

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

these terms or other comparable terminology.

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

basis for doing so, we cannot guarantee their accuracy.

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

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

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

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

New risks emerge from time to time and it is

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

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

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

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

You should not place undue reliance on any forward-looking

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

Before you invest in our securities, you should

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

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

Except as required by law, we undertake

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

to conform our statements to actual results or changed expectations.

Before you invest in our securities, you

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

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

Except as required by

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

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

Business Overview

Relmada Therapeutics, Inc.

(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 chemotheraphy regimen widely 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

(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 in late 2024 and early 2025.

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 esmethadone (d-methadone, dextromethadone or REL-1017).

Hence we accelerated ongoing

efforts to augment our development pipeline while diversifying its risk, which culminated in the licensing of NDV-01, a novel delivery

formulation of a chemotherapy regimen widely 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.

Following the 2024 REL-1017 setback and subsequent

post hoc analyses, the program has been 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.

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 the

chronic use of psychedelics, its early stage of development and the acquisition of new, more advanced product candidates, effective May

12, 2025, this program has been terminated.

REL-1017 Program Updates

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 mostly 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.

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

Strategic Business Review and New Approach

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novel and differentiated therapeutic solutions

● Addressing Unmet Medical Needs

– Targeting areas with significant gaps in treatment

Addressing Unmet Medical

Needs – Targeting areas with significant gaps in treatment

Large Market Opportunities

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Key Strategic Priorities

Under this updated 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

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

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– 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

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

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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

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.

Key Upcoming Anticipated Milestones

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These include:

NDV-01 Six-month data from ongoing Phase 2 NMBIC Study – Mid

NDV-01 Nine-month data from ongoing Phase 2 NMBIC Study – 3 rd Quarter 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

Our Development

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

Our Development Programs

Sepranolone Program

The GABAergic system is the primary inhibitory neurotransmitter pathway.

The GABAergic system is the primary inhibitory

neurotransmitter pathway.

It consists of two types of receptors, GABA A and GABA B .

GABA A receptors are a major target for neuropsychiatric

drugs, including benzodiazepines, barbiturates and anesthetic agents.

The GABAergic system regulates a host of physiological and neurological

functions and their related moods and behaviors.

The principal positive physiologic modulators of the GABAergic system are the neurotransmitter

GABA (γ-aminobutyric acid) and the positive allosteric modulator Allopregnanolone.

GABA generally inhibits nervous system excitability

and thereby produces a calming effect that reduces anxiety and compulsive behavior, among other manifestations.

While Allopregnanolone

typically enhances GABA’s calming effects, in some individuals it paradoxically exacerbates anxiety and compulsive behavior.

Sepranolone is

a synthetic version of Isoallopregnanolone, a naturally occurring neurosteroid that counteracts the effects of Allopregnanolone.

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 demonstrated that Sepranolone has the potential to improve TS symptoms versus standard of care alone, as measured

by changes in the YGTSS scoring system (the world-standard Yale Global Tic Severity Scale) compared to baseline.

In the 12-week, dual-center,

parallel-group study, 26 subjects were treated with Sepranolone (10 mg, administered by subcutaneous injection twice weekly in addition

to standard of care (SOC) versus standard of care alone.

The Phase 2a results

showed competitive tic reduction and improved quality of life while displaying no CNS off-target effects.

Sepranolone not only reduced

tic severity in its primary clinical endpoint as measured by YGTSS by 28% (p=0.051) – but also achieved positive results in four

key secondary endpoints compared with standard of care:

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

reduction in impairment (YGTSS)

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

Importantly, no

off-target CNS effects or systemic side effects were observed in this study.

Further, Sepranolone has been evaluated in multiple clinical

neuro/hormonal studies involving over 335 participants and has demonstrated a favorable safety profile.

Relmada is currently

evaluating the nonclinical and clinical strategy for the development of Sepranolone.

GABA A receptors are

a major target for neuropsychiatric drugs, including benzodiazepines, barbiturates and anesthetic agents.

The GABAergic system regulates

a host of physiological and neurological functions and their related moods and behaviors.

The principal positive physiologic modulators

of the GABAergic system are the neurotransmitter GABA (γ-aminobutyric acid) and the positive allosteric modulator Allopregnanolone.

GABA generally inhibits nervous system excitability and thereby produces a calming effect that reduces anxiety and compulsive behavior,

among other manifestations.

While Allopregnanolone typically enhances GABA’s calming effects, in some individuals it paradoxically

exacerbates anxiety and compulsive behavior.

Sepranolone is a synthetic version of Isoallopregnanolone,

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.

Data from an open-label Phase 2a randomized study

demonstrated that Sepranolone has the potential to improve TS symptoms versus standard of care alone, as measured by changes in the YGTSS

scoring system (the world-standard Yale Global Tic Severity Scale) compared to baseline.

In the 12-week, dual-center, parallel-group

study, 26 subjects were treated with Sepranolone (10 mg, administered by subcutaneous injection twice weekly in addition to standard

of care (SOC) versus standard of care alone.

The Phase 2a results showed competitive tic reduction

and improved quality of life while displaying no CNS off-target effects.

Sepranolone not only reduced tic severity in its primary clinical

endpoint as measured by YGTSS by 28% (p=0.051) – but also achieved positive results in four key secondary endpoints compared with

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)

Importantly, no off-target CNS effects or systemic

side effects were observed in this study.

Further, Sepranolone has been evaluated in multiple clinical neuro/hormonal studies involving

over 335 participants and has demonstrated a favorable safety profile.

Relmada is currently evaluating the nonclinical

and clinical strategy for the development of Sepranolone.

NDV-01 Program

The second program we recently in-licensed, 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.

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 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 currently in a Phase 2 clinical trial evaluating its safety

and efficacy in patients with aggressive NMIBC.

The Phase 2 study is a single-arm, single-center study evaluating 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.

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).

On April 28, 2025, the

Company announced positive initial data from the Phase 2 study.

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

evaluating its safety and efficacy in patients with aggressive NMIBC.

The Phase 2 study is a single-arm, single-center study evaluating

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:

patients had reached the 3-month assessment with 7 reaching the 6-month assessment.

of the initial Phase 2 data:

Response Rate (ORR)

High-Grade Recurrence-Free Survival (HGRFS) in papillary disease

100% Complete

Response in CIS patients

any time point:

HGRFS in papillary disease

100% Complete

Response in CIS patients

status at 6-month Assessment:

evaluable patients achieved disease free status.

related adverse events greater than Grade 1.

common treatment emergent adverse events (TEAEs) were urinary urgency, flank pain, and dysuria, all of which were mild and transient,

resolving in 24-28 hours.

No patients discontinued treatment due to adverse events.

Esmethadone (d-Methadone, dextromethadone,

REL-1017) as a treatment for MDD

Esmethadone’s mechanism of action, as a

low affinity, non-competitive NMDA channel blocker or antagonist, is fundamentally differentiated from most currently FDA-approved antidepressants,

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

Working through the same brain mechanisms

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

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

Relmada has paused this program pending a comprehensive

data review, after which a decision regarding the future of this program will be made.

Esmethadone (d-methadone, dextromethadone,

REL-1017) in other indications

While our strategy was to focus on the development

of esmethadone as an adjunctive treatment for MDD, we are also evaluating other indications that Relmada may explore in the future, including

restless leg syndrome and other glutamatergic system activation related diseases.

Psilocybin Program

Relmada acquired the development and commercial

rights to a novel psilocybin and derivative program from Arbormentis LLC in July of 2021.

The original focus of the program was limited

to neurodegenerative diseases.

Psilocybin has neuroplastogen™ effects that have the potential to ameliorate the consequences of

multiple neurodegenerative conditions.

The pleiotropic metabolic effects of low-dose psilocybin were discovered while studying its neuroplastogen™

potential in a rodent model deficient in neurogenesis – obese rodents maintained on a high fructose, high fat diet (HFHFD).

Specifically,

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.

Effective May 12, 2025, Relmada has terminated

this program 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.

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 (%))

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.

Our Corporate History and Background

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regulatory agencies, like the FDA in the United States, and similar organizations elsewhere in the world.

We have not generated revenues and do not anticipate

generating revenues for the foreseeable future.

We had a net loss of approximately $17,559,500 for the three months ended March 31, 2025.

At March 31, 2025, we had an accumulated deficit of approximately $658,441,500.

We have not generated revenues and do not anticipate generating revenues

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.

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.

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.

We have more than 50 issued patents and pending

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

coverage beyond 2033.

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.

In the European

Union, 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.

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 experts:

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

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 March 31, 2025 versus March 31, 2024

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

Operating Expenses

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Research and Development Expense

Research and development expense for the three

months ended March 31, 2025 was approximately $11,951,000 compared to $13,305,300 for the three months ended March 31, 2024, a decrease

of approximately $1,354,300.

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.

The change was primarily driven by:

Decrease in other research expenses of $5,269,600 primarily associated

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

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 stock-based compensation expense of $1,386,700;

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;

Decrease in compensation expense of $106,800 due to a decrease in research and development employees and their related bonus;

Increase in study costs of $4,788,000 associated with the acquisition of Sepranolone and NDV-01.

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

General and Administrative Expense

General and administrative expense for the three

months ended March 31, 2025 was approximately $6,267,400 compared to $9,682,600 for the three months ended March 31, 2024, a decrease

of approximately $3,415,200.

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.

The change was primarily due to:

Decrease in stock-based compensation expense of $2,353,700;

Decrease in other general and administrative expenses of $287,400 primarily due to an decrease in consulting services;

Increase in compensation expense of $57,700 due to an increase of general

and administrative employees and their related bonuses.

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.

Interest/investment income was approximately $321,500

and $1,055,900 for the three months ended March 31, 2025 and 2024, respectively.

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

The decrease was due to lower average investment balance.

Realized gain on short-term investments was approximately $63,000 and $53,100 for the three months ended March 31, 2025 and 2024, respectively.

Unrealized gain on short-term investments for the three months ended March 31, 2025 and 2024 was approximately $155,700 and $50,700, respectively.

The Company did not provide for income taxes for

the three months ended March 31, 2025 and 2024, since there was a loss and a full valuation allowance against all deferred tax assets.

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 March 31, 2025 and 2024 was approximately $17,559,500 and $21,828,100 respectively.

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 $0.58 and $0.72 for the three months ended March 31, 2025 and 2024, respectively.

As 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 three

months ended March 31, 2025, the Company incurred a net loss of $17,559,465 and had negative operating cash flows of $18,067,033.

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.

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.

Results of Operations

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

Operating Expenses

Research and development

General and administrative

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

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 stock-based compensation expense of $2,015,600;

Decrease in manufacturing and drug storage costs of $736,800;

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

Increase in costs of $3,980,100 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.

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.

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

and 2024 was approximately $27,425,900 and $39,596,200 respectively.

The Company had loss per share, basic and diluted of $0.86 and $1.31

for the six months ended June 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

5 unchanged sentences

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 probably.

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:

Three Months Ended

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

Cash used in operating activities

2 unchanged sentences

Cash provided by investing activities

Cash provided by financing activities

Cash (used in)/provided by financing activities

Net decrease in cash and cash equivalents

$ (2,503,675 )

For the three months ended March 31, 2025, cash

used in operating activities was $18,067,033 primarily due to the net loss of $17,559,465 offset by non-cash stock-based compensation

charges of $4,477,995.

There were realized gains and unrealized gains on short-term investments of $62,952 and $155,731, respectively.

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 three months ended March 31, 2024, cash

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

of $8,295,468.

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

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

For the three months ended March 31, 2025, cash provided by investing

activities was $15,359,713 due to $487,916 of purchases of short-term investments offset by $15,847,629 of sales of short-term investments.

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.

Net cash provided by financing activities for

the three months ended March 31, 2025 was $0.

Net cash provided by financing activities for

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

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

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.

Effects of Inflation

7 unchanged sentences

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.

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.

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.

Our unaudited condensed consolidated financial

statements are presented in accordance with U.S.

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

GAAP, and all applicable U.S.

GAAP accounting standards effective as of March 31, 2025

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

The preparation of unaudited condensed

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

and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses

for the reporting period.

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

under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that

are not readily apparent from other sources.

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

changes in facts and circumstances, historical experience, and reasonable assumptions.

After such reviews, and if deemed appropriate,

management’s estimates are adjusted accordingly.

Actual results could differ from those estimates and assumptions under different

and/or future circumstances.

GAAP accounting

standards effective as of June 30, 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:

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.

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.

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