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Item 5. Market for Registrant’s Common Equity

2022-03-25 compared with 2021-03-24 · 34 added, 272 removed, 10 unchanged (97% of the section changed)

MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

common stock is listed on NASDAQ, under the symbol “RLMD”.

of December 31, 2020, 16,332,939 shares of common stock were issued and outstanding, which were held by 178 holders of record.

These stockholders held their stock either individually or in nominee or “street”

names through various brokerage

There are no shares of Class A convertible preferred stock outstanding.

MARKET FOR REGISTRANT’S COMMON

EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Market Information

Our common stock is listed on Nasdaq Global Select

Market, under the symbol “RLMD”.

As of March 21, 2022, 29,369,490 shares of common

stock were issued and outstanding, which were held by 154 holders of record.

These stockholders held their stock either individually or

in nominee or “street” names through various brokerage firms.

There are no shares of our Class A convertible preferred stock

Our transfer agent is:

Stock Transfer

Empire Stock Transfer

1859 Whitney Mesa Drive

(702) 818-5898

Henderson, NV 89014

Telephone (702) 818-5898

www.empirestock.com

regarding stock transfers, lost certificates or address changes should be directed to the above address.

plan to retain any earnings for the foreseeable future for our operations.

We have never paid any cash dividends on our stock

and do not anticipate paying any cash dividends in the foreseeable future.

Any future determination to pay cash dividends will

be at the discretion of our Board of Directors and will depend on our financial condition, operating results, capital requirements

and such other factors as our Board of Directors deems relevant.

Authorized for Issuance under Equity Compensation Plans

Relmada has a 2014 Option and Equity Incentive

Plan, as amended (the Plan) in which its directors, officers, employees and consultants shall be eligible to participate.

allows for the granting of common stock awards, stock appreciation rights, and incentive and nonqualified stock options to purchase

shares of the Company.

On March 6, 2020, at the annual shareholders meeting, our shareholders approved the increase in shares authorized

to be granted under the Plan by 2,500,000 shares.

With these grants and approvals, as of December 31, 2020, the Company had 1,247,205

awards available to be issued.

following table summarizes our equity compensation plan information as of December 31, 2020:

Inquiries regarding stock transfers, lost certificates

or address changes should be directed to the above address.

We plan to retain any earnings for the foreseeable

future for our operations.

We have never paid any cash dividends on our stock and do not anticipate paying any cash dividends in the foreseeable

Any future determination to pay cash dividends will be at the discretion of our Board of Directors and will depend on our financial

condition, operating results, capital requirements and such other factors as our Board of Directors deems relevant.

Securities Authorized for Issuance under Equity

Compensation Plans

Relmada has a 2014 Option and Equity Incentive Plan,

as amended (the Plan) in which its directors, officers, employees and consultants shall be eligible to participate.

The Plan allows for

the granting of common stock awards, stock appreciation rights, and incentive and nonqualified stock options to purchase shares of the

On May 20, 2021, at the annual shareholders meeting, our shareholders approved our 2021 Equity Incentive Plan (the 2021 Plan)

which allows for the granting of incentive and nonqualified stock options, stock appreciation rights, restricted stock awards, performance

share awards and other equity-based awards for up to 1,500,000 shares of our common stock to directors, officers, employees and consultants.

At the annual shareholders meeting (currently anticipated for mid-May, 2022), our shareholders will vote on a management proposal to increase

the shares authorized for awards under the 2021 Plan by 3,900,000 shares but there can be no assurance such amendment will be approved.

With these grants and approvals, as of December 31, 2021, the Company had 222,320 awards available to be issued.

The following table summarizes our equity compensation

plan information as of December 31, 2021:

Equity Compensation Plan Information

5 unchanged sentences

Equity compensation plans not approved by security holders

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

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

December 31, 2020, year ended December 31, 2019 (unaudited), six months ended December 31, 2019 and year ended June 30, 2019.

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

principles in the United States.

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

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

The consolidated financial

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

however, they

are not indicative of the Company’s future performance.

See “Cautionary Note Regarding Forward Looking Statements”

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

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

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

set forth in the section entitled “

Risk Factors ”

and elsewhere herein.

The information and financial data discussed

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

Therapeutics, Inc.

contained elsewhere in this document.

Relmada’s current consolidated financial position and consolidated

results of operations;

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

See “Cautionary Note Regarding

Forward Looking Statements”

above for a discussion of forward-looking statements and the significance of such statements

in the context of this document.

Corporate History and Background

Relmada Therapeutics is a late-stage, publicly

traded biotechnology company developing (New Chemical Entities) NCEs to address areas of high unmet medical need in the treatment

of CNS diseases - primarily depression.

The Company’s lead product Esmethadone, is an NCE being developed as a rapidly acting,

oral agent for the treatment of depression and other potential indications.

We have previously completed Phase 1 single and multiple

ascending dose studies and on October 15, 2019 we reported top-line data from study REL-1017-202, a double-blind, placebo-controlled

Phase 2 clinical trial evaluating the safety, tolerability and efficacy of two doses of REL-1017, 25 mg once a day and 50 mg once

a day, as an adjunctive treatment in patients with MDD.

7, the Company announced that the first patient had been enrolled

in the first Phase 3 clinical trial (RELIANCE I) of REL-1017, as an adjunctive treatment for major depressive disorder (MDD).

Key points of the REL-017 Phase 3 program

agreed upon in discussions with FDA include:

● The Phase 3 program will consist of two

sister, two-arm, placebo-controlled clinical trials.

Each trial will be conducted in 55 clinical sites in the United States and

will include approximately 400 MDD patients with inadequate response to standard antidepressants in their current depression episode.

Patients will add either a 25 mg oral dose of REL-1017 once per day or placebo to their ongoing antidepressant treatment.

● The primary endpoint to be evaluated will

be the change from baseline on the Montgomery and Asberg Depression Rating Scale (MADRS) score at day-28 for REL-1017 compared

Success on this endpoint with the collection of sufficient safety data would support the use of REL-1017 for chronic

treatment, if approved.

● The change from baseline and the 7-day

MADRS score will serve as a key secondary endpoint and will provide data on the rapid onset of treatment effect;

statistically

significant separation between REL-1017 and the control group was achieved by day 4 in the Phase 2 proof-of-principle trial completed

● The Company expects to initiate the second

Phase 3 trial, RELIANCE II, in the first half of 2021.

Patients who complete RELIANCE I and RELIANCE II will be eligible to rollover

into the long-term, open-label study, which is also expected to include subjects who had not previously participated in a REL-1017

clinical trial.

Company changed its fiscal year end to December 31 from June 30.

This transition report was for the six-month transition period

of July 1, 2019 through December 31, 2019.

The information for the year ended December 31, 2019 is presented for comparative

purposes only and is unaudited.

We have not generated revenues and do

not anticipate generating revenues for the foreseeable future.

We had a net loss of approximately $59,456,400, $15,005,200, $8,196,500,

and $17,318,100 for the years ended December 31, 2020, December 31, 2019 (unaudited), six months ended December 31, 2019, and

for the year ended June 30, 2019, respectively.

At December 31, 2020, we have an accumulated deficit of approximately $179,315,300.

of Operations

the Year Ended December 31, 2020 vs the Year Ended December 31, 2019 (unaudited)

and Development Expense

Total research and development expense for the year ended December

31, 2020 was approximately $35,972,700, as compared to $7,859,500 for the same period of 2019, an increase of $28,113,200.

increase in research and development expense was primarily due to:

Increase in study costs of $15,238,700 associated with the execution of our Phase 2 and Phase 3 studies;

Increase in manufacturing and drug storage costs of $989,700;

Increase in pre-clinical and toxicology expenses of $1,881,900;

Increase in compensation expense of $2,376,000 related to the hiring of six additional research and development employees and their related bonuses;

Increase in stock-based compensation expense of $3,677,600 of stock-based compensation expense related to the hiring of six additional research and development employees and the related options granted to them, as well as the separation agreement with Ottavio Vitolo of approximately $1,500,000;

Increase in other research expenses of $3,949,400 primarily associated to the additional consultants contracted with to assist in the execution of our Phase 3 studies.

and Administrative Expense

Total general and administrative expense

for the year ended December 31, 2020 was approximately $24,865,900, as compared to $7,249,900 for the same period of 2019, an

increase of $17,616,000.

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

Increase in compensation expense of $2,753,800 related to the hiring of four additional general and administrative employees and their related bonuses;

Increased in stock-based compensation expense of $13,934,400 primarily related to options granted to employees and the board of directors during 2020;

Increase in other G&A expenses of $927,800.

Income and Expense, Net

Interest income and realized and unrealized

gains and losses in investments was approximately $1,382,300 and $104,100 for the years ended December 31, 2020 and 2019, respectively.

The increase of $1,278,200 resulted from the increase in investments during 2020 compared to 2019.

The Company did not provide for income

taxes for the year ended December 31, 2020 and December 31, 2019, since there was a loss and a full valuation allowance against

all deferred tax assets.

The Company recorded a net loss of approximately $59,456,400

and $15,005,200 or $3.81 and $1.62 per common share, basic and diluted, during the years ended December 31, 2020 and 2019, respectively,

based on the factors described above.

As shown in the accompanying financial statements, the Company

incurred negative operating cash flows of $27,808,801 for the year ended December 31, 2020 and has an accumulated deficit of $179,315,303

from inception through December 31, 2020.

Relmada has funded its past operations

through equity raises and most recently in the year ended December 31, 2020, Relmada raised net proceeds from the sale of common

stock of $19,791,644 and $8,056,416 through the exercise of warrants, and $735,514 through the exercise of options.

Management believes that due to the recent equity raises completed

and exercises of outstanding warrants and the resulting cash position on its balance sheet, it has obtained sufficient funding

to continue ongoing operations for at least 12 months from the filing of this annual report.

Since December 31, 2020 and to date,

the Company has received approximately $1,909,200 in warrant and option exercises, which resulted in the Company having approximately

$105.3 million in cash, cash equivalents and short term investments at March 15, 2021.

Based on its budgeted cash flow requirements,

the Company believes these funds are sufficient to fund its ongoing operations for at least 12 months after the filing of this

annual report.

The Company expects that the cash burn rate for the 12 months ended December 31, 2021, will range between $75 and

$100 million.

following table sets forth selected cash flow information for the periods indicated below:

Six Months Ended

Cash used in operating activities

$ (27,808,801 )

$ (12,092,784 )

$ (6,413,775 )

$ (10,497,854 )

Cash used in investing activities

(34,447,648 )

(80,164,823 )

Cash provided by financing activities

Net increase/(decrease) in cash and cash equivalents

$ (33,783,122 )

For the year ended December 31, 2020, cash

used in operating activities was $27,808,801 primarily due to the net loss of $59,456,394.

This was offset by non-cash expenses

which primarily consisted of stock-based compensation of $20,777,272.

There were realized losses and unrealized gains on short

term investments of $156,213 and $139,267, respectively.

In addition, there were changes in operating assets and liabilities for

the year ended December 31, 2020 of $10,849,623.

For the unaudited year ended December 31, 2019, cash used in

operating activities was $12,092,784 primarily due to the net loss of $15,005,199.

This was offset by non-cash expenses which primarily

consisted of stock-based compensation and loss on fair value of shares relinquished of $3,165,153 and $394,410, respectively.

were changes in operating assets and liabilities for the year ended December 31, 2020 of $137,309.

For the six months ended December 31, 2019,

the transition period, cash used in operating activities was $6,413,775 primarily due to the net loss of $8,196,542.

This was offset

by non-cash expenses which primarily consisted of stock-based compensation of $2,367,001.

There were changes in operating assets

and liabilities for the six months ended December 31, 2019 of $586,434.

For the year ended June 30, 2019 cash used

in operating activities was $10,497,854 primarily due to the net loss of $17,318,060.

This was offset by non-cash expenses which

primarily consisted of stock-based compensation of $1,213,996, the change in the fair value of derivative liabilities of $54,634,

loss on fair value of shares relinquished of $394,410, loss on extinguishment of promissory note of $3,774,468 and amortization

of deferred financing costs of $661,168.

There were changes in operating assets and liabilities for the years ended June 30, 2019

of $1,505,480.

For the year ended December 31, 2020, cash

used in investing activities was $34,447,648, due to $182,051,630 of purchases of short term investments offset by $147,603,982

of sales of short term investments.

For the unaudited year ended December 31,

2019, cash used in investing activities was $80,164,823, due to $84,849,198 of purchases of short term investments offset by $4,684,375

of sales of short term investments.

For the six months ended December 31, 2019,

cash used in investing activities was $80,164,823, due to $84,849,198 of purchases of short term investments offset by $4,684,375

of sales of short term investments.

For the year ended June 30, 2019, no cash

was used in investing activities.

Net cash provided by financing activities for the six months

ended December 31, 2020, was $28,473,327 due to proceeds from issuance of common stock of $19,791,644, proceeds from warrants exercised

for common stock of $8,056,416, proceeds from options exercised for common stock of $735,514 partially offset by payments of notes

payable of $110,247.

Net cash provided by financing activities

for the unaudited year ended December 31, 2019, was $126,109,375 due to proceeds from issuance of common stock of $122,031,032,

proceeds from warrants exercised for common stock of $4,447,038 partially offset by payments of notes payable of $368,695.

Net cash provided by financing activities

for the six months ended December 31, 2019, was $113,640,563 due to proceeds from issuance of common stock of $109,447,482, proceeds

from warrants exercised for common stock of $4,447,038 partially offset by payments of notes payable of $253,957.

Net cash provided by financing activities

for the year ended June 30, 2019 was $17,475,465 due to proceeds from issuance of common stock of $17,760,635 partially offset

by payments of notes payable of $285,170.

assets are primarily monetary, consisting of cash and cash equivalents.

Because of their liquidity, these assets are not directly

affected by inflation.

Because we intend to retain and continue to use our equipment, we believe that the incremental inflation

related to replacement costs of such items will not materially affect our operations.

However, the rate of inflation affects our

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

at which we use our resources.

following tables sets forth our contractual obligations for the next five years and thereafter:

Total obligations

Sheet Arrangements

do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial

condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital

resources that is material to investors.

do not have a seasonal business cycle.

Accounting Policies and Use of Estimates

preparation of financial statements in conformity with accounting principles generally accepted in the United States of America

requires management to make estimates and assumptions that affect the reported amounts of assets and 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.

Actual results could differ from those estimates.

The significant estimates are incurred costs of clinical

studies, stock-based compensation expense, valuation of derivative financial liabilities, and income taxes and valuation of deferred

and Development

Research and development costs primarily consist of research contracts

for the advancement of product development, salaries and benefits, stock-based compensation, and consultants.

The Company expenses all

research and development costs in the period incurred.

Company measures the cost of employee services received in exchange for an award of equity instruments based on the grant-date

fair value of the award.

That cost is recognized over the period during which an employee is required to provide service in exchange

for the award - the requisite service period.

The grant-date fair value of employee share options is estimated using the Black-Scholes

option pricing model adjusted for the unique characteristics of those instruments.

Compensation expense for warrants granted to

non-employees is determined by the fair value of the consideration received or the fair value of the equity instruments issued,

whichever is more reliably measured, and is recognized over the service period.

The expense is subsequently adjusted to fair value

at the end of each reporting period until such warrants vest, and the fair value of such instruments, as adjusted, is expensed

over the related vesting period.

Adjustments to fair value at each reporting date may result in income or expense, depending upon

the estimate of fair value and the amount of expense recorded prior to the adjustment.

The Company reviews its agreements and

the future performance obligation with respect to the unvested warrants for its vendors or consultants.

When appropriate, the

Company will expense the unvested warrants at the time when management deems the service obligation for future services has ceased.

Company accounts for income taxes using the asset and liability method.

Accordingly, deferred tax assets and liabilities are recognized

for the future tax consequences attributable to differences between financial statement carrying amounts of existing assets and

liabilities and their respective tax bases.

Deferred tax assets and liabilities are measured using enacted tax rates expected

to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.

on deferred tax assets and liabilities of a change in the tax rate is recognized in income or expense in the period that the change

is effective.

Tax benefits are recognized when it is probable that the deduction will be sustained.

A valuation allowance is established

when it is more likely than not that all or a portion of a deferred tax asset will either expire before the Company is able to

realize the benefit, or that future deductibility is uncertain.

As of December 31, 2020 and 2019, and June 30, 2019, the Company

recorded a valuation allowance to the full extent of our net deferred tax assets since the likelihood of realization of the benefit

does not meet the more likely than not threshold.

Accounting Pronouncements

Company lists material recent accounting pronouncements in Note 2 of the consolidated financial statements.

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

What changed 10-K

Item 5. Market for Registrant’s Common Equity