Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
Relmada
Therapeutics, Inc.
Condensed
Consolidated Balance Sheets
As of
As of
June 30,
2021
(unaudited)
December 31,
2020
Assets
Current assets:
Cash and cash equivalents
$ 4,669,345
$ 2,495,397
Short-term investments
104,399,140
114,595,525
Lease payments receivable – short term
82,845
79,457
Prepaid expenses
1,548,880
903,190
Total current assets
110,700,210
118,073,569
Fixed assets, net of accumulated depreciation
-
1,258
Other assets
25,000
25,000
Lease payments receivable – long term
44,090
86,377
Total assets
$ 110,769,300
$ 118,186,204
Commitments and Contingencies (See Note 8)
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 10,455,922
$ 8,346,475
Accrued expenses
3,460,821
4,256,983
Total current liabilities
13,916,743
12,603,458
Stockholders’ Equity:
Preferred stock, $ 0.001 par value, 200,000,000 shares authorized, none issued and outstanding
-
-
Class A convertible preferred stock, $ 0.001 par value, 3,500,000 shares authorized, none issued and outstanding
-
-
Common stock, $ 0.001 par value, 50,000,000 shares authorized, 17,468,819 and 16,332,939 shares issued and outstanding, respectively
17,469
16,333
Additional paid-in capital
324,917,516
284,881,716
Accumulated deficit
( 228,082,428 )
( 179,315,303 )
Total stockholders’ equity
96,852,557
105,582,746
Total liabilities and stockholders’ equity
$ 110,769,300
$ 118,186,204
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
Relmada
Therapeutics, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
Three months ended
Six months ended
June 30,
June 30,
2021
2020
2021
2020
Operating expenses:
Research and development
$ 17,331,507
$ 5,323,953
$ 31,353,734
$ 9,831,737
General and administrative
9,130,373
7,433,249
17,513,349
12,899,903
Total operating expenses
26,461,880
12,757,202
48,867,083
22,731,640
Loss from operations
( 26,461,880 )
( 12,757,202 )
( 48,867,083 )
( 22,731,640 )
Other (expenses) income:
Interest/investment income, net
322,807
404,004
742,781
811,657
Realized (loss) gain on short-term investments
( 123,590 )
12,810
( 176,379 )
( 158,801 )
Unrealized (loss) gain on short-term investments
( 289,281 )
1,221,947
( 466,444 )
287,027
Total other (expenses) income
( 90,064 )
1,638,761
99,958
939,883
Net loss
$ ( 26,551,944 )
$ ( 11,118,441 )
$ ( 48,767,125 )
$ ( 21,791,757 )
Loss per common share – basic and diluted
$ ( 1.56 )
$ ( 0.73 )
$ ( 2.90 )
$ ( 1.45 )
Weighted average number of common shares outstanding – basic and diluted
17,054,646
15,323,051
16,814,991
15,030,641
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
Relmada
Therapeutics, Inc.
Condensed
Consolidated Statements of Stockholders’ Equity
(Unaudited)
Six months ended June 30, 2021
Common Stock
Additional
Paid-in
Accumulated
Shares
Par Value
Capital
Deficit
Total
Balance - December 31, 2020
16,332,939
$ 16,333
$ 284,881,716
$ ( 179,315,303 )
$ 105,582,746
Stock based compensation
5,851,284
-
5,851,284
Warrant exercised for cash
273,491
273
1,460,233
-
1,460,506
Options exercised for cash
141,625
142
467,631
-
467,773
Net loss
-
-
-
( 22,215,181 )
( 22,215,181 )
Balance - March 31, 2021
16,748,055
16,748
292,660,864
( 201,530,484 )
91,147,128
Stock based compensation
-
-
8,268,376
-
8,268,376
Warrant exercised for cash
62,059
62
481,387
-
481,449
Options exercised for cash
7,031
7
49,491
-
49,498
ATM offering, net of offering costs
651,674
652
23,457,398
23,458,050
Net loss
-
-
-
( 26,551,944 )
( 26,551,944 )
Balance - June 30, 2021
17,468,819
$ 17,469
$ 324,917,516
$ ( 228,082,428 )
$ 96,852,557
Six months ended June 30, 2020
Common Stock
Additional
Paid-in
Accumulated
Shares
Par Value
Capital
Deficit
Total
Balance - December 31, 2019
14,457,013
$ 14,457
$ 235,522,746
$ ( 119,858,909 )
$ 115,678,294
Stock based compensation
5,039,362
-
5,039,362
Warrant exercised for cash
447,107
447
3,041,726
-
3,042,173
Cashless warrant exercise
34,114
34
( 34 )
-
-
Options exercised
2,434
3
73,017
-
73,020
Net loss
-
-
-
( 10,673,316 )
( 10,673,316 )
Balance - March 31, 2020
14,940,668
14,941
243,676,817
( 130,532,225 )
113,159,533
Stock based compensation
7,302,513
-
7,302,513
Warrant exercised for cash
368,364
368
2,576,735
-
2,577,103
Cashless warrant exercise
1,840
2
( 2 )
-
-
Options exercised
113,281
113
457,510
-
457,623
ATM offering, net of offering costs
427,700
428
19,854,590
19,855,018
Net loss
-
-
-
( 11,118,441 )
( 11,118,441 )
Balance - June 30, 2020
15,851,853
$ 15,852
$ 273,868,163
$ ( 141,650,666 )
$ 132,233,349
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
Relmada
Therapeutics, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
Six months ended
June 30,
2021
2020
Cash flows from operating activities
Net loss
$ ( 48,767,125 )
$ ( 21,791,757 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
1,258
2,075
Stock-based compensation
14,119,660
12,341,875
Realized loss on short-term investments
176,379
158,801
Unrealized loss (gain) on short-term investments
466,444
( 287,027 )
Change in operating assets and liabilities:
Lease payment receivable
38,899
35,782
Prepaid expenses
( 645,690 )
183,329
Accounts payable
2,109,447
442,506
Accrued expenses
( 796,162 )
535,997
Net cash used in operating activities
( 33,296,890 )
( 8,378,419 )
Cash flows from investing activities
Purchase of short-term investments
( 56,872,459 )
( 62,364,176 )
Sale of short-term investments
66,426,021
22,393,644
Net cash provided by (used) in investing activities
9,553,562
( 39,970,532 )
Cash flows from financing activities
Principal payments of notes payable
-
( 110,247 )
Proceeds from issuance of common stock
23,458,050
19,855,018
Proceeds from options exercised for common stock
517,271
530,643
Proceeds from warrants exercised for common stock
1,941,955
5,619,276
Net cash provided by financing activities
25,917,276
25,894,690
Net increase/(decrease) in cash and cash equivalents
2,173,948
( 22,454,261 )
Cash and cash equivalents at beginning of the period
2,495,397
36,278,519
Cash and cash equivalents at end of the period
$ 4,669,345
$ 13,824,258
Supplemental disclosure of cash flow information:
Cash paid during the period for:
Interest
$ -
$ 954
Non-cash investing and financing activities:
Cashless exercise of warrants for common stock
$ -
$ 36
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
Relmada
Therapeutics, Inc.
Notes
to Unaudited Condensed Consolidated Financial Statements
NOTE
1 - BUSINESS
Relmada
Therapeutics, Inc. (Relmada or the Company) (a Nevada corporation), is a clinical-stage, publicly traded biotechnology company focused
on the development of esmethadone (d-methadone, dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist. Esmethadone
is a New Chemical Entity (NCE) that potentially addresses areas of high unmet medical need in the treatment of central nervous system
(CNS) diseases and other disorders.
In
addition to the normal risks associated with a new business venture, there can be no assurance that the Company’s research and
development will be successfully completed or that any product will be approved or commercially viable. The Company is subject to risks
common to companies in the biotechnology industry including, but not limited to, dependence on collaborative arrangements, development
by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology,
and compliance with the Food and Drug Administration (FDA) and other governmental regulations and approval requirements.
NOTE
2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The accompanying unaudited condensed consolidated financial statements
and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S.
GAAP) for interim unaudited condensed consolidated financial information. Accordingly, they do not include all of the information and
footnotes required by U.S. GAAP for complete consolidated financial statements. The unaudited condensed consolidated financial statements
reflect all adjustments (consisting of normal recurring adjustments) which are, in the opinion of management, necessary for a fair statement
of the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. These
unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements
of the Company for the year ended December 31, 2020 and notes thereto contained in the Company’s Annual Report on Form 10-K.
Liquidity
As shown in the accompanying financial statements,
the Company incurred negative operating cash flows of $ 33,296,890 for the six months ended June 30, 2021 and has an accumulated deficit
of $ 228,082,428 from inception through June 30, 2021. At June 30, 2021, the Company had cash and short term investments of $ 109,068,485 .
Relmada has funded its past operations through
equity raises and most recently in 2021 raised net proceeds from the sale of common stock of $ 23,458,050 through our ATM offering and
$ 1,941,955 through the exercise of warrants. The Company also raised an additional $517,271 during the six months ended June 30, 2021
from the exercises of options.
Management believes that the Company’s existing cash and cash
equivalents 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 agreements. Any such expenditures related to any subsequent
trials will not be incurred until such additional financing is raised. Further, 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 at least 12 months from the issuance of these consolidated financial statements.
5
Relmada
Therapeutics, Inc.
Notes
to Unaudited Condensed Consolidated Financial Statements
NOTE
2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
Principles
of Consolidation
The
unaudited condensed consolidated financial statements include the Company’s accounts and those of the Company’s wholly-owned
subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation.
Risks
and Uncertainties
The
ongoing pandemic may adversely affect our business. Based on the Company’s current assessment, the Company does not expect any
material impact on its long-term development timeline and its liquidity due to the worldwide spread of the coronavirus (COVID-19) virus.
However, the Company is actively monitoring this situation and the possible effects on its financial condition, liquidity, operations,
suppliers, industry, and workforce.
Use
of Estimates
The
preparation of financial statements in conformity with U.S. GAAP 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 the valuation of stock-based compensation expenses and recorded amounts related to income taxes.
Cash
and Cash Equivalents
The
Company considers cash deposits and all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.
The Company’s cash deposits are held at two high-credit-quality financial institutions. The Company’s cash deposits at these
institutions exceed federally insured limits.
Short-term
Investments
The
Company’s investments consist entirely of mutual funds. The securities are measured at fair value based on the net asset value
(NAV). The Company has adopted Financial Accounting Standards Board (FASB) Accounting Standard Update (ASU) 2016-01, Financial Instruments
which requires substantially all equity investments in nonconsolidated entities to be measured at fair value with recurring changes
recognized in earnings, except for those accounted for using equity method accounting. Changes in fair value of the securities are recorded
as part of other income on the consolidated statement of operations. Short term investment activity is presented in the investing activities
section on the consolidated statement of cash flows.
Patents
Costs
related to filing and pursuing patent applications are recorded as general and administrative expense and expensed as incurred since
recoverability of such expenditures is uncertain.
Fixed
Assets
Fixed
assets are stated at cost less accumulated depreciation. Fixed assets are comprised of computers and software. Depreciation is calculated
using the straight-line method over the estimated useful life of the assets. Computers and software have an estimated useful life of
three years .
6
Relmada
Therapeutics, Inc.
Notes
to Unaudited Condensed Consolidated Financial Statements
NOTE
2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
Leases
The
Company recognizes its leases with a term of greater than a year on the balance sheet by recording right-of-use assets and lease liabilities.
Leases can be classified as either operating leases or finance leases. Operating leases will result in straight-line lease expense, while
finance leases will result in front-loaded expense. The Company’s lease consists of an operating leases for office space. The Company
does not recognize a lease liability or right-of-use asset on the balance sheet for short-term leases. Instead, the Company recognizes
short-term lease payments as an expense on a straight-line basis over the lease term. A short-term lease is defined as a lease that,
at the commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that
the lessee is reasonably certain to exercise.
Fair
Value of Financial Instruments
The
Company’s financial instruments primarily include cash, short term investments, and accounts payable. Due to the short-term nature
of cash and accounts payable the carrying amounts of these assets and liabilities approximate their fair value.
Fair
value is defined as the price that would be received to sell an asset, or paid to transfer a liability (an exit price), in an orderly
transaction between market participants at the reporting date. A fair value hierarchy has been established for valuation inputs that
gives the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable
inputs. The fair value hierarchy is as follows:
Level
1 Inputs - Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to
access at the measurement date.
Level
2 Inputs - Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly.
These might include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets
or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (such as
interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market
data by correlation or other means.
Level
3 Inputs - Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable
(supported by little or no market activity).
The Company’s short-term investment instruments
of $ 104,399,140 at June 30, 2021 consist of mutual funds, bank deposits and money market funds and are classified using Level 1 inputs
within the fair value hierarchy because the value is based on quoted prices in active markets. Unrealized gains and losses are recorded
in the condensed consolidated statement of operations under other income. The Company recorded an unrealized loss of $ 289,281 and $ 466,444
included in other income for the three and six months ended June 30, 2021, respectively. The Company recorded an unrealized gain of $ 1,221,947
and $ 287,027 included in other income for the three and six months ended June 30, 2020, respectively.
Income
Taxes
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 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. 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, 2021 and December 31, 2020, the Company had recognized a valuation allowance to the full extent
of the Company’s net deferred tax assets since the likelihood of realization of the benefit does not meet the more likely than
not threshold.
7
Relmada
Therapeutics, Inc.
Notes
to Unaudited Condensed Consolidated Financial Statements
NOTE
2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
The
Company files a U.S. Federal income tax return and various state returns. Uncertain tax positions taken on the Company’s tax returns
will be accounted for as liabilities for unrecognized tax benefits. The Company will recognize interest and penalties, if any, related
to unrecognized tax benefits in general and administrative expenses in the statements of operations. There were no liabilities recorded
for uncertain tax positions at June 30, 2021 and December 31, 2020. The open tax years, subject to potential examination by the applicable
taxing authority, for the Company are from June 30, 2018 forward.
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 consultants. 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 the 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. 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.
Net
Loss per Common Share
Basic net loss per common share attributable
to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common
shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per common share attributable
to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common
share equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised
of Class A convertible preferred stock, Series A preferred stock, restricted stock awards, options and warrants to purchase common stock.
For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due
to the Company’s net loss position.
For
the six months ended June 30, 2021 and 2020, the potentially dilutive securities that would be anti-dilutive due to the Company’s
net loss are not included in the calculation of diluted net loss per share attributable to common stockholders. The anti-dilutive securities
are as follows (in common stock equivalent shares):
Six months ended
June 30,
2021
June 30,
2020
Stock options
5,158,956
4,134,575
Common stock warrants
2,755,083
2,905,369
Total
7,914,039
7,039,944
8
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
Recent Accounting Pronouncements
In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic
740): Simplifying the Accounting for Income Taxes , which is intended to simplify various aspects related to accounting for income
taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to
improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning
after December 15, 2020. The Company adopted this standard effective January 1, 2021 and the standard did not have a significant impact
on our condensed consolidated financial statements.
In May 2021, the FASB issued ASU No. 2021-04, Earnings
Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718),
and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) . ASU 2021-04 outlines how an entity should
account for modifications made to equity-classified written call options, including stock options and warrants to purchase the entity’s
own common stock. The guidance in the ASU requires an entity to treat a modification of an equity-classified written call options that
does not cause the option to become liability-classified as an exchange of the original option for a new option. This guidance applies
whether the modification is structured as an amendment to the terms and conditions of the equity-classified written call option or as
termination of the original option and issuance of a new option. The guidance is effective prospectively for fiscal years beginning after
December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, including in an interim period as
of the beginning of the fiscal year that includes that interim period. The Company is currently in the process of evaluating the impact
of this new guidance on the condensed consolidated financial statements and the related disclosures.
Subsequent Events
The Company’s management reviewed all material
events through the date the financial statements were issued for subsequent event disclosure consideration.
NOTE 3 - PREPAID EXPENSES
Prepaid expenses consisted of the following (rounded to nearest $00):
June 30,
2021
December 31,
2020
Insurance
$ 1,325,400
$ 527,600
Research and Development
135,600
291,800
Legal
11,000
11,000
Other
76,900
72,800
Total
$ 1,548,900
$ 903,200
NOTE 4 - FIXED ASSETS
Fixed assets, net of accumulated depreciation, consisted of the following
(rounded to nearest $00):
Useful lives
June 30,
2021
December 31,
2020
Computer and Software
3 years
$ 16,700
$ 16,700
Less: accumulated depreciation
( 16,700 )
( 15,400 )
Fixed Assets
$ -
$ 1,300
For the six months ended June 30, 2021 and 2020,
the Company recognized depreciation expense of approximately $ 1,300 and $ 2,100 , respectively.
NOTE 5 - ACCRUED EXPENSES
Accrued expenses consisted of the following (rounded to nearest $00):
June 30,
2021
December 31,
2020
Research and development
$ 2,181,000
$ 2,183,800
Professional fees
138,800
150,900
Accrued bonus
650,200
1,444,900
Accrued vacation
414,400
351,200
Other
76,400
126,200
Total
$ 3,460,800
$ 4,257,000
9
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 6 - STOCKHOLDERS’ EQUITY
Common Stock
During the six months ended June 30, 2021, the
Company issued 335,550 shares of common stock, for cash exercises of warrants for proceeds of $ 1,941,955 .
During the six months ended June 30, 2021, the
Company also issued 148,656 shares of common stock for cash exercises of options for proceeds of $ 517,271 .
On May 15, 2020, the Company entered into an
Open Market Sale Agreement with Jefferies LLC, as sales agent (“Jefferies”), pursuant to which the Company may offer
and sell, from time to time, through Jefferies, shares of the Company’s common stock, having an aggregate offering price of up
to $ 75,000,000 . The Company is not obligated to sell any shares under the agreement. During the six months ended June 30, 2021, the Company
issued 651,674 shares of common stock for net cash proceeds of approximately $ 23,500,000 under the agreement. During the six months ended
June 30, 2020 the Company issued 427,700 shares of common stock for net cash proceeds of approximately $ 19,900,000 under the agreement.
Options and Warrants
In December 2014, the Board of Directors adopted and
the shareholders approved Relmada’s 2014 Stock Option and Equity Incentive Plan, as amended, which allows for the granting of common
stock awards, stock appreciation rights, and incentive and nonqualified stock options to purchase shares of the Company’s common
stock to designated employees, non-employee directors, and consultants and advisors.
In May 2021 the shareholders approved Relmada’s Board of Director
approved 2021 Equity Incentive Plan which allows for the granting of 1,500,000 options or other stock awards.
These combined plans allow for the granting of
up to 6,652,942 options or stock awards.
Stock options are exercisable generally for a
period of 10 years from the date of grant and generally vest over four years . As of June 30, 2021, there were 1,493,986 shares available
for future grants under the combined Equity Incentive Plans.
As of June 30, 2021, no stock appreciation rights
have been issued.
The Company utilizes the Black-Scholes option
pricing model to estimate the fair value of stock options and warrants. The risk-free interest rate assumptions were based upon the observed
interest rates appropriate for the expected term of the equity instruments. The expected dividend yield was assumed to be zero as the
Company has not paid any dividends since its inception and does not anticipate paying dividends in the foreseeable future. The expected
volatility was based on historical volatility. The Company routinely reviews its calculation of volatility changes in future volatility,
the Company’s life cycle, its peer group, and other factors.
The Company uses the simplified method for share-based
compensation to estimate the expected term for employee option awards for share-based compensation in its option-pricing model.
On January 6, 2021, the Company awarded a total of
1,490,000 options to employees and directors with an exercise price of $33.43 and a 10-year term vesting over a 4-year period. The
options granted include time based vesting grants and performance vesting based on the Company’s achievement of performance
metrics. The options have an aggregate fair value of $ 39.7 million calculated using the Black-Scholes option-pricing model. Variables
used in the Black-Scholes option-pricing model include: (1) discount rate of 0.59 % (2) expected life of 6.25 years, (3) expected volatility
of 101 %, and (4) zero expected dividends. As of June 30, 2021, four performance metrics for 364,000 options were met. Vesting of such
options is subject to the passage of time. At June 30, 2021, the Company incurred expense of $ 1,154,180 related to these options.
On February 18, 2021, the Company awarded a total
of 25,000 options to an employee with an exercise price of $ 35.15 and a 10 -year term, vesting over a 4 -year period. The options have an
aggregate fair value of $ 701,000 calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing
model include: (1) discount rate of 0.75 % (2) expected life of 6.25 years, (3) expected volatility of 101 %, and (4) zero expected dividends.
At June 30, 2021, the Company has unrecognized stock-based
compensation expense of approximately $ 78.4 million related to unvested stock options over the weighted average remaining service period
of 3.00 years.
10
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 6 - STOCKHOLDERS’ EQUITY (continued)
Options
A summary of the changes in options during the
six months ended June 30, 2021 is as follows:
Number of
Options
Weighted
Average
Exercise
Price For
Share
Weighted
Average
Remaining
Contractual
Term
(Years)
Aggregate
Intrinsic
Value
Outstanding and expected to vest at December 31, 2020
3,905,737
$ 24.32
8.40
$ 48,952,339
Granted
1,515,000
$ 33.46
9.53
$ -
Exercised
( 148,656 )
$ 3.48
-
$ -
Forfeited
( 113,125 )
$ 34.47
-
$ -
Outstanding and expected to vest at June 30, 2021
5,158,956
$ 27.38
8.44
$ 44,581,203
Options exercisable at June 30, 2021
1,785,828
$ 21.90
7.70
$ 25,677,980
Warrants
A summary of the changes in outstanding warrants during the six months
ended June 30, 2021 is as follows:
Number of
Shares
Weighted
Average
Exercise
Price Per
Share
Outstanding and vested at December 31, 2020
2,670,633
$ 9.11
Granted
420,000
$ 33.39
Exercised
( 335,550 )
$ 5.79
Outstanding at June 30, 2021
2,755,083
$ 13.22
Vested at June 30, 2021
2,335,864
$ 9.74
At June 30, 2021, the Company had approximately $ 13.3
million of unrecognized compensation expense related to outstanding warrants.
On January 6, 2021, the Company awarded a total of
400,000 warrants to consultants with an exercise price of $ 33.43 and a 10 -year term, vesting over 4 -year period. The warrants granted
include time based vesting grants and performance vesting based on the Company’s achievement of performance metrics. The warrants
have an aggregate fair value of $ 10.6 million calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes
option-pricing model include: (1) discount rate of 0.59 % (2) expected life of 6.25 years, (3) expected volatility of 101 %, and (4) zero
expected dividends. As of June 30, 2021, four performance metrics for 140,000 warrants were met. Vesting of such options is subject to
the passage of time. At June 30, 2021, the Company incurred expense of $ 443,916 related to these warrants.
On June 18, 2021, the Company awarded a total of 10,000 warrants to
a consultant with an exercise price of $ 30.90 and a 5 -year term, vesting over a 1 -year period. The warrants granted are time based vesting.
The warrants have an aggregate fair value of $ 190,401 calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes
option-pricing model include: (1) discount rate of 0.47 % (2) expected life of 3.00 years, (3) expected volatility of 100 %, and (4) zero
expected dividends.
On June 25, 2021, the Company awarded a total
of 10,000 warrants to a consultant with an exercise price of $ 34.35 and a 5 -year term, vesting over a 1 -year period. The warrants granted
are time based vesting. The warrants have an aggregate fair value of $ 211,653 calculated using the Black-Scholes option-pricing model.
Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 0.48 % (2) expected life of 3.00 years, (3) expected
volatility of 100 %, and (4) zero expected dividends.
At June 30, 2021, the aggregate intrinsic value
of warrants vested and outstanding was approximately $ 52.4 and $ 52.5 , respectively.
At December 31, 2020, the aggregate intrinsic
value of warrants vested and outstanding was approximately $ 61.0 and $ 61.2 million, respectively.
11
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 6 - STOCKHOLDERS’ EQUITY (continued)
The following summarizes the components of stock-based
compensation expense which includes stock options and warrants in the unaudited consolidated statements of operations for the six months
ended June 30, 2021 and 2020 (rounded to nearest $00):
Six Months
Ended
June 30,
2021
Six Months
Ended
June 30,
2020
Research and development
$ 2,506,700
$ 3,122,500
General and administrative
11,613,000
9,219,400
Total
$ 14,119,700
$ 12,341,900
NOTE 7 - RELATED PARTY TRANSACTIONS
Effective March 6, 2020, Dr. Ottavio Vitolo, the Company’s
Chief Medical Officer and Head of Research and Development, entered into a Separation and Severance Agreement with the Company. Pursuant
to the terms of the agreement, the Company agreed to pay Dr. Vitolo severance of $ 200,000 in accordance with his employment contract.
In addition, Dr. Vitolo’s options granted under the Company’s 2014 Stock Option and Equity Incentive Plan continued to vest
until September 6, 2020. Dr. Vitolo had until March 6, 2021 to exercise his vested options and he was allowed to use a cashless exercise
provision to exercise his vested options. On March 6, 2021, the remaining vested options were forfeited. The agreement also contains customary
confidentiality, release, and non-disparagement provisions, and the Company agreed to pay accrued and unpaid salary, vacation time and
attorney’s fees totaling approximately $ 45,000 .
Effective December 31, 2020, Dr. Thomas Wessel,
the Company’s Executive Vice President, Head of Research and Development, entered into a Separation and Severance Agreement with
the Company. Pursuant to the terms of the agreement, the Company agreed to pay Dr. Wessel severance of $ 237,500 in accordance with his
employment contract. In addition, Dr. Wessel’s options granted under the Company’s 2014 Stock Option and Equity Incentive
Plan continue to vest until June 30, 2021. Dr. Wessel shall have until December 31, 2021 to exercise his vested options and he shall be
allowed to use a cashless exercise provision to exercise his vested options. The agreement also contains customary confidentiality, release,
and non-disparagement provisions, and the Company agreed to pay accrued vacation time totaling approximately $ 28,940 .
NOTE 8 - COMMITMENTS AND CONTINGENCIES
License Agreements
Wonpung
On August 20, 2007, the Company entered into a License Development
and Commercialization Agreement with Wonpung Mulsan Co, a shareholder of the Company. Wonpung has exclusive territorial rights in countries
it selects in Asia to market up to two drugs the Company is currently developing and a right of first refusal (“ROFR”) for
up to an additional five drugs that the Company may develop in the future as defined in more detail in the license agreement. If the parties
cannot agree to terms of a license agreement then the Company shall be able to engage in discussions with other potential licensors. As
of August 10, 2021, no discussions are active between the Company and Wonpung.
The Company received an upfront license fee of
$ 1,500,000 and will earn royalties of up to 12 % of net sales for up to two licensed products it is currently developing. The licensing
terms for the ROFR products are subject to future negotiations and binding arbitration. The terms of each licensing agreement will expire
on the earlier of any time from 15 years to 20 years after licensing or on the date of commercial availability of a generic product to
such licensed product in the licensed territory.
Third Party Licensor
Based upon a prior acquisition, the Company assumed
an obligation to pay third parties (Dr. Charles E. Inturrisi and Dr. Paolo Manfredi – see below): (A) royalty payments up to 2%
on net sales of licensed products that are not sold by sublicensee and (B) on each and every sublicense earned royalty payment received
by licensee from its sublicensee on sales of license product by sublicensee, the higher of (i) 20% of the royalties received by licensee;
or (ii) up to 2% of net sales of sublicensee. The Company will also make milestone payments of up to $4 or $2 million, for the first commercial
sale of product in the field that has a single active pharmaceutical ingredient, and for the first commercial sale of product in the field
of product that has more than one active pharmaceutical ingredient, respectively. As of June 30, 2021, the Company has not generated any
revenue related to this license agreement.
12
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 8 - COMMITMENTS AND CONTINGENCIES (continued)
Inturrisi / Manfredi
In January 2018, we entered into an Intellectual
Property Assignment Agreement (the Assignment Agreement) and License Agreement (the License Agreement and together with the Assignment
Agreement, the Agreements) with Dr. Charles E. Inturrisi and Dr. Paolo Manfredi (collectively, the Licensor). Pursuant to the Agreements,
Relmada assigned its existing rights, including patents and patent applications, to d-methadone in the context of psychiatric use (the
Existing Invention) to Licensor. Licensor then granted Relmada under the License Agreement a perpetual, worldwide, and exclusive license
to commercialize the Existing Invention and certain further inventions regarding d-methadone. In consideration of the rights granted
to Relmada under the License Agreement, Relmada paid the Licensor an upfront, non-refundable license fee of $180,000. Additionally, Relmada
will pay Licensor $45,000 every three months until the earliest to occur of the following events: (i) the first commercial sale of a licensed
product anywhere in the world, (ii) the expiration or invalidation of the last to expire or be invalidated of the patent rights anywhere
in the world, or (iii) the termination of the License Agreement. Relmada will also pay Licensor tiered royalties with a maximum rate of
2%, decreasing to 1.75%, and 1.5% in certain circumstances, on net sales of licensed products covered under the License Agreement. Relmada
will also pay Licensor tiered payments up to a maximum of 20%, and decreasing to 17.5%, and 15% in certain circumstances, of all consideration
received by Relmada for sublicenses granted under the License Agreement. As of June 30, 2021, no events have occurred, and the Company
continues to pay Licensor $ 45,000 every three months.
Legal
From time to time, the Company may become involved
in lawsuits and other legal proceedings that arise in the course of business. Litigation is subject to inherent uncertainties, and it
is not possible to predict the outcome of litigation with total confidence. The Company is currently not aware of any legal proceedings
or potential claims against it whose outcome would be likely, individually or in the aggregate, to have a material adverse effect on the
Company’s business, financial condition, operating results, or cash flows.
Lawsuit Brought by Previous Employee
On July 15, 2020, an employee of the Company filed a Complaint alleging
unequal pay based on gender and other employment-based claims. On April 9, 2021, the Company settled this Complaint for an amount immaterial
to the consolidated financial statements.
Leases and Sublease
The Company’s corporate headquarters are
located at 880 Third Avenue, 12th Floor, New York, New York 10022 pursuant to a lease agreement for a period of one year. In accordance
with ASC 842, Leases , the Company has elected the practical expedient and recognizes rent expense evenly over the 12 months. The
monthly rent is approximately $ 8,800 . For the six months ended June 30, 2021 and 2020, the Company recognized lease expense of approximately
$ 38,700 and $ 83,000 , respectively.
On June 8, 2017, the Company entered into an Amended
and Restated License Agreement with Actinium. Pursuant to the terms of the agreement, Actinium will continue to license the furniture,
fixtures, equipment and tenant improvements located in its 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 $496,914, less any previously
paid license fees. The license of FFE qualifies as a sales-type lease. At inception, the Company derecognized the underlying assets of
$493,452, recognized discounted lease payments receivable of $397,049 using the discount rate of 8.38% and recognized loss on sales-type
lease of fixed assets of $96,403. For the six months ended June 30, 2021 and 2020, the Company recognized lease income of approximately
$ 6,300 and $ 9,400 , respectively. As of June 30, 2021, the balance of unearned interest income was approximately $ 8,600 .
Contractual Obligations
The following tables sets forth our contractual
obligations for the next five years and thereafter:
Total
Less than
1 year
1 - 2 years
3 - 5 years
More than
5 years
Office lease
$ 52,800
$ 52,800
$ -
$ -
$ -
Total obligations
$ 52,800
$ 52,800
$ -
$ -
$ -
NOTE 9 - OTHER POST-RETIREMENT BENEFIT PLAN
Relmada participates in a multiemployer 401(k)
plan that permits eligible employees to contribute funds on a pretax basis subject to maximum allowed under federal tax provisions. The
Company matches 100% of the first 3% of employee contributions, plus 50% of employee contributions that exceed 3% but do not exceed 5%.
The employees choose an amount from various investment options for
both their contributions and the Company’s matching contribution. The Company’s contribution expense was approximately $ 78,800
and $ 27,800 for the six months ended June 30, 2021 and 2020, respectively.
NOTE 10 - SUBSEQUENT EVENTS
Subsequent to June 30, 2021, 4,167 outstanding warrants were exercised for total cash proceeds of approximately $ 25,000 .
On July 12, 2021, the Company awarded a total
of 10,000 warrants to a consultant with an exercise price of $ 34.77 and a 5 year term, vesting over a 1 -year period.
On July 16, 2021, the Company executed a license
agreement with Arbormentis, LLC with an upfront fee of approximately $ 15 million, consisting of a mix of cash and equity, in addition
to potential milestone payment totaling in excess of $ 150 million. The license agreement is filed as exhibit 10.2 to this Report. Dr.
Paolo Manfredi, Relmada’s Acting Chief Scientific Officer and co-inventor of REL-1017, and Dr. Marco Pappagallo, Relmada’s
Acting Chief Medical Officer, are among the scientists affiliated with Arbormentis.
13
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.