Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
Relmada
Therapeutics, Inc.
Condensed
Consolidated Balance Sheets
As of
September 30,
As of
2023
(Unaudited)
December 31,
2022
Assets
Current assets:
Cash and cash equivalents
$ 6,698,599
$ 5,395,905
Short-term investments
99,568,502
142,926,781
Other receivables
-
512,432
Prepaid expenses
2,834,037
4,035,186
Total current assets
109,101,138
152,870,304
Other assets
47,715
34,875
Total assets
$ 109,148,853
$ 152,905,179
Commitments and Contingencies (See Note 6)
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 2,856,752
$ 5,261,936
Accrued expenses
5,565,466
7,206,941
Total current liabilities
8,422,218
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
636,434,059
602,517,138
Accumulated deficit
( 535,737,523 )
( 462,110,935 )
Total stockholders’ equity
100,726,635
140,436,302
Total liabilities and stockholders’ equity
$ 109,148,853
$ 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
Nine months ended
September 30,
September 30,
2023
2022
2023
2022
Operating expenses:
Research and development
$ 10,454,072
$ 30,529,108
$ 40,055,287
$ 86,454,632
General and administrative
12,238,566
8,208,053
36,817,686
36,092,024
Total operating expenses
22,692,638
38,737,161
76,872,973
122,546,656
Loss from operations
( 22,692,638 )
( 38,737,161 )
( 76,872,973 )
( 122,546,656 )
Other (expenses) income:
Gain on settlement of fees
-
-
-
6,351,606
Interest/investment income, net
1,321,441
827,614
3,892,478
1,544,898
Realized loss on short-term investments
( 51,714 )
( 561,648 )
( 718,422 )
( 552,171 )
Unrealized (loss) gain on short-term investments
( 579,147 )
( 947,512 )
72,329
( 3,897,135 )
Total other (expense) income – net
690,580
( 681,546 )
3,246,385
3,447,198
Net loss
$ ( 22,002,058 )
$ ( 39,418,707 )
$ ( 73,626,588 )
$ ( 119,099,458 )
Loss per common share – basic and diluted
$ ( 0.73 )
$ ( 1.31 )
$ ( 2.45 )
$ ( 4.04 )
Weighted average number of common shares outstanding – basic and diluted
30,099,203
30,063,735
30,099,203
29,470,198
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 Nine months ended September 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
Stock-based compensation
-
-
11,392,938
-
11,392,938
Net loss
-
-
-
( 22,002,058 )
( 22,002,058 )
Balance – September 30, 2023
30,099,203
$ 30,099
$ 636,434,059
$ ( 535,737,523 )
$ 100,726,635
Three and Nine months ended September 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
Stock-based compensation
-
-
8,343,139
-
8,343,139
Warrant exercised for cash
51,527
51
332,865
-
332,916
Options exercised for cash
17,886
18
286,158
-
286,176
Share exchange – Pre-funded warrants, net of fees
( 1,452,016 )
( 1,452 )
( 48,548 )
-
( 50,000 )
Net loss
-
-
-
( 39,418,707 )
( 39,418,707 )
Balance – September 30, 2022
28,641,991
$ 28,642
$ 590,482,783
$ ( 424,166,570 )
$ 166,344,855
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,
2023
2022
Cash flows from operating activities
Net loss
$ ( 73,626,588 )
$ ( 119,099,458 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
33,916,921
32,568,836
Realized loss on short-term investments
718,422
552,171
Unrealized (gain) loss on short-term investments
( 72,329 )
3,897,135
Change in operating assets and liabilities:
Lease payment receivable
-
86,377
Other receivable
512,432
-
Prepaid expenses and other assets
1,188,309
8,359,994
Accounts payable
( 2,405,184 )
( 766,661 )
Accrued expenses
( 1,641,475 )
6,482,889
Net cash used in operating activities
( 41,409,492 )
( 67,918,717 )
Cash flows from investing activities
Purchase of short-term investments
( 57,151,963 )
( 38,993,173 )
Sale of short-term investments
99,864,149
60,382,229
Net cash provided by investing activities
42,712,186
21,389,056
Cash flows from financing activities
Payment of fees for warrants issued for common stock
-
( 50,000 )
Proceeds from issuance of common stock – net
-
42,728,599
Proceeds from options exercised for common stock
-
703,720
Proceeds from warrants exercised for common stock
-
1,228,272
Net cash provided by financing activities
-
44,610,591
Net increase /(decrease) in cash and cash equivalents
1,302,694
( 1,919,070 )
Cash and cash equivalents at beginning of the period
5,395,905
44,443,439
Cash and cash equivalents at end of the period
$ 6,698,599
42,524,369
Supplemental disclosure of cash flow information:
Non-cash investing and financing activities:
Share exchange for Pre-funded warrants
$ -
$ 1,452
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 $ 41,409,492 for the nine months ended September
30, 2023 and has an accumulated deficit of $ 535,737,523 from inception through September 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 $ 6,698,599 at September 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 September 30, 2023 consisted of mutual funds with a fair value of $ 99,568,502 .
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 $ 99,568,502 at September 30, 2023 consist of mutual 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 (expenses) income. The Company recorded an unrealized loss of $ 579,147 for the three months ended
September 30, 2023 and an unrealized gain of $ 72,329 included in other (expenses) income for the nine months ended September 30, 2023.
The Company recorded unrealized loss of $ 947,512 and $ 3,897,135 included in other (expenses) income for the three and nine months ended
September 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 September 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 September 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 nine months ended September 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):
Nine months ended
September 30,
2023
September 30,
2022
Stock options
12,455,568
10,719,424
Common stock warrants
3,027,441
4,484,874
Total
15,483,009
15,204,298
7
Relmada
Therapeutics, Inc.
Notes
to Unaudited Condensed Consolidated Financial Statements
NOTE
3 – PREPAID EXPENSES
Prepaid
expenses consisted of the following (rounded to nearest $00):
September 30,
2023
December 31,
2022
Insurance
$ 445,100
$ 313,200
Research and Development
2,185,900
3,619,800
Other
203,000
102,200
Total
$ 2,834,000
$ 4,035,200
NOTE
4 – ACCRUED EXPENSES
Accrued
expenses consisted of the following (rounded to nearest $00):
September 30,
2023
December 31,
2022
Research and development
$ 3,860,700
$ 5,809,800
Professional fees
174,900
116,500
Accrued bonus
1,106,900
492,100
Accrued vacation
355,900
529,800
Other
67,100
258,700
Total
$ 5,565,500
$ 7,206,900
NOTE
5 – STOCKHOLDERS’ EQUITY
Common
Stock
During
the nine months ended September 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 September 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.
8
Relmada
Therapeutics, Inc.
Notes
to Unaudited Condensed Consolidated Financial Statements
NOTE
5 – STOCKHOLDERS’ EQUITY (continued)
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, 2023, 597,374 shares were available
for future grants under the 2014 or 2021 Plan.
As
of September 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 September 30,
2023, 690,000 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 – 4.44 % (2) expected life of 6.25 years, (3) expected
volatility of 113.3 – 115.6 %, and (4) zero expected dividends.
On September 5, 2023, Dr. Eric Schmidt, a member
of the Board of Directors (the “Board”), notified the Company that he would resign from the Board, effective immediately.
On September 22, 2023, the Board voted and approved that all of Dr. Schmidt’s unvested options would vest immediately and be exercisable
through the original term of the respective grants. In addition, the Board approved the extension of the exercise period for the options
which were vested on September 5, 2023 from 90 days to the original term of the respective options. As a result of the modifications, the
Company recorded approximately $ 1.2 million of stock-based compensation during the quarter ended September 30, 2023.
At September 30, 2023,
the Company has unrecognized stock-based compensation expense of approximately $ 61.2 million related to unvested stock options which will
be recognized over the weighted average remaining service period of 2.33 years.
Options
A
summary of the changes in options during the nine months ended September 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
690,000
$ 3.52
9.33
$ 14,600
Forfeited
( 191,099 )
$ -
-
$ -
Cancelled
( 165,939 )
$ -
-
$ -
Outstanding at September 30, 2023
12,455,568
$ 17.20
7.86
$ 14,600
Options exercisable at September 30, 2023
6,559,124
$ 20.36
7.17
$ -
Warrants
A
summary of the changes in outstanding warrants during the nine months ended September 30, 2023 is as follows:
Number of
Shares
Weighted
Average
Exercise
Price Per
Share
Outstanding at December 31, 2022
3,027,441
$ 15.24
Granted
-
$ -
Exercised
-
$ -
Outstanding at September 30, 2023
3,027,441
$ 15.24
Warrants vested at September 30, 2023
2,853,816
$ 16.08
9
Relmada
Therapeutics, Inc.
Notes
to Unaudited Condensed Consolidated Financial Statements
NOTE
5 – STOCKHOLDERS’ EQUITY (continued)
At September 30, 2023, the Company had approximately
$ 3.95 million of unrecognized compensation expense related to outstanding warrants.
At
September 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 nine months ended September 30, 2023 and 2022 (rounded to nearest $00):
Nine Months
Ended
September 30,
2023
Nine Months
Ended
September 30,
2022
Research and development
$ 5,463,100
$ 5,674,600
General and administrative
28,453,800
26,894,200
Total
$ 33,916,900
$ 32,568,800
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 September 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 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 September 30, 2023, the Company has not generated any revenue related to this license agreement.
Inturrisi
/ Manfredi
In January 2018, the Company 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 September 30, 2023, no events have occurred, and the Company continues to pay Licensor $ 45,000 every three
months.
10
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, 12 th Floor, New York, NY 10022 with monthly rent of approximately $ 14,500 that expires on December 31,
2023 . In accordance with ASC 842, Leases , the Company recognizes rent expense evenly over the 12 months. For the nine months ended
September 30, 2023 and 2022, the Company recognized lease expense of approximately $ 213,500 and $ 87,100 , 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 September 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 $ 118,800 and $ 87,900 for the nine months ended September 30, 2023 and 2022,
respectively.
NOTE
8 – SUBSEQUENT EVENTS
None.
11
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.