Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
Relmada
Therapeutics, Inc.
Condensed
Consolidated Balance Sheets
As of
September 30,
As of
2021
(Unaudited)
December 31,
2020
Assets
Current assets:
Cash and cash equivalents
$ 11,449,294
$ 2,495,397
Short-term investments
76,637,802
114,595,525
Lease payments receivable – short term
84,592
79,457
Prepaid expenses
2,715,478
903,190
Total current assets
90,887,166
118,073,569
Fixed assets, net of accumulated depreciation
-
1,258
Other assets
25,000
25,000
Lease payments receivable – long term
22,275
86,377
Total assets
$ 90,934,441
$ 118,186,204
Commitments and Contingencies (See Note 8)
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 12,708,546
$ 8,346,475
Accrued expenses
5,538,804
4,256,983
Total current liabilities
18,247,350
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, 17,501,554 and 16,332,939 shares issued and outstanding, respectively
17,502
16,333
Additional paid-in capital
343,358,208
284,881,716
Accumulated deficit
( 270,688,619 )
( 179,315,303 )
Total stockholders’ equity
72,687,091
105,582,746
Total liabilities and stockholders’ equity
$ 90,934,441
$ 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
Nine months ended
September 30,
September 30,
2021
2020
2021
2020
Operating expenses:
Research and development
$ 33,993,974
$ 11,237,186
$ 65,347,708
$ 21,068,923
General and administrative
8,659,661
5,946,396
26,173,010
18,846,299
Total operating expenses
42,653,635
17,183,582
91,520,718
39,915,222
Loss from operations
( 42,653,635 )
( 17,183,582 )
( 91,520,718 )
( 39,915,222 )
Other (expenses) income:
Interest/investment income, net
297,648
363,300
1,040,429
1,174,957
Realized loss on short-term investments
( 336,949 )
( 86,171 )
( 513,328 )
( 244,972 )
Unrealized gain (loss) on short-term investments
86,745
3,946
( 379,699 )
290,973
Total other income - net
47,444
281,075
147,402
1,220,958
Net loss
$ ( 42,606,191 )
$ ( 16,902,507 )
$ ( 91,373,316 )
$ ( 38,694,264 )
Loss per common share – basic and diluted
$ ( 2.44 )
$ ( 1.05 )
$ ( 5.36 )
$ ( 2.52 )
Weighted average number of common shares outstanding – basic and diluted
17,478,477
16,044,670
17,038,583
15,371,118
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)
Nine months ended September 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
Warrants issued for license agreement
-
-
10,241,599
-
10,241,599
Stock based compensation
-
-
8,013,970
-
8,013,970
Warrant exercised for cash
20,835
21
174,993
-
175,014
Options exercised for cash
11,900
12
52,144
-
52,156
Equity offering costs
-
-
( 42,014 )
-
( 42,014 )
Net loss
-
-
-
( 42,606,191 )
( 42,606,191 )
Balance - September 30, 2021
17,501,554
$ 17,502
$ 343,358,208
$ ( 270,688,619 )
$ 72,687,091
Nine months ended September 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
Equity offering, net
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
Stock based compensation
-
-
5,244,658
-
5,244,658
Warrant exercised for cash
214,899
215
1,566,815
-
1,567,030
Cashless warrant exercise
6,521
7
( 7 )
-
-
Options exercised
25,781
25
105,850
-
105,875
Cashless option exercised
90,204
90
( 90 )
-
-
Equity offering costs
-
-
( 38,421 )
-
( 38,421 )
Net loss
-
-
-
( 16,902,507 )
( 16,902,507 )
Balance - September 30, 2020
16,189,258
$ 16,189
$ 280,746,968
$ ( 158,553,173 )
$ 122,209,984
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)
Nine months ended
September 30,
2021
2020
Cash flows from operating activities
Net loss
$ ( 91,373,316 )
$ ( 38,694,264 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
1,258
2,929
Warrants issued for license agreement
10,241,599
-
Stock-based compensation
22,133,630
17,586,533
Realized loss on short-term investments
513,328
244,972
Unrealized loss/(gain) on short-term investments
379,699
( 290,973 )
Change in operating assets and liabilities:
Lease payment receivable
58,967
54,242
Prepaid expenses
( 1,812,288 )
( 1,825,336 )
Accounts payable
4,362,071
205,970
Accrued expenses
1,281,821
1,835,888
Net cash used in operating activities
( 54,213,231 )
( 20,880,039 )
Cash flows from investing activities
Purchase of short-term investments
( 82,476,539 )
( 88,763,192 )
Sale of short-term investments
119,541,235
53,380,266
Net cash provided by (used in) investing activities
37,064,696
( 35,382,926 )
Cash flows from financing activities
Principal payments of notes payable
-
( 110,247 )
Proceeds from issuance of common stock – net
23,416,036
19,816,597
Proceeds from options exercised for common stock
569,427
636,518
Proceeds from warrants exercised for common stock
2,116,969
7,186,306
Net cash provided by financing activities
26,102,432
27,529,174
Net increase /(decrease) in cash and cash equivalents
8,953,897
( 28,733,791 )
Cash and cash equivalents at beginning of the period
2,495,397
36,278,519
Cash and cash equivalents at end of the period
$ 11,449,294
7,544,728
Supplemental disclosure of cash flow information:
Cash paid during the period for:
Income taxes
$ -
$ -
Interest
$ -
$ 2,415
Non-cash investing and financing activities:
Cashless exercise of warrants for common stock
$ -
$ 43
Cashless exercise of options for common stock
$ -
$ 90
The
accompanying notes are an integral part of these unaudited condensed consolidated
financial statements.
4
Relmada Therapeutics, Inc.
Notes to Unaudited 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 condensed 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 $ 54,213,231 for the nine months ended September 30, 2021 and has an accumulated
deficit of $ 270,688,619 from inception through September 30, 2021. At September 30, 2021, the Company had cash and short term investments
of $ 88,087,096 .
Relmada has funded its past operations through equity raises and most
recently in 2021 raised net proceeds from the sale of common stock of $ 23,416,036 through our ATM offering and $ 2,116,969 through the
exercise of warrants. The Company also raised an additional $ 569,427 during the nine months ended September 30, 2021 from the exercises
of options.
5
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
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.
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 the valuation of research and development
expenses, stock-based compensation expenses and deferred tax assets and the related valuation allowance.
6
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 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 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 .
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.
7
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
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 $ 76,637,802 at September 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 gain/(loss) of
$ 86,745 and $( 379,699 ) included in other income for the three and nine months ended September 30, 2021, respectively. The Company recorded
an unrealized gain of $ 3,946 and $ 290,973 included in other income for the three and nine months ended September 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 September 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.
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 September 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.
8
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
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, 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 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 position.
For the nine months ended September 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):
Nine months ended
September 30,
2021
September 30,
2020
Stock options
5,043,931
4,110,425
Common stock warrants
3,244,248
2,674,265
Total
8,288,179
6,784,690
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.
9
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
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):
September 30,
2021
December 31,
2020
Insurance
$ 542,000
$ 527,600
Research and Development
2,025,600
291,800
Legal
11,000
11,000
Other
136,900
72,800
Total
$ 2,715,500
$ 903,200
NOTE 4 - FIXED ASSETS
Fixed assets, net of accumulated depreciation, consisted of the following
(rounded to nearest $00):
Useful
lives
September 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 nine months ended September 30, 2021 and
2020, the Company recognized depreciation expense of approximately $ 1,258 and $ 2,929 , respectively.
NOTE 5 - ACCRUED EXPENSES
Accrued expenses consisted of the following (rounded to nearest $ 00 ):
September 30,
2021
December 31,
2020
Research and development
$ 3,977,500
$ 2,183,800
Professional fees
174,200
150,900
Accrued bonus
867,000
1,444,900
Accrued vacation
413,500
351,200
Other
106,600
126,200
Total
$ 5,538,800
$ 4,257,000
10
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 6 - STOCKHOLDERS’ EQUITY
Common Stock
During the nine months ended September 30, 2021,
the Company issued 356,385 shares of common stock for cash exercises of warrants for proceeds of $ 2,116,969 .
During the nine months ended September 30, 2021,
the Company issued 160,556 shares of common stock for the exercise of options for proceeds of $ 569,427 .
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 nine months ended September 30, 2021,
the Company issued 651,674 shares of common stock for net cash proceeds of $ 23,416,036 under the agreement. During the nine months ended
September 30, 2020, the Company issued shares of common stock for net cash proceeds of $ 19,816,597 .
Options and Warrants
In December 2014, the Board of Directors adopted
and the Company’s shareholders approved Relmada’s 2014 Stock Option and Equity Incentive Plan, as amended (the “Plan”),
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 Company’s shareholders
approved Relmada’s Board of Director approved 2021 Equity Incentive Plan which allows for the granting of 1,500,000 options or 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 September 30, 2021, 1,609,011 shares were available
for future grants under the Plan.
As of September 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 equity 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 September 30, 2021, five performance metrics for 468,000 options were met. Vesting of
such options is subject to the passage of time. At September 30, 2021, the Company incurred expense of $ 2,268,562 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 September 30, 2021, the Company has unrecognized
stock-based compensation expense of approximately $ 67.6 million related to unvested stock options over the weighted average remaining
service period of 2.76 years.
11
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
nine months ended September 30, 2021 is as follows:
Number
of
Options
Weighted
Average
Exercise
Price
Per
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
9.28
$
-
Exercised
( 160,556
)
$
3.56
-
$
-
Forfeited
( 216,250
)
$
39.61
-
$
-
Outstanding at September 30, 2021
5,043,931
$
27.07
8.18
$
33,664,009
Options exercisable at September 30, 2021
2,079,396
$
22.59
7.54
$
21,827,709
Warrants
A summary of the changes in outstanding warrants during the nine months
ended September 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
930,000
$ 32.21
Exercised
( 356,385 )
$ 5.94
Outstanding at September 30, 2021
3,244,248
$ 16.08
Warrants Vested at September 30, 2021
2,829,873
$ 8.13
12
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 6 - STOCKHOLDERS’ EQUITY (continued)
At September 30, 2021, the Company had approximately
$ 12.5 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 September 30, 2021, five performance metrics for 180,000 warrants were met. Vesting of such options is subject
to the passage of time. At September 30, 2021, the Company incurred expense of $ 872,524 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 0.43 % (2) expected life of 3.00 years, (3) expected
volatility of 100 %, and (4) zero expected dividends.
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. The warrants granted
are time based vesting. The warrants have an aggregate fair value of $ 212,219 calculated using the Black-Scholes option-pricing model.
Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 0.43 % (2) expected life of 3.00 years, (3) expected
volatility of 99 %, and (4) zero expected dividends.
On July 16, 2021, the Company awarded a total
of 500,000 warrants to Arbormentis, LLC with an exercise price of $ 31.17 and a 7 -year term, vesting immediately. The warrants have an
aggregate fair value of $ 10,241,599 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 3.50 years, (3) expected volatility of 101 %, and (4) zero expected dividends.
At September 30, 2021, the aggregate intrinsic
value of warrants vested and outstanding was approximately $ 40.0 million and $ 40.1 million, respectively.
At December 31, 2020, the aggregate intrinsic
value of warrants vested and outstanding was approximately $ 61.0 million and $ 61.2 million, respectively.
The following table summarizes the components
of stock-based compensation expense which includes stock options and warrants in the unaudited consolidated statements of operations for
the nine months ended September 30, 2021 and 2020 (rounded to nearest $00):
Nine
Months
Ended
September 30,
2021
Nine
Months
Ended
September 30,
2020
Research and development
$ 14,341,700
$ 4,635,300
General and administrative
18,033,500
12,951,200
Total
$ 32,375,200
$ 17,586,500
13
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
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 November 12, 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.
14
Relmada
Therapeutics, Inc.
Notes
to Unaudited Condensed Consolidated Financial Statements
NOTE
8 - COMMITMENTS AND CONTINGENCIES (continued)
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 September 30, 2021, the Company has not generated any revenue related to this license agreement.
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 September 30, 2021, 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.
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.
15
Relmada
Therapeutics, Inc.
Notes
to Unaudited Condensed Consolidated Financial Statements
NOTE
8 - 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 for a period of 4 months. 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 5 months. The monthly
rent is approximately $ 11,000 . For the nine months ended September 30, 2021 and 2020, the Company recognized lease expense of approximately
$ 87,100 and $ 124,400 , 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. 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 nine months ended September 30, 2021 and 2020, the Company recognized lease
income of approximately $ 8,800 and $ 13,500 , respectively. As of September 30, 2021, the balance of unearned interest income was approximately
$ 6,100 .
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
$ 33,000
$ 33,000
$ -
$ -
$ -
Total obligations
$ 33,000
$ 33,000
$ -
$ -
$ -
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 $ 101,100 and $ 58,500 for the nine months ended September 30, 2021 and 2020,
respectively.
NOTE
10 - SUBSEQUENT EVENTS
Subsequent to September 30, 2021, 29,276 outstanding
warrants were exercised for total cash proceeds of approximately $ 178,170 .
On October 1, 2021, the Company awarded a total of
42,000 warrants to a consultant with an exercise price of $ 26.74 and a 10 -year term, vesting over a 4 -year period.
16
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.