Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
Relmada Therapeutics, Inc.
Condensed Consolidated Balance Sheets
As of
September 30,
As of
2025
(Unaudited)
December 31,
2024
Assets
Current assets:
Cash and cash equivalents
$ 1,384,484
$ 3,857,026
Short-term investments
12,502,040
41,052,356
Prepaid expenses
967,745
886,461
Total current assets
14,854,269
45,795,843
Other assets
21,975
21,975
Total assets
$ 14,876,244
$ 45,817,818
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 1,453,102
$ 4,130,563
Accrued expenses
3,736,496
6,160,827
Total current liabilities
5,189,598
10,291,390
Stock appreciation rights
221,107
4,467
Total liabilities
5,410,705
10,295,857
Commitments and Contingencies (See Note 8)
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
687,831,786
676,373,822
Accumulated deficit
( 678,399,438 )
( 640,882,035 )
Total stockholders’ equity
9,465,539
35,521,961
Total liabilities and stockholders’ equity
$ 14,876,244
$ 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
Nine months ended
September 30,
September 30,
2025
2024
2025
2024
Operating expenses:
Research and development
$ 4,036,267
$ 11,149,136
$ 18,806,667
$ 35,175,531
General and administrative
6,291,079
11,859,702
19,960,421
29,639,951
Total operating expenses
10,327,346
23,008,838
38,767,088
64,815,482
Loss from operations
( 10,327,346 )
( 23,008,838 )
( 38,767,088 )
( 64,815,482 )
Other (expenses) income:
Interest/investment income, net
247,013
856,478
1,008,758
2,875,379
Realized (loss) gain on short-term investments
( 81,438 )
147,835
28,717
334,082
Unrealized gain on short-term investments
70,275
278,555
212,210
283,803
Total other (expense) income – net
235,850
1,282,868
1,249,685
3,493,264
Net loss
$ ( 10,091,496 )
$ ( 21,725,970 )
$ ( 37,517,403 )
$ ( 61,322,218 )
Loss per common share – basic and diluted
$ ( 0.30 )
$ ( 0.72 )
$ ( 1.16 )
$ ( 2.03 )
Weighted average number of common shares outstanding – basic and diluted
33,191,622
30,174,202
32,274,238
30,160,242
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 Nine months ended September 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
Stock-based compensation
-
-
3,607,554
-
3,607,554
Net loss
-
-
-
( 10,091,496 )
( 10,091,496 )
Balance – September 30, 2025
33,191,622
$ 33,191
$ 687,831,786
$ ( 678,399,438 )
$ 9,465,539
Three and Nine months ended September 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 exercises 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
Stock-based compensation
-
-
7,949,125
-
7,949,125
ATM Expenses
-
-
( 89,601 )
-
( 89,601 )
Net loss
-
-
-
( 21,725,970 )
( 21,725,970 )
Balance – September 30, 2024
30,174,202
$ 30,174
$ 669,819,907
$ ( 622,224,899 )
$ 47,625,182
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
3
Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Nine months ended
September 30,
2025
2024
Cash flows from operating activities
Net loss
$ ( 37,517,403 )
$ ( 61,322,218 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
11,534,002
23,458,012
Realized gain on short-term investments
( 28,717 )
( 334,082 )
Unrealized gain on short-term investments
( 212,210 )
( 283,803 )
Fair value changes on stock appreciation rights
216,640
12,562
Change in operating assets and liabilities:
Prepaid expenses and other assets
( 81,285 )
( 378,596 )
Accounts payable
( 2,677,461 )
( 1,160,468 )
Accrued expenses
( 2,424,331 )
( 2,947,571 )
Net cash used in operating activities
( 31,190,765 )
( 42,956,164 )
Cash flows from investing activities
Purchase of short-term investments
( 1,043,307 )
( 11,424,986 )
Sale of short-term investments
29,834,551
51,641,225
Net cash provided by investing activities
28,791,244
40,216,239
Cash flows from financing activities
Proceeds from options exercised for common stock
-
246,747
ATM Expenses
( 73,021 )
( 114,601 )
Net cash (used in)/provided by financing activities
( 73,021 )
132,146
Net decrease in cash and cash equivalents
( 2,472,542 )
( 2,607,779 )
Cash and cash equivalents at beginning of the period
3,857,026
4,091,568
Cash and cash equivalents at end of the period
$ 1,384,484
1,483,789
Supplemental disclosure of cash flow information:
Cash paid during the period for:
Interest
$ -
$ -
Income Tax
$ -
$ -
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
4
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 1 - BUSINESS
Relmada Therapeutics, Inc. (Relmada or the Company)
(a Nevada corporation), is a clinical-stage, publicly traded biotechnology company focused on the development of 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.
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.
On September 15, 2025, the Company received written
notice of compliance from Nasdaq stating that for 10 consecutive trading days, from August 29, 2025 to September 12, 2025, the closing
bid price of the Company’s common stock had been at $ 1.00 per share or greater, and accordingly, the Company regained compliance
with Nasdaq Listing Rule 5550(a)(2). Nasdaq informed the Company in the compliance notice that it now considered this matter closed.
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, the Company 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 nine months
ended September 30, 2025, the Company incurred a net loss of $ 37,517,403 and had negative operating cash flows of $ 31,190,765 . At September,
30, 2025, the Company was projecting insufficient liquidity to sustain its operations through one year following the date that the financial
statements are issued.
On November 5, 2025 the Company announced the
closing of its underwritten offering of 40,142,000 shares of its common stock and, in lieu of common stock to certain investors, pre-funded
warrants to purchase up to 5,315,000 shares of common stock. The shares of common stock were sold at an offering price of $ 2.20 per share,
and the pre-funded warrants were sold at an offering price of $ 2.199 per pre-funded warrant, which represents the per share offering price
for the common stock less the $ 0.001 per share exercise price for each such pre-funded warrant. The net proceeds to Relmada from the offering,
before deducting other expenses payable by Relmada, and excluding the exercise of any pre-funded warrants, are approximately $ 94 million.
As of the date of this report, Management believes that the Company’s
existing cash and cash equivalents and short-term investments will enable it to fund operating expenses and capital expenditure requirements
for at least 12 months from the issuance of these unaudited condensed consolidated quarterly financial statements. Beyond that point management
will evaluate the size and scope of any subsequent trials that will affect the timing of additional financings through public or private
sales of equity or debt securities or from bank or other loans or through strategic collaboration and/or licensing agreements. Any such
expenditures related to any subsequent clinical trials will not be incurred until such additional financing is raised. As a result, the
Company concluded that management’s plans alleviated substantial doubt about the Company’s ability to continue as a going
concern as of September 30, 2025 and the Company has sufficient funds to maintain operations for at least 12 months from the issuance
of these unaudited condensed consolidated financial statements.
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 unaudited condensed consolidated 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 $ 1,384,484 and $ 3,857,026 at September 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 September 30, 2025 and December 31, 2024
consisted of mutual funds with a fair value of $ 12,502,040 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 $ 12,502,040
at September 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 gain of $ 70,275 and $ 212,210 included in other income for the three and nine
months ended September 30, 2025, respectively. The Company recorded unrealized gains of $ 278,555 and $ 283,803 included in other income
for the three and nine months ended September 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 September 30, 2025, the stock appreciation rights liability had
a fair value of $ 221,107 . Significant inputs for Level 3 stock appreciation rights liability fair value measurement at September
30, 2025 are (1) discount rate of 3.74 % - 3.84 %, (2) expected life of 5 – 6 years, (3) expected volatility of 132 % - 137 %, (4) zero
expected dividends, (5) stock price of $ 2.01 and (6) exercise price of $ 0.45 - $ 3.84 .
There have been no transfers in and out of level
3 during the three and nine months ended September 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 September 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 September 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 nine months ended September 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):
Nine months ended
September 30,
2025
September 30,
2024
Stock options
14,149,986
13,052,592
Common stock warrants
750,908
1,663,451
Total
14,900,894
14,716,043
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
was 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.
In July 2025, the One Big Beautiful Bill Act (OBBBA)
was enacted in the United States. The OBBBA makes permanent key elements of the Tax Cuts and Jobs Act of 2017, including domestic research
cost expensing among other changes. Many of the tax provisions of the OBBBA are designed to accelerate tax deductions, which could lead
to lower tax payments. The new legislation has multiple effective dates, with certain provisions effective in 2025 and others in the future.
While the Company continues to assess the impact of the tax provisions of the OBBBA on its condensed consolidated financial statements,
the Company currently believes that the tax provisions of the legislation are not expected to have a material impact on the Company’s
Statement of Operations.
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, with updates applied prospectively. 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, with updates applied retrospectively or modified retrospectively. 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):
September 30,
2025
December 31,
2024
Insurance
$ 542,300
$ 403,100
Research and Development
333,400
391,200
Other
92,000
92,200
Total
$ 967,700
$ 886,500
NOTE 5 - ACCRUED EXPENSES
Accrued expenses consisted of the following (rounded to nearest $00):
September 30,
2025
December 31,
2024
Research and development
$ 1,526,300
$ 4,514,800
Professional fees
215,400
362,600
Accrued bonus
1,381,300
732,300
Accrued vacation
532,600
421,700
Other
80,900
129,400
Total
$ 3,736,500
$ 6,160,800
NOTE 6 - STOCK APPRECIATION RIGHTS
During the nine months ended September 30, 2025,
775,000 cash-settled SARs were 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 September 30, 2025, the Company revalued the
cash-settled SARs using a stock price of $ 2.01 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 3.74 % - 3.84 %, (2) expected life of 5 – 6 years, (3) expected
volatility of 132 % - 137 % and (4) zero expected dividends.
As of September 30, 2025, the total liability
related to cash-settled SARs is $ 221,107 , reflecting the fair value as of the reporting date. For the nine months ended September 30,
2025, the Company recorded compensation related to the cash-settled SARs in the amount of $ 216,640 , included $ 202,159 and $ 14,481 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 nine months ended September
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 9.56 $ -
Outstanding at September 30, 2025 885,000 $ 0.97 9.47 $ -
SARs vested at September 30, 2025 -
$ -
- $ -
At September 30, 2025, the Company has unrecognized
compensation expense of approximately $ 1,450,100 related to unvested SARs which will be recognized over the weighted
average remaining service period of 3.46 years.
10
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 7 - STOCKHOLDERS’ EQUITY
Common Stock
During the nine months ended September 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 nine months ended September 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 September 30, 2025, no shares have been issued under this agreement.
On November 5, 2025 the Company announced the closing of its underwritten
offering of 40,142,000 shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase up
to 5,315,000 shares of common stock. The shares of common stock were sold at an offering price of $ 2.20 per share, and the pre-funded
warrants were sold at an offering price of $ 2.199 per pre-funded warrant, which represents the per share offering price for the common
stock less the $ 0.001 per share exercise price for each such pre-funded warrant. The net proceeds to Relmada from the offering, before
deducting other expenses payable by Relmada, and excluding the exercise of any pre-funded warrants, are approximately $ 94 million.
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 September 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 September 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 ( 1,216,598 ) $ 17.39 -
$ -
Outstanding at September 30, 2025 14,149,986 $ 13.05 6.73 $ 4,218,100
Options exercisable at September 30, 2025 9,732,827 $ 17.96 5.72 $ 242,635
At September 30, 2025, the Company has unrecognized
stock-based compensation expense of approximately $ 7.7 million related to unvested stock options which will be recognized over the weighted
average remaining service period of 2.87 years.
Warrants
A summary of the changes in outstanding warrants during the nine months
ended September 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
( 631,705 )
-
Outstanding at September 30, 2025
750,908
$ 28.86
Warrants Vested at September 30, 2025
745,658
$ 28.87
At September 30, 2025, the Company does not have
any unrecognized compensation expense related to outstanding warrants.
At September 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 nine months ended September 30, 2025 and 2024 (rounded to nearest $00):
Nine Months
Ended
September 30,
2025
Nine Months
Ended
September 30,
2024
Research and development
$ 1,419,500
$ 5,007,300
General and administrative
10,114,500
18,450,700
Total
$ 11,534,000
$ 23,458,000
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 September 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.
On July 7, 2025, the Company delivered to the Licensor 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 ceased
as of October 5, 2025, which was 90 days after the date of the notice. There were no fees or costs associated with the termination of
the License Agreement.
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 ceased as of August 10, 2025, which
was 90 days after the date of notice. There were no fees or costs associated with the termination of the License Agreement.
13
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
NOTE 8 - COMMITMENTS AND CONTINGENCIES (continued)
Trigone
On March 24, 2025, the Company 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, the Company 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, the Company 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 lease term.
For the nine months ended September 30, 2025 and
2024, the Company recognized lease expense of approximately $ 141,600 and $ 179,700 , respectively.
Legal
From time to time, the Company may become involved
in lawsuits and other legal proceedings that arise in the course of business. Litigation is subject to inherent uncertainties, and it
is not possible to predict the outcome of litigation with total confidence. The Company is currently not aware of any legal proceedings
or potential claims against it whose outcome would be likely, individually or in the aggregate, to have a material adverse effect on the
Company’s business, financial condition, operating results, or cash flows.
NOTE 9 - OTHER POST-RETIREMENT BENEFIT PLAN
Relmada participates in a multiemployer 401(k)
plan that permits eligible employees to contribute funds on a pretax basis subject to maximum allowed under federal tax provisions. The
Company matches 100 % of the first 3 % of employee contributions, plus 50 % of employee contributions that exceed 3 % but do not exceed 5 %.
The employees choose an amount from various investment
options for both their contributions and the Company’s matching contribution. The Company’s contribution expense was approximately
$ 151,200 and $ 107,300 for the nine months ended September 30, 2025 and 2024, respectively.
14
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
Statements
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 nine months ended September 30, 2025 and 2024 (rounded to the nearest
$00):
Three months ended
September 30,
Nine months ended
September 30,
2025
2024
2025
2024
Clinical Study Expense
$ 1,083,100
$ 2,345,300
$ 9,823,300
$ 7,105,400
Other Research Expense
852,800
5,956,400
3,386,000
19,262,700
Manufacturing and Drug Storage Expense
752,000
301,400
989,200
1,275,400
Pre-clinical Expense
-
-
-
33,700
Compensation Expense
990,400
805,300
2,986,500
2,478,300
Stock-based Compensation Expense
358,000
1,740,700
1,621,700
5,020,000
Total Research and Development Expense
$ 4,036,300
$ 11,149,100
$ 18,806,700
$ 35,175,500
NOTE 11 - SUBSEQUENT EVENTS
On October 1, 2025, the Company awarded a total
of 50,000 stock options to a consultant with an exercise price of $ 2.16 and a 10 year term, vesting over a 4 -year period.
On November 5, 2025 the Company announced the closing of its underwritten
offering of 40,142,000 shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase up
to 5,315,000 shares of common stock. The shares of common stock were sold at an offering price of $ 2.20 per share, and the pre-funded
warrants were sold at an offering price of $ 2.199 per pre-funded warrant, which represents the per share offering price for the common
stock less the $ 0.001 per share exercise price for each such pre-funded warrant. The net proceeds to Relmada from the offering, before
deducting other expenses payable by Relmada, and excluding the exercise of any pre-funded warrants, are approximately $ 94 million.
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.