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Item 2. Management’s Discussion and Analysis

2025-05-12 compared with 2024-11-07 · 333 added, 435 removed, 88 unchanged (90% of the section changed)

5 unchanged sentences

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

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

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

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

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

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

these terms or other comparable terminology.

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

basis for doing so, we cannot guarantee their accuracy.

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

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

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

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

New risks emerge from time to time and it is

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

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

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

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

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

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

We have attempted to identify

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

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

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

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

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

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

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

Moreover, we operate in a very competitive

and rapidly changing environment.

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

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

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

All forward-looking statements included in this document

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

You should not place undue reliance on any forward-looking

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

Before you invest in our securities, you

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

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

Except as required by

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

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

Before you invest in our securities, you should

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

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

Except as required by law, we undertake

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

to conform our statements to actual results or changed expectations.

Business Overview

Relmada Therapeutics, Inc.

(Relmada or the Company,

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

REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist.

Esmethadone, an isomer of methadone, is a new chemical entity (NCE) that

potentially addresses areas of high unmet medical need in the treatment of central nervous system (CNS) diseases and other disorders.

Our lead product candidate, esmethadone, is being

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

On October 15, 2019, we reported

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

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

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

(RELIANCE II and RELIGHT).

Relmada also intends, in 2024, to enter human

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

with psychedelic effects for metabolic indications.

Esmethadone (d-Methadone, dextromethadone,

Phase 2 Clinical Trial

In the REL-1017-202 study, 62 subjects, with

an average age of 49.2 years, with an average Hamilton Depression Rating Scale score of 25.3 and an average Montgomery-Asberg Depression

Rating Scale (MADRS) score of 34.0 (severe depression), were randomized.

Other demographic characteristics were balanced across all arms.

After an initial screening period, subjects were randomized to one of three arms:

placebo, REL-1017 25 mg or REL-1017 50 mg, in addition

to stable background antidepressant therapy.

Subjects in the REL-1017 treatment arms received one loading dose of either 75 mg (25 mg

arm) or 100 mg (50 mg arm) of REL-1017.

Subjects were treated inpatient for 7 days and discharged home at Day 9.

They returned for follow-up

visits at Day 14 and Day 21.

Efficacy was measured on Days 2, 4 and 7 in the dosing period and on Day 14, one week after treatment discontinuation.

61 subjects received all treatment doses and were included in the per-protocol population (PPP) treatment analysis;

57 subjects completed

All 62 randomized subjects were part of the intention-to-treat (ITT) analysis.

No differences were observed between the ITT

and PPP analyses and results.

We observed that subjects in both the REL-1017

25 mg and 50 mg treatment groups experienced statistically significant improvement on all efficacy measures tested as compared to subjects

in the placebo group, including:

the Clinical Global Impression – Severity (CGI-S) scale;

the Clinical Global Impression

– Improvement (CGI-I) scale;

and the Symptoms of Depression Questionnaire (SDQ).

Improvements on the MADRS endpoint appeared on

Day 4 in both REL-1017 dose groups and continued through Day 7 and Day 14, seven days after treatment discontinuation, with P values<

0.03 and large effect sizes (a measure of quantifying the difference between two groups), ranging from 0.7 to 1.0.

Similar findings emerged

from the CGI-S and CGI-I scales.

The study also confirmed the tolerability profile

of REL-1017, which was observed in the Phase 1 studies.

Subjects experienced only mild and moderate adverse events (AEs), and no serious

adverse events, without significant differences between placebo and treatment groups.

The AEs observed in the Phase 2a clinical study

were of the same nature as those observed in the Phase 1 clinical studies of d-Methadone, and there was no evidence of either treatment

induced psychotomimetic and dissociative AEs or withdrawal signs and symptoms upon treatment discontinuation.

Phase 3 Program

On December 20, 2020, Relmada announced that

the first patient had been enrolled in the first Phase 3 clinical trial (RELIANCE I) for the Company’s lead product candidate,

REL-1017, as an adjunctive treatment for MDD.

On April 1, 2021, Relmada announced the initiation

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

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

On October 4, 2021, Relmada announced the initiation

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

In addition, on October 4, 2021, Relmada announced

that in order to support potential regulatory submissions seeking approval for REL-1017 as adjunctive and monotherapy treatment, the

Food and Drug Administration (FDA) confirmed that, based on what was known at the time, Relmada would not be required to conduct a two-year

carcinogenicity study of REL-1017, as sufficient clinical data had been generated to date.

The FDA also confirmed that Relmada would

not need to conduct a TQT cardiac study in humans to support cardiac safety in potential regulatory submissions for REL-1017, as the

data already provided and the data to be generated by the Phase 3 program would be adequate to evaluate the cardiac safety profile of

On August 9, 2022, Relmada announced that the

FDA granted Fast Track designation to REL-1017 as a monotherapy for the treatment of MDD.

On October 13, 2022, Relmada announced that its

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

significant improvement in depression symptoms compared to placebo as measured by MADRS on Day 28.

In the study, the REL-1017 treatment

arm showed a MADRS reduction of 14.8 points at Day 28 versus 13.9 points for the placebo arm, a higher than expected placebo response.

On December 7, 2022, Relmada announced that its

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

significant improvement in depression symptoms compared to placebo as measured by MADRS on Day 28.

In the study, the REL-1017 treatment

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

difference of 2.3 points on the MADRS.

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

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

Additionally, in a prespecified protocol population

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

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

Patients who completed the RELIANCE trials were

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

in a REL-1017 clinical trial.

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

On September 20, 2023, Relmada announced efficacy

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

of REL-1017 in patients with MDD.

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

sustained improvements in depressive symptoms and associated functional impairment.

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

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

The most commonly reported adverse events deemed to be

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

No new safety signals were detected.

On August 23, 2023, Relmada announced the dosing

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

Human Abuse Potential (HAP) Studies

Top-line Results -Oxycodone:

On July 27, 2021, Relmada announced top-line

results that showed that all three doses of REL-1017 (25 mg, 75 mg and 150 mg, the therapeutic, supratherapeutic and maximum tolerated

doses (MTD), respectively) tested in recreational opioid users, demonstrated a highly statistically significant difference vs.

control drug, oxycodone 40 mg.

The study’s primary endpoint was a measure of “likability” with the subjects rating

the maximum effect (or Emax) for Drug Liking “at the moment”, using a 1=100 bipolar rating scale (known as a visual analog

scale or VAS), with 100 as the highest likability, 50 as neutral (placebo-like), and 0 the highest dislike.

In summary, all tested doses

of REL-1017, including the 150 mg MTD, showed a highly statistically significant difference in abuse potential versus oxycodone with

p-values less than 0.05.

Consistent results were seen for the secondary endpoints.

Additionally, all REL-1017 doses including 150 mg

(6 times the therapeutic dose and MTD) were statistically equivalent to placebo (p<0.05).

These results support the lack of opioid

effects of REL-1017.

Top-line Results -Ketamine:

On February 23, 2022, Relmada announced top-line

results that showed that all three doses of REL-1017 (25 mg, 75 mg, and 150 mg, the therapeutic, supratherapeutic and MTD, respectively)

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

the active control

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

The study’s primary

endpoint was a measure of “likability” with the subjects rating the maximum effect (or Emax) for Drug Liking “at this

moment”, using a 1-100 bipolar rating scale (known as a visual analog scale or VAS), with 100 as the highest likability, 50 as

neutral (placebo-like), and 0 the highest dislike.

Consistent results are seen for the secondary endpoints.

Psilocybin Program (REL-P11):

On October 11, 2023, Relmada announced that it

intends to enter human studies of its proprietary, modified-release formulation of psilocybin (REL-P11) for metabolic indications in

doses that we believe are lower than those associates with psychedelic effects.

The Company plans to commence a single-ascending dose

Phase 1 trial in obese subjects in 2024 to define the pharmacokinetic, safety and tolerability profile of Relmada's modified-release

psilocybin formulation (REL-P11) in this population, followed by a Phase 2a trial to establish clinical proof-of-concept.

Pre-clinical data in a rodent model of metabolic

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

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

(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

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.

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 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

● 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.

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.

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:

Conduct a formal interim analysis, with futility and

sample size re-estimation analyses, of RELIANCE II study by year-end 2024.

Outcome of RELIANCE II interim analysis expected before year-end 2024.

Initiate Phase 1 trial in obese subjects with the

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

Our Development Program

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

Sepranolone Program

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.

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.

NDV-01 potentially addresses these limitations

by enabling a single administration in less than 10 minutes, delivering sustained, localized chemotherapy for up to 10 days.

This extended

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.

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

In 2021, the National Institute of Mental Health

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

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

received treatment in 2021.

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

depression patients do not achieve adequate therapeutic benefits according to the Sequenced Treatment Alternatives to Relieve Depression

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

In addition to the high failure rate, only two

of the marketed products for depression, esketamine (marketed by Johnson and Johnson as Spravato®), an in-clinic nasal spray treatment,

and dextromethorphan-bupropion (marketed by Axsome as Auvelity ä ), can demonstrate rapid

antidepressant effects, while the other currently approved products can take two to eight weeks to show activity.

The urgent need for

improved, faster acting antidepressant treatments is underscored by the fact that severe depression can be life-threatening, due to heightened

risk of suicide.

Esmethadone Overview and Mechanism of Action

Esmethadone’s mechanism of action, as a

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

Working through the same brain

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

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

In chemistry an enantiomer, also known as an

optical isomer, is one of two stereoisomers that are mirror images of each other that are non-superimposable (not identical), much as

one’s left and right hands are the same except for being reversed along one axis.

A racemic compound, or racemate, is one that

has equal amounts of left- and right-handed enantiomers of a chiral molecule.

For racemic drugs, often only one of a drug’s enantiomers

is responsible for the desired physiologic effects, while the other enantiomer is less active or inactive.

As a single isomer of racemic methadone, esmethadone

has been shown to possess NMDA antagonist properties with virtually no traditional opioid or ketamine-like adverse events at the expected

therapeutic doses.

In contrast, racemic methadone is associated with common opioid side effects that include anxiety, nervousness, restlessness,

sleep problems (insomnia), nausea, vomiting, constipation, diarrhea, drowsiness, and others.

It has been shown that the left (levo) isomer,

l-methadone, is largely responsible for methadone’s opioid activity, while the right (dextro) isomer, esmethadone, at the currently

therapeutic doses used in development is virtually inactive as an opioid while maintaining affinity for the NMDA receptor.

NMDA receptors are present in many parts of the

CNS and play important roles in regulating neuronal activity and promoting synaptic plasticity in brain areas important for cognitive

functions such as executive function, learning and memory.

Based on these premises, esmethadone could show benefits in several different

CNS indications.

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 current strategy is currently to focus

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

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

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

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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.

Our Corporate History and Background

1 unchanged sentence

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

of depression and other CNS diseases.

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

metabolic indications.

Currently, none of our product candidates have

of cancer, neurological disorders, depression and other diseases.

Currently, none of our product candidates has

been approved for sale in the United States or elsewhere.

4 unchanged sentences

generating revenues for the foreseeable future.

We had a net loss of $61,322,218 for the nine months ended September 30, 2024.

30, 2024, we had an accumulated deficit of $622,224,899.

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.

Business Strategy

Our strategy is to leverage our considerable

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

with significant market potential that can fulfill unmet medical needs in the treatment of CNS diseases.

We have assembled a management

team along with both scientific advisors, including recognized experts in the fields of depression, and business advisors with significant

industry and regulatory experience to lead and execute the development and commercialization of esmethadone.

We plan to further develop esmethadone as our

priority program.

As the drug esmethadone is an NCE, the regulatory pathway required to support a new drug application (NDA) submission

involves a full clinical development program.

We plan to continue to generate intellectual property (IP) that will further protect our

products from competition.

We will also continue to prioritize our product development activities after taking into account the resources

we have available, market dynamics and potential for adding value.

Market Opportunity

We believe that the market for addressing areas

of high unmet medical need in the treatment of CNS diseases will continue to be large for the foreseeable future and that it will represent

a sizable revenue opportunity for us.

For example, the World Health Organization (WHO) has estimated that CNS diseases affect nearly

2 billion people globally, making up approximately 40% of total disease burden (based on disability adjusted life years), compared with

13% for cancer and 12% for cardiovascular disease.

The depression treatment market is segmented on

the basis of antidepressants drugs, devices, and therapies.

Antidepressants are the largest and most popular market segment.

The antidepressants

segment consists of large pharmaceutical and generic companies, such as Eli Lilly, Pfizer, GlaxoSmithKline, Allergan, Sage Therapeutics

and Johnson & Johnson.

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

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

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

We have over 50 issued patents and pending patent

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

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.

We have more than 40 issued patents and pending

patent applications related to Sepranolone for multiple uses, including diseases and disorders exhibiting compulsive behaviors such as

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

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

Compelling lead product opportunity, REL-1017 currently in two Phase

3 trials for the adjunctive treatment of MDD (RELIANCE II and RELIGHT) that build on the knowledge obtained from RELIANCE I, which

did not meet its primary endpoint.

Robust and highly statistically significant, efficacy seen with esmethadone

in a randomized Phase 2 trial with the primary endpoint at 7 days, with onset of action seen at 4 days, and the effect carrying through

to 14 days (7 days post-treatment).

Successful Phase 1 safety studies of esmethadone and strong clinical

activity signal in depression established in three independent animal models in preclinical studies.

Potential in additional multiple indications in underserved markets

with large patient population in other affective disorders, and cognitive disorders.

Substantial esmethadone IP Portfolio and market protection:

and filed patent applications provide coverage beyond 2033.

Portfolio diversification with the development of a novel psilocybin (REL-P11) for the treatment of metabolic indications.

This program is expected to enter human studies, to define its pharmacokinetic, safety and tolerability profile, in 2024.

support of leading experts:

Our scientific advisors include clinicians and scientists who

are affiliated with a number of highly regarded medical institutions such as Harvard, Cornell,

Yale, and University of Pennsylvania.

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.

Available Information

3 unchanged sentences

Results of Operations

For the Three Months Ended September 30, 2024 versus September

September 30,

For the Three Months Ended March 31, 2025 versus March 31, 2024

Operating Expenses

Research and development

$ (1,354,283 )

General and administrative

$ (4,769,425 )

Research and Development Expense

Research and development expense for the three

months ended September 30, 2024, was approximately $11,149,100 compared to $10,454,100 for the three months ended September 30, 2023,

an increase of approximately $695,000.

The increase was due to:

● Decrease in study costs of

$842,900 associated with the completion of the long-term, open-label study, Study 310 in the 3 rd Quarter 2023, as well as

RELIANCE I and III in late 2022;

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.

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 stock-based compensation expense of $629,000;

Decrease in manufacturing and drug storage costs of $136,900;

in compensation expense of $115,100 due to a decrease in research and development employees and their related bonuses;

in stock-based compensation expense of $18,200 related to options granted to employees;

● Increase in other research

expenses of $1,915,500 primarily associated with the ramp-up of the 302 and 304 studies in 2024;

● Increase in stock appreciation rights expense of $12,600

related to stock appreciation rights granted to employees.

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.

General and Administrative Expense

General and administrative expense for the three months ended September

30, 2024, was approximately $11,859,700 compared to $12,238,600 for the three months ended September 30, 2023, a decrease of approximately

The decrease was due to:

Decrease in stock-based compensation of $3,425,600 which can be attributed to two key factors.

First, equity grants from four years ago have dropped off the amortization schedule, as they reached the end of their vesting period.

Second, the Company granted significantly fewer options this past year due to the lack of shareholder approval to increase the 2021 Equity Incentive Plan.

Without this approval, the company was unable to issue a substantial number of new stock options, further contributing to the reduction in stock-based compensation expenses for the current period.

These two factors combined have led to the notable decrease in these expenses;

Increase in cash compensation expense of $2,060,100 related to retention bonuses.

These bonuses were designed to help offset the absence

of equity-based compensation, ensuring that the Company's leadership remained incentivized and aligned with the organization's long-term

Increase in other general and administrative expenses of $986,600 primarily due to an increase in consulting services.

Other Income (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.

The change was primarily due to:

Decrease in stock-based compensation expense of $3,185,500;

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.

Interest/investment income was approximately $440,300

$856,500 and $1,321,400 for the three months ended September 30, 2024 and 2023, respectively.

The decrease was due to lower interest

rates and investment yields.

Realized gain on short-term investments was approximately $147,800 and realized loss on short-term investments

was approximately $51,700 for the three months ended September 30, 2024 and 2023, respectively.

Unrealized gain on short-term investments

was approximately $278,600 and unrealized loss on short-term investments was approximately $579,100 for the three months ended September

30, 2024 and 2023, respectively.

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

2024 and 2023 was approximately $21,726,000 and $22,002,100, respectively.

The Company had loss per share basic and diluted of $0.72 and

$0.73 for the three months ended September 30, 2024 and 2023, respectively.

The Company did not provide for income taxes

for the three months ended September 30, 2024 and 2023, since there was a loss and a full valuation allowance against all deferred tax

Results of Operations

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

September 30,

Operating Expenses

Research and development

$ (4,879,756 )

General and administrative

$ (12,057,491 )

Research and Development Expense

Research and development expense for the nine

months ended September 30, 2024 was approximately $35,175,500 compared to $40,055,300 for the nine months ended September 30, 2023, a

decrease of approximately $4,879,800.

The decrease was due to:

in study costs of $7,925,700 associated with the completion of the long-term, open-label study, Study 310 in the 3 rd Quarter

2023, as well as RELIANCE I and III in late 2022

● Decrease in

stock-based compensation expense of $455,700;

in compensation expense of $261,900 due to a decrease in research and development employees and their related bonuses;

in other research expenses of $3,587,500 primarily associated with the ramp-up of the 302 and 304 studies in 2024;

in manufacturing and drug storage costs of $129,700;

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

● Increase in stock appreciation right expenses of $12,600.

General and Administrative Expense

General and administrative expense for the nine months ended September

30, 2024 was approximately $29,640,000 compared to $36,817,700 for the nine months ended September 30, 2023, a decrease of approximately

The decrease was due to:

Decrease in stock-based compensation of $10,003,100 which can be attributed to two key factors.

First, equity grants from four years ago have dropped off the amortization schedule, as they reached the end of their vesting period.

Second, the Company granted significantly fewer options this past year due to the lack of shareholder approval to increase the 2021 Equity Incentive Plan.

Without this approval, the company was unable to issue a substantial number of new stock options, further contributing to the reduction in stock-based compensation expenses for the current period.

These two factors combined have led to the notable decrease in these expenses;

● Increase in cash compensation expense of $2,034,700 related to the retention bonuses.

These bonuses were designed to help offset the absence

of equity-based compensation, ensuring that the company's leadership remained incentivized and aligned with the organization's long-term

in other general and administrative expenses of $790,700 primarily due to an increase in consulting services.

Other Income (Expense)

Interest / investment income was approximately $2,875,400 and $3,892,500

for the nine months ended September 30, 2024 and 2023, respectively.

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

Realized gain on short-term investments was approximately $334,100 and realized loss on short term investments was approximately $718,400

for the nine months ended September 30, 2024 and 2023, respectively.

Unrealized gain on short-term investments was approximately $283,800

and $72,300 for the nine months ended September 30, 2024 and 2023, respectively.

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

2024 and 2023 was approximately $61,322,200 and $73,626,600, respectively.

The Company had loss per share basic and diluted of $2.03 and

$2.45 for the nine months ended September 30, 2024 and 2023, respectively.

The Company did not provide for income taxes

for the nine months ended September 30, 2024 and 2023, since there was a loss and a full valuation allowance against all deferred tax

As shown in the accompanying unaudited condensed

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, 2024, the Company incurred a net loss of $61,322,218 and had negative operating cash flows

of $42,956,164.

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

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

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.

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.

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

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.

Because management’s

plans have not yet been finalized and are not within the Company’s control, the implementation of such plans cannot be considered

As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s

ability to continue as a going concern.

The following table sets forth selected cash flow information for

the periods indicated below:

September 30,

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 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

Cash used in operating activities

3 unchanged sentences

Cash provided by financing activities

Net (decrease) increase in cash and cash equivalents

Net decrease in cash and cash equivalents

$ (2,707,320 )

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.

There were realized and unrealized gains on short-term investments of $334,082 and $283,803, respectively.

there was a decrease in operating assets and liabilities of $4,474,073.

For the nine months ended September 30, 2023,

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

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.

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

For the three months ended March 31, 2024, cash

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

of $8,295,468.

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

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

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

For the nine months ended September 30, 2024, cash provided by investing

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 nine months ended September 30, 2023,

cash provided by investing activities was $42,712,186, due to $57,151,963 of purchases of short-term investments offset by $99,864,149

of sales of short-term investments.

For the 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 nine months ended September 30, 2024 was $132,146, due to proceeds from options exercised for common stock of $246,747 offset by ATM

fees of $114,601.

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

Net cash provided by financing activities for

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

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

Effects of Inflation

5 unchanged sentences

Commitments and Contingencies

Please refer to Note 7 in our Annual Report on

Form 10-K for the year ended December 31, 2023 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.

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.

Critical Accounting Policies and Estimates

5 unchanged sentences

GAAP, and all applicable U.S.

GAAP accounting standards effective as of September 30,

2024 have been taken into consideration in preparing the unaudited condensed consolidated financial statements.

The preparation of unaudited

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

assets, liabilities, and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial

statements and the reported amounts of revenues and expenses for the reporting period.

Management bases its estimates on historical experience

and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making

judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.

On a continual basis,

management reviews its estimates utilizing currently available information, changes in facts and circumstances, historical experience,

and reasonable assumptions.

After such reviews, and if deemed appropriate, management’s estimates are adjusted accordingly.

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.

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.

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