Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
Relmada Therapeutics, Inc.
Condensed Consolidated Balance Sheets
As of
March 31,
As of
2025
(Unaudited)
December 31,
2024
Assets
Current assets:
Cash and cash equivalents
$ 1,149,706
$ 3,857,026
Short-term investments
25,911,326
41,052,356
Prepaid expenses
596,410
886,461
Total current assets
27,657,442
45,795,843
Other assets
21,975
21,975
Total assets
$ 27,679,417
$ 45,817,818
Commitments and Contingencies (See Note 8)
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 1,265,010
$ 4,130,563
Accrued expenses
3,966,411
6,160,827
Total current liabilities
5,231,421
10,291,390
Stock appreciation rights
7,505
4,467
Total liabilities
5,238,926
10,295,857
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, 33,191,622 and 30,174,202 shares issued and outstanding, respectively
33,191
30,174
Additional paid-in capital
680,848,800
676,373,822
Accumulated deficit
( 658,441,500 )
( 640,882,035 )
Total stockholders’ equity
22,440,491
35,521,961
Total liabilities and stockholders’ equity
$ 27,679,417
$ 45,817,818
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,
2025
2024
Operating expenses:
Research and development
$ 11,951,023
$ 13,305,306
General and administrative
6,267,412
9,682,554
Total operating expenses
18,218,435
22,987,860
Loss from operations
( 18,218,435 )
( 22,987,860 )
Other income:
Interest/investment income, net
440,287
1,055,888
Realized gain on short-term investments
62,952
53,133
Unrealized gain on short-term investments
155,731
50,713
Total other income
658,970
1,159,734
Net loss
$ ( 17,559,465 )
$ ( 21,828,126 )
Loss per common share – basic and diluted
$ ( 0.58 )
$ ( 0.72 )
Weighted average number of common shares outstanding – basic and diluted
30,408,890
30,132,170
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, 2025
Common Stock
Additional
Paid-in
Accumulated
Shares
Par Value
Capital
Deficit
Total
Balance - December 31, 2024
30,174,202
$ 30,174
$ 676,373,822
$ ( 640,882,035 )
$ 35,521,961
Stock based compensation
-
-
3,572,769
-
3,572,769
Issuance of Restricted Common Stock
3,017,420
3,017
902,209
-
905,226
Net loss
-
-
-
( 17,559,465 )
( 17,559,465 )
Balance – March 31, 2025
33,191,622
$ 33,191
$ 680,848,800
$ ( 658,441,500 )
$ 22,440,491
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
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,
2025
2024
Cash flows from operating activities
Net loss
$ ( 17,559,465 )
$ ( 21,828,126 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
4,477,995
8,295,468
Realized gain on short-term investments
( 62,952 )
( 53,133 )
Unrealized gain on short-term investments
( 155,731 )
( 50,713 )
Change in operating assets and liabilities:
Prepaid expenses
290,051
432,723
Accounts payable
( 2,865,553 )
1,683,092
Accrued expenses
( 2,194,416 )
( 1,516,059 )
Stock appreciation rights compensation
3,038
-
Net cash used in operating activities
( 18,067,033 )
( 13,036,748 )
Cash flows from investing activities
Purchase of short-term investments
( 487,916 )
( 7,013,933 )
Sale of short-term investments
15,847,629
17,072,384
Net cash provided by investing activities
15,359,713
10,058,451
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 in cash and cash equivalents
( 2,707,320 )
( 2,756,550 )
Cash and cash equivalents at beginning of the period
3,857,026
4,091,568
Cash and cash equivalents at end of the period
$ 1,149,706
$ 1,335,018
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 NDV-01 and Sepranolone.
NDV-01 is a novel,
controlled-release intravesical formulation of gemcitabine and docetaxel. NDV-01 is currently in a Phase 2 clinical trial to assess its
safety and efficacy in patients with aggressive forms of non-muscle invasive bladder cancer (NMIBC).
Sepranolone is
a novel neurosteroid epimer of allopregnanolone. Sepranolone is being developed for the potential treatment of Prader-Willi Syndrome,
Tourette Syndrome, excessive tremor and other diseases related to excessive GABAergic activity.
The Esmethadone (d-methadone, dextromethadone,
REL-1017) program has been paused pending a comprehensive data review of the data generated so far. Esmethadone 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 was also developing a proprietary, modified-release formulation
of psilocybin (REL-P11) for metabolic indications. This program was terminated effective May 12, 2025, after a successful P1 study and
in light of the adversely changed regulatory environment affecting chronic administration of psylocibin and potentially other psychedelic
drugs.
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.
On January 21,
2025, we received a deficiency letter from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market
advising that, for 30 consecutive business days preceding the notification letter, the Company did not meet the minimum $ 1.00 per share
bid price requirement for continued inclusion on The Nasdaq Global Select Market. The deficiency letter does not result in the immediate
delisting of our common stock from the Nasdaq Global Select Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A) (the “Compliance
Period Rule”), we have been provided an initial period of 180 calendar days, or until July 21, 2025 (the “Compliance Date”),
to regain compliance with the minimum bid price requirement. If, at any time before the Compliance Date, the bid price for our common
stock closes at $ 1.00 per share or more for a minimum of 10 consecutive business days, as required by the Compliance Period Rule, the
Staff will provide written notification to us that we comply with the minimum bid price requirement, unless the Staff exercises its discretion
to extend this 10-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). While we intend to regain compliance with the minimum bid price requirement,
there can be no assurance that we will be able to maintain continued compliance with this rule or the other listing requirements of The
Nasdaq Stock Market. If we were unable to meet these requirements, we would receive another delisting notice from the Nasdaq Stock Market
for failure to comply with one or more of the continued listing requirements. If our common stock were to be delisted from The Nasdaq
Global Select Market, trading of our common stock most likely will be conducted in the over-the-counter market on an electronic bulletin
board established for unlisted securities such as the OTC Markets or in the “pink sheets.” Such a downgrading in our listing
market may limit our ability to make a market in our common stock and which may impact purchases or sales of our securities.
On February 3,
2025, the Company entered into an Asset Purchase Agreement (the Purchase Agreement) with Asarina Pharma AB (Asarina), a Swedish corporation,
pursuant to which the Company has agreed, subject to the terms and conditions set forth therein, to purchase from Asarina all right,
title, and interest in Sepranolone, a phase 2b ready neurosteroid being developed for the potential treatment of Prader-Willi Syndrome,
Tourette Syndrome, essential tremor and other diseases related to excessive GABAergic activity. The total purchase price for Sepranolone
is € 3,000,000 . The Company paid Asarina $ 2,756,000 on February 5, 2025, which includes a credit of $ 250,000 for a previous
payment made by the Company to Asarina pursuant to an exclusivity agreement dated October 25, 2024.
On March 24,
2025, we entered into an Exclusive License Agreement with Trigone, an Israeli company. The license agreement is for Trigone’s
NDV-01 product, which is a novel, sustained-release, intravesical gemcitabine/docetaxel, ready-for-use product candidate for the
treatment of NMIBC. Under the terms of the agreement, the Company made a $ 3,500,000 upfront payment on March 25, 2025, and issued
3,017,420 shares of common stock, which represented 10 % of the Company’s outstanding shares on such date, for exclusive worldwide rights
to NDV-01, excluding Israel, India and South Africa.
In addition, the Company will pay up to approximately $ 200 million
in development, regulatory and sales milestones pending successful commercialization. The Company will also pay a royalty of 3 % on any
net sales.
NOTE 2 - GOING
CONCERN
These unaudited
condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles applicable
to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
As shown in the accompanying unaudited condensed consolidated financial statements, the Company has incurred losses and negative cash flows from operations since inception and expects to incur additional losses until such time that it can generate significant revenue from the commercialization of its product candidates. During the three months ended March 31, 2025, the Company incurred a net loss of $ 17,559,465 and had negative operating cash flows of $ 18,067,033 . Given the Company’s projected operating requirements and its existing cash and cash equivalents and short-term investments, the Company is projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements are issued. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern.
5
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 2 - GOING
CONCERN (continued)
In response to
these conditions, management is currently evaluating the size and scope of any subsequent operations and clinical trials that will affect
the timing to obtain the required funding of future operations. Financing strategies may include, but are not limited to, the public
or private sale of equity or debt securities or from bank or other loans or through strategic collaboration and/or licensing agreements.
There can be no assurances that the Company will be able to secure additional financing, or if available, that it will be sufficient
to meet its needs or on favorable terms. Because management’s plans have not yet been finalized and are not within the Company’s
control, the implementation of such plans cannot be considered probable. As a result, the Company has concluded that management’s
plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern.
The unaudited
condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded
asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
NOTE 3 - 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, 2024 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.
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 and cash equivalents. The Company’s cash deposits
are held at two high-credit-quality financial institutions. The Company’s cash and cash equivalents are carried at cost, which approximates
their fair value. The Company’s cash and cash equivalents balance of $ 1,149,706 and $ 3,857,026 at March 31, 2025 and December 31,
2024, respectively, at these institutions exceed the federally insured limits.
Short-term Investments
The Company’s investments consist entirely
of mutual funds. The securities are measured at fair value based on the net asset value “NAV”. Substantially all equity investments
in nonconsolidated entities are measured at fair value with recurring changes recognized in earnings, except for those accounted for using
equity accounting methods. 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 condensed consolidated
statement of cash flows.
Short-term investments at March 31, 2025 and December
31, 2024 consisted of mutual funds with a fair value of $ 25,911,326 and $ 41,052,356 , 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 leases consists of operating leases for office space for terms of 12 months or less. 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.
6
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
Fair Value of Financial Instruments
The Company’s financial instruments primarily
include cash, short term investments, and stock appreciation rights. 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 $ 25,911,326 at March 31, 2025 consist of mutual funds and are classified using Level 1 inputs
within the fair value hierarchy because they are valued using NAV. Unrealized gains and losses are recorded in the condensed consolidated
statement of operations as unrealized gain on short-term investment. The Company recorded unrealized gains of $ 155,731 and $ 50,713 included
in other income (expense) for the three months ended March 31, 2025 and 2024, respectively.
The Company’s stock appreciation rights
liability is a mark-to-market liability and classified within Level 3 of the fair value hierarchy as the Company is using a Black-Scholes
option pricing model. Significant unobservable inputs included expected term and volatility. The expected term was calculated using
the simplified method. The volatility is calculated based on the Company’s historical stock price over a period of time.
As of March 31, 2025, the stock appreciation rights
liability had a fair value of $ 7,505 . Significant inputs for Level 3 stock appreciation rights liability fair value measurement
at March 31, 2025 are (1) discount rate of 3.96 % - 4.03 %, (2) expected life of 5.50 – 6.00 years, (3) expected volatility of 128 %
- 131 %, (4) zero expected dividends, (5) stock price of $ 0.27 and (6) exercise price of $ 0.45 - $ 3.84 .
There have been no transfers in and out of level 3 during the three-months
ended March 31, 2025.
7
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 3 - 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 March 31, 2025
and December 31, 2024, 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 March 31, 2025 and December
31, 2024. The open tax years, subject to potential examination by the applicable taxing authority, for the Company are from December 31,
2020 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.
Stock Appreciation Rights
Pursuant to the terms of the Company’s 2021
Equity Incentive Plan, the Company may grant cash-settled Stock Appreciation Rights (“SARs”) that are classified as liabilities
under ASC 718 ( Compensation—Stock Compensation ). These SARs allow employees to receive cash payments based on the appreciation
of the Company’s stock price over a specified period.
The initial fair value of SARs is determined on
the grant date using the Black-Scholes option pricing model. SARs are remeasured at fair value at each reporting date using the Black-Scholes
pricing model until they are exercised or expire. Changes in fair value are recognized in the income statement as a compensation expense.
Compensation expense is recognized over the service period, which is the period during which employees are required to provide service
in exchange for the award.
Upon exercise, the Company will settle SARs in
cash based on the difference between the fair value of the underlying shares at the exercise date and the exercise price.
8
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
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, 2025 and
2024, 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,
2025
March 31,
2024
Stock options
11,258,927
17,013,135
Common stock warrants
872,908
2,235,412
Total
12,131,835
19,248,547
Adoption of Recent Accounting Standards
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 adopted
this standard effective January 1, 2024 and the standard did not have significant impact on our consolidated financial statements.
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 was effective for our annual periods beginning
January 1, 2025. The Company adopted this standard effective January 1, 2025 and the updated standard did not have a significant impact
on our consolidated financial statement disclosures.
Recent Accounting Standards
In November 2024, the FASB issued ASU 2024-03,
Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40) . ASU 2024-03 requires
specified information about certain costs and expenses be disclosed in the notes to the financial statements, including the expense caption
on the face of the income statement in which they are disclosed, in addition to a qualitative description of remaining amounts not separately
disaggregated. Entities will also be required to disclose their definition of “selling expenses” and the total amount in each
annual period. The standard is effective for the Company for annual periods beginning January 1, 2027 and for interim periods beginning
January 1, 2028, with updates applied either prospectively or retrospectively. Early adoption is permitted. The Company is currently evaluating
the impact of this guidance on its disclosures.
9
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 4 - PREPAID EXPENSES
Prepaid expenses consisted of the following (rounded to nearest $00):
March 31,
2025
December 31,
2024
Insurance
$ 195,000
$ 403,100
Research and Development
265,900
391,200
Other
135,500
92,200
Total
$ 596,400
$ 886,500
NOTE 5 - ACCRUED EXPENSES
Accrued expenses consisted of the following (rounded to nearest $00):
March 31,
2025
December 31,
2024
Research and development
$ 2,566,400
$ 4,514,800
Professional fees
313,200
362,600
Accrued bonus
457,300
732,300
Accrued vacation
561,900
421,700
Other
67,600
129,400
Total
$ 3,966,400
$ 6,160,800
NOTE 6 - STOCK APPRECIATION RIGHTS
During the three months ended March 31, 2025,
300,000 cash-settled stock appreciation rights have been issued to consultants with an exercise price of $ 0.45 with a 10 -year term and
vesting over a 4 -year period. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 4.43 %, (2) expected
life of 6.25 years, (3) expected volatility of 135 %, and (4) zero expected dividends.
At March 31, 2025, the Company revalued the cash-settled
stock appreciation rights using a stock price of $ 0.27 and an exercise price of $ 0.45 - $ 3.84 . Variables used in the Black-Scholes option-pricing
model include: (1) discount rate of 3.96 % - 4.03 %, (2) expected life of 5.50 – 6.00 years, (3) expected volatility of 128 % - 131 %
and (4) zero expected dividends.
As of March 31, 2025, the total liability related
to cash-settled SARs is $ 7,505 , reflecting the fair value as of the reporting date. During the quarter ended March 31, 2025, the Company
recorded compensation related to the cash-settled SARs in the amount of $ 3,038 , included in research and development expenses in the accompanying
unaudited condensed consolidated statements of operations.
A summary of the changes in SARs during the three months ended March
31, 2025 is as follows:
Number of Cash-Settled
SARS Weighted
Average
Exercise
Price Weighted
Average
Remaining
Contractual
Term Aggregate
Intrinsic
Value
Outstanding at December 31, 2024 110,000 $ 0.99 9.58 $ -
Granted 300,000 $ 0.33 9.76 $ -
Outstanding at March 31, 2025 410,000 $ 1.32 9.65 $ -
SARs vested at March 31, 2025 -
$ -
- $ -
At March 31, 2025, the Company has unrecognized
compensation expense of approximately $ 82,300 related to unvested stock appreciation rights which will be recognized over the weighted
average remaining service period of 3.65 years.
10
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 7 - STOCKHOLDERS’ EQUITY
Common Stock
During the year ended December 31, 2024, the Company
issued 74,999 shares of common stock for the exercise of options for proceeds of $ 246,747 .
During the three months ended March 31, 2025, the Company issued 3,017,420 shares
of restricted common stock in accordance with the license agreement with Trigone Pharma. The Company recognized $ 905,226 of research and
development compensation expense related to the restricted common stock issued as part of the transaction.
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, 2025, 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 .
The Company uses the simplified method for share-based
compensation to estimate the expected term for employee option awards for share-based compensation in its option-pricing model.
From January 1, 2025 through March 31, 2025, 203,567 options
were issued with an exercise price of $ 0.30 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 $ 54,963 calculated using the Black-Scholes option-pricing
model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 4.05 % - 4.16 % (2) expected life of 6.25 years,
(3) expected volatility of 126 %, and (4) zero expected dividends.
11
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 7 - STOCKHOLDERS’ EQUITY (continued)
Options
A summary of the changes in options during the
three months ended March 31, 2025 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, 2024 12,263,017 $ 16.61 6.01 $ -
Granted 203,567 $ 0.30 -
$
Cancelled ( 1,207,657 ) $ 17.34 - $ -
Outstanding at March 31, 2025 11,258,927 $ 16.24 6.46 $ -
Options exercisable at March 31, 2025 8,748,097 $ 19.02 6.02 $ -
At March 31, 2025, the Company has unrecognized stock-based compensation
expense of approximately $ 12.8 million related to unvested stock options which will be recognized over the weighted average remaining
service period of 1.99 years.
Warrants
A summary of the changes in outstanding warrants during the three months
ended March 31, 2025 is as follows:
Number of
Shares
Weighted
Average
Exercise
Price
Per
Share
Outstanding Warrants at December 31, 2024
1,382,613
$ 17.02
Expired
( 509,705 )
-
Outstanding at March 31, 2025
872,908
$ 29.25
Warrants Vested at March 31, 2025
865,033
$ 29.28
At March 31, 2025, the Company had approximately
$ 112,300 of unrecognized compensation expense related to outstanding warrants.
At March 31, 2025, 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 restricted stock, stock options, and warrants in the unaudited consolidated statements
of operations for the three months ended March 31, 2025 and 2024 (rounded to nearest $00):
Three Months
Ended
March 31,
2025
Three Months
Ended
March 31,
2024
Research and development
$ 1,067,300
$ 1,699,300
General and administrative
3,410,700
6,596,200
Total
$ 4,478,000
$ 8,295,500
12
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 8 - COMMITMENTS AND CONTINGENCIES
License Agreements
Third Party Licensor
Based upon a prior acquisition, the Company
assumed an obligation to pay a third party (Dr. Charles E. Inturrisi and Dr. Paolo Manfredi – see below): (A) royalty payments
up to 2 % on net sales of licensed products that are not sold by sublicensee and (B) on each and every sublicense earned royalty
payment received by licensee from its sublicensee on sales of license product by sublicensee, the higher of (i) 20 % of the royalties
received by licensee; or (ii) up to 2 % of net sales of sublicensee. The Company will also make milestone payments of up to $ 4 or $ 2
million, for the first commercial sale of product in the field that has a single active pharmaceutical ingredient, and for the first
commercial sale of product in the field of product that has more than one active pharmaceutical ingredient, respectively. As of
March 31, 2025, 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, 2025, 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, co-inventor of REL-1017, and Dr. Marco Pappagallo, are among the scientists affiliated with
Arbormentis, LLC.
On May 12, 2025, the Company delivered to
Arbormentis LLC a formal notice of termination of the License Agreement, ending the Company’s participation in the previously
announced psilocybin development program. As a result of the cancellation, all obligations under the license agreement with
Arbormentis will cease as of the effective termination date, which is 90 days after the date of notice.
Trigone
On March 24, 2025, we entered into an Exclusive
License Agreement with Trigone, an Israeli company. The license agreement is for Trigone’s NDV-01 product, which is a novel, sustained-release,
intravesical gemcitabine/docetaxel, ready-for-use product candidate for the treatment of NMIBC. Under the terms of the agreement, the
Company made a $ 3,500,000 upfront payment on March 25, 2025, and issued 3,017,420 shares of common stock, which represent 10 % of the Company’s
outstanding shares, for exclusive worldwide rights to NDV-01, excluding Israel, India and South Africa.
In addition, the Company will pay up to $ 200 million
in development, regulatory and sales milestones pending successful commercialization. The Company will also pay a royalty of 3 % on any
net sales.
13
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 8 - COMMITMENTS AND CONTINGENCIES (continued)
Leases and Subleases
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 each subsequent year
with monthly rent for the years end December 31, 2025 and 2024 of approximately $ 4,100 , and $ 7,000 , respectively.
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 was terminated on May
31, 2024 .
Beginning on May 29, 2024, we leased office space
at 12 E 49 th Street, New York, NY 10022 with monthly rent of approximately $ 10,500 ; that lease expires on May 30, 2025 .
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, 2025 and
2024, the Company recognized lease expense of approximately $ 44,800 and $ 62,400 , 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 9 - OTHER POSTRETIREMENT 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 $ 47,700
and $ 35,000 for the three months ended March 31, 2025 and 2024, respectively.
NOTE 10 - SEGMENT REPORTING
The Company determined its reporting units in
accordance with ASC 280, Segment Reporting . Reportable operating segments are determined based on the management approach, as defined
by ASC 280, is based on the way that the chief operating decision-maker (CODM) organizes segments within the Company for making operating
decisions, assessing performance, and allocating resources. Reportable segments are based on products and services, geography, legal structure,
management structure, or any other manner in which management disaggregates the Company.
Management determined the Company’s operations
constitute a single reportable segment in accordance with ASC 280: clinical stage drug development. The Company derives all of its losses
from the development of clinical stage drugs expenses. The Company’s CODM is its chief executive officer and chief financial officer.
The CODM assesses performance and makes operating decisions about allocating resources based on the research and development operating
expenses on the Consolidated Statements of Operations. The CODM does not review assets in evaluating the results of the clinical stage
development, and therefore, such information is not presented.
The following table provides the operating expenses
of our clinical stage drug development segment (rounded to the nearest $00):
March 31,
March 31,
2025
2024
Clinical Study Expense
$ 7,960,600
$ 3,172,600
Other Research Expense
1,831,000
7,066,900
Manufacturing and Drug Storage Expense
155,600
292,500
Pre-clinical Expense
-
33,700
Compensation Expense
933,500
1,040,300
Stock-based Compensation Expense
1,070,300
1,699,300
Total Research and Development Expense
$ 11,951,000
$ 13,305,300
NOTE 11 - SUBSEQUENT EVENTS
On May 12, 2025, the Company delivered to Arbormentis
LLC a formal notice of termination of the Company’s License Agreement with Arbormentis LLC, ending the Company’s participation
in the previously announced psilocybin development program. This decision was made following a strategic review of the Company’s
research and development priorities. As a result of the cancellation, all obligations under the license agreement with Arbormentis will
cease as of the effective termination date, which is 90 days after the date of notice. The Company does not expect any material financial
impact resulting from this termination.
14
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.