Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
Relmada
Therapeutics, Inc.
Condensed
Consolidated Balance Sheets
As of
June 30,
2023
(Unaudited)
As of
December 31,
2022
Assets
Current assets:
Cash and cash equivalents
$ 14,469,354
$ 5,395,905
Short-term investments
104,059,737
142,926,781
Other receivables
-
512,432
Prepaid expenses
3,474,540
4,035,186
Total current assets
122,003,631
152,870,304
Other assets
34,590
34,875
Total assets
$ 122,038,221
$ 152,905,179
Commitments and Contingencies (See Note 6)
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 4,853,616
$ 5,261,936
Accrued expenses
5,848,850
7,206,941
Total current liabilities
10,702,466
12,468,877
Stockholders’ Equity:
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, 30,099,203 shares issued and outstanding
30,099
30,099
Additional paid-in capital
625,041,121
602,517,138
Accumulated deficit
( 513,735,465 )
( 462,110,935 )
Total stockholders’ equity
111,335,755
140,436,302
Total liabilities and stockholders’ equity
$ 122,038,221
$ 152,905,179
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,
2023
2022
2023
2022
Operating expenses:
Research and development
$ 13,740,205
$ 30,912,671
$ 29,601,215
$ 55,925,524
General and administrative
12,286,521
14,599,401
24,579,120
27,883,971
Total operating expenses
26,026,726
45,512,072
54,180,335
83,809,495
Loss from operations
( 26,026,726 )
( 45,512,072 )
( 54,180,335 )
( 83,809,495 )
Other (expenses) income:
Gain on settlement of fees
-
6,351,606
-
6,351,606
Interest/investment income, net
1,363,406
387,333
2,571,037
717,282
Realized (loss) gain on short-term investments
-
24,502
( 666,708 )
9,480
Unrealized (loss) gain on short-term investments
( 639,634 )
( 1,186,337 )
651,476
( 2,949,624 )
Total other income
723,772
5,577,104
2,555,805
4,128,744
Net loss
$ ( 25,302,954 )
$ ( 39,934,968 )
$ ( 51,624,530 )
$ ( 79,680,751 )
Loss per common share – basic and diluted
$ ( 0.84 )
$ ( 1.33 )
$ ( 1.72 )
$ ( 2.73 )
Weighted average number of common shares outstanding – basic and diluted
30,099,203
29,935,895
30,099,203
29,168,511
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, 2023
Common Stock
Additional
Paid-in
Accumulated
Shares
Par Value
Capital
Deficit
Total
Balance – December 31, 2022
30,099,203
$ 30,099
$ 602,517,138
$ ( 462,110,935 )
$ 140,436,302
Stock based compensation
-
-
11,354,466
-
11,354,466
Net loss
-
-
-
( 26,321,576 )
( 26,321,576 )
Balance – March 31, 2023
30,099,203
30,099
613,871,604
( 488,432,511 )
125,469,192
Stock based compensation
-
-
11,169,517
-
11,169,517
Net loss
-
-
( 25,302,954 )
( 25,302,954 )
Balance – June 30, 2023
30,099,203
$ 30,099
$ 625,041,121
$ ( 513,735,465 )
$ 111,335,755
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
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,
2023
2022
Cash flows from operating activities
Net loss
$
( 51,624,530
)
$
( 79,680,751
)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
22,523,983
24,225,697
Gain on settlement of fees
-
( 6,351,606
)
Realized loss (gain) on short-term investments
666,708
( 9,480
)
Unrealized (gain) loss on short-term investments
( 651,476
)
2,949,624
Change in operating assets and liabilities:
Lease payment receivable
-
44,143
Other receivables
512,432
( 256,192
)
Prepaid expenses and other assets
560,931
7,810,846
Accounts payable
( 408,320
)
2,698,790
Accrued expenses
( 1,358,091
)
7,513,045
Net cash (used in) operating activities
( 29,778,363
)
( 41,055,884
)
Cash flows from investing activities
Purchase of short-term investments
( 45,577,832
)
( 33,412,425
)
Sale of short-term investments
84,429,644
23,244,237
Net cash provided by (used in) investing activities
38,851,812
( 10,168,188
)
Cash flows from financing activities
Proceeds from issuance of common stock, net
-
42,728,599
Proceeds from options exercised for common stock
-
417,544
Proceeds from warrants exercised for common stock
-
895,356
Net cash provided by financing activities
-
44,041,499
Net increase/(decrease) in cash and cash equivalents
9,073,449
( 7,182,573
)
Cash and cash equivalents at beginning of the period
5,395,905
44,443,439
Cash and cash equivalents at end of the period
$
14,469,354
$
37,260,866
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, 2022 and notes thereto contained in the Company’s Annual Report on Form
10-K.
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.
Liquidity
As shown in the accompanying unaudited condensed
consolidated financial statements, the Company incurred negative operating cash flows of $ 29,778,363 for the six months ended June 30,
2023 and has an accumulated deficit of $ 513,735,465 from inception through June 30, 2023.
Management believes that the Company’s existing
cash and cash equivalents and short-term investments will enable it to fund operating expenses and capital expenditure requirements for
at least 12 months from the issuance of these unaudited condensed consolidated financial statements. Beyond that point management will
evaluate the size and scope of any subsequent operations and clinical 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.
Further, additional financing 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.
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.
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 and cash equivalents balance of $ 14,469,354 at June 30,
2023 at these institutions exceed the federally insured limits.
5
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
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 in nonconsolidated entities are 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, 2023 consisted
of mutual funds with a fair value of $ 104,059,737 .
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.
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 judgment and may affect the valuation of the fair value of assets and liabilities and their placement
within the fair value hierarchy levels.
The Company’s short-term investment
instruments of $ 104,059,737 at June 30, 2023 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 unaudited condensed consolidated statement of operations under other income. The Company recorded
unrealized loss of $ 639,634 and an unrealized gain of $ 651,476 included in other income for the three and six months ended June 30,
2023, respectively. The Company recorded unrealized losses of $ 1,186,337 and $ 2,949,624 included in other income for the three and
six months ended June 30, 2022, respectively.
6
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
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, 2023 and
December 31, 2022, 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, 2023 and December
31, 2022. The open tax years, subject to potential examination by the applicable taxing authority, for the Company are from June 30, 2018
forward.
Research and Development
Research and development costs primarily consist
of research contracts for the advancement of product development, salaries and benefits, stock-based compensation, and consultants. The
Company expenses all research and development costs in the period incurred. The Company makes an estimate of costs in relation to clinical
study contracts. The Company analyzes the progress of studies, including the progress of clinical studies and phases, invoices received
and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability.
Stock-Based Compensation
The Company measures the cost of employee services
received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over
the period during which an employee is required to provide service in exchange for the award - the requisite service period. The grant-date
fair value of employee share options is estimated using the Black-Scholes option pricing model adjusted for the unique characteristics
of those instruments.
Net Loss per Common Share
Basic 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 losses in each period.
For the six months ended June 30, 2023 and 2022, 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,
2023
June 30,
2022
Stock options
12,483,856
10,427,310
Common stock warrants
3,027,441
3,084,385
Total
15,511,297
13,511,695
7
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
Recent Accounting Pronouncements
In June 2016, the FASB issued ASU 2016-13, Financial Instruments
- Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments . The standard requires enhanced disclosure of certain
loan refinancings and restructurings by creditors when a borrower is experiencing financial difficulty and eliminates certain current
recognition and measurement accounting guidance. This ASU also requires the disclosure of current-period gross write-offs by year of origination
for financing receivables and net investments in leases. The adoption of this ASU did not have a significant impact on the Company’s
unaudited condensed consolidated financial statements.
NOTE 3 - PREPAID EXPENSES
Prepaid expenses consisted of the following (rounded to nearest $00):
June 30,
2023
December 31,
2022
Insurance
$ 600,400
$ 313.200
Research and Development
2,618,600
3,619,800
Other
255,500
102,200
Total
$ 3,474,500
$ 4,035,200
NOTE 4 - ACCRUED EXPENSES
Accrued expenses consisted of the following (rounded to nearest $00):
June 30,
2023
December 31,
2022
Research and development
$ 4,590,300
$ 5,809,800
Professional fees
149,900
116,500
Accrued bonus
706,600
492,100
Accrued vacation
328,900
529,800
Other
73,200
258,700
Total
$ 5,848,900
$ 7,206,900
8
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 5 - STOCKHOLDERS’ EQUITY
Common Stock
During the six months ended June 30, 2023, no
shares of common stock were issued.
On April 6, 2022, the Company 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. As of June 30, 2023, no shares have been issued under this agreement.
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 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 (the “2021 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 Plan to increase the shares of the Company’s common stock available for
issuance thereunder by 3,900,000 shares.
In May 2023, the Company’s Board of Directors
adopted and shareholders approved an amendment to the 2021 Plan to increase the shares of the Company’s common stock available for
issuance thereunder by 2,500,000 shares.
These combined plans allowed for the granting
of up to 13,052,942 options or other stock awards.
Stock options are exercisable generally for a
period of 10 years from the date of grant and generally vest over four years . As of June 30, 2023, 569,086 shares were
available for future grants under the 2014 or 2021 Plan.
As of June 30, 2023, 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 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.
From January 1, 2023 through June 30, 2023, 680,000
options were issued to various consultants and employees with an exercise price ranging from $ 2.28 to $ 4.30 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
$ 2.1 million calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include:
(1) discount rate of 3.43 – 4.12 % (2) expected life of 6.25 years, (3) expected volatility of 114.2 - 115.6 %, and (4) zero expected
dividends.
At June 30, 2023, the Company has unrecognized
stock-based compensation expense of approximately $ 74.3 million related to unvested stock options which will be recognized over the weighted
average remaining service period of 2.45 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, 2023 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, 2022
12,122,606
$ 18.19
8.5
$ 417,998
Granted
680,000
$ 3.53
9.57
$ 900
Forfeited
( 157,811 )
$ 32.11
-
$ -
Cancelled
( 160,939 )
$ 19.16
-
$ -
Outstanding at June 30, 2023
12,483,856
$ 17.20
8.09
$ 900
Options exercisable at June 30, 2023
5,601,974
$ 20.80
7.20
$ -
Warrants
A summary of the changes in outstanding warrants during the six months
ended June 30, 2023 is as follows:
Number of
Shares
Weighted
Average
Exercise
Price Per
Share
Outstanding at December 31, 2022
3,027,441
$ 17.02
Granted
-
$ -
Exercised
-
$ -
Outstanding at June 30, 2023
3,027,441
$ 17.02
Warrants vested at June 30, 2023
2,826,191
$ 15.91
At June 30, 2023, the Company had approximately
$ 4.7 million of unrecognized compensation expense related to outstanding warrants.
At June 30, 2023, the aggregate intrinsic value
of warrants vested and outstanding was $ 0 .
Stock -based compensation by class of expense
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 six months ended June 30, 2023 and 2022 (rounded to nearest $00):
Six Months
Ended
June 30,
2023
Six Months
Ended
June 30,
2022
Research and development
$ 3,716,800
$ 2,494,800
General and administrative
18,807,200
21,730,900
Total
$ 22,524,000
$ 24,225,700
10
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 6 - 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, 2023, no discussions are active between the Company and Wonpung.
The Company received an upfront license fee of
$ 1,500,000 and will earn royalties of up to 12 % of net sales for up to two licensed products it is currently developing. The licensing
terms for the ROFR products are subject to future negotiations and binding arbitration. The terms of each licensing agreement will expire
on the earlier of any time from 15 years to 20 years after licensing or on the date of commercial availability of a generic product to
such licensed product in the licensed territory.
Third Party Licensor
Based upon a prior acquisition, the Company assumed
an obligation to pay third parties (Dr. Charles E. Inturrisi and Dr. Paolo Manfredi – see below): (A) royalty payments up to 2%
on net sales of licensed products that are not sold by sublicensee and (B) on each and every sublicense earned royalty payment received
by licensee from its sublicensee on sales of license product by sublicensee, the higher of (i) 20% of the royalties received by licensee;
or (ii) up to 2% of net sales of sublicensee. The Company will also make milestone payments of up to $4 million 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, 2023, 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 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, 2023, no events have occurred, and the Company continues to pay Licensor $ 45,000 every three months.
11
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 6 - COMMITMENTS AND CONTINGENCIES (continued)
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 prior 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.
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 and 2023 with monthly rent of approximately $ 9,000 and $ 7,000 , respectively. Beginning on January 1, 2023, we also leased office
space at 880 Third Avenue, 12th Floor, New York, NY 10022 with monthly rent of approximately $ 13,000 , that expires on December 31, 2023.
In accordance with ASC 842, Leases , the Company recognizes rent expense evenly over the 12 months. For the six months ended
June 30, 2023 and 2022, the Company recognized lease expense of approximately $ 137,000 and $ 44,000 , respectively.
On June 8, 2017, the Company entered into an agreement
with Actinium Pharmaceuticals, Inc. Pursuant to the terms of the agreement, Actinium licensed 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. On July 7, 2022, Actinium exercised
its 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 . As of June 30, 2023 and 2022, there was no unearned interest income.
NOTE 7 - 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
$ 80,900 and $ 62,800 for the six months ended June 30, 2023 and 2022, respectively.
NOTE 9 - SUBSEQUENT EVENTS
On
August 1, 2023, 5,000 options were granted to a new employee with an exercise price of $ 2.56 .
12
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.