2 unchanged sentences
Condensed Consolidated Balance Sheets
−Removed: September 30,
Current assets:
12 unchanged sentences
Stockholders’ Equity:
+Added: 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
11 unchanged sentences
Three months ended
−Removed: Nine months ended
−Removed: September 30,
−Removed: September 30,
Operating expenses:
5 unchanged sentences
( 22,987,860 )
−Removed: ( 64,815,482 )
−Removed: ( 76,872,973 )
−Removed: Other (expenses) income:
+Added: Other income:
Interest/investment income, net
−Removed: Realized (loss) gain on short-term investments
−Removed: Unrealized (loss) gain on short-term investments
−Removed: Total other (expense) income – net
−Removed: $ ( 21,725,970 )
−Removed: $ ( 22,002,058 )
+Added: Realized gain on short-term investments
+Added: Unrealized gain on short-term investments
+Added: Total other income
$ ( 17,559,465 )
5 unchanged sentences
Relmada Therapeutics, Inc.
−Removed: Condensed Consolidated Statements of Stockholders’
−Removed: Three and Nine months ended September 30, 2024
+Added: Condensed Consolidated Statements of Changes
+Added: in Stockholders’ Equity
+Added: Three months ended March 31, 2025
Balance - December 31, 2024
2 unchanged sentences
Stock based compensation
−Removed: Options exercises for common stock
+Added: Issuance of Restricted Common Stock
( 17,559,465 )
2 unchanged sentences
$ 680,848,800
−Removed: Stock-based compensation
$ ( 658,441,500 )
−Removed: ( 17,768,122 )
−Removed: Balance – June 30, 2024
−Removed: ( 600,498,929 )
−Removed: Stock-based compensation
−Removed: ( 21,725,970 )
−Removed: ( 21,725,970 )
−Removed: Balance – September 30, 2024
−Removed: $ 669,819,907
−Removed: $ ( 622,224,899 )
−Removed: Three and Nine months ended September 30, 2023
+Added: Three months ended March 31, 2024
Balance - December 31, 2023
1 unchanged sentence
$ ( 560,902,681 )
−Removed: $ 140,436,302
Stock based compensation
+Added: Options exercised for common stock
( 21,828,126 )
2 unchanged sentences
$ 654,746,964
−Removed: Stock-based compensation
$ ( 582,730,807 )
−Removed: ( 25,302,954 )
−Removed: Balance – June 30, 2023
−Removed: ( 513,735,465 )
−Removed: Stock-based compensation
−Removed: ( 22,002,058 )
−Removed: ( 22,002,058 )
−Removed: Balance – September 30, 2023
−Removed: $ 636,434,059
−Removed: $ ( 535,737,523 )
−Removed: $ 100,726,635
The accompanying notes are an integral part of
2 unchanged sentences
Condensed Consolidated Statements of Cash Flows
−Removed: Nine months ended
−Removed: September 30,
+Added: Three months ended
Cash flows from operating activities
3 unchanged sentences
Stock-based compensation
−Removed: Realized (gain) loss on short-term investments
−Removed: Unrealized (gain) loss on short-term investments
+Added: Realized gain on short-term investments
+Added: Unrealized gain on short-term investments
Change in operating assets and liabilities:
−Removed: Other receivable
−Removed: Prepaid expenses and other assets
+Added: Prepaid expenses
Accounts payable
( 2,865,553 )
−Removed: ( 2,405,184 )
Accrued expenses
8 unchanged sentences
( 7,013,933 )
−Removed: ( 57,151,963 )
Sale of short-term investments
3 unchanged sentences
Net cash provided by financing activities
−Removed: Net increase /(decrease) in cash and cash equivalents
+Added: Net decrease in cash and cash equivalents
( 2,707,320 )
+Added: ( 2,756,550 )
Cash and cash equivalents at beginning of the period
Cash and cash equivalents at end of the period
−Removed: Supplemental disclosure of cash flow information:
−Removed: Cash paid during the period for:
The accompanying notes are an integral part of
3 unchanged sentences
NOTE 1 - BUSINESS
−Removed: Relmada Therapeutics, Inc.
−Removed: (Relmada or the Company)
−Removed: (a Nevada corporation), is a clinical-stage, publicly traded biotechnology company focused on the development of esmethadone (d-methadone,
−Removed: dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist.
−Removed: Esmethadone is a new chemical entity (NCE) that potentially
−Removed: addresses areas of high unmet medical need in the treatment of central nervous system (CNS) diseases and other disorders.
−Removed: also developing a proprietary, modified-release formulation of psilocybin (REL-P11) for metabolic indications.
−Removed: In addition to the normal risks associated with
−Removed: a new business venture, there can be no assurance that the Company’s research and development will be successfully completed or
−Removed: that any product will be approved or commercially viable.
−Removed: The Company is subject to risks common to companies in the biotechnology industry
−Removed: including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors of new technological
−Removed: innovations, dependence on key personnel, protection of proprietary technology, and compliance with the Food and Drug Administration
−Removed: (FDA) and other governmental regulations and approval requirements.
−Removed: NOTE 2 – GOING CONCERN
−Removed: These unaudited condensed consolidated financial
−Removed: statements have been prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates
−Removed: the realization of assets and the satisfaction of liabilities in the normal course of business.
−Removed: As shown in the accompanying unaudited condensed
−Removed: consolidated financial statements, the Company has incurred losses and negative cash flows from operations since inception and expects
−Removed: to incur additional losses until such time that it can generate significant revenue from the commercialization of its product candidates.
−Removed: During the nine months ended September 30, 2024, the Company incurred a net loss of $ 61,322,218 and had negative operating cash flows
−Removed: of $ 42,956,164 .
−Removed: Given the Company’s projected operating requirements and its existing cash and cash equivalents and short-term investments,
−Removed: the Company is projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements
+Added: Relmada Therapeutics,
+Added: (Relmada or the Company) (a Nevada corporation), is a clinical-stage, publicly traded biotechnology company focused on the development
+Added: of NDV-01 and Sepranolone.
+Added: NDV-01 is a novel,
+Added: controlled-release intravesical formulation of gemcitabine and docetaxel.
+Added: NDV-01 is currently in a Phase 2 clinical trial to assess its
+Added: safety and efficacy in patients with aggressive forms of non-muscle invasive bladder cancer (NMIBC).
+Added: Sepranolone is
+Added: a novel neurosteroid epimer of allopregnanolone.
+Added: Sepranolone is being developed for the potential treatment of Prader-Willi Syndrome,
+Added: Tourette Syndrome, excessive tremor and other diseases related to excessive GABAergic activity.
+Added: The Esmethadone (d-methadone, dextromethadone,
+Added: REL-1017) program has been paused pending a comprehensive data review of the data generated so far.
+Added: Esmethadone an N-methyl-D-aspartate
+Added: (NMDA) receptor antagonist.
+Added: Esmethadone is a new chemical entity (NCE) that potentially addresses areas of high unmet medical need in
+Added: the treatment of central nervous system (CNS) diseases and other disorders.
+Added: Relmada was also developing a proprietary, modified-release formulation
+Added: of psilocybin (REL-P11) for metabolic indications.
+Added: This program was terminated effective May 12, 2025, after a successful P1 study and
+Added: in light of the adversely changed regulatory environment affecting chronic administration of psylocibin and potentially other psychedelic
+Added: In addition to
+Added: the normal risks associated with a new business venture, there can be no assurance that the Company’s research and development
+Added: will be successfully completed or that any product will be approved or commercially viable.
+Added: The Company is subject to risks common to
+Added: companies in the biotechnology industry including, but not limited to, dependence on collaborative arrangements, development by the Company
+Added: or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, and compliance
+Added: with the Food and Drug Administration (FDA) and other governmental regulations and approval requirements.
+Added: On January 21,
+Added: 2025, we received a deficiency letter from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market
+Added: advising that, for 30 consecutive business days preceding the notification letter, the Company did not meet the minimum $ 1.00 per share
+Added: bid price requirement for continued inclusion on The Nasdaq Global Select Market.
+Added: The deficiency letter does not result in the immediate
+Added: delisting of our common stock from the Nasdaq Global Select Market.
+Added: In accordance with Nasdaq Listing Rule 5810(c)(3)(A) (the “Compliance
+Added: Period Rule”), we have been provided an initial period of 180 calendar days, or until July 21, 2025 (the “Compliance Date”),
+Added: to regain compliance with the minimum bid price requirement.
+Added: If, at any time before the Compliance Date, the bid price for our common
+Added: stock closes at $ 1.00 per share or more for a minimum of 10 consecutive business days, as required by the Compliance Period Rule, the
+Added: Staff will provide written notification to us that we comply with the minimum bid price requirement, unless the Staff exercises its discretion
+Added: to extend this 10-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H).
+Added: While we intend to regain compliance with the minimum bid price requirement,
+Added: there can be no assurance that we will be able to maintain continued compliance with this rule or the other listing requirements of The
+Added: Nasdaq Stock Market.
+Added: If we were unable to meet these requirements, we would receive another delisting notice from the Nasdaq Stock Market
+Added: for failure to comply with one or more of the continued listing requirements.
+Added: If our common stock were to be delisted from The Nasdaq
+Added: Global Select Market, trading of our common stock most likely will be conducted in the over-the-counter market on an electronic bulletin
+Added: board established for unlisted securities such as the OTC Markets or in the “pink sheets.” Such a downgrading in our listing
+Added: market may limit our ability to make a market in our common stock and which may impact purchases or sales of our securities.
+Added: On February 3,
+Added: 2025, the Company entered into an Asset Purchase Agreement (the Purchase Agreement) with Asarina Pharma AB (Asarina), a Swedish corporation,
+Added: pursuant to which the Company has agreed, subject to the terms and conditions set forth therein, to purchase from Asarina all right,
+Added: title, and interest in Sepranolone, a phase 2b ready neurosteroid being developed for the potential treatment of Prader-Willi Syndrome,
+Added: Tourette Syndrome, essential tremor and other diseases related to excessive GABAergic activity.
+Added: The total purchase price for Sepranolone
+Added: is € 3,000,000 .
+Added: The Company paid Asarina $ 2,756,000 on February 5, 2025, which includes a credit of $ 250,000 for a previous
+Added: payment made by the Company to Asarina pursuant to an exclusivity agreement dated October 25, 2024.
+Added: 2025, we entered into an Exclusive License Agreement with Trigone, an Israeli company.
+Added: The license agreement is for Trigone’s
+Added: NDV-01 product, which is a novel, sustained-release, intravesical gemcitabine/docetaxel, ready-for-use product candidate for the
+Added: treatment of NMIBC.
+Added: Under the terms of the agreement, the Company made a $ 3,500,000 upfront payment on March 25, 2025, and issued
+Added: 3,017,420 shares of common stock, which represented 10 % of the Company’s outstanding shares on such date, for exclusive worldwide rights
+Added: to NDV-01, excluding Israel, India and South Africa.
+Added: In addition, the Company will pay up to approximately $ 200 million
+Added: in development, regulatory and sales milestones pending successful commercialization.
+Added: The Company will also pay a royalty of 3 % on any
+Added: NOTE 2 - GOING
+Added: These unaudited
+Added: condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles applicable
+Added: to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
+Added: 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.
+Added: During the three months ended March 31, 2025, the Company incurred a net loss of $ 17,559,465 and had negative operating cash flows of $ 18,067,033 .
+Added: 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.
−Removed: In response to these conditions, management is
−Removed: currently evaluating the size and scope of any subsequent operations and clinical trials that will affect the timing to obtain the required
−Removed: funding of future operations.
−Removed: Financing strategies may include, but are not limited to, the public or private sale of equity or debt securities
−Removed: or from bank or other loans or through strategic collaboration and/or licensing agreements.
−Removed: There can be no assurances that the Company
−Removed: will be able to secure additional financing, or if available, that it will be sufficient to meet its needs or on favorable terms.
−Removed: management’s plans have not yet been finalized and are not within the Company’s control, the implementation of such plans
−Removed: cannot be considered probable.
−Removed: As a result, the Company has concluded that management’s plans do not alleviate substantial doubt
−Removed: about the Company’s ability to continue as a going concern.
−Removed: The unaudited condensed consolidated financial
−Removed: statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and
−Removed: classification of liabilities that might result from the outcome of this uncertainty.
−Removed: NOTE 3 - SUMMARY OF SIGNIFICANT
−Removed: ACCOUNTING POLICIES
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Condensed Consolidated Financial
+Added: NOTE 2 - GOING
+Added: CONCERN (continued)
+Added: In response to
+Added: these conditions, management is currently evaluating the size and scope of any subsequent operations and clinical trials that will affect
+Added: the timing to obtain the required funding of future operations.
+Added: Financing strategies may include, but are not limited to, the public
+Added: or private sale of equity or debt securities or from bank or other loans or through strategic collaboration and/or licensing agreements.
+Added: There can be no assurances that the Company will be able to secure additional financing, or if available, that it will be sufficient
+Added: to meet its needs or on favorable terms.
+Added: Because management’s plans have not yet been finalized and are not within the Company’s
+Added: control, the implementation of such plans cannot be considered probable.
+Added: As a result, the Company has concluded that management’s
+Added: plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern.
+Added: The unaudited
+Added: condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded
+Added: asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
+Added: NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING
Basis of Presentation
6 unchanged sentences
GAAP for complete consolidated financial statements.
−Removed: The unaudited condensed consolidated
−Removed: financial statements reflect all adjustments (consisting of normal recurring adjustments) which are, in the opinion of management, necessary
−Removed: for a fair statement of the results for the interim periods presented.
−Removed: Interim results are not necessarily indicative of the results
−Removed: for the full year.
−Removed: These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated
−Removed: financial statements of the Company for the year ended December 31, 2023 and notes thereto contained in the Company’s Annual Report
−Removed: on Form 10-K.
+Added: The unaudited condensed consolidated financial
+Added: statements reflect all adjustments (consisting of normal recurring adjustments) which are, in the opinion of management, necessary for
+Added: a fair statement of the results for the interim periods presented.
+Added: Interim results are not necessarily indicative of the results for the
+Added: These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial
+Added: statements of the Company for the year ended December 31, 2024 and notes thereto contained in the Company’s Annual Report on Form
Principles of Consolidation
6 unchanged sentences
GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
−Removed: of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts
−Removed: of revenues and expenses for the reporting period.
+Added: of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the
+Added: reporting period.
Actual results could differ from those estimates.
−Removed: The significant estimates are stock-based
−Removed: compensation expenses and recorded amounts related to income taxes.
−Removed: Relmada Therapeutics, Inc.
−Removed: Notes to Unaudited Condensed Consolidated Financial
−Removed: NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
+Added: The significant estimates are stock-based compensation expenses and
+Added: recorded amounts related to income taxes.
Cash and Cash Equivalents
The Company considers cash deposits and all highly
−Removed: liquid investments with a maturity of three months or less when purchased to be cash equivalents.
−Removed: The Company’s cash deposits are
−Removed: held at two high-credit-quality financial institutions.
−Removed: The Company’s cash and cash equivalents balance of $ 1,483,789 at September
−Removed: 30, 2024 at these institutions exceed the federally insured limits.
+Added: liquid investments with a maturity of three months or less when purchased to be cash and cash equivalents.
+Added: The Company’s cash deposits
+Added: are held at two high-credit-quality financial institutions.
+Added: The Company’s cash and cash equivalents are carried at cost, which approximates
+Added: their fair value.
+Added: The Company’s cash and cash equivalents balance of $ 1,149,706 and $ 3,857,026 at March 31, 2025 and December 31,
+Added: 2024, respectively, at these institutions exceed the federally insured limits.
Short-term Investments
2 unchanged sentences
The securities are measured at fair value based on the net asset value “NAV”.
−Removed: Substantially all equity investments in
−Removed: nonconsolidated entities are measured at fair value with recurring changes recognized in earnings, except for those accounted for using
−Removed: equity method accounting.
+Added: Substantially all equity investments
+Added: in nonconsolidated entities are measured at fair value with recurring changes recognized in earnings, except for those accounted for using
+Added: equity accounting methods.
Changes in fair value of the securities are recorded as part of other income on the unaudited condensed consolidated
−Removed: statements of operations.
−Removed: Short-term investment activity is presented in the investing activities section on the unaudited condensed
−Removed: consolidated statements of cash flows.
−Removed: Short-term investments at September 30, 2024
−Removed: and December 31, 2023, consisted of mutual funds with a fair value of $ 52,633,938 and $ 92,232,292 , respectively.
+Added: statement of operations.
+Added: Short-term investment activity is presented in the investing activities section on the condensed consolidated
+Added: statement of cash flows.
+Added: Short-term investments at March 31, 2025 and December
+Added: 31, 2024 consisted of mutual funds with a fair value of $ 25,911,326 and $ 41,052,356 , respectively.
Costs related to filing and pursuing patent applications
4 unchanged sentences
operating leases or finance leases.
−Removed: Operating leases will result in straight-line lease expense, while finance leases will result in
−Removed: front-loaded expense.
−Removed: The Company’s lease consists of an operating lease for office space.
−Removed: The Company does not recognize a lease
−Removed: liability or right-of-use asset on the balance sheet for short-term leases.
−Removed: Instead, the Company recognizes short-term lease payments
−Removed: as an expense on a straight-line basis over the lease term.
−Removed: A short-term lease is defined as a lease that, at the commencement date,
−Removed: 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
+Added: Operating leases will result in straight-line lease expense, while finance leases will result in front-loaded
+Added: The Company’s leases consists of operating leases for office space for terms of 12 months or less.
+Added: The Company does not
+Added: recognize a lease liability or right-of-use asset on the balance sheet for short-term leases.
+Added: Instead, the Company recognizes short-term
+Added: lease payments as an expense on a straight-line basis over the lease term.
+Added: A short-term lease is defined as a lease that, at the commencement
+Added: 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
+Added: certain to exercise.
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Condensed Consolidated Financial
+Added: NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
Fair Value of Financial Instruments
The Company’s financial instruments primarily
−Removed: include cash, short-term investments, and accounts payable.
−Removed: Due to the short-term nature of cash and accounts payable the carrying amounts
−Removed: of these assets and liabilities approximate their fair value.
+Added: include cash, short term investments, and stock appreciation rights.
+Added: Due to the short-term nature of cash and accounts payable the carrying
+Added: amounts of these assets and liabilities approximate their fair value.
Fair value is defined as the price that would
4 unchanged sentences
The fair value hierarchy is as follows:
−Removed: Level 1 Inputs – Unadjusted quoted
−Removed: prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date.
−Removed: Level 2 Inputs – Inputs other
−Removed: than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly.
−Removed: These might include
−Removed: quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets
−Removed: that are not active, inputs other than quoted prices that are observable for the asset or liability (such as interest rates, volatilities,
−Removed: prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market data by correlation or other
−Removed: Level 3 Inputs – Prices or valuation
−Removed: techniques that require inputs that are both significant to the fair value measurement and unobservable (supported by little or no market
−Removed: Relmada Therapeutics, Inc.
−Removed: Notes to Unaudited Condensed Consolidated Financial
−Removed: NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
+Added: 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.
+Added: Level 2 Inputs - Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly.
+Added: 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.
+Added: 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.
−Removed: 820 – 10 Fair Value Measurement , financial assets and liabilities are classified based on the lowest level
−Removed: of input that is significant to the fair value measurement.
−Removed: The Company’s assessment of the significance of a particular input
−Removed: to the fair value measurement requires judgment and may affect the valuation of the fair value of assets and liabilities and their placement
−Removed: within the fair value hierarchy levels.
+Added: 820 - 10 Fair Value Measurement , financial assets and liabilities are classified based on the lowest level of input
+Added: that is significant to the fair value measurement.
+Added: The Company’s assessment of the significance of a particular input to the fair
+Added: value measurement requires judgment and may affect the valuation of the fair value of assets and liabilities and their placement within
+Added: the fair value hierarchy levels.
The Company’s short-term investment instruments
−Removed: of $ 52,633,938 at September 30, 2024 consist of mutual funds and are classified using Level 1 inputs within the fair value hierarchy
−Removed: because the value is based on quoted prices in active markets.
−Removed: Unrealized gains and losses are recorded in the unaudited condensed consolidated
−Removed: statements of operations under other income.
−Removed: The Company recorded realized gains of $ 147,835 and $ 334,082 included in other income for
−Removed: the three and nine months ended September 30, 2024, respectively.
+Added: of $ 25,911,326 at March 31, 2025 consist of mutual funds and are classified using Level 1 inputs
+Added: within the fair value hierarchy because they are valued using NAV.
+Added: Unrealized gains and losses are recorded in the condensed consolidated
+Added: statement of operations as unrealized gain on short-term investment.
The Company recorded unrealized gains of $ 155,731 and $ 50,713 included
−Removed: in other income for the three and nine months ended September 30, 2024, respectively.
+Added: in other income (expense) for the three months ended March 31, 2025 and 2024, respectively.
+Added: The Company’s stock appreciation rights
+Added: 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
+Added: option pricing model.
+Added: Significant unobservable inputs included expected term and volatility.
+Added: The expected term was calculated using
+Added: the simplified method.
+Added: The volatility is calculated based on the Company’s historical stock price over a period of time.
+Added: As of March 31, 2025, the stock appreciation rights
+Added: liability had a fair value of $ 7,505 .
+Added: Significant inputs for Level 3 stock appreciation rights liability fair value measurement
+Added: at March 31, 2025 are (1) discount rate of 3.96 % - 4.03 %, (2) expected life of 5.50 – 6.00 years, (3) expected volatility of 128 %
+Added: - 131 %, (4) zero expected dividends, (5) stock price of $ 0.27 and (6) exercise price of $ 0.45 - $ 3.84 .
+Added: There have been no transfers in and out of level 3 during the three-months
+Added: ended March 31, 2025.
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Condensed Consolidated Financial
+Added: NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
The Company accounts for income taxes using the
6 unchanged sentences
recognized in income or expense in the period that the change is effective.
−Removed: Tax benefits are recognized when it is probable that the
−Removed: deduction will be sustained.
−Removed: A valuation allowance is established when it is more likely than not that all or a portion of a deferred
−Removed: tax asset will either expire before the Company is able to realize the benefit, or that future deductibility is uncertain.
−Removed: As of September
−Removed: 30, 2024, and December 31, 2023, the Company had recognized a valuation allowance to the full extent of the Company’s net deferred
−Removed: tax assets since the likelihood of realization of the benefit does not meet the more likely than not threshold.
+Added: Tax benefits are recognized when it is probable that the deduction
+Added: will be sustained.
+Added: A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset
+Added: will either expire before the Company is able to realize the benefit, or that future deductibility is uncertain.
+Added: As of March 31, 2025
+Added: and December 31, 2024, the Company had recognized a valuation allowance to the full extent of the Company’s net deferred tax assets
+Added: since the likelihood of realization of the benefit does not meet the more likely than not threshold.
The Company files a U.S.
1 unchanged sentence
and various state returns.
−Removed: Uncertain tax positions taken on the Company’s tax returns will be accounted for as liabilities for
−Removed: unrecognized tax benefits.
−Removed: The Company will recognize interest and penalties, if any, related to unrecognized tax benefits in general
−Removed: and administrative expenses in the statements of operations.
−Removed: There were no liabilities recorded for uncertain tax positions at September
−Removed: 30, 2024 and December 31, 2023.
−Removed: The open tax years, subject to potential examination by the applicable taxing authority, for the Company
−Removed: are from September 30, 2018 forward.
+Added: Uncertain tax positions taken on the Company’s tax returns will be accounted for as liabilities for unrecognized
+Added: tax benefits.
+Added: The Company will recognize interest and penalties, if any, related to unrecognized tax benefits in general and administrative
+Added: expenses in the statements of operations.
+Added: There were no liabilities recorded for uncertain tax positions at March 31, 2025 and December
+Added: The open tax years, subject to potential examination by the applicable taxing authority, for the Company are from December 31,
+Added: 2020 forward.
Research and Development
16 unchanged sentences
Pursuant to the terms of the Company’s 2021
−Removed: Equity Incentive Plan, the Company grants cash-settled Stock Appreciation Rights (“SARs”) that are classified as liabilities
+Added: Equity Incentive Plan, the Company may grant cash-settled Stock Appreciation Rights (“SARs”) that are classified as liabilities
under ASC 718 ( Compensation—Stock Compensation ).
1 unchanged sentence
of the Company’s stock price over a specified period.
−Removed: The initial fair value of SARs is determined
−Removed: on the grant date using the Black-Scholes option pricing model.
−Removed: SARs are remeasured at fair value at each reporting date using the
−Removed: Black-Scholes pricing model until they are exercised or expire.
−Removed: Changes in fair value are recognized in the income statement as a
−Removed: compensation expense.
−Removed: Compensation expense is recognized over the service period, which is the period during which employees are
−Removed: required to provide service in exchange for the award.
+Added: The initial fair value of SARs is determined on
+Added: the grant date using the Black-Scholes option pricing model.
+Added: SARs are remeasured at fair value at each reporting date using the Black-Scholes
+Added: pricing model until they are exercised or expire.
+Added: Changes in fair value are recognized in the income statement as a compensation expense.
+Added: Compensation expense is recognized over the service period, which is the period during which employees are required to provide service
+Added: in exchange for the award.
Upon exercise, the Company will settle SARs in
2 unchanged sentences
Notes to Unaudited Condensed Consolidated Financial
−Removed: NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
+Added: NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
Net Loss per Common Share
2 unchanged sentences
outstanding for the period, without consideration for common stock equivalents.
−Removed: Diluted loss per common share attributable to common
−Removed: stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common share
−Removed: equivalents outstanding for the period determined using the treasury-stock method.
−Removed: Dilutive common stock equivalents are comprised of
−Removed: options and warrants to purchase common stock.
−Removed: For all periods presented, there is no difference in the number of shares used to calculate
−Removed: basic and diluted shares outstanding due to the Company’s net losses in each period.
−Removed: For the nine months ended September 30, 2024
−Removed: and 2023, the potentially dilutive securities that would be anti-dilutive due to the Company’s net loss are not included in the
−Removed: calculation of diluted net loss per share attributable to common stockholders.
−Removed: The anti-dilutive securities are as follows (in common
−Removed: stock equivalent shares):
−Removed: Nine months ended
−Removed: September 30,
−Removed: September 30,
+Added: Diluted loss per common share attributable to common stockholders
+Added: is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common share equivalents outstanding
+Added: for the period determined using the treasury-stock method.
+Added: Dilutive common stock equivalents are comprised of options and warrants to
+Added: purchase common stock.
+Added: For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares
+Added: outstanding due to the Company’s net losses in each period.
+Added: For the three months ended March 31, 2025 and
+Added: 2024, the potentially dilutive securities that would be anti-dilutive due to the Company’s net loss are not included in the calculation
+Added: of diluted net loss per share attributable to common stockholders.
+Added: The anti-dilutive securities are as follows (in common stock equivalent
+Added: Three months ended
Stock options
Common stock warrants
−Removed: Recent Accounting Pronouncements
−Removed: In October 2021, the FASB issued ASU 2021-08,
−Removed: “Business Combinations (Topic 805):
−Removed: Accounting for Contract Assets and Contract Liabilities from Contracts with Customers”.
−Removed: The amendments in this ASU require that an entity (acquirer) recognize, and measure contract assets and contract liabilities acquired
−Removed: in a business combination, including contract assets and contract liabilities arising from revenue contracts with customers, as if it
−Removed: had originated the contracts as of the acquisition date.
−Removed: The amendments in this ASU were effective for annual and interim periods beginning
−Removed: after December 15, 2022.
−Removed: The Company adopted this standard effective January 1, 2023 and the standard did not have a significant impact
−Removed: on our consolidated financial statements.
+Added: Adoption of Recent Accounting Standards
In November 2023, The FASB issued ASU 2023-07,
2 unchanged sentences
for reportable segments, primarily through enhanced disclosures about significant segment expenses.
−Removed: ASU 2023-07 is effective for our
−Removed: annual periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted.
−Removed: is currently evaluating the potential effect that the updated standard will have on our financial statement disclosures.
+Added: ASU 2023-07 is effective for our annual
+Added: periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted.
+Added: The Company adopted
+Added: 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):
−Removed: Improvements to Income Tax Disclosures” to expand the disclosure requirements for income taxes,
−Removed: specifically related to the rate reconciliation and income taxes paid.
−Removed: ASU 2023-09 is effective for our annual periods beginning January
−Removed: 1, 2025, with early adoption permitted.
−Removed: The Company is currently evaluating the potential effect that the updated standard will have
−Removed: on our financial statement disclosures.
−Removed: Subsequent Events
−Removed: The Company’s management reviewed all material
−Removed: events through the date the unaudited condensed consolidated financial statements were issued for subsequent event disclosure consideration.
+Added: Improvements to Income Tax Disclosures ” to expand the disclosure requirements for income
+Added: taxes, specifically related to the rate reconciliation and income taxes paid.
+Added: ASU 2023-09 was effective for our annual periods beginning
+Added: January 1, 2025.
+Added: The Company adopted this standard effective January 1, 2025 and the updated standard did not have a significant impact
+Added: on our consolidated financial statement disclosures.
+Added: Recent Accounting Standards
+Added: In November 2024, the FASB issued ASU 2024-03,
+Added: Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40) .
+Added: ASU 2024-03 requires
+Added: specified information about certain costs and expenses be disclosed in the notes to the financial statements, including the expense caption
+Added: on the face of the income statement in which they are disclosed, in addition to a qualitative description of remaining amounts not separately
+Added: disaggregated.
+Added: Entities will also be required to disclose their definition of “selling expenses” and the total amount in each
+Added: annual period.
+Added: The standard is effective for the Company for annual periods beginning January 1, 2027 and for interim periods beginning
+Added: January 1, 2028, with updates applied either prospectively or retrospectively.
+Added: Early adoption is permitted.
+Added: The Company is currently evaluating
+Added: the impact of this guidance on its disclosures.
Relmada Therapeutics, Inc.
2 unchanged sentences
Prepaid expenses consisted of the following (rounded to nearest $00):
−Removed: September 30,
Research and Development
1 unchanged sentence
Accrued expenses consisted of the following (rounded to nearest $00):
−Removed: September 30,
Research and development
2 unchanged sentences
Accrued vacation
−Removed: Relmada Therapeutics, Inc.
−Removed: Notes to Unaudited Condensed Consolidated Financial
NOTE 6 - STOCK APPRECIATION RIGHTS
−Removed: During the nine months ended September 30, 2024,
−Removed: 110,000 stock appreciation rights have been issued to employees with an exercise price of $ 3.84 - $ 3.69 respectively with a 10 -year term,
−Removed: and vesting over a 4 -year period.
+Added: During the three months ended March 31, 2025,
+Added: 300,000 cash-settled stock appreciation rights have been issued to consultants with an exercise price of $ 0.45 with a 10 -year term and
+Added: vesting over a 4 -year period.
Variables used in the Black-Scholes option-pricing model include:
−Removed: (1) discount rate of 3.87 –
−Removed: 4.15 %, (2) expected life of 6.25 years, (3) expected volatility of 113 %, and (4) zero expected dividends.
−Removed: At September 30, 2024, the Company revalued the
+Added: (1) discount rate of 4.43 %, (2) expected
+Added: life of 6.25 years, (3) expected volatility of 135 %, and (4) zero expected dividends.
+Added: At March 31, 2025, the Company revalued the cash-settled
stock appreciation rights using a stock price of $ 0.27 and an exercise price of $ 0.45 - $ 3.84 .
1 unchanged sentence
model include:
−Removed: (1) discount rate of 3.63 %, (2) expected life of 6 years, (3) expected volatility of 112 %, and (4) zero expected dividends.
−Removed: of September 30, 2024, the total liability related to SARs is $ 12,562 , reflecting the fair value as of the reporting date.
−Removed: quarter ended September 30, 2024, the Company recorded compensation related to the SARs in the amount of $ 12,562 , included in research
−Removed: and development expenses in the accompanying consolidated statements of operations.
−Removed: A summary of the changes in SARs during the nine months ended September
+Added: (1) discount rate of 3.96 % - 4.03 %, (2) expected life of 5.50 – 6.00 years, (3) expected volatility of 128 % - 131 %
+Added: and (4) zero expected dividends.
+Added: As of March 31, 2025, the total liability related
+Added: to cash-settled SARs is $ 7,505 , reflecting the fair value as of the reporting date.
+Added: During the quarter ended March 31, 2025, the Company
+Added: recorded compensation related to the cash-settled SARs in the amount of $ 3,038 , included in research and development expenses in the accompanying
+Added: unaudited condensed consolidated statements of operations.
+Added: A summary of the changes in SARs during the three months ended March
31, 2025 is as follows:
+Added: Number of Cash-Settled
SARS Weighted
3 unchanged sentences
Granted 300,000 $ 0.33 9.76 $ -
−Removed: Outstanding at September 30, 2024 110,000 $ 3.70 9.84 $ -
−Removed: SARs vested at September 30, 2024 -
−Removed: At September 30, 2024, the Company has unrecognized compensation
−Removed: expense of approximately $ 0.3 million related to unvested stock appreciation rights which will be recognized over the weighted average
−Removed: remaining service period of 3.83 years.
+Added: Outstanding at March 31, 2025 410,000 $ 1.32 9.65 $ -
+Added: SARs vested at March 31, 2025 -
+Added: At March 31, 2025, the Company has unrecognized
+Added: compensation expense of approximately $ 82,300 related to unvested stock appreciation rights which will be recognized over the weighted
+Added: average remaining service period of 3.65 years.
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Condensed Consolidated Financial
NOTE 7 - STOCKHOLDERS’ EQUITY
−Removed: During the nine months ended September 30, 2024,
−Removed: the Company issued 74,999 shares of common stock for the exercise of options for proceeds of $ 246,747 .
−Removed: On April 6, 2022, the Company entered into a new
−Removed: Open Market Sale Agreement with Jefferies LLC, as sales agent, pursuant to which we may offer and sell, from time to time, through Jefferies
−Removed: LLC, shares of our common stock, having an aggregate offering price of up to $ 100,000,000 .
−Removed: We are not obligated to sell any shares under
−Removed: the agreement.
−Removed: As of September 30, 2024, no shares have been issued under this agreement.
+Added: During the year ended December 31, 2024, the Company
+Added: issued 74,999 shares of common stock for the exercise of options for proceeds of $ 246,747 .
+Added: During the three months ended March 31, 2025, the Company issued 3,017,420 shares
+Added: of restricted common stock in accordance with the license agreement with Trigone Pharma.
+Added: The Company recognized $ 905,226 of research and
+Added: development compensation expense related to the restricted common stock issued as part of the transaction.
+Added: On April 6, 2022, the Company entered into a
+Added: new Open Market Sale Agreement with Jefferies, as sales agent, pursuant to which we may offer and sell, from time to time, through Jefferies,
+Added: shares of our common stock, having an aggregate offering price of up to $ 100,000,000 .
+Added: We are not obligated to sell any shares under the
+Added: As of March 31, 2025, no shares have been issued under this agreement.
Options and Warrants
In December 2014, the Board of Directors adopted,
−Removed: and the Company’s shareholders approved Relmada’s 2014 Stock Option and Equity Incentive Plan, as amended (the “ 2014
−Removed: Plan”), which allows for the granting of 5,152,942 common stock awards, stock appreciation rights, and incentive and nonqualified
−Removed: stock options to purchase shares of the Company’s common stock to designated employees, non-employee directors, and consultants
−Removed: and advisors.
+Added: and the Company’s shareholders approved Relmada’s 2014 Stock Option and Equity Incentive Plan, as amended (the “Plan”),
+Added: which allows for the granting of 5,152,942 common stock awards, stock appreciation rights, and incentive and nonqualified stock options
+Added: 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
5 unchanged sentences
In May 2023, the Company’s Board of Directors
−Removed: adopted and shareholders approved an amendment to the 2021 Plan to increase the shares of the Company’s common stock available
−Removed: for issuance thereunder by 2,500,000 shares.
+Added: adopted and shareholders approved an amendment to the 2021 Plan to increase the shares of the Company’s common stock available for
+Added: issuance thereunder by 2,500,000 shares.
These combined plans allowed for the granting
of up to 13,052,942 options or other stock awards.
−Removed: options are exercisable generally for a period of 10 years from the date of grant and generally vest over four years .
−Removed: As of September 30, 2024, 350 shares were available
−Removed: for future grants under the 2014 or 2021 Plan.
−Removed: The Company utilizes the Black-Scholes option
−Removed: pricing model to estimate the fair value of stock options and warrants.
−Removed: The risk-free interest rate assumptions were based upon the observed
−Removed: interest rates appropriate for the expected term of the equity instruments.
−Removed: The expected dividend yield was assumed to be zero as the
−Removed: Company has not paid any dividends since its inception and does not anticipate paying dividends in the foreseeable future.
−Removed: volatility was based on historical volatility.
+Added: Stock options are exercisable generally for a
+Added: period of 10 years from the date of grant and generally vest over four years .
The Company uses the simplified method for share-based
−Removed: compensation to estimate the expected term for equity awards for share-based compensation in its option-pricing model.
+Added: compensation to estimate the expected term for employee option awards for share-based compensation in its option-pricing model.
+Added: From January 1, 2025 through March 31, 2025, 203,567 options
+Added: were issued with an exercise price of $ 0.30 and a 10 -year term, vesting over a 4 year period.
+Added: The options granted include
+Added: time-based vesting grants.
+Added: The options have an aggregate fair value of approximately $ 54,963 calculated using the Black-Scholes option-pricing
+Added: Variables used in the Black-Scholes option-pricing model include:
+Added: (1) discount rate of 4.05 % - 4.16 % (2) expected life of 6.25 years,
+Added: (3) expected volatility of 126 %, and (4) zero expected dividends.
Relmada Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial
−Removed: NOTE 7 - STOCKHOLDERS’ EQUITY
−Removed: From January 1, 2024 through September 30, 2024,
−Removed: 487,434 options were issued to various consultants and employees with an exercise price ranging from $ 3.05 to $ 3.44 and a 10 -year term,
−Removed: vesting over a 3.56 - 4 year period.
−Removed: The options granted include time-based vesting grants.
−Removed: The options have an aggregate fair value
−Removed: of approximately $ 1.3 million calculated using the Black-Scholes option-pricing model.
−Removed: Variables used in the Black-Scholes option-pricing
−Removed: model include:
−Removed: (1) discount rate of 4.10 – 4.51 % - (2) expected life of 5.92 - 6.25 years, (3) expected volatility of 113.5 % -
−Removed: 114.1 %, and (4) zero expected dividends.
−Removed: September 30, 2024, the Company has unrecognized stock-based compensation expense of approximately $ 32 million related to unvested stock
−Removed: options which will be recognized over the weighted average remaining service period of 1.78 years.
+Added: NOTE 7 - STOCKHOLDERS’ EQUITY (continued)
A summary of the changes in options during the
−Removed: nine months ended September 30, 2024 is as follows:
+Added: three months ended March 31, 2025 is as follows:
Options Weighted
3 unchanged sentences
Granted 203,567 $ 0.30 -
−Removed: Exercised ( 74,999 ) $ -
−Removed: Forfeited ( 18,407 ) $ -
Cancelled ( 1,207,657 ) $ 17.34 - $ -
−Removed: Outstanding at September 30, 2024 13,052,592 $ 16.47 7.02 $ 599,973
−Removed: Options exercisable at September 30, 2024 8,888,189 $ 19.28 6.52 $ 111,698
−Removed: A summary of the changes in outstanding warrants during the nine months
−Removed: ended September 30, 2024 is as follows:
−Removed: Outstanding at December 31, 2023
−Removed: Outstanding at September 30, 2024
−Removed: Warrants vested at September 30, 2024
−Removed: At September 30, 2024, the Company had approximately $ 0.9 million of
−Removed: unrecognized compensation expense related to outstanding warrants.
−Removed: At September 30, 2024, the aggregate intrinsic value of warrants vested
−Removed: and outstanding was $ 3,240 .
−Removed: Stock -based compensation for options and warrants
−Removed: by class of expense
+Added: Outstanding at March 31, 2025 11,258,927 $ 16.24 6.46 $ -
+Added: Options exercisable at March 31, 2025 8,748,097 $ 19.02 6.02 $ -
+Added: At March 31, 2025, the Company has unrecognized stock-based compensation
+Added: expense of approximately $ 12.8 million related to unvested stock options which will be recognized over the weighted average remaining
+Added: service period of 1.99 years.
+Added: A summary of the changes in outstanding warrants during the three months
+Added: ended March 31, 2025 is as follows:
+Added: Outstanding Warrants at December 31, 2024
+Added: Outstanding at March 31, 2025
+Added: Warrants Vested at March 31, 2025
+Added: At March 31, 2025, the Company had approximately
+Added: $ 112,300 of unrecognized compensation expense related to outstanding warrants.
+Added: At March 31, 2025, the aggregate intrinsic value
+Added: of warrants vested and outstanding was $ 0 .
+Added: Stock-based compensation by class of expense
The following table summarizes the components
−Removed: of stock-based compensation expense which includes stock options and warrants in the unaudited consolidated statements of operations
−Removed: for the nine months ended September 30, 2024 and 2023 (rounded to nearest $00):
−Removed: September 30,
−Removed: September 30,
+Added: of stock-based compensation expense which includes restricted stock, stock options, and warrants in the unaudited consolidated statements
+Added: of operations for the three months ended March 31, 2025 and 2024 (rounded to nearest $00):
Research and development
4 unchanged sentences
License Agreements
−Removed: On August 20, 2007, the Company entered into
−Removed: a License Development and Commercialization Agreement with Wonpung Mulsan Co, a shareholder of the Company.
−Removed: Wonpung has exclusive territorial
−Removed: rights in countries it selects in Asia to market up to two drugs the Company was developing at the time of the signing of the agreement
−Removed: and a right of first refusal (“ROFR”) for up to an additional five drugs that the Company may develop in the future as defined
−Removed: in more detail in the license agreement.
−Removed: If the parties cannot agree to terms of a license agreement then the Company shall be able to
−Removed: engage in discussions with other potential licensors.
−Removed: As of September 30, 2024, no discussions are active between the Company and Wonpung.
−Removed: The Company received an upfront license fee of
−Removed: $ 1,500,000 and will earn royalties of up to 12 % of net sales for up to two licensed products it is currently developing.
−Removed: The licensing
−Removed: terms for the ROFR products are subject to future negotiations and binding arbitration.
−Removed: The terms of each licensing agreement will expire
−Removed: on the earlier of any time from 15 years to 20 years after licensing or on the date of commercial availability of a generic product to
−Removed: such licensed product in the licensed territory.
Third Party Licensor
−Removed: Based upon a prior acquisition, the Company assumed
−Removed: an obligation to pay third parties (Dr.
+Added: Based upon a prior acquisition, the Company
+Added: assumed an obligation to pay a third party (Dr.
Inturrisi and Dr.
Paolo Manfredi – see below):
−Removed: (A) royalty payments up to 2 %
−Removed: on net sales of licensed products that are not sold by sublicensee and (B) on each and every sublicense earned royalty payment received
−Removed: by licensee from its sublicensee on sales of license product by sublicensee, the higher of (i) 20 % of the royalties received by licensee;
+Added: (A) royalty payments
+Added: up to 2 % on net sales of licensed products that are not sold by sublicensee and (B) on each and every sublicense earned royalty
+Added: payment received by licensee from its sublicensee on sales of license product by sublicensee, the higher of (i) 20 % of the royalties
+Added: received by licensee;
or (ii) up to 2 % of net sales of sublicensee.
−Removed: The Company will also make milestone payments of up to $ 4 million or $ 2 million, for the
−Removed: first commercial sale of product in the field that has a single active pharmaceutical ingredient, and for the first commercial sale of
−Removed: product in the field of product that has more than one active pharmaceutical ingredient, respectively.
−Removed: As of September 30, 2024, the
−Removed: Company has not generated any revenue related to this license agreement.
+Added: The Company will also make milestone payments of up to $ 4 or $ 2
+Added: million, for the first commercial sale of product in the field that has a single active pharmaceutical ingredient, and for the first
+Added: commercial sale of product in the field of product that has more than one active pharmaceutical ingredient, respectively.
+Added: March 31, 2025, the Company has not generated any revenue related to this license agreement.
Inturrisi / Manfredi
−Removed: In January 2018, the Company entered into
−Removed: an Intellectual Property Assignment Agreement (the Assignment Agreement) and License Agreement (the License Agreement and together with
−Removed: the Assignment Agreement, the Agreements) with Dr.
+Added: In January 2018, we entered into an Intellectual
+Added: Property Assignment Agreement (the Assignment Agreement) and License Agreement (the License Agreement and together with the Assignment
+Added: Agreement, the Agreements) with Dr.
Inturrisi and Dr.
Paolo Manfredi (collectively, the Licensor).
−Removed: to the Agreements, Relmada assigned its existing rights, including patents and patent applications, to esmethadone in the context of
−Removed: psychiatric use (the Existing Invention) to Licensor.
−Removed: Licensor then granted Relmada under the License Agreement a perpetual, worldwide,
−Removed: and exclusive license to commercialize the Existing Invention and certain further inventions regarding esmethadone, in the context of
−Removed: other indications such as those contemplated above.
−Removed: In consideration of the rights granted to Relmada under the License Agreement,
−Removed: Relmada paid the Licensor an upfront, non-refundable license fee of $ 180,000 .
−Removed: Additionally, Relmada will pay Licensor $ 45,000 every three
−Removed: months until the earliest to occur of the following events:
−Removed: (i) the first commercial sale of a licensed product anywhere in the world,
−Removed: (ii) the expiration or invalidation of the last to expire or be invalidated of the patent rights anywhere in the world, or (iii) the
−Removed: termination of the License Agreement.
−Removed: Relmada will also pay Licensor tiered royalties with a maximum rate of 2 %, decreasing to 1.75 %,
−Removed: and 1.5 % in certain circumstances, on net sales of licensed products covered under the License Agreement.
−Removed: Relmada will also pay Licensor
−Removed: tiered payments up to a maximum of 20 %, and decreasing to 17.5 %, and 15 % in certain circumstances, of all consideration received by Relmada
−Removed: for sublicenses granted under the License Agreement.
−Removed: As of September 30, 2024, no events have occurred, and the Company continues to
−Removed: pay Licensor $ 45,000 every three months.
−Removed: Arbormentis, LLC
−Removed: On July 16, 2021, the Company entered into a
−Removed: License Agreement with Arbormentis, LLC, a privately held Delaware limited liability company, by which the Company acquired development
−Removed: and commercial rights to a novel psilocybin and derivate program from Arbormentis, LLC, worldwide excluding the countries of Asia.
−Removed: The Company will collaborate with Arbormentis, LLC on the development of new therapies targeting neurological and psychiatric disorders,
−Removed: leveraging its understanding of neuroplasticity, and focusing on this emerging new class of drugs targeting the neuroplastogen mechanism
−Removed: Under the terms of the License Agreement, the Company paid Arbormentis, LLC an upfront fee of $ 12.7 million, consisting
−Removed: of a mix of cash and warrants to purchase the Company’s common stock, in addition to potential milestone payments totaling up to
−Removed: approximately $ 160 million related to pre-specified development and commercialization milestones.
−Removed: Arbormentis, LLC is also eligible
−Removed: to receive a low single digit royalty on net sales of any commercialized therapy resulting from this agreement.
+Added: Pursuant to the Agreements,
+Added: Relmada assigned its existing rights, including patents and patent applications, to esmethadone in the context of psychiatric use (the
+Added: Existing Invention) to Licensor.
+Added: Licensor then granted Relmada under the License Agreement a perpetual, worldwide, and exclusive license
+Added: to commercialize the Existing Invention and certain further inventions regarding esmethadone in the context of other indications such
+Added: as those contemplated above.
+Added: In consideration of the rights granted to Relmada under the License Agreement, Relmada paid the Licensor
+Added: an upfront, non-refundable license fee of $ 180,000 .
+Added: Additionally, Relmada will pay Licensor $ 45,000 every three months until the earliest
+Added: to occur of the following events:
+Added: (i) the first commercial sale of a licensed product anywhere in the world, (ii) the expiration or invalidation
+Added: of the last to expire or be invalidated of the patent rights anywhere in the world, or (iii) the termination of the License Agreement.
+Added: Relmada will also pay Licensor tiered royalties with a maximum rate of 2 %, decreasing to 1.75 %, and 1.5 % in certain circumstances, on
+Added: net sales of licensed products covered under the License Agreement.
+Added: Relmada will also pay Licensor tiered payments up to a maximum of
+Added: 20 %, and decreasing to 17.5 %, and 15 % in certain circumstances, of all consideration received by Relmada for sublicenses granted under
the License Agreement.
−Removed: is terminable by the Company but is perpetual and not terminable by the licensor absent material breach of its terms by the Company.
+Added: As of March 31, 2025, no events have occurred, and the Company continues to pay Licensor $ 45,000 every three months.
+Added: Arbormentis, LLC
+Added: On July 16, 2021, the Company entered into a License
+Added: Agreement with Arbormentis, LLC, a privately held Delaware limited liability company, by which the Company acquired development and
+Added: commercial rights to a novel psilocybin and derivate program from Arbormentis, LLC, worldwide excluding the countries of Asia.
+Added: Company will collaborate with Arbormentis, LLC on the development of new therapies targeting neurological and psychiatric disorders, leveraging
+Added: its understanding of neuroplasticity, and focusing on this emerging new class of drugs targeting the neuroplastogen mechanism of action.
+Added: 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
+Added: and warrants to purchase the Company’s common stock, in addition to potential milestone payments totaling up to approximately $ 160
+Added: million related to pre-specified development and commercialization milestones.
+Added: Arbormentis, LLC is also eligible to receive a low
+Added: single digit royalty on net sales of any commercialized therapy resulting from this agreement.
+Added: The license agreement is terminable by
+Added: 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
1 unchanged sentence
neural plasticity.
−Removed: Paolo Manfredi, Relmada’s co-inventor of REL-1017 and Relmada’s scientific advisor, and Dr.
−Removed: Pappagallo, Relmada’s scientific advisor, are among the scientists affiliated with Arbormentis, LLC.
+Added: Paolo Manfredi, co-inventor of REL-1017, and Dr.
+Added: Marco Pappagallo, are among the scientists affiliated with
+Added: Arbormentis, LLC.
+Added: On May 12, 2025, the Company delivered to
+Added: Arbormentis LLC a formal notice of termination of the License Agreement, ending the Company’s participation in the previously
+Added: announced psilocybin development program.
+Added: As a result of the cancellation, all obligations under the license agreement with
+Added: Arbormentis will cease as of the effective termination date, which is 90 days after the date of notice.
+Added: On March 24, 2025, we entered into an Exclusive
+Added: License Agreement with Trigone, an Israeli company.
+Added: The license agreement is for Trigone’s NDV-01 product, which is a novel, sustained-release,
+Added: intravesical gemcitabine/docetaxel, ready-for-use product candidate for the treatment of NMIBC.
+Added: Under the terms of the agreement, the
+Added: 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
+Added: outstanding shares, for exclusive worldwide rights to NDV-01, excluding Israel, India and South Africa.
+Added: In addition, the Company will pay up to $ 200 million
+Added: in development, regulatory and sales milestones pending successful commercialization.
+Added: The Company will also pay a royalty of 3 % on any
Relmada Therapeutics, Inc.
1 unchanged sentence
NOTE 8 - COMMITMENTS AND CONTINGENCIES (continued)
−Removed: Leases and Sublease
−Removed: On August 1, 2021, the Company relocated its
−Removed: corporate headquarters to 2222 Ponce de Leon, Floor 3, Coral Gables, FL 33134, pursuant to a lease agreement with monthly rent of approximately
+Added: Leases and Subleases
+Added: On August 1, 2021, the Company relocated its corporate
+Added: headquarters to 2222 Ponce de Leon, Floor 3, Coral Gables, FL 33134, pursuant to a lease agreement with monthly rent of approximately
The lease period was for five months .
−Removed: The lease agreement expired on December 31, 2021 and was renewed for the calendar years
−Removed: 2022, 2023, and 2024, with monthly rent of approximately $ 9,000 , $ 7,000 , and $ 7,000 , respectively.
−Removed: Beginning on January 1, 2023, we also leased
−Removed: office space at 880 Third Avenue, 12 th Floor, New York, NY 10022 with monthly rent of approximately $ 14,500 ;
−Removed: that lease was
−Removed: terminated on November 30, 2023 .
+Added: The lease agreement expired on December 31, 2021 and was renewed for each subsequent year
+Added: 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
6 unchanged sentences
Company has elected the practical expedient and recognizes rent expense evenly over the 12 months.
−Removed: For the nine months ended September 30, 2024 and
+Added: For the three months ended March 31, 2025 and
2024, the Company recognized lease expense of approximately $ 44,800 and $ 62,400 , respectively.
4 unchanged sentences
The Company is currently not aware of any legal proceedings
−Removed: or potential claims against it whose outcome would be likely, individually or in the aggregate, to have a material adverse effect on
−Removed: the Company’s business, financial condition, operating results, or cash flows.
−Removed: NOTE 9 - OTHER POST-RETIREMENT BENEFIT
+Added: or potential claims against it whose outcome would be likely, individually or in the aggregate, to have a material adverse effect on the
+Added: Company’s business, financial condition, operating results, or cash flows.
+Added: NOTE 9 - OTHER POSTRETIREMENT BENEFIT PLAN
Relmada participates in a multiemployer 401(k)
3 unchanged sentences
options for both their contributions and the Company’s matching contribution.
−Removed: The Company’s contribution expense was approximately
−Removed: $ 107,300 and $ 118,800 for the nine months ended September 30, 2024 and 2023, respectively.
+Added: The Company’s contribution expense was $ 47,700
+Added: and $ 35,000 for the three months ended March 31, 2025 and 2024, respectively.
+Added: NOTE 10 - SEGMENT REPORTING
+Added: The Company determined its reporting units in
+Added: accordance with ASC 280, Segment Reporting .
+Added: Reportable operating segments are determined based on the management approach, as defined
+Added: by ASC 280, is based on the way that the chief operating decision-maker (CODM) organizes segments within the Company for making operating
+Added: decisions, assessing performance, and allocating resources.
+Added: Reportable segments are based on products and services, geography, legal structure,
+Added: management structure, or any other manner in which management disaggregates the Company.
+Added: Management determined the Company’s operations
+Added: constitute a single reportable segment in accordance with ASC 280:
+Added: clinical stage drug development.
+Added: The Company derives all of its losses
+Added: from the development of clinical stage drugs expenses.
+Added: The Company’s CODM is its chief executive officer and chief financial officer.
+Added: The CODM assesses performance and makes operating decisions about allocating resources based on the research and development operating
+Added: expenses on the Consolidated Statements of Operations.
+Added: The CODM does not review assets in evaluating the results of the clinical stage
+Added: development, and therefore, such information is not presented.
+Added: The following table provides the operating expenses
+Added: of our clinical stage drug development segment (rounded to the nearest $00):
+Added: Clinical Study Expense
+Added: Other Research Expense
+Added: Manufacturing and Drug Storage Expense
+Added: Pre-clinical Expense
+Added: Compensation Expense
+Added: Stock-based Compensation Expense
+Added: Total Research and Development Expense
NOTE 11 - SUBSEQUENT EVENTS
+Added: On May 12, 2025, the Company delivered to Arbormentis
+Added: LLC a formal notice of termination of the Company’s License Agreement with Arbormentis LLC, ending the Company’s participation
+Added: in the previously announced psilocybin development program.
+Added: This decision was made following a strategic review of the Company’s
+Added: research and development priorities.
+Added: As a result of the cancellation, all obligations under the license agreement with Arbormentis will
+Added: cease as of the effective termination date, which is 90 days after the date of notice.
+Added: The Company does not expect any material financial
+Added: impact resulting from this termination.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.