Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
Relmada Therapeutics, Inc.
Condensed Consolidated Balance Sheets
As of
June 30,
2022
(unaudited)
As of
December 31,
2021
Assets
Current assets:
Cash and cash equivalents
$ 37,260,866
$ 44,443,439
Short-term investments
174,694,211
167,466,167
Lease payments receivable – short term
42,234
86,377
Prepaid expenses
3,483,744
11,301,535
Other current assets
256,192
-
Total current assets
215,737,247
223,297,518
Other assets
35,238
28,293
Total assets
$ 215,772,485
$ 223,325,811
Commitments and Contingencies (See Note 7)
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 7,539,686
$ 11,192,502
Accrued expenses
11,381,468
3,868,423
Total current liabilities
18,921,154
15,060,925
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, 150,000,000 shares authorized, 30,024,594 and 27,740,147 shares issued and outstanding, respectively
30,025
27,740
Additional paid-in capital
581,569,169
513,304,258
Accumulated deficit
( 384,747,863 )
( 305,067,112 )
Total stockholders’ equity
196,851,331
208,264,886
Total liabilities and stockholders’ equity
$ 215,772,485
$ 223,325,811
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,
2022
2021
2022
2021
Operating expenses:
Research and development
$ 30,912,671
$ 17,331,507
$ 55,925,524
$ 31,353,734
General and administrative
14,599,401
9,130,373
27,883,971
17,513,349
Total operating expenses
45,512,072
26,461,880
83,809,495
48,867,083
Loss from operations
( 45,512,072 )
( 26,461,880 )
( 83,809,495 )
( 48,867,083 )
Other (expenses) income:
Gain on settlement of fees
6,351,606
6,351,606
Interest/investment income, net
387,333
322,807
717,282
742,781
Realized (loss) gain on short-term investments
24,502
( 123,590 )
9,480
( 176,379 )
Unrealized loss on short-term investments
( 1,186,337 )
( 289,281 )
( 2,949,624 )
( 466,444 )
Total other (expenses) income
5,577,104
( 90,064 )
4,128,744
99,958
Net loss
$ ( 39,934,968 )
$ ( 26,551,944 )
$ ( 79,680,751 )
$ ( 48,767,125 )
Loss per common share – basic and diluted
$ ( 1.33 )
$ ( 1.56 )
$ ( 2.73 )
$ ( 2.90 )
Weighted average number of common shares outstanding – basic and diluted
29,935,895
17,054,646
29,168,511
16,814,991
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)
Three and Six months ended June 30, 2022
Common Stock
Additional
Paid-in
Accumulated
Shares
Par Value
Capital
Deficit
Total
Balance - December 31, 2021
27,740,147
$ 27,740
$ 513,304,258
$ ( 305,067,112 )
$ 208,264,886
Stock based compensation
-
-
11,930,681
-
11,930,681
ATM offering, net
1,609,343
1,610
29,581,932
-
29,583,542
Warrant exercised for cash
33,334
33
299,973
-
300,006
Options exercised for cash
20,000
20
64,780
-
64,800
Net loss
-
-
-
( 39,745,783 )
( 39,745,783 )
Balance – March 31, 2022
29,402,824
29,403
555,181,624
( 344,812,895 )
210,398,132
Stock based compensation
-
-
12,295,016
-
12,295,016
Warrant exercised for cash
91,058
91
595,259
-
595,350
Options exercised for cash
45,812
46
352,698
-
352,744
ATM offering, net of offering costs
484,900
485
13,144,572
-
13,145,057
Net loss
-
-
-
( 39,934,968 )
( 39,934,968 )
Balance – June 30, 2022
30,024,594
$ 30,025
$ 581,569,169
$ ( 384,747,863 )
$ 196,851,331
Three and 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
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,
2022
2021
Cash flows from operating activities
Net loss
$ ( 79,680,751 )
$ ( 48,767,125 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
-
1,258
Stock-based compensation
24,225,697
14,119,660
Gain on settlement of fees
( 6,351,606
)
Realized loss (gain) on short-term investments
( 9,480 )
176,379
Unrealized loss on short-term investments
2,949,624
466,444
Change in operating assets and liabilities:
Lease payment receivable
44,143
38,899
Other current assets
( 256,192 )
-
Prepaid expenses and other assets
7,810,846
( 645,690 )
Accounts payable
2,698,790
2,109,447
Accrued expenses
7,513,045
( 796,162 )
Net cash used in operating activities
( 41,055,884 )
( 33,296,890 )
Cash flows from investing activities
Purchase of short-term investments
( 33,412,425 )
( 56,872,459 )
Sale of short-term investments
23,244,237
66,426,021
Net cash (used in) provided by investing activities
( 10,168,188 )
9,553,562
Cash flows from financing activities
Proceeds from issuance of common stock, net
42,728,599
23,458,050
Proceeds from options exercised for common stock
417,544
517,271
Proceeds from warrants exercised for common stock
895,356
1,941,955
Net cash provided by financing activities
44,041,499
25,917,276
Net (decrease)/increase in cash and cash equivalents
( 7,182,573 )
2,173,948
Cash and cash equivalents at beginning of the period
44,443,439
2,495,397
Cash and cash equivalents at end of the period
$ 37,260,866
$ 4,669,345
Supplemental disclosure of cash flow information:
Cash paid during the period for:
Interest
$ -
$ -
Income Tax
$ -
$ -
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, 2021 and notes thereto contained in the Company’s Annual Report
on Form 10-K.
Liquidity
As shown in the accompanying unaudited condensed consolidated financial
statements, the Company incurred negative operating cash flows of $ 41,055,884 for the six months ended June 30, 2022 and has an accumulated
deficit of $ 384,747,863 from inception through June 30, 2022.
Relmada has funded its past operations through equity raises and most
recently in the six months ended June 30, 2022, the Company raised net proceeds of $ 42,728,599 from the sale of common stock through our
at-the-market (ATM) equity offering, $ 417,544 through the exercise of options and $ 895,356 through the exercise of warrants.
On April 8, 2022, we raised net proceeds of $ 13,145,057
from the sale of common stock through our ATM equity offering. On April 6, 2022, we entered into a new Open Market Sale Agreement with
Jefferies, as sales agent, pursuant to which we may offer and sell, from time to time, through Jefferies, shares of our common stock,
having an aggregate offering price of up to $ 100,000,000 . We are not obligated to sell any shares under the agreement.
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 clinical trials will not be incurred until such additional financing is raised. Further, additional financing
related to subsequent clinical 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 unaudited
condensed consolidated financial statements.
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). 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 stock-based compensation expenses and
recorded amounts related to income taxes.
5
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
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 balance of $ 37,260,866 at June 30, 2022 at these institutions
exceed the 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). Substantially all equity investments are
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 unaudited condensed consolidated
statement of operations. Short term investment activity is presented in the investing activities section on the unaudited condensed consolidated
statement of cash flows.
Short-term investments at June 30, 2022 consisted
of mutual funds with a fair value of $ 174,694,211 .
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.
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 lease 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.
Other Current Assets
The Company recognizes other current assets as a transaction that will
be converted into cash within a year on the balance sheet. The Company’s other current assets consist entirely of unsettled funds
from an option exercise on June 30, 2022.
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).
As required by Accounting Standard Codification
(ASC) Topic No. 820 – 10 Fair Value Measurement , financial assets and liabilities are classified based on the lowest level
of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input
to the fair value measurement requires judgement and may affect the valuation of the fair value of assets and liabilities and their placement
within the fair value hierarchy levels.
6
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
The Company’s short-term investment instruments
of $ 174,694,211 at June 30, 2022 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 unrealized loss of $ 1,186,337 and $ 2,949,624
included in other income for the three and six months ended June 30, 2022, respectively. The Company recorded unrealized losses of $ 289,281
and $ 466,444 included in other income for the three and six months ended June 30, 2021, 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, 2022 and December 31, 2021, 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.
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,
2022 and December 31, 2021. 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 and non-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 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 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
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 in each period.
For the six months ended June 30, 2022 and 2021,
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,
2022
June 30,
2021
Stock options
10,427,310
5,158,956
Common stock warrants
3,084,385
2,755,083
Total
13,511,695
7,914,039
7
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
Recent Accounting Pronouncements
In November 2021, the FASB issued ASU 2021-10,
“ Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance ”. The amendments
in this ASU require annual disclosures to increase the transparency of government assistance received by a business entity including
information about the nature of the government transactions, related accounting policy, the line items on the balance sheet and income
statement that are affected, amounts applicable to each financial statement line item, and significant terms and conditions of the transactions,
including commitments and contingencies. The amendments in this ASU are effective for annual periods beginning after December 15, 2021.
The Company adopted this standard effective January 1, 2022 and the standard did not have a significant impact on our condensed consolidated
financial statements.
In October 2021, the FASB issued ASU 2021-08,
“ Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers ”.
The amendments in this ASU require that an entity (acquirer) recognize, and measure contract assets and contract liabilities acquired
in a business combination, including contract assets and contract liabilities arising from revenue contracts with customers, as if it
had originated the contracts as of the acquisition date. The amendments in this ASU are effective for annual and interim periods beginning
after December 15, 2022. Early adoption is permitted. The Company does not expect this standard to have a material impact on the consolidated
financial statements.
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 adopted this standard effective January 1, 2022 and
the standard did not have a significant impact on our condensed consolidated financial statements.
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,
2022
December 31,
2021
Insurance
$ 643,300
$ 353,300
Research and Development
2,624,600
10,708,800
Legal
11,000
11,000
Other
204,800
228,400
Total
$ 3,483,700
$ 11,301,500
NOTE 4 - ACCRUED EXPENSES
Accrued expenses consisted of the following (rounded to nearest $00):
June 30,
2022
December 31,
2021
Research and development
$
9,799,100
$
1,928,000
Professional fees
111,800
168,000
Accrued bonus
780,400
1,191,000
Accrued vacation
572,000
450,400
Other
118,200
131,000
Total
$
11,381,500
$
3,868,400
8
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 5 - STOCKHOLDERS’ EQUITY
Common Stock
During the six months ended June 30, 2022, the
Company issued 124,392 shares of common stock, for cash exercises of warrants for proceeds of $ 895,356 .
During the six months ended June 30, 2022, the
Company issued 65,812 shares of common stock for cash exercises of options for proceeds of $ 417,544 .
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 was not obligated to sell any shares under the agreement. During the six months ended June 30, 2022, the Company issued 2,094,243
shares of common stock for net cash proceeds of $ 42,728,599 under the agreement.
Options and Warrants
In December 2014, the Board of Directors adopted
and Company’s shareholders approved Relmada’s 2014 Stock Option and Equity Incentive Plan, as amended (the “Plan”),
which allows for the granting of 5,152,942 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 Company’s Board of Directors adopted and shareholders approved Relmada’s 2021 Equity Incentive Plan which
allows for the granting of 1,500,000 options or stock awards. In May 2022, the Company’s Board of Directors adopted and
Shareholders approved an amendment to the 2021 Equity Incentive Plan to increase the shares of the Company’s common stock available
for issuance thereunder by 3,900,000 shares.
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, 2022, there were 125,632 shares
available for future grants under the combined Equity Incentive Plans.
As of June 30, 2022, 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 equity awards for share-based compensation in its option-pricing model.
On January 1, 2022, 50,000 options were
issued to a consultant with an exercise price of $ 22.53 and a 10 -year term, vesting over a 1 -year period. The options granted
include performance vesting based on the Company’s achievement of performance metrics. The options have an aggregate fair value
of $ 847,583 , calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include:
(1) discount rate of 1.53 % (2) expected life of 5.5 years, (3) expected volatility of 96 %, and (4) zero expected
dividends.
From January 1, 2022 through March 14, 2022, 110,000 options
were issued to various consultants with an exercise price ranging from $ 18.00 to $ 21.46 and a 10 -year term, vesting over
a 4 -year period. The options granted include time-based vesting grants. The options have an aggregate fair value of approximately
$ 1.6 million, calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include:
(1) discount rate of 1.53 – 2.00 % (2) expected life of 6.25 years, (3) expected volatility of 98 %,
and (4) zero expected dividends.
On March 28, 2022, the
Company awarded a total of 15,000 options to an employee with an exercise price of $ 25.76 and a 10 -year term vesting
over a 4 -year period. The options granted include time-based vesting grants. The options have an aggregate fair value of $ 307,845 calculated
using the Black Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate
of 2.55 % (2) expected life of 6.25 years, (3) expected volatility of 98 %, and (4) zero expected dividends.
From April 25, 2022 through May 5, 2022, 260,000 options
were issued to various consultants with an exercise price ranging from $ 22.40 to $ 25.52 and a 10 -year term, vesting over
a 4 -year period. The options granted include time-based vesting grants. The options have an aggregate fair value of approximately
$ 4.6 million, calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include:
(1) discount rate of 2.85 – 3.04 % (2) expected life of 6.25 years, (3) expected volatility of 95 %,
and (4) zero expected dividends.
At June 30, 2022, the Company has unrecognized
stock-based compensation expense of approximately $ 122.7 million related to unvested stock options over the weighted average remaining
service period of 2.51 years.
9
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 5 - STOCKHOLDERS’ EQUITY (continued)
Options
A summary of the changes in options during the
six months ended June 30, 2022 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, 2021
10,330,622
$ 22.52
9.00
$ 46,088,534
Granted
435,000
$ 21.65
9.75
$ -
Exercised
( 65,812 )
$ 6.34
-
$ -
Forfeited
( 272,500 )
$ 29.30
-
$ -
Outstanding and expected to vest at June 30, 2022
10,427,310
$ 22.41
8.60
$ 19,951,999
Options exercisable at June 30, 2022
3,252,058
$ 21.43
7.30
$ 18,294,480
Warrants
A summary of the changes in outstanding warrants during the six months
ended June 30, 2022 is as follows:
Number of
Shares
Weighted
Average
Exercise
Price Per
Share
Outstanding and vested at December 31, 2021
3,208,777
$ 16.45
Granted
-
$ -
Exercised
( 124,392 )
$ 7.20
Outstanding at June 30, 2022
3,084,385
$ 16.82
Vested at June 30, 2022
2,763,948
$ 14.93
At June 30, 2022, the Company had approximately
$ 7.7 million of unrecognized compensation expense related to outstanding warrants.
At June 30, 2022, the aggregate intrinsic value
of warrants vested and outstanding was approximately $ 22.9 million.
Stock -based compensation by class of expense
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, 2022 and 2021 (rounded to nearest $00):
Six Months
Ended
June 30,
2022
Six Months
Ended
June 30,
2021
Research and development
$ 2,494,800
$ 2,506,700
General and administrative
21,730,900
11,613,000
Total
$ 24,225,700
$ 14,119,700
10
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 6 - 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. Dr. Vitolo exercised 126,562 options during 2020 and the remaining options
expired on March 6, 2021. The agreement also contains customary confidentiality, release, and non-disparagement provisions, and the Company
paid 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 had until December 31, 2021 to exercise his vested options and he was allowed to
use a cashless exercise provision to exercise his vested options. All of Dr. Wessel’s options expired on December 31, 2021. The
agreement also contains customary confidentiality, release, and non-disparagement provisions, and the Company paid accrued vacation time
totaling approximately $ 28,940 .
NOTE 7 - 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 was developing at the time of the signing of the agreement
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 June 30, 2022, 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 was developing at the time of the signing
of the agreement. 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, 2022, the Company has not
generated any revenue related to this license agreement.
11
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 7 - 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 esmethadone 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 esmethadone, in the context of other indications such
as those contemplated above. 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, 2022, no events have occurred, and the Company continues to pay Licensor $ 45,000 every three months.
Arbormentis, LLC
On July 16, 2021, the Company entered into a
License Agreement with Arbormentis, LLC, a privately held Delaware limited liability company, by which the Company acquired development
and commercial rights to a novel psilocybin and derivate program from Arbormentis, LLC, worldwide excluding the countries of Asia.
The Company will collaborate with Arbormentis, LLC on the development of new therapies targeting neurological and psychiatric disorders,
leveraging its understanding of neuroplasticity, and focusing on this emerging new class of drugs targeting the neuroplastogen mechanism
of action. Under the terms of the License Agreement, the Company paid Arbormentis, LLC an upfront fee of $12.7 million, consisting
of a mix of cash and warrants to purchase the Company’s common stock, in addition to potential milestone payments totaling up to
approximately $160 million related to pre-specified development and commercialization milestones. Arbormentis, LLC is also eligible
to receive a low single digit royalty on net sales of any commercialized therapy resulting from this agreement. The license agreement
is terminable by the Company but is perpetual and not terminable by the licensor absent material breach of its terms by the Company.
The new licensed program stems from an international
collaboration among U.S., European and Swiss scientists that has focused on the discovery and development of compounds that may promote
neural plasticity. 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, LLC.
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.
12
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 7 - COMMITMENTS AND CONTINGENCIES (continued)
Leases and Sublease
On August 1, 2021, the Company relocated its corporate
headquarters to 2222 Ponce de Leon, Floor 3, Coral Gables, FL 33134, pursuant to a lease agreement with monthly rent of approximately
$ 11,000 . The lease period was for five months . The lease agreement expired on December 31, 2021 and was renewed for the calendar
year 2022 with monthly rent of approximately $ 9,000 . The Company’s previous lease at 880 Third Avenue, 12 th Floor,
New York, NY 10022 was terminated as of July 31, 2021. In accordance with ASC 842, Leases , the Company has elected the practical
expedient and recognizes rent expense evenly over the 12 months. For the six months ended June 30, 2022 and 2021, the Company recognized
lease expense of approximately $ 44,000 and $ 38,700 , respectively.
On June 8, 2017, the Company entered into an Amended
and Restated License Agreement with Actinium Pharmaceuticals, Inc. 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. On July 7, 2022, Actinium exercised their right to purchase the FFE for $52,698. The license of FFE qualified 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, 2022 and 2021, the Company recognized lease income of approximately $ 2,500 and $ 6,300 , respectively. As of June 30, 2022, there
was no unearned interest income as a result of the exercised right to purchase.
NOTE 8 - 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
$ 62,800 and $ 78,800 for the six months ended June 30, 2022 and 2021, respectively.
NOTE 9 - SUBSEQUENT EVENTS
On July 1, 2022, 150,000 options were granted
to a consultant with an exercise price of $ 18.30 .
Subsequent to June 30, 2022, 17,886 outstanding
options were exercised for total cash proceeds of $ 286,176 .
Subsequent to June 30, 2022, 18,038 outstanding warrants were exercised
for total cash proceeds of $ 129,478 .
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.