What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2026-05-12 compared with 2025-11-13 · 253 added, 282 removed, 142 unchanged (79% of the section changed)

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FORWARD-LOOKING STATEMENT NOTICE

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

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

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

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

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

We have attempted to identify forward-looking

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

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

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

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

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

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

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

We have attempted to identify

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

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

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

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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

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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 was terminated effective July 7, 2025.

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

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

Effective May 12, 2025, this program was terminated.

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

intravesical formulation of gemcitabine and docetaxel.

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

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

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

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

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

Our second product, Sepranolone is a novel neurosteroid

epimer of allopregnanolone.

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

tremor and other diseases related to excessive GABAergic activity.

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

the first-half of 2026.

development candidates, while terminating 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 was terminated effective July 7, 2025.

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

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

Effective May 12, 2025, this program was

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

controlled-release intravesical formulation of gemcitabine and docetaxel.

NDV-01 is currently in a Phase 2 clinical trial in Israel to

assess its safety and efficacy in patients with aggressive forms of NMIBC.

We intend to develop NDV-01 for two separate indications:

the treatment of high-risk, 2nd line Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC and (2) the treatment of intermediate risk

patients in the adjuvant setting.

We expect to initiate Phase 3 programs for each indication mid-2026.

Our second product, sepranolone is a novel

neurosteroid epimer of allopregnanolone.

Sepranolone is being developed for the potential treatment of PWS, with additional

potential indications in TS, essential tremor and other diseases related to excessive GABAergic activity.

We expect to initiate a

Phase 2b study in PWS mid-2026.

Progress in Strategic Execution

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 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 with additional potential indications in TS, essential tremor and other diseases related to the excessive GABAergic

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

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These include:

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

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

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

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

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

NDV-01 United States Investigational New Drug (IND) filing with the U.S.

Food and Drug Administration (FDA) to initiate a clinical trial in NMIBC – Mid-2026

NDV-01 High-risk, 2nd line BCG-unresponsive NMIBC Phase 3 Trial Initiation - Mid-2026

NDV-01 Intermediate Risk in the Adjuvant Setting Phase 3 Trial Initiation – Mid-2026

Sepranolone - Initiation of a Phase 2 clinical trial in PWS – Mid-2026

NDV-01 Initial 3-Month Data from Phase 3 High-risk, 2nd line BCG-unresponsive NMIBC Trial – Year-end 2026

Our Development Programs

NDV-01 Program

NDV-01, our lead program, was in-licensed on

March 24, 2025, NDV-01, is a novel intravascular delivery technology designed for the long-acting, controlled release of gemcitabine

and docetaxel.

This combination therapy has gained significant interest as an alternative to BCG for treating NMIBC, especially

given the global BCG shortage since 2019 and for patients that do not respond adequately to BCG.

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 5 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, followed

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).

Twelve-Month Safety and Efficacy Data

We obtained twelve-month safety and efficacy data

for our Phase 2 study of NDV-01 in high-risk NMIBC.

Among 48 enrolled patients who received at least one dose, no new safety signals were

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

No patients experienced Grade ≥3 treatment-related adverse

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

Of the 48 patients, 30 (63%) experienced a treatment-related adverse

Among treatment-related adverse events, 54% were transient uncomfortable urination (dysuria), 8% were asymptomatic positive urine

culture and 8% were hematuria.

Efficacy and Tolerability

Efficacy Evaluable Patients (Complete Response (CR))

12 month KM analysis

N= 48 patients in overall population;

Kaplan-Meier analysis;

patients awaiting 3 month response assessment

BCG-UR Subpopulation* CR

12 month KM analysis

N= 20 patients dosed in BCG-UR subpopulation;

* BCG-UR defined by FDA definition;

Bacillus Calmette-Guérin (BCG)- Unresponsive;

Kaplan-Meier analysis;

awaiting 3 month assessment

No patient had progression to muscle-invasive disease

No patient underwent radical cystectomy

The Company also previously announced the successful

completion and receipt of written feedback from a Type B pre-IND submissions with the U.S.

Food and Drug Administration (FDA) regarding

the planned Phase 3 program for NDV-01 in NMIBC patients.

Relmada secured FDA alignment on certain key elements of the planned Phase 3

pivotal program for NDV-01, expected to begin in mid-2026, and incorporating two studies for two separate indications:

A single-arm, open-label clinical trial in this high-grade, BCG-unresponsive with Carcinoma in situ (CIS) population

A single registrational study in intermediate risk NMIBC in the adjuvant setting, which will follow an open-label, randomized-to-observation design

Also, importantly, the

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

non-clinical safety assessment of NDV-01 because this is a proposed 505(b)(2) approval.

About the Planned High-Grade Registrational

The planned pivotal Phase

3 study in 2nd-line, refractory, high-grade BCG-unresponsive NMIBC with CIS will be an open-label, single-arm trial evaluating:

Primary endpoint:

CR rate at any time

Key secondary endpoint:

Cystoscopy, cytology, and biopsy per protocol

The design reflects FDA’s

written guidance on the study population, endpoint selection, and evaluation methodology and is consistent with prior FDA precedents for

single-arm registrational trials in NMIBC.

About the Planned

Intermediate-Risk Registrational Study

The planned pivotal Phase

3 study in intermediate-risk NMIBC in the adjuvant setting will be an open label randomized-to-observation study:

Primary endpoint:

Disease Free Survival (DFS)

Key secondary endpoint:

Cystoscopy, cytology, and biopsy per protocol

The design reflects FDA’s written guidance on the study population,

endpoint selection, and evaluation methodology.

Sepranolone Program

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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.

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

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

35% greater clinical improvement and ~75% fewer patients worsening on the Tourette Syndrome-Clinical Global Impression (TS-CGI) scale

Importantly, no off-target CNS effects or systemic

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

over 335 participants and has demonstrated a favorable safety profile.

Relmada expects to initiate a Phase II pilot study of Sepranolone

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

NDV-01 Program

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

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

This combination

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

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

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

tumor exposure time.

NDV-01 potentially addresses these limitations

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).

Nine-Month Safety and Efficacy Data

We obtained nine-month safety and efficacy data

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

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

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

No patients experienced Grade ≥3 treatment-related

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

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

adverse event.

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

urine culture and 7% were hematuria.

The below table summarizes the efficacy data from the study.

Complete Response (CR)

Includes patients with CR after re-induction.

60% CR rate after re-induction.

Two patients have reached the 12-month assessment,

and both have a CR.

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

are awaiting the three-month response assessment.

The Company also recently announced the successful completion and receipt

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

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

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

Relmada secured FDA alignment on certain key elements of the planned

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

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

● Intermediate risk NMIBC in the adjuvant setting

Following are the key outcomes from the FDA

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

FDA Feedback on proposed NDV-01 Phase III

The FDA indicated that

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

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

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

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

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

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

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

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

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

We have protocols in active development for both the

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

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

We intend to develop NDV-01 for the treatment

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

We expect to initiate

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

over 335 participants.

Sepranolone was well tolerated with no serious

treatment emergent adverse events reported.

The most common adverse events were of mild or moderate intensity related to injection sites,

with pain, erythema and pruritus being the most common.

Relmada expects to initiate a Phase 2 pilot study

of sepranolone in PWS in mid-2026.

Our Corporate History and Background

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

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

disorders, and other diseases.

We are a clinical-stage, publicly traded biotechnology

company developing new chemical entities (NCE) and novel versions of drug products that potentially address areas of high unmet medical

need in the treatment of cancer, neurological disorders, and other diseases.

Currently, none of our product candidates has

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for the foreseeable future.

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

We had a net loss of approximately $19,052,000 for the three months ended March 31, 2026.

At March 31, 2026,

we had an accumulated deficit of approximately $717,319,200.

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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.

TS, obsessive-compulsive disorder, and gambling disorder, potentially providing coverage beyond 2038.

We have more than 10 issued patents and pending

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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:

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

In April 2026, the Company filed a provisional patent application with

the United States Patent and Trademark Office directed to pharmaceutical formulations and methods of treatment related to NDV-01.

provisional filing has the potential to form the basis for broad world-wide patent filings for the NDV-01 program.

If issued, patents

claiming priority to the provisional filing will be expected to have a term until April 2047.

Available Information

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Results of Operations

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

September 30,

For the Three Months Ended March 31, 2026 versus March 31, 2025

Operating Expenses

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General and administrative

$ (12,681,492 )

Research and Development Expense

Research and development expense for the three months ended September

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

Research and development expense for the three months ended March 31,

2026 was approximately $8,087,800 compared to $11,951,000 for the three months ended March 31, 2025, a decrease of approximately $3,863,200.

The change was primarily driven by:

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

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

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

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

of the REL-1017 studies;

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

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

research and development employees and their related bonus.

in study costs of $6,489,500 along with the acquisition of sepranolone of approximately $2.9 million and the license agreement of

NDV-01 for approximately $3.5 million in 2025;

in other research expenses of $712,600 primarily associated with the winding down of the REL-1017 302 and 304 studies in 2025;

in stock-based compensation expense of $30,700;

Increase in manufacturing and drug storage costs of $2,628,600 related to materials purchased to support the start of NDV-01 and sepranolone studies;

in compensation expense of $741,000 due to an increase in research and development employees and their related bonus.

General and Administrative Expense

General and administrative expense for the three months ended September

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

General and administrative expense for the three

months ended March 31, 2026 was approximately $11,373,900 compared to $6,267,400 for the three months ended March 31, 2025, an increase

of approximately $5,106,500.

The change was primarily due to:

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

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

general and administrative employees and their related bonuses;

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

due to an decrease in consulting services.

Interest/investment income was approximately $247,000

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

The decrease was due to lower average investment balance.

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

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

Unrealized gain on short-term

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

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

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

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

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

The Company did not provide for income taxes

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

Results of Operations

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

September 30,

Operating Expenses

Research and development

$ (16,368,864 )

General and administrative

$ (26,048,394 )

Research and Development Expense

Research and development expense for the nine months ended September

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

The decrease was primarily due to:

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

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

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

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

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

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

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

research and development employees and their related bonuses.

General and Administrative Expense

General and administrative expense for the nine months ended September

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

The decrease was primarily due to:

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

to option grants to employees and key consultants;

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

primarily due to a decrease in consulting services;

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

of general and administrative employees and their related bonuses.

in compensation expense of $5,339,500 due to an increase of general and administrative employees and their related bonuses;

in other general and administrative expenses of $583,500 primarily due to an increase in consulting services;

in stock-based compensation expense of $816,500.

Interest/investment income was approximately $959,800

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

The decrease was due to lower interest

rates and investment yields and a lower average balance.

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

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

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

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

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

and $440,300 for the three months ended March 31, 2026 and 2025, respectively.

The increase was due to higher average investment balance.

Realized loss on short-term investments was approximately $9,900 and realized gain on short-term investments was approximately $63,000

for the three months ended March 31, 2026 and 2025, respectively.

Unrealized loss on short-term investments and unrealized gain on short-term

investments for the three months ended March 31, 2026 and 2025 was approximately $540,100 and $155,700, respectively.

The Company did not provide for income taxes for

the three months ended March 31, 2026 and 2025, 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, 2026

and 2025 was approximately $19,052,000 and $17,559,500 respectively.

The Company had loss per share, basic and diluted of $0.22 and $0.58

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

The Company did not provide for income taxes for

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

As shown in the accompanying unaudited consolidated financial statements,

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

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

During the nine months ended September

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

At September 30, 2025,

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

for the three months ended March 31, 2026 and 2025, 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, 2026, the Company incurred a net loss of $19,051,956 and had negative operating cash flows of $15,067,488.

On November 5, 2025, the Company announced the

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

The net proceeds to Relmada from the offering,

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

The net proceeds to the Company from the

offering, after deducting other expenses payable by the Company, and excluding the exercise of any pre-funded warrants, were approximately

On March 9, 2026, the Company entered into a Securities

Purchase Agreement for a private placement with certain institutional and accredited investors (collectively, the Purchasers).

The Purchasers

purchased 29,474,569 shares of the Company’s common stock, par value $0.001 per share and pre-funded warrants up to 4,210,527 shares

of common stock.

The closing of the Private Placement occurred on March 11, 2026.

The shares of common stock were sold at an offering

price of $4.75 per share, and the pre-funded warrants were sold at an offering price of $4.749 per pre-funded warrant, which represents

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

The net proceeds

from the Purchase Agreement, after deducting fees payable by the Company, and excluding the exercise of any pre-funded warrants, were

approximately $150 million.

As of the date of this report, Management believes

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

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

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

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

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

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

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

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

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

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

issuance of these unaudited condensed consolidated financial statements.

the Company concluded the Company has sufficient funds to maintain operations for at least 12 months from the issuance of these unaudited

condensed consolidated financial statements.

The following table sets forth selected cash flow information for the

periods indicated below:

Nine Months Ended

September 30,

Nine Months Ended

September 30,

Cash used in operating activities

1 unchanged sentence

$ (18,067,033 )

Cash provided by investing activities

Cash (used in)/provided by financing activities

Net decrease in cash and cash equivalents

Cash (used in)/provided by investing activities

(135,226,997 )

For the nine months ended September 30, 2025,

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

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

There were realized gains and unrealized gains

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

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

of $5,183,077.

For the nine months ended September 30, 2024,

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

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

There were realized and unrealized gains on short-term

Cash provided by financing activities

Net increase/(decrease) in cash and cash equivalents

$ (2,707,320 )

For the three months ended March 31, 2026, cash

used in operating activities was $15,067,488 primarily due to the net loss of $19,051,956 offset by non-cash stock-based compensation

charges of $956,186 and stock appreciation rights compensation of $2,677,652.

There were realized and unrealized losses on short-term

investments of $9,867 and $540,097, respectively.

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

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

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

For the nine months ended September 30, 2024,

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

of sales of short-term investments.

Net cash used by financing activities for the

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

Net cash provided by financing activities for the nine months ended

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

In addition, there was an increase in operating assets and liabilities of $199,334.

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 $3,572,769 and stock appreciation rights compensation of $3,038.

There were realized 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 $4,769,918.

For the three months ended March 31, 2026, cash

used in investing activities was $135,226,997 due to $149,517,480 of purchases of short-term investments offset by $14,290,483 of sales

of short-term investments.

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, 2026, net

cash from financing activities totaled $156,574,345 due to proceeds from the issuance of common stock for $159,999,996 offset by fees

for issuance of common stock of $3,360,000 and ATM fees of $65,651.

Net cash provided by financing activities for

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

Effects of Inflation

18 unchanged sentences

GAAP, and all applicable U.S.

GAAP accounting standards effective as of September 30,

2025 have been taken into consideration in preparing the unaudited condensed consolidated financial statements.

The preparation of unaudited

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

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

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

Management bases its estimates on historical experience

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

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

On a continual basis, management

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

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

Actual results could

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

Management considers an accounting estimate to

be critical if:

GAAP accounting standards effective as of March 31, 2026

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.

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