Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
Relmada Therapeutics, Inc.
Condensed Consolidated Balance Sheets
As of
March 31,
As of
2024
(Unaudited)
December 31,
2023
Assets
Current assets:
Cash and cash equivalents
$ 1,335,018
$ 4,091,568
Short-term investments
82,277,687
92,232,292
Prepaid expenses
752,334
1,185,057
Total current assets
84,365,039
97,508,917
Other assets
43,125
43,125
Total assets
$ 84,408,164
$ 97,552,042
Commitments and Contingencies (See Note 6)
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 5,189,101
$ 3,506,009
Accrued expenses
7,172,732
8,688,791
Total current liabilities
12,361,833
12,194,800
Total liabilities
12,361,833
12,194,800
Stockholders’ Equity:
Preferred stock, $ 0.001 par value, 200,000,000 shares authorized, none issued and outstanding
-
-
Class A convertible preferred stock, $ 0.001 par value, 3,500,000 shares authorized, none issued and outstanding
-
-
Common stock, $ 0.001 par value, 150,000,000 shares authorized, 30,174,202
and 30,099,203 shares issued and outstanding, respectively
30,174
30,099
Additional paid-in capital
654,746,964
646,229,824
Accumulated deficit
( 582,730,807 )
( 560,902,681 )
Total stockholders’ equity
72,046,331
85,357,242
Total liabilities and stockholders’ equity
$ 84,408,164
$ 97,552,042
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
March 31,
2024
2023
Operating expenses:
Research and development
$ 13,305,306
$ 15,861,010
General and administrative
9,682,554
12,292,599
Total operating expenses
22,987,860
28,153,609
Loss from operations
( 22,987,860 )
( 28,153,609 )
Other income (expenses):
Interest/investment income, net
1,055,888
1,207,631
Realized gain (loss) on short-term investments
53,133
( 666,708 )
Unrealized gain on short-term investments
50,713
1,291,110
Total other income (expenses)
1,159,734
1,832,033
Net loss
$ ( 21,828,126 )
$ ( 26,321,576 )
Loss per common share – basic and diluted
$ ( 0.72 )
$ ( 0.87 )
Weighted average number of common shares outstanding – basic and diluted
30,132,170
30,099,203
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
2
Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Changes
in Stockholders’ Equity
(Unaudited)
Three months ended March 31, 2024
Common Stock
Additional
Paid-in
Accumulated
Shares
Par Value
Capital
Deficit
Total
Balance - December 31, 2023
30,099,203
$ 30,099
$ 646,229,824
$ ( 560,902,681 )
$ 85,357,242
Stock based compensation
-
-
8,295,468
-
8,295,468
Options exercised for common stock
74,999
75
246,672
-
246,747
ATM Fees
-
-
( 25,000 )
-
( 25,000 )
Net loss
-
-
-
( 21,828,126 )
( 21,828,126 )
Balance – March 31, 2024
30,174,202
$ 30,174
$ 654,746,964
$ ( 582,730,807 )
$ 72,046,331
Three months ended March 31, 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
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)
Three months ended
March 31,
2024
2023
Cash flows from operating activities
Net loss
$ ( 21,828,126 )
$ ( 26,321,576 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
8,295,468
11,354,466
Realized (gain) loss on short-term investments
( 53,133 )
666,708
Unrealized gain on short-term investments
( 50,713 )
( 1,291,110 )
Change in operating assets and liabilities:
Other receivables
-
512,432
Prepaid expenses
432,723
945,606
Accounts payable
1,683,092
( 839,971 )
Accrued expenses
( 1,516,059 )
( 1,531,649 )
Net cash used in operating activities
( 13,036,748 )
( 16,505,094 )
Cash flows from investing activities
Purchase of short-term investments
( 7,013,933 )
( 34,767,287 )
Sale of short-term investments
17,072,384
74,770,836
Net cash provided by investing activities
10,058,451
40,003,549
Cash flows from financing activities
Proceeds from options exercised for common stock
246,747
-
ATM Fees
( 25,000 )
-
Net cash provided by financing activities
221,747
-
Net (decrease) increase in cash and cash
equivalents
( 2,756,550 )
23,498,455
Cash and cash equivalents at beginning of the period
4,091,568
5,395,905
Cash and cash equivalents at end of the period
$ 1,335,018
$ 28,894,360
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. Relmada is also developing a proprietary, modified-release formulation of psilocybin (REL-P11) for metabolic indications.
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, 2023 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 $ 13,036,748 for the three months ended March
31, 2024 and has an accumulated deficit of $ 582,730,807 from inception through March 31, 2024.
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 $ 1,335,018 at March
31, 2024 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 condensed consolidated
statement of operations. Short term investment activity is presented in the investing activities section on the condensed consolidated
statement of cash flows.
Short-term investments at March 31, 2024 and December 31, 2023 consisted of mutual funds with a fair value of $ 82,277,687 and 92,232,292 ,
respectively.
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 $ 82,277,687 at March 31, 2024 consist of mutual funds, bank deposits and money market funds and are classified using Level 1
inputs within the fair value hierarchy because the value is based on quoted prices in active markets. Unrealized gains and losses are
recorded in the condensed consolidated statement of operations under other income. The Company recorded unrealized gain of $ 50,713 and
an unrealized loss of $ 1,291,110 included in other income for the three months ended March 31, 2024 and 2023, 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 March
31, 2024 and December 31, 2023, 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.
6
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
The Company files a U.S. Federal income tax return
and various state returns. Uncertain tax positions taken on the Company’s tax returns will be accounted for as liabilities for
unrecognized tax benefits. The Company will recognize interest and penalties, if any, related to unrecognized tax benefits in general
and administrative expenses in the statements of operations. There were no liabilities recorded for uncertain tax positions at March
31, 2024 and December 31, 2023. 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 three months ended March 31, 2024 and
2023, 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):
Three months ended
March 31,
2024
March 31,
2023
Stock options
17,013,135
12,487,917
Common stock warrants
2,235,412
3,027,441
Total
19,248,547
15,515,358
Recent Accounting Pronouncements
In October 2021, the FASB issued ASU 2021-08,
“ Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers ”.
The amendments in this ASU require that an entity (acquirer) recognize, and measure contract assets and contract liabilities acquired
in a business combination, including contract assets and contract liabilities arising from revenue contracts with customers, as if it
had originated the contracts as of the acquisition date. The amendments in this ASU were effective for annual and interim periods beginning
after December 15, 2022. The Company adopted this standard effective January 1, 2023 and the standard did not have a significant impact
on our consolidated financial statements.
In November 2023, The FASB issued ASU 2023-07,
“ Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures ” which expands annual and interim disclosures
for reportable segments, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for our annual
periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted. The Company is currently
evaluating the potential effect that the updated standard will have on our financial statement disclosures.
In December 2023, the FASB issued ASU 2023-09,
“ Income Taxes (Topic 740): Improvements to Income Tax Disclosures ” to expand the disclosure requirements for income
taxes, specifically related to the rate reconciliation and income taxes paid. ASU 2023-09 is effective for our annual periods beginning
January 1, 2025, with early adoption permitted. The Company is currently evaluating the potential effect that the updated standard will
have on our financial statement disclosures.
7
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):
March 31,
2024
December 31,
2023
Insurance
$ 135,000
$ 365,100
Research and Development
477,900
695,000
Other
139,400
125,000
Total
$ 752,300
$ 1,185,100
NOTE 4 - ACCRUED EXPENSES
Accrued expenses consisted of the following (rounded to nearest $00):
March 31,
2024
December 31,
2023
Research and development
$ 6,133,700
$ 5,394,700
Professional fees
256,200
174,000
Accrued bonus
305,800
2,632,400
Accrued vacation
371,500
372,200
Other
105,500
115,500
Total
$ 7,172,700
$ 8,688,800
NOTE 5 - STOCKHOLDERS’ EQUITY
Common Stock
During the three
months ended March 31, 2024, the Company issued 74,999 shares of common stock for the exercise
of options for proceeds of $ 246,747 .
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 March 31, 2024, 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 other 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 March 31, 2024, no shares were available for future
grants under the 2014 or 2021 Plan. The shareholders will vote at their annual meeting in 2024 on a management proposal to increase the
shares available to be issued under the 2021 Plan by 4.5 million shares. There can be no assurance such amendment will be approved. As
of March 31, 2024, options for 3,960,193 shares of common stock had been issued subject to approval by the shareholders of this amendment.
If the amendment is not approved, such options will be forfeited.
As of March 31, 2024, no stock appreciation rights
have been issued.
8
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 5 - STOCKHOLDERS’ EQUITY (continued)
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, 2024 through March 31, 2024, 50,000 options
were issued to a consultant with an exercise price of $ 3.44 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 $ 148,000 calculated using the Black-Scholes
option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 4.1 % (2) expected life
of 6.25 years, (3) expected volatility of 113.5 %, and (4) zero expected dividends.
At March 31, 2024, the Company has unrecognized
stock-based compensation expense of approximately $ 54.0 million related to unvested stock options which will be recognized over the weighted
average remaining service period of 2.30 years.
Options
A summary of the changes in options during the
three months ended March 31, 2024 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, 2023
17,416,192
$ 12.99
8.3
$ 11,183,370
Granted
50,000
$ 3.44
9.81
$ 60,500
Exercised
( 74,999 )
$ -
-
$ -
Forfeited
( 18,057 )
$ -
-
$ -
Cancelled
( 360,001 )
$ -
-
$ -
Outstanding at March 31, 2024
17,013,135
$ 13.20
8.02
$ 15,146,066
Options exercisable at March 31, 2024
7,947,879
$ 19.39
6.94
$ 2,491,510
Warrants
A summary of the changes in outstanding warrants during the three
months ended March 31, 2024 is as follows:
Number of
Shares
Weighted
Average
Exercise
Price
Per
Share
Outstanding Warrants at December 31, 2023
2,381,366
$ 20.02
Forfeited
( 145,954 )
-
Outstanding at March 31, 2024
2,235,412
$ 20.81
Warrants Vested at March 31, 2024
2,117,037
$ 20.17
At March 31, 2024, the Company had approximately
$ 2.4 million of unrecognized compensation expense related to outstanding warrants.
At March 31, 2024, the aggregate intrinsic value
of warrants vested and outstanding was $ 39,119 .
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 three months ended March 31, 2024 and 2023 (rounded to nearest $00):
Three Months
Ended
March 31,
2024
Three Months
Ended
March 31,
2023
Research and development
$ 1,699,300
$ 1,994,200
General and administrative
6,596,200
9,360,300
Total
$ 8,295,500
$ 11,354,500
9
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 March 31, 2024, 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 March 31, 2024, 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 March 31, 2024, 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 Safety/Adjudication Officer, are among the scientists affiliated with Arbormentis, LLC.
10
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 6 - COMMITMENTS AND CONTINGENCIES (continued)
Leases and Sublease
On August 1, 2021, the Company relocated its corporate
headquarters to 2222 Ponce de Leon, Floor 3, Coral Gables, FL 33134, pursuant to a lease agreement with monthly rent of approximately
$ 11,000 . The lease period was for five months . The lease agreement expired on December 31, 2021 and was renewed for the calendar years
2022, 2023, and 2024, with monthly rent of approximately $ 9,000 , $ 7,000 , 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 lease was terminated
on November 30, 2023 .
Beginning on December 1, 2023, we leased office
space at 12 E 49 th Street, New York, NY 10022 with monthly rent of approximately $ 12,000 ; that lease expires on July 31, 2024 .
In accordance with ASC 842, Leases , the
Company has elected the practical expedient and recognizes rent expense evenly over the 12 months.
For the three months ended March 31, 2024 and
2023, the Company recognized lease expense of approximately $ 62,400 and $ 51,700 , respectively.
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.
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
$ 35,000 and $40,400 for the three months ended March 31, 2024 and 2023, 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.