What changed in this filing

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Item 5. Market for Registrant’s Common Equity

2021-03-24 compared with 2019-09-24 · 258 added, 367 removed, 24 unchanged (96% of the section changed)

MARKET FOR REGISTRANT’S

COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Market Information

Our common stock is listed on OTCQB, under

the symbol “RLMD”.

The following table shows, for the years

ended June 30, 2019 and 2018, the high and low closing prices per share of our common stock as reported by the OTCQB quotation

These closing prices represent prices quoted by broker-dealers on the OTCQB quotation service.

The quotations reflect

inter-dealer prices, without retail mark-up, mark-down or commissions, and may not represent actual transactions.

For the Year Ended June 30, 2019

Three months ended June 30, 2019

Three months ended March 31, 2019

Three months ended December 31, 2018

Three months ended September 30, 2018

For the Year Ended June 30, 2018

Three months ended June 30, 2018

Three months ended March 31, 2018

Three months ended December 31, 2017

Three months ended September 30, 2017

Lack of a Public Market for Common Stock

There is no assurance that our shares will

continue to be traded on the bulletin board, or if traded, that a public market will materialize.

The SEC has adopted rules that regulate

broker-dealer practices in connection with transactions in penny stocks.

Penny stocks are generally equity securities with a price

of less than $5.00, other than securities registered on certain national securities exchanges or quoted on the NASDAQ system, provided

that current price and volume information with respect to transactions in such securities is provided by the exchange or system.

The penny stock rules require a broker-dealer, prior to a transaction in a penny stock, to deliver a standardized risk disclosure

document prepared by the SEC, that:

(a) contains a description of the nature and level of risk in the market for penny stocks in

both public offerings and secondary trading;(b) contains a description of the broker’s or dealer’s duties to the customer

and of the rights and remedies available to the customer with respect to a violation to such duties or other requirements of Securities’

the significance of the spread between the bid and ask price;(d) contains a toll-free telephone number for inquiries on disciplinary

actions;(e) defines significant terms in the disclosure document or in the conduct of trading in penny stocks;

and;(f) contains

such other information and is in such form, including language, type, size and format, as the SEC shall require by rule or regulation.

The broker-dealer also must provide, prior

to effecting any transaction in a penny stock, the customer with;

(a) bid and offer quotations for the penny stock;(b) the compensation

of the broker-dealer and its salesperson in the transaction;(c) the number of shares to which such bid and ask prices apply, or

other comparable information relating to the depth and liquidity of the market for such stock;

and (d) a monthly account statements

showing the market value of each penny stock held in the customer’s account.

In addition, the penny stock rules require

that prior to a transaction in a penny stock not otherwise exempt from those rules;

the broker-dealer must make a special written

determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written acknowledgment

of the receipt of a risk disclosure statement, a written agreement to transactions involving penny stocks, and a signed and dated

copy of a written suitability statement.

These disclosure requirements may have

the effect of reducing the trading activity in the secondary market for our stock if it becomes subject to these penny stock rules.

Therefore, because our common stock is subject to the penny stock rules, stockholders may have difficulty selling those securities.

As of June 30, 2019, 38,978,555 shares

of common stock were issued and outstanding, which were held by 331 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 Class A convertible

preferred stock outstanding.

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.

Our transfer agent is:

Empire Stock Transfer

Stock Transfer

Whitney Mesa Drive

Henderson, NV 89014

Telephone (702) 818-5898

(702) 818-5898

www.empirestock.com

Inquiries regarding stock transfers, lost

certificates or address changes should be directed to the above address.

Registration Rights

As required by the Unit Purchase Agreements,

the investors also became parties to Registration Rights Agreements dated as of October 12, 2018, October 18, 2018, November 2,

2018, December 5, 2018, and February 12, 2019 pursuant to which the Company was required to register with the Securities and Exchange

Commission such common shares and the shares of common stock underlying the warrants.

The Registration Statement was declared

effective by the SEC on March 1, 2019.

As required by the Unit Purchase Agreements,

the investors also became parties to Registration Rights Agreements dated as of May 14, 2019, June 14, 2019, June 20, 2019, and

June 28, 2019 pursuant to which the Company will be required to register with the Securities and Exchange Commission such common

shares and the shares of common stock underlying the warrants.

If the registration statement is not filed or declared effective

within the timeframe set forth in the Registration Rights Agreements, the Company is obligated to pay the investors an amount equal

to 1% of the total purchase price of the securities per month (up to a maximum of 6% in the aggregate) until such failure is cured.

Form S-1 registration statement was filed with the SEC on August 12, 2019, but has not been declared effective by the SEC.

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 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.

Securities Authorized for Issuance under

Equity Compensation Plans

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.

The Plan allows for the granting of common stock awards, stock appreciation rights, and incentive and nonqualified stock options

to purchase shares of the Company.

As of June 30, 2019, the Company has 4,668,153 awards available to be issued.

The following table summarizes our equity

compensation plan information as of June 30, 2019.

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:

Equity Compensation Plan Information

5 unchanged sentences

Equity compensation plans not approved by security holders

SELECTED FINANCIAL DATA

Smaller reporting companies are not required

to provide the information required by this item.

MANAGEMENT’S DISCUSSION

AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The information and financial data discussed

below is derived from the consolidated financial statements of Relmada for the year ended June 30, 2019 and for the year ended

June 30, 2018.

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.

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.

This discussion contains forward-looking

statements reflecting our current expectations that involve risks and uncertainties.

Actual 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

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.

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.

Our Corporate History and Background

Relmada Therapeutics is a clinical-stage,

publicly traded biotechnology company developing NCEs together with novel versions of proven drug products that potentially address

areas of high unmet medical need in the treatment of CNS diseases - primarily depression.

The Company has a diversified portfolio

of four products at various stages of development, including d-methadone (dextromethadone, REL-1017), a NMDA receptor antagonist

for treating depression and neuropathic pain;

LevoCap ER (REL-1015), an abuse resistant, sustained release dosage form of the opioid

analgesic levorphanol;

BuTab (oral buprenorphine, REL-1028), an oral dosage form of the opioid analgesic buprenorphine;

(topical mepivacaine, REL-1021), an orphan drug designated topical formulation of the local anesthetic mepivacaine.

Following a pipeline prioritization and

strategic review of our business, we emerged with clear priorities as a refocused research and clinical development company.

identified d-methadone as the most promising clinical program on which we will focus the majority of our development efforts going

We believe this refined strategy will drive Relmada’s long-term success.

As we continue the development of d-methadone,

we are seeking strategic partnerships with established healthcare companies to pursue further development, regulatory approval

and commercialization of our remaining pipeline programs.

We do not expect to manufacture finished products in-house, nor conduct

direct or indirect sales of products which may allow the Company to avoid significant capital investment in production facilities

and sales and marketing teams.

It is difficult to predict whether we will be able to enter into beneficial commercial partner relationships

with recognized healthcare companies.

Our lead product candidate, d-methadone,

is a NCE being developed as a rapidly acting, oral agent for the treatment of depression, neuropathic pain, and/or other potential

We have completed Phase 1 single and multiple ascending dose studies and have confirmed safety, tolerability, and dose

range for a planned Phase 2 study in TRD.

A Phase 2 study in major depressive disorder is ongoing, with first patient dosed in

June 2018 and last patient dosed in July 2019.

We expect to have top line results in the second half of 2019.

We have not generated revenues and do not

anticipate generating revenues for the foreseeable future.

We had net loss of approximately $17,318,100 and $8,961,000 for the

years ended June 30, 2019 and 2018, respectively.

At June 30, 2019, we have an accumulated deficit of approximately $111,662,400.

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;

For the year ended June 30, 2019 versus June 30, 2018

Research and Development Expense

Total research and development spending

for the year ended June 30, 2019 was approximately $7,024,800, as compared to $2,942,600 for the same period of 2018, an increase

of $4,082,200.

The increase in research and development expenses was primarily due to:

Increase in study costs of $4,334,200 associated

with the execution of our Phase 2a study;

Increase in manufacturing and drug storage costs

Increase in pre-clinical and toxicology expenses

Increase in stock based compensation expense

of research and development staff of $153,500.

Decrease in research

expenses of $913,700

General and Administrative Expense

Total general and administrative expenses

were approximately $5,703,200 for the year ended June 30, 2019, as compared to $3,974,900 for the prior year, an increase of $1,728,300.

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 legal and settlement expenses

from the resolution of the “Babul”

litigation of $1,249,900;

Increase in stock-based compensation of $542,400;

Increase in other G&A of $121,100

Decreased non-litigation professional fees of $185,100;

Change in Fair Value of Derivative Liabilities

The change in the fair value of derivative

liabilities was an unrealized loss of approximately $54,600 for the year ended June 30, 2019, as compared to the prior year unrealized

loss of $708,900.

For the year ended June 30, 2019, the Company

elected to early adopt ASU 2017-11 and reversed the derivative liability into equity effective July 1, 2018.

During the year ended

June 30, 2019, the Company had warrants resulting from equity offerings in May 2014 and June 2014 that do not have fixed settlement

provisions because their exercise prices may be lowered if the Company issues securities at lower prices in the future, the Company

concluded that the instruments are not indexed to the Company’s stock.

These warrants expired unexercised in the quarter

ended June 30, 2019.

For the year ended June 30, 2018, derivative

liabilities included warrants issued with the May 2014 and June 2014 offerings.

The derivative liability would decrease when warrants

were exercised, expire or when the anti-dilution feature was eliminated.

The anti-dilution feature will be eliminated when the

Company is up-listed to a National Exchange (NYSE or NASDAQ).

The derivative liabilities were affected by factors that are subject

to significant fluctuations and are not under the Company’s control.

Therefore, the resulting effect upon our net income

or loss was subject to significant fluctuations.

The accounting guidance applicable to these warrants required the Company (assuming

all other inputs to the pricing model remain constant) to record a non-cash loss when the Company’s stock price was rising

and to record non-cash income when the Company’s stock price was decreasing.

Interest Income and Expense, Net

Net interest expense for the year ended

June 30, 2019 was approximately $761,000 as compared to net interest expense of $1,336,800 for the year ended June 30, 2018.

difference primarily consisted of decreased interest expense resulting from the extinguishment of the two-year convertible promissory

notes on October 18, 2018.

March 10, 2016 and effective as of January 1, 2016, Relmada entered into an Office Space License Agreement (the License)

with Actinium Pharmaceuticals, Inc.

(Actinium), for office space located at 275 Madison Avenue, 7th Floor, New York, New York 10016.

The term of the License was for three years from the effective date, with an automatic renewal provision.

The cost of the License

is approximately $16,600 per month for Actinium, subject to customary escalations and adjustments.

The Company recorded the license

fees as other income in the consolidated statements of operations.

On June 6, 2017, the landlord and Relmada agreed to assign the

lease for all of the office space at 275 Madison Avenue to Actinium.

As of such date all rights, titles, and interest to the lease,

including related duties, liabilities, and obligations, were transferred from the Company to Actinium.

Pursuant to the assignment

of the lease, the Company derecognized its deferred rent liability and recorded gain on assignment of office lease.

On June 8, 2017, the Company entered into an Amended and Restated License Agreement with Actinium.

to the terms of the agreement, Actinium will continue to license the furniture, fixtures, equipment and tenant improvements located

in the office (FFE) for a license fee of $7,529 per month until December 8, 2022.

Actinium shall have at any time during the term

of this agreement the right to purchase the FFE for $496,909, less any previously paid license fees.

The license of FFE qualifies

as a sales-type lease.

At inception, the Company derecognized the underlying assets, recognized a discounted lease payments receivable

using the discount rate of 8.38% and recognized a loss on the lease of fixed assets.

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 years ended June 30, 2019 and 2018 since there were losses for both years and a full valuation allowance against

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.

Loss per Common Share

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

$17,318,100 and $8,960,900 or $0.69 and $0.71 per common share, basic and diluted, for the years ended June 30, 2019

and 2018, respectively, based on the factors described above.

As shown in the accompanying financial

statements, the Company incurred negative operating cash flows of $10,497,854 for the year ended June 30, 2019 and has an accumulated

deficit of $111,662,367 from inception through June 30, 2019.

During the year ended June 30, 2019, the Company incurred non-recurring

expenses of approximately $1,600,000 related to the settlement with Najib Babul (see Note 12) and related legal fees.

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 June 30, 2019 Relmada raised net proceeds from the sale of common stock

and warrants of $17,760,635.

Further, the Company was able to reduce its debt obligations by converting $8,030,365 of promissory

notes and accrued interest into common stock.

In Note 2 of the notes to the Company’s

audited consolidated financial statements as of and for the year ended June 30, 2018, and subsequently in each of the Company’s

quarterly unaudited condensed consolidated financial statements, management stated that the Company had incurred significant losses,

negative operating cash flows and as of those dates needed to raise additional funds to meet its obligations and sustain its operations.

As a result, the Company concluded that there was substantial doubt as to the Company’s ability to continue as a going concern.

Management believes that due to the following

it has obtained sufficient funding to alleviate the probability of substantial doubt about the Company’s ability to continue

as a going concern for the next twelve months from the issuance of these consolidated financial statements.

Of the above mentioned

financings of $17,760,635, the Company raised approximately $10,900,000 in the fourth quarter through private placements of common

stock and warrants, and subsequent to June 30, 2019, the Company raised approximately an additional $975,000 through private placements

of common stock and exercises of outstanding investor warrants, which resulted in the Company having approximately $7,735,000 in

cash and cash equivalents at September 23, 2019.

Based on its budgeted cash flow requirements, the Company believes these funds

are sufficient to fund its ongoing operations for at least one year after the issuance of these consolidated financial statements.

The Company expects that the cash burn rate for the 12 months ended September 30, 2020, will be between $5-6 million, which includes

approximately $2 million of discretionary research and development (“R&D”) spending, as the data analysis on the

Phase 2a clinical trial is completed and the planning and preparation for the next clinical trial is conducted.

Regardless of the

results of any ongoing clinical trial, we have control over our expenditures and have the ability to adjust spending accordingly

based on the budgeted cash flow requirements developed and the excess cash on hand.

The results of the Company’s ongoing clinical trial, when

known, will impact the size and scope of any subsequent trials, and 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 trials will not be incurred until such additional financing is raised.

additional financing related to subsequent trials does not affect the Company’s conclusion that based on the cash on hand

and the budgeted cash flow requirements, the Company has sufficient funds to maintain operations for the next twelve months from

the issuance of these consolidated financial statements.

Effects of Inflation

Our 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.

Contractual Obligations

The following tables sets forth our contractual

obligations for the next five years and thereafter:

Total obligations

The following tables sets forth selected

cash flow information for the periods indicated below:

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

1 unchanged sentence

$ (12,092,784 )

$ (6,413,775 )

$ (10,497,854 )

Cash used in investing activities

Cash raised in financing activities

Net increase in cash and cash equivalents

For the years ended June 30, 2019 and 2018,

cash used in operating activities was $10,497,854 and $6,002,078, respectively, primarily due to the net loss for each respective

period, of approximately $17,318,100 and $8,960,900, respectively.

This was offset by non-cash expenses which primarily consisted

of stock-based compensation of $1,213,996 and $517,999, the change in the fair value of derivative liabilities of $54,634 and

$708,901, loss on extinguishment of promissory note of $3,774,468 and $0 and amortization of deferred financing costs of $661,168

and $1,029,183, respectively, for the years ended June 30, 2019 and 2018.

There were changes in operating assets and liabilities

for the years ended June 30, 2019 and 2018 of approximately $1,140,500 and $700,100, respectively.

Off-Balance Sheet Arrangements

We 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.

We do not have a seasonal business cycle.

Critical Accounting Policies and Use

The 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 tax assets.

Research and Development

Research and development costs primarily

consist of research contracts for the advancement of product development, salaries and benefits, stock-based compensation, and

The Company expenses all research and development costs in the period incurred.

The Company makes an estimate of costs

in relation to clinical study contracts.

The Company analyzes the progress of studies, including the progress of clinical studies

and phases, invoices received and contracted costs when evaluating the adequacy of the amount expensed and any related prepaid

asset and accrued liability.

Stock-Based Compensation

The 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.

recognized over the period during which an employee is required to provide service in exchange for the award - the requisite service

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.

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.

The 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

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.

The effect 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 June 30, 2019 and 2018, 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.

All derivatives are recorded at fair value

on the balance sheet.

The Company has determined fair values using market based pricing models incorporating readily prices and

or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (supported

by little or no market activity) that requires judgment and estimates.

Recent Accounting Pronouncements

The Company lists material recent accounting

pronouncements in Note 2 of the consolidated financial statements.

(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