Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
Relmada Therapeutics, Inc.
Condensed Consolidated Balance Sheets
As of
June 30,
As of
2025
(Unaudited)
December 31,
2024
Assets
Current assets:
Cash and cash equivalents
$ 1,353,351
$ 3,857,026
Short-term investments
19,266,190
41,052,356
Prepaid expenses
474,628
886,461
Total current assets
21,094,169
45,795,843
Other assets
21,975
21,975
Total assets
$ 21,116,144
$ 45,817,818
Commitments and Contingencies (See Note 8)
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 1,361,911
$ 4,130,563
Accrued expenses
3,772,636
6,160,827
Total current liabilities
5,134,547
10,291,390
Stock appreciation rights
32,116
4,467
Total liabilities
5,166,663
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
684,224,232
676,373,822
Accumulated deficit
( 668,307,942 )
( 640,882,035 )
Total stockholders’ equity
15,949,481
35,521,961
Total liabilities and stockholders’ equity
$ 21,116,144
$ 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
Six months ended
June 30,
June 30,
2025
2024
2025
2024
Operating expenses:
Research and development
$ 2,819,377
$ 10,721,089
$ 14,770,400
$ 24,026,395
General and administrative
7,401,929
8,097,695
13,669,342
17,780,249
Total operating expenses
10,221,306
18,818,784
28,439,742
41,806,644
Loss from operations
( 10,221,306 )
( 18,818,784 )
( 28,439,742 )
( 41,806,644 )
Other (expenses) income:
Interest/investment income, net
321,458
963,013
761,745
2,018,901
Realized (loss) gain on short-term investments
47,203
133,114
110,156
186,247
Unrealized (loss) gain on short-term investments
( 13,797 )
( 45,465 )
141,934
5,248
Total other income
354,864
1,050,662
1,013,835
2,210,396
Net loss
$ ( 9,866,442 )
$ ( 17,768,122 )
$ ( 27,425,907 )
$ ( 39,596,248 )
Loss per common share – basic and diluted
$ ( 0.30 )
$ ( 0.59 )
$ ( 0.86 )
$ ( 1.31 )
Weighted average number of common shares outstanding – basic and diluted
33,191,622
30,174,202
31,807,943
30,153,186
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 and Six months ended June 30, 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
Stock based compensation
-
-
3,448,453
-
3,448,453
ATM Expenses
-
-
( 73,021 )
-
( 73,021 )
Net loss
-
-
-
( 9,866,442 )
( 9,866,442 )
Balance – June 30, 2025
33,191,622
$ 33,191
$ 684,224,232
$ ( 668,307,942 )
$ 15,949,481
Three and Six months ended June 30, 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 Expenses
-
-
( 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
Stock based compensation
-
-
7,213,419
-
7,213,419
Net loss
-
-
-
( 17,768,122 )
( 17,768,122 )
Balance – June 30, 2024
30,174,202
$ 30,174
$ 661,960,383
$ ( 600,498,929 )
$ 61,491,628
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
3
Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Six months ended
June 30,
2025
2024
Cash flows from operating activities
Net loss
$ ( 27,425,907 )
$ ( 39,596,248 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
7,926,448
15,508,887
Realized (gain) on short-term investments
( 110,156 )
( 186,247 )
Unrealized (gain) on short-term investments
( 141,934 )
( 5,248 )
Change in operating assets and liabilities:
Prepaid expenses and other assets
411,834
637,035
Accounts payable
( 2,768,652 )
668,559
Accrued expenses
( 2,388,191 )
( 3,326,511 )
Stock appreciation rights compensation
27,649
-
Net cash (used in) operating activities
( 24,468,909 )
( 26,299,773 )
Cash flows from investing activities
Purchase of short-term investments
( 809,375 )
( 8,313,312 )
Sale of short-term investments
22,847,630
32,386,030
Net cash provided by investing activities
22,038,255
24,072,718
Cash flows from financing activities
Proceeds from options exercised for common stock
-
246,747
ATM Expenses
( 73,021 )
( 25,000 )
Net cash (used in)/provided by financing activities
( 73,021 )
221,747
Net (decrease)/increase in cash and cash equivalents
( 2,503,675 )
( 2,005,308 )
Cash and cash equivalents at beginning of the period
3,857,026
4,091,568
Cash and cash equivalents at end of the period
$ 1,353,351
$ 2,086,260
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 terminated effective July 7, 2025.
Relmada was also developing a proprietary, modified-release formulation
of psilocybin (REL-P11) for metabolic indications. This program was terminated effective May 12, 2025.
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.
As previously disclosed, on January 21, 2025,
Relmada Therapeutics, Inc. (the “Company”) received a written notification from the Listing Qualifications Department of the
Nasdaq Stock Market (“Nasdaq”) notifying the Company that, for the 30 consecutive business days ended January 17, 2025, the
Company’s security did not maintain a minimum bid price of $ 1 per share. Nasdaq stated in its letter that in accordance with Nasdaq
Listing Rule 5810(c)(3)(A), the Company had a compliance period of 180 calendar days from the date of the notice (“Initial Compliance
Period”), and that it may regain compliance if the closing bid of the Company’s security is at least $ 1 for a minimum of ten
consecutive business days during the Initial Compliance Period, which ended on July 21, 2025.
On July 22, 2025, Nasdaq notified the Company
that it had approved the Company’s application to transfer its listing to the Nasdaq Capital Market. The Company’s common
stock was transferred to the Nasdaq Capital Market at the opening of business on July 24, 2025. Nasdaq also approved a 180-day extension,
or until January 19, 2026 (the “Compliance Period”), to regain compliance with the minimum bid price in accordance with Nasdaq
Listing Rule 5550(a)(2). To regain compliance, the Company’s common stock must maintain a closing bid price of at least $ 1.00 per
share for a minimum of 10 consecutive business days at any time prior to the expiration of the Compliance Period.
The Company intends to actively monitor the Company’s bid price
during the Compliance Period and intends to take all reasonable measures available to regain compliance with the requirements for continued
listing on the Nasdaq Capital Market. While the Company plans to make diligent efforts to maintain the listing of its common stock on
Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with the applicable continued listing
standards set forth in the Nasdaq Listing Rules.
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, a privately held 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 commercial milestones pending successful commercialization. The Company will also pay a royalty
of 3 % on any net sales.
5
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
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 six months ended June 30, 2025, the Company incurred a net loss of $ 27,425,907 and had negative operating cash flows of $ 24,468,909 .
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.
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 $ 1,353,351 and $ 3,857,026 at June 30, 2025 and
December 31, 2024, respectively, at these institutions exceed the federally insured limits.
6
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 3 - 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 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 June 30, 2025 and December
31, 2024 consisted of mutual funds with a fair value of $ 19,266,190 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.
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 $ 19,266,190 at June 30, 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 an unrealized loss of $ 13,797 and an unrealized gains of $ 141,934 included in other
income for the three and six months ended June 30, 2025, respectively. The Company recorded an unrealized loss of $ 45,465 and a realized
gain of $ 5,248 included in other income for the three and six months ended June 30, 2024, respectively.
7
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
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 June 30, 2025, the stock appreciation rights liability had a
fair value of $ 32,116 . Significant inputs for Level 3 stock appreciation rights liability fair value measurement at June 30, 2025
are (1) discount rate of 3.79 % - 3.89 %, (2) expected life of 5.25 – 6.25 years, (3) expected volatility of 132 % - 136 %, (4) zero
expected dividends, (5) stock price of $ 0.60 and (6) exercise price of $ 0.45 - $ 3.84 .
There have been no transfers in and out of level 3 during the three
and six months ended June 30, 2025, 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 June 30, 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 June 30, 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 six months ended June 30, 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):
Six months ended
June 30,
2025
June 30,
2024
Stock options
14,158,927
13,052,592
Common stock warrants
750,908
1,813,455
Total
14,909,835
14,866,047
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.
In May 2025, the FASB issued ASU 2025-03, Business
Combinations (Topic 805) and Consolidation (Topic 810) . This ASU provides clarifications related to step acquisitions and simplifies
certain consolidation assessments involving variable interest entities. The standard is effective for the Company for annual periods beginning
January 1, 2026, and for interim periods beginning January 1, 2027. Early adoption is permitted. The Company is currently evaluating the
impact of this guidance on its consolidated financial statements.
In May 2025, the FASB issued ASU 2025-04, Compensation
– Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic 606). This ASU clarifies when awards fall
under stock compensation guidance. This standard is effective for the Company for annual periods beginning January 1, 2026, and interim
periods beginning January 1, 2027. Early adoption is permitted. The Company is currently evaluating the impact of this guidance on its
consolidated financial statements.
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):
June 30,
2025
December 31,
2024
Insurance
$ 68,000
$ 403,100
Research and Development
307,100
391,200
Other
99,500
92,200
Total
$ 474,600
$ 886,500
NOTE 5 - ACCRUED EXPENSES
Accrued expenses consisted of the following (rounded to nearest $00):
June 30,
2025
December 31,
2024
Research and development
$ 1,890,500
$ 4,514,800
Professional fees
257,000
362,600
Accrued bonus
1,035,900
732,300
Accrued vacation
509,800
421,700
Other
79,400
129,400
Total
$ 3,772,600
$ 6,160,800
NOTE 6 - STOCK APPRECIATION RIGHTS
During the six months ended June 30, 2025, 775,000 cash-settled stock
appreciation rights have been issued to employees and consultants with an exercise price ranging from $ 0.45 to $ 0.67 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 3.90 % - 4.43 %,
(2) expected life of 6.25 years, (3) expected volatility of 135 % - 140 %, and (4) zero expected dividends.
At June 30, 2025, the Company revalued the cash-settled stock appreciation
rights using a stock price of $ 0.60 and an exercise price ranging from $ 0.45 to $ 3.84 . Variables used in the Black-Scholes option-pricing
model include: (1) discount rate of 3.79 % - 3.89 %, (2) expected life of 5.25 – 6.25 years, (3) expected volatility of 132 % - 136 %
and (4) zero expected dividends.
As of June 30, 2025, the total liability related
to cash-settled SARs is $ 32,116 , reflecting the fair value as of the reporting date. For the six months ended June 30, 2025, the Company
recorded compensation related to the cash-settled SARs in the amount of $ 24,611 , included $ 24,439 and $ 172 in research and development
and general and administrative expense, respectively, in the accompanying unaudited condensed consolidated statements of operations.
A summary of the changes in SARs during the six months ended June
30, 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 9.65 $ -
Granted 775,000 $ 0.58 9.81 $ -
Outstanding at June 30, 2025 885,000 $ 0.97 9.72 $ -
SARs vested at June 30, 2025 - $ - - $ -
At June 30, 2025, the Company has unrecognized
compensation expense of approximately $ 440,800 related to unvested stock appreciation rights which will be recognized over the weighted
average remaining service period of 3.72 years.
10
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 7 - STOCKHOLDERS’ EQUITY
Common Stock
During the six months ended June 30, 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.
During the six months ended June 30, 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 (the “ATM”), pursuant to which we may offer and sell, from time
to time, through Jefferies, shares of our common stock, having an aggregate offering price of up to $ 100,000,000 . We are not obligated
to sell any shares under the agreement. As of June 30, 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.
In May 2025, 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 2,000,000 shares.
These combined plans allowed for the granting
of up to 15,052,942 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 June 30, 2025, 3,103,567 options
were issued with a weighted average exercise price of $ 0.65 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 $ 1,894,177 calculated using the Black-Scholes option-pricing
model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 3.90 % - 4.16 % (2) expected life of 6.25 years,
(3) expected volatility of 126 % - 132 %, 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 June 30, 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 3,103,567 $ 0.65 - $
Cancelled ( 1,207,657 ) $ 17.34 - $ -
Outstanding at June 30, 2025 14,158,927 $ 13.05 6.98 $ 61,131
Options exercisable at June 30, 2025 9,162,258 $ 18.63 5.84 $ 66
At June 30, 2025, the Company has unrecognized
stock-based compensation expense of approximately $ 11.2 million related to unvested stock options which will be recognized over the weighted
average remaining service period of 2.98 years.
Warrants
A summary of the changes in outstanding warrants during the six months
ended June 30, 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
( 631,905 )
-
Outstanding at June 30, 2025
750,908
$ 28.86
Warrants Vested at June 30, 2025
745,658
$ 28.87
At June 30, 2025, the Company had approximately
$ 56,800 of unrecognized compensation expense related to outstanding warrants.
At June 30, 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 six months ended June 30, 2025 and 2024 (rounded to nearest $00):
Six Months
Ended
June 30,
2025
Six Months
Ended
June 30,
2024
Research and development
$ 1,236,200
$ 3,279,300
General and administrative
6,690,200
12,229,600
Total
$ 7,926,400
$ 15,508,900
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 June 30, 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 June
30, 2025, no events have occurred, and the Company continued to pay Licensor $ 45,000 every three months. See Note 11 below.
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.
13
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 8 - COMMITMENTS AND CONTINGENCIES (continued)
Trigone
On March 24, 2025, we entered into an
Exclusive License Agreement with Trigone, a privately held 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 commercial milestones pending successful commercialization. The Company will also pay a royalty of
3 % on any net sales.
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 expired on May 30, 2025 with
the Company continuing to lease the space under a month-to-month option.
In accordance with ASC 842, Leases , the
Company has elected the practical expedient and recognizes rent expense evenly over the 12 months.
For the six months ended June 30, 2025 and 2024, the Company recognized
lease expense of approximately $ 98,500 and $ 122,100 , 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.
14
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 approximately $ 100,700
and $ 69,400 for the six months ended June 30, 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 for the three and six months ended June 30, 2025 and 2024 (rounded to the nearest $00):
Three months ended
June 30,
Six months ended
June 30,
2025
2024
2025
2024
Clinical Study Expense
$ 779,600
$ 1,587,500
$ 8,740,200
$ 4,760,100
Other Research Expense
702,200
6,239,500
2,533,200
13,306,300
Manufacturing and Drug Storage Expense
81,600
681,500
237,200
974,000
Pre-clinical Expense
-
-
-
33,700
Compensation Expense
1,062,700
632,600
1,996,100
1,673,000
Stock-based Compensation Expense
193,300
1,580,000
1,263,700
3,279,300
Total Research and Development Expense
$ 2,819,400
$ 10,721,100
$ 14,770,400
$ 24,026,400
NOTE 11 - SUBSEQUENT EVENTS
On July 7, 2025, the Company delivered to the
Licensor under the License Agreement with Dr. Charles E. Inturrisi and Dr. Paolo Manfredi formal notice of termination of the License
Agreement, ending the Company’s participation in the previously announced esmethadone development program. As a result of the notice
of termination, all material obligations under the license agreement with the Licensor will cease 90 days after the date of the notice.
15
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.