FINANCIAL STATEMENTS
−Removed: Therapeutics, Inc.
−Removed: Balance Sheets
+Added: Relmada Therapeutics, Inc.
+Added: Consolidated Balance Sheets
+Added: September 30,
Current assets:
12 unchanged sentences
Accrued expenses
−Removed: Notes payable
Total current liabilities
11 unchanged sentences
$ 117,136,140
−Removed: accompanying notes are an integral part of these unaudited consolidated financial statements.
−Removed: Therapeutics, Inc.
−Removed: Statements of Operations
+Added: The accompanying notes are an integral part
+Added: of these unaudited consolidated financial statements.
+Added: Relmada Therapeutics, Inc.
+Added: Consolidated Statements of Operations
Three months ended
−Removed: Six months ended
+Added: Nine months ended
+Added: September 30,
+Added: September 30,
Operating expenses:
5 unchanged sentences
(39,915,222 )
+Added: (10,545,116 )
Other (expenses) income:
Interest/investment income, net
−Removed: Realized gain (loss) on short-term investments
+Added: Realized loss on short-term investments
Unrealized gain on short-term investments
8 unchanged sentences
basic and diluted
−Removed: accompanying notes are an integral part of these unaudited consolidated financial statements.
+Added: The accompanying notes are an integral part
+Added: of these unaudited consolidated financial statements.
Relmada Therapeutics, Inc.
Consolidated Statements of Stockholders’
−Removed: Six months ended June 30, 2020
−Removed: Additional Paid-in
+Added: Nine months ended September 30, 2020
Balance - December 31, 2019
10 unchanged sentences
$ 243,676,817
+Added: $ (130,532,225 )
+Added: $ 113,159,533
Stock based compensation
2 unchanged sentences
Options exercised
−Removed: ATM offering, net of offering costs
+Added: Equity offering, net
(11,118,441 )
4 unchanged sentences
$ 132,233,349
−Removed: Six months ended June 30, 2019
−Removed: Additional Paid-in
+Added: Stock based compensation
+Added: Warrant exercised for cash
+Added: Cashless warrant exercise
+Added: Options exercised
+Added: Cashless option exercised
+Added: Equity offering costs
+Added: (16,902,507 )
+Added: (16,902,507 )
+Added: Balance - September 30, 2020
+Added: $ 280,746,968
+Added: $ (158,553,173 )
+Added: $ 122,209,984
+Added: Nine months ended September 30, 2019
Balance - December 31, 2018
6 unchanged sentences
$ 108,005,928
+Added: $ (107,539,775 )
Stock-based compensation expense
4 unchanged sentences
$ (111,662,367 )
+Added: Stock-based compensation expense
+Added: Purchase of common stock
+Added: Warrants exercised
+Added: Balance - September 30, 2019
+Added: $ 121,299,210
+Added: $ (115,331,861 )
The accompanying notes are an integral part
of these unaudited consolidated financial statements.
−Removed: Therapeutics, Inc.
−Removed: Statements of Cash Flows
−Removed: Six months ended
+Added: Relmada Therapeutics, Inc.
+Added: Consolidated Statements of Cash Flows
+Added: Nine months ended
+Added: September 30,
Cash flows from operating activities
8 unchanged sentences
Change in operating assets and liabilities:
−Removed: Other receivable
Lease payment receivable
3 unchanged sentences
Net cash used in operating activities
+Added: (20,880,039 )
Cash flows from investing activities
6 unchanged sentences
Principal payments of notes payable
−Removed: Proceeds from issuance of common stock
+Added: Proceeds from issuance of common stock - net
Proceeds from options exercised for common stock
9 unchanged sentences
Cashless exercise of warrants for common stock
+Added: Cashless exercise of options for common stock
Notes payable issued in connection with directors and officers insurance policies
−Removed: accompanying notes are an integral part of these unaudited consolidated financial statements.
−Removed: Therapeutics, Inc.
−Removed: to Unaudited Consolidated Financial Statements
−Removed: Therapeutics, Inc.
−Removed: (Relmada or the Company) (a Nevada corporation), is a clinical-stage, publicly traded biotechnology company
−Removed: focused on the development of d-methadone (dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist.
−Removed: is a New Chemical Entity (NCE) that potentially addresses areas of high unmet medical need in the treatment of central nervous
−Removed: system (CNS) diseases and other disorders.
−Removed: On October 7, 2019, our application to list
−Removed: our common stock on the NASDAQ Capital Market was approved.
−Removed: On October 10, 2019, our common stock began trading on Nasdaq under
−Removed: our existing symbol, “RLMD.”
−Removed: On July 14, 2020, our common stock was uplisted to The Nasdaq Global Select Market and
−Removed: continues to trade under the symbol “RLMD”.
−Removed: December 19, 2019, the Board of Directors of the Company approved a change to its end of fiscal year from June 30 to December
−Removed: The change in fiscal year became effective for the Company’s 2020 fiscal year, which began on January 1, 2020 and will
−Removed: end December 31, 2020.
−Removed: addition to the normal risks associated with a new business venture, there can be no assurance that the Company’s research
−Removed: and development will be successfully completed or that any product will be approved or commercially viable.
−Removed: The Company is subject
−Removed: to risks common to companies in the biotechnology industry including, but not limited to, dependence on collaborative arrangements,
−Removed: development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary
−Removed: technology, and compliance with the FDA and other governmental regulations and approval requirements.
−Removed: 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
−Removed: of Presentation
−Removed: accompanying unaudited consolidated financial statements and related notes have been prepared in accordance with accounting principles
−Removed: generally accepted in the United States of America (U.S.
+Added: The accompanying notes are an integral part
+Added: of these unaudited consolidated financial statements.
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Consolidated Financial
+Added: NOTE 1 - BUSINESS
+Added: Relmada Therapeutics, Inc.
+Added: the Company, we or us) (a Nevada corporation), is a clinical-stage biotechnology company focused on the development of REL-1017
+Added: (d-methadone, dextromethadone), an N-methyl-D-aspartate (NMDA) receptor antagonist.
+Added: d-methadone is a new chemical entity (NCE)
+Added: that potentially addresses areas of high unmet medical need in the treatment of central nervous system (CNS) diseases and other
+Added: On October 7, 2019, our application to
+Added: list our common stock on the NASDAQ Capital Market was approved.
+Added: On October 10, 2019, our common stock began trading on Nasdaq
+Added: under our existing symbol, “RLMD.”
+Added: On July 14, 2020, our common stock was uplisted to The Nasdaq Global Select Market
+Added: and continues to trade under the symbol “RLMD”.
+Added: On December 19, 2019, the Board of Directors
+Added: of the Company approved a change to its end of fiscal year from June 30 to December 31.
+Added: The change in fiscal year became effective
+Added: for the Company’s 2020 fiscal year, which began on January 1, 2020 and will end December 31, 2020.
+Added: In addition to the normal risks associated
+Added: with a new business venture, there can be no assurance that the Company’s research and development will be successfully completed
+Added: or that any product will be approved or commercially viable.
+Added: The Company is subject to risks common to companies in the biotechnology
+Added: industry including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors
+Added: of new technological innovations, dependence on key personnel, protection of proprietary technology, and compliance with the FDA
+Added: and other governmental regulations and approval requirements.
+Added: NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING
+Added: Basis of Presentation
+Added: The accompanying unaudited consolidated
+Added: financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United
+Added: States of America (U.S.
GAAP) for interim unaudited consolidated financial information.
−Removed: they do not include all of the information and footnotes required by U.S.
+Added: Accordingly, they do not include all of
+Added: the information and footnotes required by U.S.
GAAP for complete consolidated financial statements.
−Removed: The unaudited consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) which are,
−Removed: in the opinion of management, necessary for a fair statement of the results for the interim periods presented.
−Removed: Interim results
−Removed: are not necessarily indicative of the results for the full year.
−Removed: These unaudited consolidated financial statements should be read
−Removed: in conjunction with the audited consolidated financial statements of the Company for the six months ended December 31, 2019 and
−Removed: notes thereto contained in the Company’s Transition Report on Form 10-KT.
+Added: The unaudited consolidated
+Added: financial statements reflect all adjustments (consisting of normal recurring adjustments) which are, in the opinion of management,
+Added: necessary for a fair statement of the results for the interim periods presented.
+Added: Interim results are not necessarily indicative
+Added: of the results for the full year.
+Added: These unaudited consolidated financial statements should be read in conjunction with the audited
+Added: consolidated financial statements of the Company for the six months ended December 31, 2019 and notes thereto contained in the
+Added: Company’s Transition Report on Form 10-KT.
On September 26, 2019, the Company’s
5 unchanged sentences
retroactively restated to reflect this reverse stock split.
−Removed: As shown in the accompanying financial
−Removed: statements, the Company incurred negative operating cash flows of $8,378,419 for the six months ended June 30, 2020 and has an
−Removed: accumulated deficit of $141,650,666 from inception through June 30, 2020.
−Removed: At June 30, 2020 the Company had cash and short term
−Removed: investments of approximately $134,087,800.
+Added: As shown in the accompanying financial statements,
+Added: the Company incurred negative operating cash flows of $20.9 million for the nine months ended September 30, 2020 and has an accumulated
+Added: deficit of $158.6 million from inception through September 30, 2020.
+Added: At September 30, 2020 the Company had cash and short term
+Added: investments of $123.1 million.
Relmada has funded its past operations
−Removed: through equity raises and most recently in 2020 raised net proceeds from the sale of common stock of $19,855,018 through our ATM
−Removed: offering and $5,619,276 through the exercise of warrants.
−Removed: The Company also raised an additional $530,643 during the six months
−Removed: ended June 30, 2020 from the exercises of options.
−Removed: Therapeutics, Inc.
−Removed: to Unaudited Consolidated Financial Statements
−Removed: 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
−Removed: Management believes that due to the recent equity raises completed
−Removed: and exercises of outstanding warrants and the current cash position on its balance sheet, it has obtained sufficient funding to
−Removed: continue ongoing operations for at least 12 months from the issuance of these unaudited consolidated quarterly financial statements.
−Removed: Since June 30, 2020 and to date, the Company has received approximately $1,230,000 in warrant exercises, which resulted in the
−Removed: Company having approximately $131,549,600 million in cash, cash equivalents, and short term investments at August 5, 2020.
−Removed: on its budgeted cash flow requirements, the Company believes these funds are sufficient to fund its ongoing operations for at least
−Removed: 12 months after the issuance of these unaudited consolidated quarterly financial statements.
−Removed: Regardless of the results of any ongoing
−Removed: clinical trial, the Company has control over its expenditures and has the ability to adjust spending accordingly based on the budgeted
−Removed: cash flow requirements developed and the excess cash on hand.
−Removed: believes that their existing cash and cash equivalents will enable them to fund operating expenses and capital expenditure requirement
−Removed: for at least the next 12 months.
−Removed: Beyond that point management will evaluate the size and scope of any subsequent trials that will
−Removed: affect the timing of additional financings through public or private sales of equity or debt securities or from bank or other
−Removed: loans or through strategic collaboration and/or licensing agreements.
−Removed: Any such expenditures related to any subsequent trials will
−Removed: not be incurred until such additional financing is raised.
−Removed: Further, additional financing related to subsequent trials does not
−Removed: affect the Company’s conclusion that based on the cash on hand and the budgeted cash flow requirements, the Company has
−Removed: sufficient funds to maintain operations for at least 12 months from the issuance of these consolidated financial statements.
−Removed: of Consolidation
−Removed: unaudited consolidated financial statements include the Company’s accounts and those of the Company’s wholly-owned
−Removed: All significant intercompany accounts and transactions have been eliminated in consolidation.
−Removed: and Uncertainties
−Removed: pandemic caused by an outbreak of a new strain of coronavirus (COVID-19) has resulted, and is likely to continue to result, in
−Removed: significant national and global economic disruption and may adversely affect our business.
−Removed: Based on the Company’s current
−Removed: assessment, the Company does not expect any material impact on its long-term development timeline and its liquidity due to the
−Removed: worldwide spread of the COVID-19 virus.
−Removed: However, the Company is actively monitoring this situation and the possible effects on
−Removed: its financial condition, liquidity, operations, suppliers, industry, and workforce.
−Removed: preparation of financial statements in conformity with U.S.
−Removed: GAAP requires management to make estimates and assumptions that affect
−Removed: the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial
−Removed: statements and the reported amounts of revenues and expenses for the reporting period.
−Removed: Actual results could differ from those
−Removed: The significant estimates are the valuation of stock-based compensation expenses and recorded amounts related to income
−Removed: Therapeutics, Inc.
−Removed: to Unaudited Consolidated Financial Statements
−Removed: 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
−Removed: and Cash Equivalents
−Removed: Company considers cash deposits and all highly liquid investments with a maturity of three months or less when purchased to be
−Removed: cash equivalents.
−Removed: The Company’s cash deposits are held at two high-credit-quality financial institutions.
+Added: through equity raises and most recently in 2020 raised net proceeds from the sale of common stock of $19,816,597 and $7,186,306 through the exercise of warrants.
+Added: The Company also raised an additional $636,518 during the nine months
+Added: ended September 30, 2020 from the exercises of options.
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Consolidated Financial
+Added: NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
+Added: Management believes that due to the
+Added: recent equity raises completed and exercises of outstanding options and warrants and the current cash position on its balance
+Added: sheet, it has obtained sufficient funding to continue ongoing operations for at least 12 months from the issuance of these
+Added: unaudited consolidated quarterly financial statements.
+Added: Management believes that their existing
+Added: cash and cash equivalents will enable them to fund operating expenses and capital expenditure requirement for at least the next
+Added: Beyond that point management will evaluate the size and scope of any subsequent trials that will affect the timing of
+Added: additional financings through public or private sales of equity or debt securities or from bank or other loans or through strategic
+Added: collaboration and/or licensing agreements.
+Added: Any such expenditures related to any subsequent trials will not be incurred until such
+Added: additional financing is raised.
+Added: Further, additional financing related to subsequent trials does not affect the Company’s
+Added: conclusion that based on the cash on hand and the budgeted cash flow requirements, the Company has sufficient funds to maintain
+Added: operations for at least 12 months from the issuance of these consolidated financial statements.
+Added: Principles of Consolidation
+Added: The unaudited consolidated financial statements
+Added: include the Company’s accounts and those of the Company’s wholly-owned subsidiary.
+Added: All significant intercompany accounts
+Added: and transactions have been eliminated in consolidation.
+Added: Risks and Uncertainties
+Added: The pandemic caused by an outbreak of a
+Added: new strain of coronavirus (COVID-19) has resulted, and is likely to continue to result, in significant national and global economic
+Added: disruption and may adversely affect our business.
+Added: Based on the Company’s current assessment, the Company does not expect
+Added: any material impact on its long-term development timeline and its liquidity due to the worldwide spread of the COVID-19 virus.
+Added: However, the Company is actively monitoring this situation and the possible effects on its financial condition, liquidity, operations,
+Added: suppliers, industry, and workforce.
+Added: Use of Estimates
+Added: The preparation of financial statements
+Added: in conformity with U.S.
+Added: GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and
+Added: liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts
+Added: of revenues and expenses for the reporting period.
+Added: Actual results could differ from those estimates.
+Added: The significant estimates
+Added: are the valuation of stock-based compensation expenses and recorded amounts related to income taxes.
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Consolidated Financial
+Added: NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
+Added: Cash and Cash Equivalents
+Added: The Company considers cash deposits and
+Added: all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.
The Company’s
−Removed: cash deposits at these institutions exceed federally insured limits.
−Removed: Company’s investments consist entirely of mutual funds.
−Removed: The securities are measured at fair value based on the net asset
−Removed: The Company adopted Financial Accounting Standards Board (FASB) Accounting Standard Update (ASU) 2016-01, Financial
−Removed: Instruments, for the six months ended December 31, 2019 which requires substantially all equity investments in nonconsolidated
−Removed: entities to be measured at fair value with recurring changes recognized in earnings, except for those accounted for using equity
−Removed: method accounting.
−Removed: Changes in fair value of the securities are recorded as part of other income on the consolidated statement
−Removed: of operations.
−Removed: Short term investment activity is presented in the investing activities section on the consolidated statement of
−Removed: related to filing and pursuing patent applications are recorded as general and administrative expense and expensed as incurred
−Removed: since recoverability of such expenditures is uncertain.
−Removed: assets are stated at cost less accumulated depreciation.
−Removed: Fixed assets are comprised of computers and software, leasehold improvements,
−Removed: and furniture and fixtures.
−Removed: Depreciation is calculated using the straight-line method over the estimated useful life of the assets.
−Removed: Computers and software have an estimated useful life of three years.
−Removed: Furniture and fixtures have an estimated useful life of approximately
−Removed: Company recognizes its leases with a term of greater than a year on the balance sheet by recording right-of-use assets and lease
−Removed: Leases can be classified as either operating leases or finance leases.
−Removed: Operating leases will result in straight-line
−Removed: lease expense, while finance leases will result in front-loaded expense.
−Removed: The Company’s lease consists of an operating leases
−Removed: for office space.
−Removed: The Company does not recognize a lease liability or right-of-use asset on the balance sheet for short-term leases.
−Removed: Instead, the Company recognizes short-term lease payments as an expense on a straight-line basis over the lease term.
−Removed: 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
−Removed: to purchase the underlying asset that the lessee is reasonably certain to exercise.
−Removed: Therapeutics, Inc.
−Removed: to Unaudited Consolidated Financial Statements
−Removed: 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
−Removed: Value of Financial Instruments
−Removed: Company’s financial instruments primarily include cash, short term investments, and accounts payable.
−Removed: Due to the short-term
−Removed: nature of cash and accounts payable the carrying amounts of these assets and liabilities approximate their fair value.
−Removed: 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
−Removed: orderly transaction between market participants at the reporting date.
−Removed: A fair value hierarchy has been established for valuation
−Removed: inputs that gives the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority
−Removed: to unobservable inputs.
−Removed: The fair value hierarchy is as follows:
−Removed: 1 Inputs - Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability
−Removed: to access at the measurement date.
−Removed: 2 Inputs - Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly
−Removed: or indirectly.
−Removed: These might include quoted prices for similar assets or liabilities in active markets, quoted prices for identical
−Removed: or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset
−Removed: or liability (such as interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs that are derived principally
−Removed: from or corroborated by market data by correlation or other means.
−Removed: 3 Inputs - Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable
−Removed: (supported by little or no market activity).
+Added: cash deposits are held at two high-credit-quality financial institutions.
+Added: The Company’s cash deposits at these institutions
+Added: exceed federally insured limits.
+Added: Short-term Investments
+Added: The Company’s investments consist
+Added: entirely of mutual funds.
+Added: The securities are measured at fair value based on the net asset value (NAV).
+Added: The Company adopted Financial
+Added: Accounting Standards Board (FASB) Accounting Standard Update (ASU) 2016-01, Financial Instruments, for the six months ended December
+Added: 31, 2019 which requires substantially all equity investments in nonconsolidated entities to be measured at fair value with recurring
+Added: changes recognized in earnings, except for those accounted for using equity method accounting.
+Added: Changes in fair value of the securities
+Added: are recorded as part of other income on the consolidated statement of operations.
+Added: Short term investment activity is presented in
+Added: the investing activities section on the consolidated statement of cash flows.
+Added: Costs related to filing and pursuing patent
+Added: applications are recorded as general and administrative expense and expensed as incurred since recoverability of such expenditures
+Added: is uncertain.
+Added: Fixed assets are stated at cost less accumulated
+Added: depreciation.
+Added: Fixed assets are comprised of computers and software, leasehold improvements, and furniture and fixtures.
+Added: is calculated using the straight-line method over the estimated useful life of the assets.
+Added: Computers and software have an estimated
+Added: useful life of three years.
+Added: Furniture and fixtures have an estimated useful life of approximately seven years.
+Added: The Company recognizes its leases with
+Added: a term of greater than a year on the balance sheet by recording right-of-use assets and lease liabilities.
+Added: Leases can be classified
+Added: as either operating leases or finance leases.
+Added: Operating leases will result in straight-line lease expense, while finance leases
+Added: will result in front-loaded expense.
+Added: The Company’s lease consists of an operating lease for office space.
+Added: The Company does
+Added: not recognize a lease liability or right-of-use asset on the balance sheet for short-term leases.
+Added: Instead, the Company recognizes
+Added: short-term lease payments as an expense on a straight-line basis over the lease term.
+Added: A short-term lease is defined as a lease
+Added: that, at the commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying
+Added: asset that the lessee is reasonably certain to exercise.
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Consolidated Financial
+Added: NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
+Added: Fair Value of Financial Instruments
+Added: The Company’s financial instruments
+Added: primarily include cash, short term investments, and accounts payable.
+Added: Due to the short-term nature of cash and accounts payable
+Added: the carrying amounts of these assets and liabilities approximate their fair value.
+Added: Fair value is defined as the price that
+Added: would be received to sell an asset, or paid to transfer a liability (an exit price), in an orderly transaction between market participants
+Added: at the reporting date.
+Added: A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted
+Added: prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs.
+Added: The fair value hierarchy
+Added: is as follows:
+Added: Level 1 Inputs - Unadjusted quoted prices
+Added: 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
+Added: prices included in Level 1 that are observable for the asset or liability, either directly or indirectly.
+Added: These might include quoted
+Added: prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets
+Added: that are not active, inputs other than quoted prices that are observable for the asset or liability (such as interest rates, volatilities,
+Added: prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market data by correlation
+Added: or other means.
+Added: Level 3 Inputs - Prices or valuation techniques
+Added: that require inputs that are both significant to the fair value measurement and unobservable (supported by little or no market
The Company’s short-term investment
−Removed: instruments of $120,263,581 at June 30, 2020 are classified using Level 1 inputs within the fair value hierarchy because they
−Removed: are valued using NAV.
+Added: instruments of $115,593,750 at September 30, 2020 are classified using Level 1 inputs within the fair value hierarchy because
+Added: they are valued using NAV.
Unrealized gains and losses are recorded in the consolidated statement of operations under other income.
−Removed: The Company recorded an unrealized gain of $287,027 included in other income for the six months ended June 30, 2020.
−Removed: Therapeutics, Inc.
−Removed: to Unaudited Consolidated Financial Statements
−Removed: 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
−Removed: Company accounts for income taxes using the asset and liability method.
−Removed: Accordingly, deferred tax assets and liabilities are recognized
−Removed: for the future tax consequences attributable to differences between financial statement carrying amounts of existing assets and
−Removed: liabilities and their respective tax bases.
−Removed: Deferred tax assets and liabilities are measured using enacted tax rates expected
−Removed: to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.
−Removed: 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
−Removed: is effective.
−Removed: Tax benefits are recognized when it is probable that the deduction will be sustained.
−Removed: A valuation allowance is established
−Removed: 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
−Removed: realize the benefit, or that future deductibility is uncertain.
−Removed: As of June 30, 2020 and December 31, 2019, the Company had recognized
−Removed: a valuation allowance to the full extent of the Company’s net deferred tax assets since the likelihood of realization of
−Removed: the benefit does not meet the more likely than not threshold.
−Removed: Company files a U.S.
−Removed: Federal income tax return and various state returns.
−Removed: Uncertain tax positions taken on the Company’s
−Removed: tax returns will be accounted for as liabilities for unrecognized tax benefits.
−Removed: The Company will recognize interest and penalties,
−Removed: if any, related to unrecognized tax benefits in general and administrative expenses in the statements of operations.
−Removed: no liabilities recorded for uncertain tax positions at June 30, 2020 and December 31, 2019.
−Removed: The open tax years, subject to potential
−Removed: examination by the applicable taxing authority, for the Company are from June 30, 2017 forward.
−Removed: and Development
−Removed: and development costs primarily consist of research contracts for the advancement of product development, salaries and benefits,
−Removed: stock-based compensation, and consultants.
+Added: The Company recorded an unrealized gain of $290,973 included in other income for the nine months ended September 30, 2020.
+Added: The Company accounts for income taxes using
+Added: the asset and liability method.
+Added: Accordingly, deferred tax assets and liabilities are recognized for the future tax consequences
+Added: attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective
+Added: Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the
+Added: years in which those temporary differences are expected to be recovered or settled.
+Added: The effect on deferred tax assets and liabilities
+Added: of a change in the tax rate is recognized in income or expense in the period that the change is effective.
+Added: Tax benefits are recognized
+Added: when it is probable that the deduction will be sustained.
+Added: A valuation allowance is established when it is more likely than not
+Added: 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
+Added: deductibility is uncertain.
+Added: As of September 30, 2020 and December 31, 2019, the Company had recognized a valuation allowance to
+Added: the full extent of the Company’s net deferred tax assets since the likelihood of realization of the benefit does not meet
+Added: the more likely than not threshold.
+Added: The Company files a U.S.
+Added: Federal income
+Added: tax return and various state returns.
+Added: Uncertain tax positions taken on the Company’s tax returns will be accounted for as
+Added: liabilities for unrecognized tax benefits.
+Added: The Company will recognize interest and penalties, if any, related to unrecognized tax
+Added: benefits in general and administrative expenses in the statements of operations.
+Added: There were no liabilities recorded for uncertain
+Added: tax positions at September 30, 2020 and December 31, 2019.
+Added: The open tax years, subject to potential examination by the applicable
+Added: taxing authority, for the Company are from June 30, 2017 forward.
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Consolidated Financial
+Added: NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
+Added: Research and Development
+Added: Research and development costs primarily
+Added: consist of research contracts for the advancement of product development, salaries and benefits, stock-based compensation, and
The Company expenses all research and development costs in the period incurred.
−Removed: Company makes an estimate of costs in relation to clinical study contracts.
−Removed: The Company analyzes the progress of studies, including
−Removed: the progress of clinical studies and phases, invoices received and contracted costs when evaluating the adequacy of the amount
−Removed: expensed and the related prepaid asset and accrued liability.
−Removed: Company measures the cost of employee services received in exchange for an award of equity instruments based on the grant-date
−Removed: fair value of the award.
−Removed: That cost is recognized over the period during which an employee is required to provide service in exchange
−Removed: for the award - the requisite service period.
−Removed: The grant-date fair value of employee share options is estimated using the Black-Scholes
−Removed: option pricing model adjusted for the unique characteristics of those instruments.
−Removed: per Common Share
−Removed: Basic loss per common share attributable to
−Removed: common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of
−Removed: common shares outstanding for the period, without consideration for common stock equivalents.
−Removed: Diluted loss per common share attributable
−Removed: to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number
−Removed: of common share equivalents outstanding for the period determined using the treasury-stock method.
−Removed: Dilutive common stock equivalents
−Removed: are comprised of options and warrants to purchase common stock.
−Removed: For all periods presented, there is no difference in the number
−Removed: of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.
−Removed: the six months ended June 30, 2020 and 2019, the potentially dilutive securities that would be anti-dilutive due to the Company’s
−Removed: net loss are not included in the calculation of diluted net loss per share attributable to common stockholders.
−Removed: The anti-dilutive
−Removed: securities are as follows (in common stock equivalent shares):
−Removed: Six months ended
+Added: The Company makes an estimate of costs
+Added: in relation to clinical study contracts.
+Added: The Company analyzes the progress of studies, including the progress of clinical studies
+Added: and phases, invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid
+Added: asset and accrued liability.
+Added: Stock-Based Compensation
+Added: The Company measures the cost of employee
+Added: services received in exchange for an award of equity instruments based on the grant-date fair value of the award.
+Added: recognized over the period during which an employee is required to provide service in exchange for the award - the requisite service
+Added: The grant-date fair value of employee share options is estimated using the Black-Scholes option pricing model adjusted
+Added: for the unique characteristics of those instruments.
+Added: Loss per Common Share
+Added: Basic loss per common share attributable
+Added: to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number
+Added: of common shares outstanding for the period, without consideration for common stock equivalents.
+Added: Diluted loss per common share
+Added: attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average
+Added: number of common share equivalents outstanding for the period determined using the treasury-stock method.
+Added: Dilutive common stock
+Added: equivalents are comprised of options and warrants to purchase common stock.
+Added: For all periods presented, there is no difference in
+Added: the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.
+Added: For the nine months ended September 30,
+Added: 2020 and 2019, the potentially dilutive securities that would be anti-dilutive due to the Company’s net loss are not included
+Added: in the calculation of diluted net loss per share attributable to common stockholders.
+Added: The anti-dilutive securities are as follows
+Added: (in common stock equivalent shares):
+Added: Nine months ended
+Added: September 30,
+Added: September 30,
Stock options
Common stock warrants
−Removed: Therapeutics, Inc.
−Removed: to Unaudited Consolidated Financial Statements
−Removed: 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
−Removed: Accounting Pronouncements
−Removed: December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740):
−Removed: Simplifying the Accounting for Income Taxes , which
−Removed: is intended to simplify various aspects related to accounting for income taxes.
−Removed: ASU 2019-12 removes certain exceptions to the
−Removed: general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application.
−Removed: This guidance
−Removed: is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption
−Removed: We do not expect the adoption of ASU 2019-12 to have a material impact on our consolidated financial statements.
−Removed: In August 2018, FASB issued ASU 2018-13, Fair
−Removed: Value Measurement –
+Added: Recent Accounting Pronouncements
+Added: In December 2019, the FASB issued ASU 2019-12,
+Added: Income Taxes (Topic 740):
+Added: Simplifying the Accounting for Income Taxes , which is intended to simplify various aspects related
+Added: to accounting for income taxes.
+Added: ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies
+Added: and amends existing guidance to improve consistent application.
+Added: This guidance is effective for fiscal years, and interim periods
+Added: within those fiscal years, beginning after December 15, 2020, with early adoption permitted.
+Added: We do not expect the adoption of ASU
+Added: 2019-12 to have a material impact on our consolidated financial statements.
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Consolidated Financial
+Added: NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
+Added: In August 2018, FASB issued ASU
+Added: 2018-13, Fair Value Measurement –
Disclosure Framework (Topic 820).
−Removed: The updated guidance improves the disclosure requirements on fair
−Removed: value measurements, primarily associated with Level 3 fair value measurements and is effective for fiscal years, and interim periods
−Removed: within those fiscal years, beginning December 15, 2019.
−Removed: Early adoption is permitted upon issuance of the standard disclosures
−Removed: modified or removed with a delay of adoption of the additional disclosures until their effective date.
−Removed: The Company adopted this
−Removed: standard effective January 1, 2020 and the standard did not have a significant impact on the Company’s financial statements.
−Removed: In November 2018, FASB issued ASU 2018-18 –
−Removed: Collaborative
−Removed: Arrangements (Topic 808):
−Removed: Clarifying the Interaction between Topic 808 and Topic 606 , which, among other things, provides guidance
−Removed: on how to assess whether certain collaborative arrangement transactions should be accounted for under Topic 606.
−Removed: The amendments
−Removed: in the ASU are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with
−Removed: early adoption permitted.
−Removed: The Company adopted this standard on January 1, 2020 and the standard did not have a significant impact
−Removed: on the Company’s financial statements.
−Removed: Company’s management reviewed all material events through the date the financial statements were issued for subsequent event
−Removed: disclosure consideration.
−Removed: 3 - PREPAID EXPENSES
−Removed: expenses consisted of the following (rounded to nearest $00):
+Added: The updated guidance improves the disclosure
+Added: requirements on fair value measurements, primarily associated with Level 3 fair value measurements and is effective for
+Added: fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019.
+Added: Early adoption is permitted
+Added: upon issuance of the standard disclosures modified or removed with a delay of adoption of the additional disclosures until
+Added: their effective date.
+Added: The Company adopted this standard effective January 1, 2020 and the standard did not have a significant
+Added: impact on the Company’s financial statements.
+Added: In November 2018, FASB issued ASU 2018-18
+Added: Collaborative Arrangements (Topic 808):
+Added: Clarifying the Interaction between Topic 808 and Topic 606 , which, among
+Added: other things, provides guidance on how to assess whether certain collaborative arrangement transactions should be accounted for
+Added: under Topic 606.
+Added: The amendments in the ASU are effective for fiscal years, and interim periods within those fiscal years, beginning
+Added: after December 15, 2019, with early adoption permitted.
+Added: The Company adopted this standard on January 1, 2020 and the standard did
+Added: not have a significant impact on the Company’s financial statements.
+Added: Subsequent Events
+Added: The Company’s management reviewed
+Added: all material events through the date the financial statements were issued for subsequent event disclosure consideration.
+Added: NOTE 3 - PREPAID EXPENSES
+Added: Prepaid expenses consisted of the following (rounded to nearest
+Added: September 30,
Research and Development
−Removed: 4 - FIXED ASSETS
−Removed: assets, net of accumulated depreciation, consisted of the following (rounded to nearest $00):
+Added: NOTE 4 - FIXED ASSETS
+Added: Fixed assets, net of accumulated depreciation, consisted of
+Added: the following (rounded to nearest $00):
+Added: September 30,
Computer and Software
accumulated depreciation
−Removed: 5 - ACCRUED EXPENSES
−Removed: expenses consisted of the following (rounded to nearest $00):
+Added: NOTE 5 - ACCRUED EXPENSES
+Added: Accrued expenses consisted of the following (rounded to nearest
+Added: September 30,
Research and development
3 unchanged sentences
Legal settlement
−Removed: Therapeutics, Inc.
−Removed: to Unaudited Consolidated Financial Statements
−Removed: 6 - NOTES PAYABLE
−Removed: June 2019, the Company entered into a note for approximately $364,200 in conjunction with a renewal of its director and officer
−Removed: insurance policy.
−Removed: The interest rate was 3.09% per annum.
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Consolidated Financial
+Added: NOTE 6 - NOTE PAYABLE
+Added: In June 2019, the Company entered into
+Added: a note for approximately $364,200 in conjunction with a renewal of its director and officer insurance policy.
+Added: The interest rate
+Added: was 3.09% per annum.
The note matured on April 9, 2020.
−Removed: June 30, 2020 and December 31, 2019, the note payable outstanding balances were approximately $0 and $110,200, respectively.
−Removed: 7 - STOCKHOLDERS’
+Added: At September 30, 2020 and December 31,
+Added: 2019, the note payable outstanding balances were approximately $0 and $110,200, respectively.
+Added: NOTE 7 - STOCKHOLDERS’
On September 26, 2019, the Company’s
5 unchanged sentences
retroactively restated to reflect this reverse stock split.
−Removed: During the six months ended June 30,
+Added: During the nine months ended September
30, 2020, the Company issued shares of common stock for cashless exercise of warrants.
−Removed: The Company also issued
−Removed: 815,471 shares of common stock for cash exercises of warrants for proceeds of $5,619,276.
−Removed: During the six months ended June 30, 2020,
+Added: The Company also issued shares of common
+Added: stock for cash exercises of warrants for proceeds of $7,186,306.
+Added: During the nine months ended September
+Added: 30, 2020, the Company issued shares of common stock for cashless exercise of options.
+Added: During the nine months ended September 30,
2020, the Company issued shares of common stock for the exercise of options for proceeds of $636,518.
−Removed: On May 15, 2020, the Company entered into an
−Removed: Open Market Sale Agreement with Jefferies LLC, as sales agent (“Jefferies”), pursuant to which the Company may
−Removed: offer and sell, from time to time, through Jefferies, shares of the Company’s common stock, having an aggregate offering
+Added: On May 15, 2020, the Company entered into
+Added: an Open Market Sale Agreement with Jefferies LLC, as sales agent (“Jefferies”), pursuant to which the Company
+Added: may offer and sell, from time to time, through Jefferies, shares of the Company’s common stock, having an aggregate offering
price of up to $75,000,000 .
The Company is not obligated to sell any shares under the agreement.
−Removed: During the six months ended June
−Removed: 30, 2020 the Company issued 427,700 shares of common stock for net cash proceeds of $19,900,000 million under the agreement.
+Added: During the nine months ended
+Added: September 30, 2020 the Company issued shares of common stock for net cash proceeds of $19,816,597 under the agreement.
+Added: Options and Warrants
In December 2014, the Board of Directors
3 unchanged sentences
The Plan allowed for the granting of 5,152,942 options or stock awards.
−Removed: Stock options are exercisable generally for a period of 10 years
−Removed: from the date of grant and generally vest over four years.
−Removed: As of June 30, 2020, 1,018,367 shares were available for future grants
−Removed: under the Plan.
−Removed: of June 30, 2020, no stock appreciation rights have been issued.
−Removed: The Company utilizes the Black-Scholes option pricing model
−Removed: 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
−Removed: as the Company has not paid any dividends since its inception and does not anticipate paying dividends in the foreseeable future.
+Added: Stock options are exercisable generally for
+Added: a period of 10 years from the date of grant and generally vest over four years.
+Added: As of September 30, 2020, 1,042,520 shares were
+Added: available for future grants under the Plan.
+Added: As of September 30, 2020, no stock appreciation
+Added: rights have been issued.
+Added: The Company utilizes the Black-Scholes
+Added: option pricing model to estimate the fair value of stock options and warrants.
+Added: The risk-free interest rate assumptions were based
+Added: upon the observed interest rates appropriate for the expected term of the equity instruments.
+Added: The expected dividend yield was assumed
+Added: to be zero as the Company has not paid any dividends since its inception and does not anticipate paying dividends in the foreseeable
The expected volatility was based on historical volatility.
−Removed: The Company routinely reviews its calculation of volatility changes
−Removed: in future volatility, the Company’s life cycle, its peer group, and other factors.
−Removed: Company uses the simplified method for share-based compensation to estimate the expected term for employee option awards for share-based
−Removed: compensation in its option-pricing model.
−Removed: March 9, 2020, the Company awarded a total of 350,000 options to an employee with exercise price of $45.61 and a 10-year term
−Removed: vesting over 4-year period.
+Added: The Company routinely reviews its calculation of volatility
+Added: changes in future volatility, the Company’s life cycle, its peer group, and other factors.
+Added: The Company uses the simplified
+Added: method for share-based compensation to estimate the expected term for equity awards for share-based compensation in its
+Added: option-pricing model.
+Added: During the nine months ended September
+Added: 30, 2020, the Company awarded a total of 950,000 options to employees with exercise price ranging from $28.00- $45.61 and a 10-year
+Added: term vesting over 4-year period.
The options have an aggregate fair value of $31.1 million calculated using the Black-Scholes option-pricing
2 unchanged sentences
6.25 years, (3) expected volatility of 106%-108%, and (4) zero expected dividends.
−Removed: Therapeutics, Inc.
−Removed: to Unaudited Consolidated Financial Statements
−Removed: 7 - STOCKHOLDERS’
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Consolidated Financial
+Added: NOTE 7 - STOCKHOLDERS’
EQUITY (continued)
−Removed: March 19, 2020, the Company awarded a total of 100,000 options to an employee with exercise price of $28.00 and a 10-year term
−Removed: vesting over a 4-year period.
−Removed: The options have an aggregate fair value of $2.3 million calculated using the Black-Scholes option-pricing
−Removed: Variables used in the Black-Scholes option-pricing model include:
−Removed: (1) discount rate of 0.83% (2) expected life of 6.25
−Removed: years, (3) expected volatility of 108%, and (4) zero expected dividends.
−Removed: March 25, 2020, the Company awarded a total of 150,000 options to an employee with exercise price of $31.88 and a 10-year term
−Removed: vesting over a 4-year period.
−Removed: The options have an aggregate fair value of $4.0 million calculated using the Black-Scholes option-pricing
−Removed: Variables used in the Black-Scholes option-pricing model include:
−Removed: (1) discount rate of 0.67% (2) expected life of 6.25
−Removed: years, (3) expected volatility of 108%, and (4) zero expected dividends.
−Removed: On April 21, 2020, the Company awarded
−Removed: a total of 100,000 options to an employee with exercise price of $33.29 and a 10-year term vesting over a 4-year period.
−Removed: have an aggregate fair value of $2.7 million calculated using the Black-Scholes option-pricing model.
−Removed: Variables used in the Black-Scholes
−Removed: option-pricing model include:
−Removed: (1) discount rate of 0.41% (2) expected life of 6.25 years, (3) expected volatility of 108%, and
−Removed: (4) zero expected dividends.
−Removed: On May 20, 2020, the Company awarded a
−Removed: total of 150,000 options to an employee with exercise price of $45.25 and a 10-year term vesting over a 4-year period.
−Removed: have an aggregate fair value of $5.6 million calculated using the Black-Scholes option-pricing model.
−Removed: Variables used in the Black-Scholes
−Removed: option-pricing model include:
−Removed: (1) discount rate of 0.44% (2) expected life of 6.25 years, (3) expected volatility of 107%, and
−Removed: (4) zero expected dividends
−Removed: At June 30, 2020, the Company has unrecognized
−Removed: stock-based compensation expense of approximately $69,788,000 related to unvested stock options over the weighted average remaining
−Removed: service period of 3.5 years.
−Removed: During the six months
−Removed: ended June 30, 2020, the Company recognized additional compensation expense of approximately $1.5 million related to acceleration
−Removed: of vesting and a nominal amount related to the modification of certain options in connection with the separation and settlement
−Removed: agreement with Dr.
+Added: At September 30, 2020, the Company has
+Added: unrecognized stock-based compensation expense of approximately $67,964,000 related to unvested stock options over the weighted
+Added: average remaining service period of 3.29 years.
+Added: the nine months ended September 30, 2020, the Company recognized additional compensation expense of approximately $1,500,000 related
+Added: to acceleration of vesting and a nominal amount related to the modification of certain options in connection with the separation
+Added: and settlement agreement with Dr.
Ottavio Vitolo (see note 8).
−Removed: summary of the changes in options during the six months ended June 30, 2020 is as follows:
+Added: A summary of the changes in options during
+Added: the nine months ended September 30, 2020 is as follows:
Outstanding and expected to vest at December 31, 2019
−Removed: Outstanding and expected to vest at June 30, 2020
−Removed: Options exercisable at June 30, 2020
+Added: Outstanding at September 30, 2020
+Added: Options exercisable at September 30, 2020
A summary of the changes in outstanding warrants during the
−Removed: six months ended June 30, 2020 is as follows:
+Added: nine months ended September 30, 2020 is as follows:
Outstanding and vested at December 31, 2019
−Removed: Outstanding and vested at June 30, 2020
−Removed: Therapeutics, Inc.
−Removed: to Unaudited Consolidated Financial Statements
−Removed: 7 - STOCKHOLDERS’
+Added: Outstanding at September 30, 2020
+Added: Warrants exercisable at September 30, 2020
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Consolidated Financial
+Added: NOTE 7 - STOCKHOLDERS’
EQUITY (continued)
14 unchanged sentences
zero expected dividends.
−Removed: At June 30, 2020 the Company had approximately
−Removed: $103,000 of unrecognized compensation expense related to outstanding warrants.
−Removed: At June 30, 2020 and December 31,
−Removed: 2019, the aggregate intrinsic value of warrants vested and outstanding was approximately $106,423,000 and $115,731,000,
−Removed: respectively.
+Added: At September 30, 2020, the Company had
+Added: approximately $90,400 of unrecognized compensation expense related to outstanding warrants.
+Added: At September 30, 2020 and December 31,
+Added: 2019, the aggregate intrinsic value of warrants vested and outstanding was approximately $78,875,000 and $115,731,000, respectively.
The following summarizes the components
of stock-based compensation expense which includes stock options and warrants in the unaudited consolidated statements of operations
−Removed: for the six months ended June 30, 2020 and 2019 (rounded to nearest $00):
+Added: for the nine months ended September 30, 2020 and 2019 (rounded to nearest $00):
+Added: September 30,
+Added: September 30,
Research and development
General and administrative
−Removed: 8 - RELATED PARTY TRANSACTIONS
−Removed: March 6, 2020, Dr.
−Removed: Vitolo entered into a Separation and Severance Agreement with the Company.
−Removed: Pursuant to the terms of the agreement,
−Removed: the Company agreed to pay Dr.
+Added: NOTE 8 - RELATED PARTY TRANSACTIONS
+Added: Effective March 6, 2020, Dr.
+Added: Vitolo entered
+Added: into a Separation and Severance Agreement with the Company.
+Added: Pursuant to the terms of the agreement, the Company agreed to pay Dr.
Vitolo severance of $200,000 in accordance with his employment contract.
In addition, Dr.
−Removed: Vitolo’s
−Removed: options granted under the Company’s 2014 Stock Option and Equity Incentive Plan will continue to vest until September 6,
−Removed: Vitolo shall have until March 6, 2021 to exercise his vested options and he shall be allowed to use a cashless exercise
−Removed: provision to exercise his vested options.
−Removed: The agreement also contains customary confidentiality, release, and non-disparagement
−Removed: provisions, and the Company agreed to pay accrued and unpaid salary, vacation time and attorney’s fees totaling approximately $45,000.
−Removed: March 9, 2020, the Company appointed Dr.
+Added: Vitolo’s options granted under
+Added: the Company’s 2014 Stock Option and Equity Incentive Plan continued to vest until September 6, 2020.
+Added: have until March 6, 2021 to exercise his vested options and he shall be allowed to use a cashless exercise provision to exercise
+Added: his vested options.
+Added: The agreement also contains customary confidentiality, release, and non-disparagement provisions, and the Company
+Added: agreed to pay accrued and unpaid salary, vacation time and attorney’s fees totaling approximately $45,000.
+Added: On March 9, 2020, the Company appointed
Thomas Wessel as the Company’s Executive Vice President, Head of Research and Development.
−Removed: 9 - COMMITMENTS AND CONTINGENCIES
−Removed: On August 20, 2007, the Company
−Removed: entered into a License Development and Commercialization Agreement with Wonpung Mulsan Co, a shareholder of the Company.
−Removed: Wonpung has exclusive territorial rights in countries it selects in Asia to market up to two drugs the Company is currently
−Removed: developing and a right of first refusal (“ROFR”) for up to an additional five drugs that the Company may develop
−Removed: in the future as defined in more detail in the license agreement.
−Removed: If the parties cannot agree to terms of a license agreement
−Removed: then the Company shall be able to engage in discussions with other potential licensors.
−Removed: As of July 2020, no discussions are
−Removed: active between the Company and Wonpung.
−Removed: Company received an upfront license fee of $1,500,000 and will earn royalties of up to 12% of net sales for up to two licensed
−Removed: products it is currently developing.
−Removed: The licensing terms for the ROFR products are subject to future negotiations and binding
−Removed: The terms of each licensing agreement will expire on the earlier of any time from 15 years to 20 years after licensing
−Removed: or on the date of commercial availability of a generic product to such licensed product in the licensed territory.
−Removed: Therapeutics, Inc.
−Removed: to Unaudited Consolidated Financial Statements
−Removed: 9 - COMMITMENTS AND CONTINGENCIES (continued)
−Removed: Party Licensor
+Added: NOTE 9 - COMMITMENTS AND CONTINGENCIES
+Added: License Agreements
+Added: On August 20, 2007, the Company entered
+Added: into a License Development and Commercialization Agreement with Wonpung Mulsan Co, a shareholder of the Company.
+Added: Wonpung has exclusive
+Added: territorial rights in countries it selects in Asia to market up to two drugs the Company is currently developing and a right of
+Added: first refusal (“ROFR”) for up to an additional five drugs that the Company may develop in the future as defined in
+Added: more detail in the license agreement.
+Added: If the parties cannot agree to terms of a license agreement then the Company shall be able
+Added: to engage in discussions with other potential licensors.
+Added: As of November 12, 2020, no discussions are active between the Company
+Added: The Company received an upfront license
+Added: fee of $1,500,000 and will earn royalties of up to 12% of net sales for up to two licensed products it is currently developing.
+Added: The licensing terms for the ROFR products are subject to future negotiations and binding arbitration.
+Added: The terms of each licensing
+Added: agreement will expire on the earlier of any time from 15 years to 20 years after licensing or on the date of commercial availability
+Added: of a generic product to such licensed product in the licensed territory.
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Consolidated Financial
+Added: NOTE 9 - COMMITMENTS AND CONTINGENCIES
+Added: Third Party Licensor
Based upon a prior acquisition, the Company
10 unchanged sentences
first commercial sale of product in the field of product that has more than one active pharmaceutical ingredient, respectively.
−Removed: As of June 30, 2020, the Company has not generated any revenue related to this license agreement.
−Removed: In January 2018, we entered into an Intellectual
−Removed: Property Assignment Agreement (the Assignment Agreement) and License Agreement (the License Agreement and together with the Assignment
−Removed: Agreement, the Agreements) with Dr.
+Added: As of September 30, 2020, the Company has not generated any revenue related to this license agreement.
+Added: Inturrisi / Manfredi
+Added: In January 2018, we entered into an
+Added: Intellectual Property Assignment Agreement (the Assignment Agreement) and License Agreement (the License Agreement and together
+Added: with the Assignment Agreement, the Agreements) with Dr.
Inturrisi and Dr.
Paolo Manfredi (collectively, the Licensor).
−Removed: the Agreements, Relmada assigned its existing rights, including patents and patent applications, to d-methadone in the context
−Removed: of psychiatric use (the Existing Invention) to Licensor.
−Removed: Licensor then granted Relmada under the License Agreement a perpetual,
−Removed: worldwide, and exclusive license to commercialize the Existing Invention and certain further inventions regarding d-methadone.
−Removed: consideration of the rights granted to Relmada under the License Agreement, Relmada paid the Licensor an upfront, non-refundable
−Removed: license fee of $180,000.
−Removed: Additionally, Relmada will pay Licensor $45,000 every three months until the earliest to occur of the
−Removed: following events:
−Removed: (i) the first commercial sale of a licensed product anywhere in the world, (ii) the expiration or invalidation
−Removed: of the last to expire or be invalidated of the patent rights anywhere in the world, or (iii) the termination of the License Agreement.
−Removed: Relmada will also pay Licensor tiered royalties with a maximum rate of 2%, decreasing to 1.75%, and 1.5% in certain circumstances,
−Removed: on net sales of licensed products covered under the License Agreement.
−Removed: Relmada will also pay Licensor tiered payments up to a maximum
−Removed: of 20%, and decreasing to 17.5%, and 15% in certain circumstances, of all consideration received by Relmada for sublicenses granted
−Removed: under the License Agreement.
−Removed: time to time, the Company may become involved in lawsuits and other legal proceedings that arise in the course of business.
−Removed: is subject to inherent uncertainties, and it is not possible to predict the outcome of litigation with total confidence.
−Removed: is currently not aware of any legal proceedings or potential claims against it whose outcome would be likely, individually or
−Removed: in the aggregate, to have a material adverse effect on the Company’s business, financial condition, operating results, or
−Removed: Brought by Former Officer
−Removed: February 6, 2019, the Company entered into a settlement agreement in its previous dispute with Najib Babul, Relmada’s former
−Removed: Babul relinquished his 303,392 shares in Relmada, signed a consulting contract and Relmada committed to a $500,000
−Removed: initial payment and four subsequent payments of $250,000 on March 31, 2019, June 30, 2019, September 30, 2019 and December 31,
−Removed: The Company recorded a loss on the settlement of $1.1 million in the first quarter of 2019.
−Removed: Therapeutics, Inc.
−Removed: to Unaudited Consolidated Financial Statements
−Removed: 9 - COMMITMENTS AND CONTINGENCIES (continued)
+Added: Pursuant to the Agreements, Relmada assigned its existing rights, including patents and patent applications, to d-methadone in
+Added: the context of psychiatric use (the Existing Invention) to Licensor.
+Added: Licensor then granted Relmada under the License Agreement
+Added: a perpetual, worldwide, and exclusive license to commercialize the Existing Invention and certain further inventions regarding
+Added: In consideration of the rights granted to Relmada under the License Agreement, Relmada paid the Licensor an upfront,
+Added: non-refundable license fee of $180,000.
+Added: Additionally, Relmada will pay Licensor $45,000 every three months until the earliest to
+Added: occur of the following events:
+Added: (i) the first commercial sale of a licensed product anywhere in the world, (ii) the expiration or
+Added: invalidation of the last to expire or be invalidated of the patent rights anywhere in the world, or (iii) the termination of the
+Added: License Agreement.
+Added: Relmada will also pay Licensor tiered royalties with a maximum rate of 2%, decreasing to 1.75%, and 1.5% in
+Added: certain circumstances, on net sales of licensed products covered under the License Agreement.
+Added: Relmada will also pay Licensor tiered
+Added: payments up to a maximum of 20%, and decreasing to 17.5%, and 15% in certain circumstances, of all consideration received by Relmada
+Added: for sublicenses granted under the License Agreement.
+Added: From time to time, the Company may become
+Added: involved in lawsuits and other legal proceedings that arise in the course of business.
+Added: Litigation is subject to inherent uncertainties,
+Added: and it is not possible to predict the outcome of litigation with total confidence.
+Added: The Company is currently not aware of any legal
+Added: proceedings or potential claims against it whose outcome would be likely, individually or in the aggregate, to have a material
+Added: adverse effect on the Company’s business, financial condition, operating results, or cash flows.
+Added: Lawsuit Brought by Former Officer
+Added: On February 6, 2019, the Company entered
+Added: into a settlement agreement in its previous dispute with Najib Babul, Relmada’s former President.
+Added: Babul relinquished his
+Added: 303,392 shares in Relmada, signed a consulting contract and Relmada committed to a $500,000 initial payment and four subsequent
+Added: payments of $250,000 on March 31, 2019, June 30, 2019, September 30, 2019 and December 31, 2019.
+Added: The Company recorded a loss on
+Added: the settlement of $1.1 million in the first quarter of 2019.
+Added: July 15, 2020, an employee of the Company filed a Complaint alleging unequal pay based on gender and other employment based claims.
+Added: The Company intends to defend the lawsuit vigorously and does not expect that the lawsuit will have a material effect on its financial
+Added: Relmada Therapeutics, Inc.
+Added: Notes to Unaudited Consolidated Financial
+Added: NOTE 9 - COMMITMENTS AND CONTINGENCIES (continued)
+Added: Leases and Sublease
The Company’s corporate headquarters
3 unchanged sentences
The monthly rent is approximately $13,800.
−Removed: For the six months ended June 30, 2020 and 2019, the Company recognized lease
−Removed: expense of approximately $83,000 and $46,800, respectively.
−Removed: On June 8, 2017, the Company entered into an
−Removed: Amended and Restated License Agreement with Actinium.
+Added: For the nine months ended September 30, 2020 and 2019, the Company recognized
+Added: lease expense of approximately $124,400 and $70,300, respectively.
+Added: On June 8, 2017, the Company entered into
+Added: an Amended and Restated License Agreement with Actinium.
Pursuant to the terms of the agreement, Actinium will continue to license
7 unchanged sentences
rate of 8.38% and recognized loss on sales-type lease of fixed assets of $96,403.
−Removed: For the six months ended June 30, 2020 and 2019,
−Removed: the Company recognized lease income of approximately $9,400 and $12,300, respectively.
−Removed: As of June 30, 2020, the balance of unearned
−Removed: interest income was approximately $22,700.
−Removed: following tables sets forth our contractual obligations for the next five years and thereafter:
+Added: For the nine months ended September 30, 2020
+Added: and 2019, the Company recognized lease income of approximately $13,500 and $17,900, respectively.
+Added: As of September 30, 2020, the
+Added: balance of unearned interest income was approximately $18,600.
+Added: Contractual Obligations
+Added: The following tables sets forth our contractual
+Added: obligations for the next five years and thereafter:
Total obligations
−Removed: 10 - SUBSEQUENT EVENTS
−Removed: Subsequent to June 30,
−Removed: 2020, 172,093 outstanding warrants were exercised for total cash proceeds of approximately $1,230,000.
−Removed: These warrant exercises
−Removed: include 481 shares issued with a cashless exercise.
−Removed: 15, 2020, an employee of the Company filed a Complaint alleging unequal pay based on gender and other employment based claims.
−Removed: The Company intends to defend the lawsuit vigorously and does not expect that the lawsuit will have a material effect on its financial
−Removed: On July 22, 2020, the Company awarded a
−Removed: total of 100,000 options to two new employees with an exercise price of $41.70 and a 10-year term vesting over a 4-year period.
−Removed: MANAGEMENT’S
−Removed: DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION
−Removed: FORWARD-LOOKING
−Removed: STATEMENT NOTICE
−Removed: Quarterly Report on Form 10-Q (this Report) contains forward looking statements that involve risks and uncertainties, principally
−Removed: in the sections entitled “Description of Business,”
+Added: NOTE 10 - SUBSEQUENT EVENTS
+Added: to September 30, 2020, 52,268 outstanding warrants were exercised for total cash proceeds of approximately $437,100.
+Added: On October 25, 2020, the Company awarded
+Added: a total of 25,000 options to a new employee with an exercise price of $33.34 and a 10-year term vesting over a four year period.
+Added: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION
+Added: FORWARD-LOOKING STATEMENT NOTICE
+Added: This Quarterly Report on Form 10-Q (this
+Added: Report) contains forward looking statements that involve risks and uncertainties, principally in the sections entitled “Description
+Added: of Business,”
“Risk Factors,”
−Removed: and “Management’s Discussion
−Removed: and Analysis of Financial Condition and Results of Operations.”
−Removed: All statements other than statements of historical fact
−Removed: contained in this Quarterly Report, including statements regarding future events, our future financial performance, business strategy
−Removed: and plans and objectives of management for future operations, are forward-looking statements.
−Removed: We have attempted to identify forward-looking
−Removed: statements by terminology including “anticipates,”
+Added: and “Management’s Discussion and Analysis of Financial Condition and
+Added: Results of Operations.”
+Added: All statements other than statements of historical fact contained in this Quarterly Report, including
+Added: statements regarding future events, our future financial performance, business strategy and plans and objectives of management
+Added: for future operations, are forward-looking statements.
+Added: We have attempted to identify forward-looking statements by terminology
+Added: including “anticipates,”
“believes,”
11 unchanged sentences
or “will”
−Removed: or the negative of these terms or
−Removed: other comparable terminology.
−Removed: Although we do not make forward-looking statements unless we believe we have a reasonable basis
−Removed: for doing so, we cannot guarantee their accuracy.
−Removed: These statements are only predictions and involve known and unknown risks, uncertainties
−Removed: and other factors, including the risks outlined under “Risk Factors”
−Removed: or elsewhere in this Quarterly Report, which
−Removed: may cause our or our industry’s actual results, levels of activity, performance or achievements expressed or implied by
−Removed: these forward-looking statements.
−Removed: Moreover, we operate in a very competitive and rapidly changing environment.
−Removed: New risks emerge
−Removed: from time to time and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our
−Removed: business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from
−Removed: those contained in any forward-looking statements.
−Removed: All forward-looking statements included in this document are based on information
−Removed: available to us on the date hereof, and we assume no obligation to update any such forward-looking statements.
−Removed: should not place undue reliance on any forward-looking statement, each of which applies only as of the date of this Quarterly
−Removed: Report on Form-10-Q.
−Removed: Before you invest in our securities, you should be aware that the occurrence of the events described in the
−Removed: section entitled “Risk Factors”
−Removed: and elsewhere in this Quarterly Report could negatively affect our business, operating
−Removed: results, financial condition and stock price.
−Removed: Except as required by law, we undertake no obligation to update or revise publicly
−Removed: any of the forward-looking statements after the date of this Quarterly Report on Form-10-Q to conform our statements to actual
−Removed: results or changed expectations.
+Added: or the negative of these terms or other comparable terminology.
+Added: Although we do not
+Added: make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy.
+Added: These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks
+Added: outlined under “Risk Factors”
+Added: or elsewhere in this Quarterly Report, which may cause our or our industry’s actual
+Added: results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.
+Added: operate in a very competitive and rapidly changing environment.
+Added: New risks emerge from time to time and it is not possible for us
+Added: to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or
+Added: combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements.
+Added: All forward-looking statements included in this document are based on information available to us on the date hereof, and we assume
+Added: no obligation to update any such forward-looking statements.
+Added: You should not place undue reliance on
+Added: any forward-looking statement, each of which applies only as of the date of this Quarterly Report on Form-10-Q.
+Added: Before you invest
+Added: in our securities, you should be aware that the occurrence of the events described in the section entitled “Risk Factors”
+Added: and elsewhere in this Quarterly Report could negatively affect our business, operating results, financial condition and stock price.
+Added: Except as required by law, we undertake no obligation to update or revise publicly any of the forward-looking statements after
+Added: the date of this Quarterly Report on Form-10-Q to conform our statements to actual results or changed expectations.
+Added: Business Overview
Relmada Therapeutics, Inc.
−Removed: (Relmada or the
−Removed: Company, we or us) (a Nevada corporation), is a clinical-stage biotechnology company focused on the development of REL-1017 (d-methadone
−Removed: dextromethadone), an N-methyl-D-aspartate (NMDA) receptor antagonist.
−Removed: d-methadone 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: receptors are present in many parts of the central nervous system and play important roles in regulating neuronal activity.
−Removed: believe that dextromethadone acting as an NMDA receptor antagonist can have potential applications in a number of disease indications
−Removed: which mitigates risk and offers significant upside.
−Removed: On October 7, 2019, our application to list
−Removed: its common stock on the NASDAQ Capital Market was approved.
+Added: the Company, we or us) (a Nevada corporation), is a clinical-stage biotechnology company focused on the development of REL-1017
+Added: (d-Methadone dextromethadone), an N-methyl-D-aspartate (NMDA) receptor antagonist.
+Added: d-Methadone is a new chemical entity (NCE) that
+Added: potentially addresses areas of high unmet medical need in the treatment of central nervous system (CNS) diseases and other disorders.
+Added: NMDA receptors are present in many parts of
+Added: the CNS and play important roles in regulating neuronal activity and promoting synaptic plasticity in brain areas important for
+Added: mood, behavioral aspects and cognitive functions such as learning and memory.
+Added: Based on these premises, d-methadone could show benefits
+Added: in several different CNS indications.
+Added: On October 7, 2019, our application to
+Added: list its common stock on the NASDAQ Capital Market was approved.
On October 10, 2019, the Company’s common stock began trading
2 unchanged sentences
Market and continues to trade under the symbol “RLMD.”
−Removed: December 19, 2019, the Board of Directors of the Company approved a change to its end of fiscal year from June 30 to December
−Removed: The change in fiscal year became effective for the Company’s 2020 fiscal year, which began on January 1, 2020 and will
−Removed: end December 31, 2020.
−Removed: Our lead product candidate, d-methadone, is
−Removed: an NCE being developed as a rapidly acting, sustained effect oral agent for the treatment of depression and other potential indications.
−Removed: We have previously completed Phase 1 single and multiple ascending dose studies and on October 15, 2019 we reported top-line data
−Removed: from study REL-1017-202.
−Removed: This was a double-blind, placebo-controlled Phase 2 clinical trial evaluating the safety, tolerability
−Removed: and efficacy of two oral doses of REL-1017, 25 mg once a day and 50 mg once a day, as an adjunctive treatment in patients with
−Removed: major depressive disorder (MDD), who experienced an inadequate response to 1 to 3 treatments with an antidepressant medications.
−Removed: In the REL-1017-202 study, 62 subjects, average
−Removed: age 49.2 years, with an average Hamilton Depression Rating Scale score of 25.3 and an average Montgomery-Asberg Depression Rating
−Removed: Scale (MADRS) score of 34.0 (severe depression), were randomized.
+Added: On December 19, 2019, the Board of Directors
+Added: of the Company approved a change to its end of fiscal year from June 30 to December 31.
+Added: The change in fiscal year became effective
+Added: for the Company’s 2020 fiscal year, which began on January 1, 2020 and will end December 31, 2020.
+Added: Our lead product candidate,
+Added: d-methadone, is an NCE in development as a rapidly acting, sustained effect oral agent for the treatment of depression and
+Added: other potential indications.
+Added: We have previously successfully completed Phase 1 single and multiple ascending dose studies
+Added: with safety and tolerability supporting further development.
+Added: On October 15, 2019 we reported top-line data from the proof of
+Added: concept study REL-1017-202.
+Added: This was a double-blind, placebo-controlled Phase 2 clinical trial evaluating the safety,
+Added: tolerability and efficacy of two oral doses of REL-1017, 25 mg once a day and 50 mg once a day, as an adjunctive treatment in
+Added: patients with major depressive disorder (MDD), who experienced an inadequate response to 1 to 3 treatments with an
+Added: antidepressant medications.
+Added: In the REL-1017-202 study, 62 subjects,
+Added: average age 49.2 years, with an average Hamilton Depression Rating Scale score of 25.3 and an average Montgomery-Asberg Depression
+Added: Rating Scale (MADRS) score of 34.0 (severe depression), were randomized.
Demographic characteristics were balanced across all arms.
−Removed: an initial screening period, subjects were randomized to one of three arms:
−Removed: placebo, REL-1017 25 mg or REL-1017 50 mg, in addition
−Removed: to stable background antidepressant therapy.
−Removed: Subjects in the REL-1017 treatment arms received one loading dose of either 75 mg
−Removed: (25 mg arm) or 100 mg (50 mg arm) of REL-1017.
+Added: After an initial screening period, subjects were randomized to one of three arms:
+Added: placebo, REL-1017 25 mg or REL-1017 50 mg, in
+Added: addition to stable background antidepressant therapy.
+Added: Subjects in the REL-1017 treatment arms received one loading dose of either
+Added: 75 mg (25 mg arm) or 100 mg (50 mg arm) of REL-1017.
Subjects were treated as inpatients for 7 days and discharged home at Day
−Removed: returned for follow-up visits at Day 14 and Day 21.
−Removed: Efficacy was measured on Days 2, 4 and 7 in the dosing period and on Day 14,
−Removed: one week after treatment discontinuation.
−Removed: 61 subjects received all treatment doses and were included in the per-protocol population
−Removed: (PPP) treatment analysis;
+Added: They returned for follow-up visits at Day 14 and Day 21.
+Added: Efficacy was measured on Days 2, 4 and 7 in the dosing period and on
+Added: Day 14, one week after treatment discontinuation.
+Added: 61 subjects received all treatment doses and were included in the per-protocol
+Added: population (PPP) treatment analysis;
57 subjects completed all visits.
−Removed: All 62 randomized subjects were part of the intention-to-treat (ITT)
+Added: All 62 randomized subjects were part of the intention-to-treat
+Added: (ITT) analysis.
No differences were observed between the ITT and PPP analyses and results.
−Removed: observed that subjects in both the REL-1017 25 mg and 50 mg treatment groups experienced statistically significant improvement
−Removed: on all efficacy measures tested as compared to subjects in the placebo group, including:
−Removed: the Montgomery-Asberg Depression Rating
−Removed: Scale (MADRS);
−Removed: the Clinical Global Impression –
+Added: Key findings:
+Added: We observed that subjects in both the REL-1017
+Added: 25 mg and 50 mg treatment groups experienced statistically significant improvement on all efficacy measures tested as compared
+Added: to subjects in the placebo group, including:
+Added: the Montgomery-Asberg Depression Rating Scale (MADRS);
+Added: the Clinical Global Impression
Severity (CGI-S) scale;
the Clinical Global Impression –
−Removed: (CGI-I) scale;
−Removed: and the Symptoms of Depression Questionnaire (SDQ).
−Removed: on the MADRS endpoint appeared on Day 4 in both REL-1017 dose groups and continued through Day 7 and Day 14, seven days after
−Removed: treatment discontinuation, with P values< 0.03 and large effect sizes (a measure of quantifying the difference between two
−Removed: groups), ranging from 0.7 to 1.0.
+Added: Improvement (CGI-I) scale;
+Added: and the Symptoms of Depression
+Added: Questionnaire (SDQ).
+Added: Statistically significant improvements on the MADRS endpoint
+Added: appeared on Day 4 in both REL-1017 dose groups and continued through Day 7 and Day 14, seven days after treatment discontinuation,
+Added: with P values< 0.03 and large effect sizes (a measure of quantifying the difference between two groups), ranging from 0.7 to
Similar findings emerged from the CGI-S and CGI-I scales.
−Removed: Analysis of Change from Baseline to Day 7 and to Day 14 ITT Population
−Removed: Means Difference
−Removed: LS Means Difference
−Removed: Means Difference
−Removed: Means Difference
+Added: Analysis of Change from Baseline
+Added: to Day 7 and to Day 14 ITT Population
REL-1017 25mg vs Placebo
REL-1017 50mg vs Placebo
−Removed: = Least Squares;
−Removed: d = Cohen’s effect size
−Removed: study also confirmed the favorable tolerability profile of REL-1017, which was also observed in the Phase 1 studies.
−Removed: experienced mild and moderate adverse events (AEs), and no serious adverse events, without significant differences between placebo
−Removed: and treatment groups.
−Removed: The AEs observed in the Phase 2a clinical study were of the same nature as those observed in the Phase 1
−Removed: clinical studies in d-Methadone, and there was no evidence of either treatment induced psychotomimetic and dissociative AEs or
−Removed: withdrawal signs and symptoms upon treatment discontinuation.
−Removed: Upcoming Anticipated Milestones
−Removed: expect multiple key milestones over the next 12 months.
+Added: LS = Least Squares;
+Added: d = Cohen’s effect
+Added: The study also confirmed the favorable tolerability profile
+Added: of REL-1017, which was observed in the Phase 1 studies.
+Added: Subjects experienced only mild and moderate adverse events (AEs), and no
+Added: serious adverse events, without significant differences between placebo and treatment groups.
+Added: The AEs observed in the Phase 2a
+Added: clinical study were of the same nature as those observed in the Phase 1 clinical studies in d-methadone, and there was no evidence
+Added: of either treatment induced psychotomimetic and dissociative AEs or withdrawal signs and symptoms upon treatment discontinuation.
+Added: Key Upcoming Anticipated Milestones
+Added: We expect multiple key milestones over
+Added: the next 12 months.
These include:
−Removed: of full details of the Phase 2 data for REL-1017.
−Removed: of pivotal studies for REL-1017 as an adjunctive treatment of MDD in the second half of 2020.
−Removed: of Phase 2 study in MDD.
−Removed: We plan to start a Phase 2 MDD study in the second half of 2020, though development plans may change
−Removed: based on the FDA’s feedback and other factors.
−Removed: receptors are present in many parts of the CNS and play important roles in regulating neuronal activity and promoting synaptic
−Removed: plasticity in brain areas important for cognitive functions such as executive function, learning and memory.
−Removed: Based on these premises,
−Removed: d-methadone could show benefits in several different CNS indications.
−Removed: Phase 1 Clinical Safety Studies
−Removed: safety data from two Company-funded d-methadone Phase 1 clinical safety studies and a third study conducted by researchers at
−Removed: Memorial Sloan-Kettering Cancer Center indicate that d-methadone was well tolerated in both healthy subjects and cancer patients
−Removed: at all projected therapeutic doses tested.
−Removed: Corporate History and Background
−Removed: are a clinical-stage, publicly traded biotechnology company developing NCEs and novel versions of proven drug products that potentially
−Removed: address areas of high unmet medical need in the treatment of depression and other CNS diseases.
−Removed: none of our product candidates have been approved for sale in the United States or elsewhere.
−Removed: We have no commercial products nor
−Removed: do we have a sales or marketing infrastructure.
−Removed: In order to market and sell our products we must conduct clinical trials on patients
−Removed: and obtain regulatory approvals from appropriate regulatory agencies, like the FDA in the United States, and similar organizations
−Removed: elsewhere in the world.
−Removed: We have not generated revenues and do not
−Removed: anticipate generating revenues for the foreseeable future.
−Removed: We had net loss of $21,791,757 for the six months ended June 30, 2020.
−Removed: At June 30, 2020, we have an accumulated deficit of $141,650,666.
+Added: Start of first pivotal Phase III
+Added: adjunctive MDD trial
+Added: Start of second pivotal Phase
+Added: III adjunctive MDD trial
+Added: Start of Phase II monotherapy
+Added: Results of human abuse potential
+Added: Results of Phase II monotherapy
+Added: Results of Phase III adjunctive
+Added: NMDA receptors are present in many parts
+Added: of the CNS and play important roles in regulating neuronal activity and promoting synaptic plasticity in brain areas important
+Added: for cognitive functions such as executive function, learning and memory.
+Added: Based on these premises, d-methadone could show benefits
+Added: in several different CNS indications.
+Added: d-Methadone Phase 1 Clinical Safety Studies
+Added: The safety data from two Company-funded
+Added: d-methadone Phase 1 clinical safety studies and a third study conducted by researchers at Memorial Sloan-Kettering Cancer Center
+Added: indicate that d-methadone was well tolerated in both healthy subjects and cancer patients at all projected therapeutic doses tested.
+Added: Our Corporate History and Background
+Added: We are a clinical-stage, publicly traded biotechnology company
+Added: developing NCEs that potentially address areas of high unmet medical need in the treatment of depression and other CNS diseases.
+Added: Currently, none of our product candidates
+Added: have been approved for sale in the United States or elsewhere.
+Added: We have no commercial products nor do we have a sales or marketing
+Added: infrastructure.
+Added: In order to market and sell our products we must conduct clinical trials on patients and obtain regulatory approvals
+Added: from appropriate regulatory agencies, like the FDA in the United States, and similar organizations elsewhere in the world.
+Added: We have not generated revenues and do
+Added: not anticipate generating revenues for the foreseeable future.
+Added: We had net loss of $38,694,264 for the nine months ended September
+Added: At September 30, 2020, we have an accumulated deficit of $158,553,173.
+Added: Business Strategy
Our strategy is to leverage our considerable
4 unchanged sentences
industry and regulatory experience to lead and execute the development and commercialization of REL-1017.
−Removed: We plan to further develop REL-1017 as our
−Removed: priority program.
−Removed: As the drug d-methadone is an NCE, the regulatory pathway required to support and NDA submission will consist
−Removed: of conducting a full clinical development program.
−Removed: We plan to also generate intellectual property (IP) that will further protect
−Removed: our products from competition.
−Removed: We will continue to prioritize our product development activities after taking into account the
−Removed: resources we have available, market dynamics and potential for adding value.
+Added: We plan to further develop REL-1017 as our priority program.
+Added: As the drug d-methadone is an NCE, the regulatory pathway required to support and NDA submission will consist of conducting a full
+Added: clinical development program.
+Added: We plan to continue to generate intellectual property (IP) that will further protect our products
+Added: from competition.
+Added: We will also continue to prioritize our product development activities after taking into account the resources
+Added: we have available, market dynamics and potential for adding value.
Market Opportunity
−Removed: We believe that the market for addressing areas
−Removed: of high unmet medical need in the treatment of CNS diseases will continue to be large for the foreseeable future and that it will
−Removed: represent a sizable revenue opportunity for us.
−Removed: For example, the World Health Organization (WHO) has estimated that CNS diseases
−Removed: affect nearly 2 billion people globally, making up approximately 40% of total disease burden (based on disability adjusted life
−Removed: years), compared with 13% for cancer and 12% for cardiovascular disease.
+Added: We believe that the market for addressing
+Added: areas of high unmet medical need in the treatment of CNS diseases will continue to be large for the foreseeable future and that
+Added: it will represent a sizable revenue opportunity for us.
+Added: For example, the World Health Organization (WHO) has estimated that CNS
+Added: diseases affect nearly 2 billion people globally, making up approximately 40% of total disease burden (based on disability adjusted
+Added: life years), compared with 13% for cancer and 12% for cardiovascular disease.
The depression treatment market is segmented
9 unchanged sentences
(Johnson & Johnson).
−Removed: Intellectual Property Portfolio and Market
−Removed: over 50 issued patents and pending patent applications related to REL-1017 for multiple uses, including psychological and neurological
−Removed: We have also secured an Orphan Drug Designation from the FDA for d-methadone for “the treatment of postherpetic
−Removed: neuralgia”, which, if pursed and upon potential NDA approval, would carry 7-year FDA Orphan Drug marketing exclusivity.
−Removed: the European Union, some of our products may be eligible up to 10 years of market exclusivity, which includes 8 years data exclusivity
−Removed: and 2 years market exclusivity.
−Removed: In addition to any granted patents, REL-1017 will be eligible for market exclusivity to run concurrently
−Removed: with the term of the patent for 5 years in the U.S.
−Removed: (Hatch Waxman plus pediatric exclusivity) and up to 10 years of in the E.U.
−Removed: We believe an extensive intellectual property estate of US and foreign patents and applications, once approved, will protect our
−Removed: technology and products.
+Added: Intellectual Property Portfolio and
+Added: Market Exclusivity
+Added: have over 50 issued patents and pending patent applications related to REL-1017 for multiple uses, including psychological and
+Added: neurological conditions.
+Added: We have also secured an Orphan Drug Designation from the FDA for d-methadone for “the treatment
+Added: of postherpetic neuralgia”, which, if pursed and upon potential NDA approval, would carry 7-year FDA Orphan Drug marketing
+Added: In the European Union, some of our products may be eligible up to 10 years of market exclusivity, which includes
+Added: 8 years data exclusivity and 2 years market exclusivity.
+Added: In addition to any granted patents, REL-1017 will be eligible for market
+Added: exclusivity to run concurrently with the term of the patent for 5 years in the U.S.
+Added: (Hatch Waxman) plus additional 6 months of
+Added: pediatric exclusivity and up to 10 years of in the E.U.
+Added: We believe an extensive intellectual property estate of US and foreign
+Added: patents and applications, once approved, will protect our technology and products.
+Added: Key Strengths
We believe that the key elements for our market success include:
1 unchanged sentence
Potential in multiple indications in underserved markets with large patient population, such as MDD, other affective disorders, and cognitive disorders.
−Removed: Scientific support of leading experts:
−Removed: Our scientific advisors include clinicians and scientists who are affiliated with a number of highly regarded medical institutions such as Harvard, Cornell, Yale, and University of Pennsylvania.
+Added: Scientific support
+Added: of leading experts:
+Added: Our scientific advisors include clinicians and scientists who are affiliated with a number of highly regarded
+Added: medical institutions such as Harvard, Cornell, Yale, and University of Miami.
Substantial IP portfolio and market protection:
approved and filed patent applications provide coverage beyond 2030.
−Removed: we file with the Securities and Exchange Commission (SEC) pursuant to the Exchange Act of 1934, as amended (the Exchange Act),
−Removed: including annual and quarterly reports, and other reports we file, can be inspected and copied at the public reference facilities
−Removed: maintained by the SEC at 100 F Street NE, Washington, D.C.
+Added: A vailable Information
+Added: Reports we file with the Securities and
+Added: Exchange Commission (SEC) pursuant to the Exchange Act of 1934, as amended (the Exchange Act), including annual and quarterly reports,
+Added: and other reports we file, can be inspected and copied at the public reference facilities maintained by the SEC at 100 F Street
+Added: NE, Washington, D.C.
+Added: Reverse Stock Split
On September 26, 2019, our Board of Directors
5 unchanged sentences
restated to reflect this reverse stock split.
−Removed: of Operations
−Removed: the Three Months Ended June 30, 2020 versus June 30, 2019
−Removed: and development
−Removed: and administrative
+Added: Results of Operations
+Added: For the Three Months Ended September 30, 2020 versus September
+Added: September 30,
+Added: September 30,
+Added: Operating Expenses
+Added: Research and development
+Added: General and administrative
Research and Development Expense
−Removed: Research and development expense for the three months ended
−Removed: June 30, 2020 was approximately $ 5,323,900 compared to $ 3,069,900 for the three months ended June 30, 2019, an increase of approximately
−Removed: The increase was driven by an increase in study costs of $431,900, of which the majority pertained to completion of
−Removed: our Phase 2 study and manufacturing costs, as well as an increase in compensation costs of $1,822,200 as a result of hiring 4 additional
−Removed: research and development employees and the related options granted to them.
−Removed: and Administrative Expense
−Removed: General and administrative expense for the three months ended
−Removed: June 30, 2020 was approximately $7,433,200 compared to $1,065,800 for the three months ended June 30, 2019, an increase of approximately
−Removed: The increase resulted from an increase in compensation costs of $484,700 as a result of hiring an additional employee;
−Removed: an increase in stock-based compensation costs of $5,673,200 primarily related to warrant expenses from consultants of approximately
−Removed: a net increase in other G&A expenses of $209,500 that pertained primarily to investor relations.
−Removed: Income (Expense)
−Removed: Interest / investment income was approximately $404,000 and
−Removed: $13,100 for the three months ended June 30, 2020 and 2019, respectively.
−Removed: Unrealized gain on short-term investments was approximately
−Removed: $1,221,900 for the three months ended June 30, 2020.
−Removed: Realized gain on short-term investments was approximately $12,800 for the
−Removed: three months ended June 30, 2020.
−Removed: All investments were classified as cash equivalents at June 30, 2019.
−Removed: There was no unrealized
−Removed: gain or loss or realized gain or loss at June 30, 2019.
+Added: Research and development expense for
+Added: the three months ended September 30, 2020 was approximately $11,237,200 compared to $1,887,400 for the three months ended
+Added: September 30, 2019, an increase of approximately $9,349,800.
+Added: The increase was driven by an increase in development costs of
+Added: $7,511,400, of which the majority pertained to cost associated with toxicology, and in vitro metabolic studies along with the
+Added: preparation of the Phase 3 program, as well as an increase in compensation costs of $1,838,400 as a result of hiring four
+Added: additional research and development employees and the related options granted to them.
+Added: General and Administrative Expense
+Added: General and administrative expense for
+Added: the three months ended September 30, 2020 was approximately $5,946,400 compared to $1,820,000 for the three months ended September
+Added: 30, 2019, an increase of approximately $4,126,400.
+Added: The increase resulted from an increase in compensation costs of $552,400 as
+Added: a result of hiring four additional employees;
+Added: an increase in stock-based compensation costs of $3,047,200 primarily related to options
+Added: granted to employees during 2020;
+Added: a net increase in other G&A expenses of $526,800 that pertained primarily to insurance expense
+Added: and state and city franchise taxes.
+Added: Other Income (Expense)
+Added: Interest / investment income was approximately
+Added: $363,300 and $37,900 for the three months ended September 30, 2020 and 2019, respectively.
+Added: Unrealized gain on short-term investments
+Added: was approximately $3,946 for the three months ended September 30, 2020.
+Added: Realized loss on short-term investments was approximately
+Added: $86,171 for the three months ended September 30, 2020.
+Added: All investments were classified as cash equivalents at September 30, 2019.
+Added: There was no unrealized gain or loss or realized gain or loss at September 30, 2019.
+Added: The Company did not provide for income
+Added: taxes for the three months ended September 30, 2020 and 2019, since there was a loss and a full valuation allowance against all
+Added: deferred tax assets.
The net loss for the Company for the three
−Removed: months ended June 30, 2020 and 2019 was approximately $11,118,400 and $4,122,600, respectively.
+Added: months ended September 30, 2020 and 2019 was approximately $16,902,500 and $3,669,500 respectively.
The Company had loss per share,
−Removed: of basic and diluted $0.73 and $0.50 for the three months ended June 30, 2020 and 2019, respectively.
−Removed: Company did not provide for income taxes for the three months ended June 30, 2020 and 2019, since there was a loss and a full
−Removed: valuation allowance against all deferred tax assets.
−Removed: of Operations
−Removed: the Six Months Ended June 30, 2020 versus June 30, 2019
+Added: basic and diluted of $1.05 and $0.38 for the three months ended September 30, 2020 and 2019, respectively.
+Added: For the Nine Months Ended September 30, 2020 versus September
+Added: September 30,
+Added: September 30,
Operating Expenses
2 unchanged sentences
Research and Development Expense
−Removed: Research and development expense for the six months ended June
−Removed: 30, 2020 was approximately $9,831,700 compared to $4,345,800 for the six months ended June 30, 2019, an increase of approximately
−Removed: The increase was driven by an increase in study costs of $1,298,700, of which the majority pertained to completion
−Removed: of our Phase 2 study and manufacturing costs, as well as an increase in compensation costs of $4,187,200 which included the approximately
−Removed: $2,936,100 of stock based compensation expense primarily related to the separation agreement with Ottavio Vitolo, the remaining
−Removed: increase was a result of hiring 4 additional research and development employees and the related options granted to them.
+Added: Research and development expense for the nine months ended September
+Added: 30, 2020 was approximately $21,068,900 compared to $6,233,200 for the nine months ended September 30, 2019, an increase of approximately
+Added: The increase was driven by an increase in development costs of $8,810,000, of which the majority pertained to completion
+Added: of our Phase 2 study, costs associated with the toxicology, and in vitro metabolic studies along with the preparation of the Phase
+Added: 3 program, as well as an increase in compensation costs of $6,025,700 which included the approximately $4,375,900 of stock based
+Added: compensation expense related to the hiring of four additional research and development employees and the related options granted
+Added: to them, and the separation agreement with Ottavio Vitolo.
General and Administrative Expense
−Removed: General and administrative expense for the six months ended
−Removed: June 30, 2020 was approximately $12,899,900 compared to $2,491,900 for the six months ended June 30, 2019, an increase of approximately
−Removed: The increase resulted from an increase in compensation costs of $1,442,100, as a result of hiring additional employees
−Removed: and their related bonuses;
−Removed: an increase in stock-based compensation costs of $8,607,600 related to warrant expenses from consultants
−Removed: of approximately $2,500,000;
−Removed: a net increase in other G&A expenses of $358,300 that pertained primarily to investor relations
−Removed: and professional fees.
+Added: General and administrative expense for
+Added: the nine months ended September 30, 2020 was approximately $18,846,300 compared to $4,311,900 for the nine months ended September
+Added: 30, 2019, an increase of approximately $14,534,400.
+Added: The increase resulted from an increase in compensation costs of $1,981,400,
+Added: as a result of hiring four additional employees and their related bonuses;
+Added: an increase in stock-based compensation costs of $11,654,800
+Added: primarily related to options granted to employees during 2020;
+Added: a net increase in other G&A expenses of $898,200 that pertained
+Added: primarily to insurance expense and state and city tax expense.
Other Income (Expense)
Interest / investment income was approximately
−Removed: $811,700 and $29,000 for the six months ended June 30, 2020 and 2019, respectively.
−Removed: Unrealized gain on short-term investments was
−Removed: approximately $287,000 for the six months ended June 30, 2020.
+Added: $1,175,000 and $67,000 for the nine months ended September 30, 2020 and 2019, respectively.
+Added: Unrealized gain on short-term investments
+Added: was approximately $291,000 for the nine months ended September 30, 2020.
Realized loss on short-term investments was approximately
−Removed: for the six months ended June 30, 2020.
−Removed: All investments were classified as cash equivalents at June 30, 2019.
−Removed: There was no unrealized
−Removed: gain or loss or realized gain or loss at June 30, 2019.
−Removed: The net loss for the Company for the six
−Removed: months ended June 30, 2020 and 2019 was approximately $21,791,800 and $6,808,700 respectively.
+Added: $245,000 for the nine months ended September 30, 2020.
+Added: All investments were classified as cash equivalents at September 30, 2019.
+Added: There was no unrealized gain or loss or realized gain or loss at September 30, 2019.
+Added: The Company did not provide for income
+Added: taxes for the nine months ended September 30, 2020 and 2019, since there was a loss and a full valuation allowance against all
+Added: deferred tax assets.
+Added: The net loss for the Company for the nine
+Added: months ended September 30, 2020 and 2019 was approximately $38,694,300 and $10,478,200 respectively.
The Company had loss per share,
−Removed: of basic and diluted $1.45 and $0.86 for the six months ended June 30, 2020 and 2019, respectively.
−Removed: Company did not provide for income taxes for the six months ended June 30, 2020 and 2019, since there was a loss and a full valuation
−Removed: allowance against all deferred tax assets.
−Removed: As shown in the accompanying financial statements,
−Removed: the Company incurred negative operating cash flows of approximately $8,378,400 for the six months ended June 30, 2020 and has an
−Removed: accumulated deficit of approximately $141,650,700 from inception through June 30, 2020.
−Removed: At June 30, 2020 the Company had cash and
−Removed: short term investments of approximately $134,087,800.
−Removed: Relmada has funded its past operations through equity raises
−Removed: and most recently in 2020 raised net proceeds from the sale of common stock of $19,855,018 through our ATM offering and $5,619,276
−Removed: through the exercise of warrants.
−Removed: The Company also raised an additional $530,643 during the six months ended June 30, 2020 from
−Removed: the exercises of options.
−Removed: Management believes that
−Removed: due to the recent equity raises completed and exercises of outstanding warrants and the current cash position on its balance sheet,
−Removed: it has obtained sufficient funding to continue ongoing operations for the at least 12 months from the issuance of the accompanying
−Removed: consolidated quarterly financial statements.
−Removed: Since June 30, 2020 and to date, the Company has received approximately $1,230,000
−Removed: in warrant exercises, which resulted in the Company having approximately $131,549,600 million in cash, cash equivalents and short
−Removed: term investments at August 5, 2020.
−Removed: Based on its budgeted cash flow requirements, the Company believes these funds are sufficient
−Removed: to fund its ongoing operations for at least 12 months after the issuance of these consolidated quarterly financial statements.
−Removed: following table sets forth selected cash flow information for the periods indicated below:
−Removed: Six Months Ended
−Removed: Six Months Ended
+Added: basic and diluted of $2.52 and $1.23 for the nine months ended September 30, 2020 and 2019, respectively.
+Added: As shown in the accompanying financial
+Added: statements, the Company incurred negative operating cash flows of $20,880,039 for the nine months ended September 30, 2020 and
+Added: has an accumulated deficit of $158,553,173 from inception through September 30, 2020.
+Added: At September 30, 2020 the Company had cash
+Added: and short term investments of $123,138,478.
+Added: Relmada has funded its past operations
+Added: through equity raises and most recently in 2020 raised net proceeds from the sale of common stock of $19,816,597, and $7,186,306 through the exercise of warrants.
+Added: The Company also raised an additional $636,518 during the nine months
+Added: ended September 30, 2020 from the exercises of options.
+Added: believes that due to the recent equity raises completed and exercises of outstanding warrants and the current cash position on
+Added: its balance sheet, it has obtained sufficient funding to continue ongoing operations for at least 12 months from the issuance of
+Added: the accompanying consolidated quarterly financial statements.
+Added: Since September 30, 2020 and to date, the Company has received approximately
+Added: $437,100 in warrant exercises, which resulted in the Company having approximately $121.5 million in cash, cash equivalents and
+Added: short term investments at November 9, 2020.
+Added: Based on its budgeted cash flow requirements, the Company believes these funds are
+Added: sufficient to fund its ongoing operations for at least 12 months after the issuance of these consolidated quarterly financial statements.
+Added: The following table sets forth selected cash flow information
+Added: for the periods indicated below:
+Added: Nine Months Ended
+Added: September 30,
+Added: Nine Months Ended
+Added: September 30,
Cash used in operating activities
+Added: $ (20,880,039 )
+Added: $ (8,213,160 )
Cash used in investing activities
+Added: (35,382,926 )
Cash provided by financing activities
Net decrease in cash and cash equivalents
−Removed: For the six months ended June 30, 2020, cash used in operating
−Removed: activities was $8,378,419 primarily due to the net loss of $21,791,757, offset by non-cash stock compensation charges of $12,341,875,
−Removed: prepaid expense of $183,329, accounts payable of $442,506, unrealized gain of $287,027, realized loss of $158,801, and accrued
−Removed: expenses of $535,997.
−Removed: For the six months ended June 30, 2019,
−Removed: cash used in operating activities was $5,679,009 primarily due to the loss from operations for the six months ended June 30, 2019
−Removed: of $6,808,657 off set by accounts payable of $565,469 prepaid expense of $381,124, and non-cash stock compensation expense of
−Removed: $798,151, offset by accrued expenses of $72,692 and shares relinquished in litigation of $394,410.
−Removed: For the six months ended June 30, 2020, cash
−Removed: used in investing activities was $39,970,532 related to the net purchase and sale of short-term investments.
−Removed: For the six months
−Removed: ended June 30, 2020, no cash was used in investing activities.
−Removed: Net cash provided by financing activities for
−Removed: the six months ended June 30, 2020 was $25,894,690 due to proceeds from options exercised for common stock of $530,643, proceeds
−Removed: from warrants exercised for common stock of $5,619,276, and sales of common stock of $19,855,018, partially offset by payments
−Removed: of notes payable of $110,247.
−Removed: Net cash provided by financing activities for the six months ended June 30, 2019 was $12,468,812
−Removed: primarily due to proceeds from the sale of common stock of $12,583,550 partially offset by payments of notes payable of $114,738.
−Removed: assets are primarily monetary, consisting of cash and cash equivalents.
−Removed: Because of their liquidity, these assets are not directly
−Removed: affected by inflation.
−Removed: Because we intend to retain and continue to use our equipment, we believe that the incremental inflation
−Removed: related to replacement costs of such items will not materially affect our operations.
−Removed: However, the rate of inflation affects our
−Removed: expenses, such as those for employee compensation and contract services, which could increase our level of expenses and the rate
−Removed: at which we use our resources.
−Removed: Sheet Arrangements
−Removed: part of our ongoing business, we do not participate in transactions that generate relationships with unconsolidated entities or
−Removed: financial partnerships, such as entities often referred to as structured finance or special purpose entities (SPEs), which would
−Removed: have been established for the purpose of facilitating off-balance sheet arrangements or other contractually limited purposes.
−Removed: As of June 30, 2020 and December 31, 2019, we were not involved in any SPE transactions.
−Removed: and Contingencies
−Removed: refer to Note 12 in our Annual Report on Form 10-KT for the six months ended December 31, 2019 under the heading Commitments and
−Removed: Contingencies.
−Removed: To our knowledge there have been no material changes to the risk factors that were previously disclosed in the
−Removed: Company’s Annual Report on Form 10-KT for the six months ended December 31, 2019.
−Removed: Additional risks and uncertainties
−Removed: not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial
−Removed: condition and/or operating results.
−Removed: Accounting Policies and Estimates
−Removed: critical accounting policy is one that is both important to the portrayal of a company’s financial condition and results
−Removed: of operations and requires management’s most difficult, subjective or complex judgments, often as a result of the need to
−Removed: make estimates about the effect of matters that are inherently uncertain.
−Removed: unaudited consolidated financial statements are presented in accordance with U.S.
+Added: $ (28,733,791 )
+Added: For the nine months ended September 30,
+Added: 2020, cash used in operating activities was $20,880,039 primarily due to the net loss of $38,694,264, partially offset by non-cash
+Added: stock compensation charges of $17,586,533, an increase in prepaid expense of $1,825,336, an unrealized gain of $290,973, an increase
+Added: in accounts payable of $205,970, a realized loss of $244,972, and an increase in accrued expenses of $1,835,888.
+Added: For the nine months ended September 30,
+Added: 2019, cash used in operating activities was $8,213,160 primarily due to the loss from operations for the nine months ended September
+Added: 30, 2019 of $10,478,151, partially offset by non-cash stock compensation charges of 1,555,867, a decrease in prepaids of $524,967,
+Added: an increase in accounts payable of $907,657, and a decrease in accrued expenses of $376,157 and shares relinquished in litigation
+Added: For the nine months ended September 30,
+Added: 2020, cash used in investing activities was $35,382,926 related to the net purchase of short-term investments.
+Added: For the nine months
+Added: ended September 30, 2019, no cash was used in investing activities.
+Added: Net cash provided by financing activities
+Added: for the nine months ended September 30, 2020 was $27,529,174 due to sales of common stock of $19,816,597, proceeds from warrants
+Added: exercised for common stock of $7,186,306, and proceeds from options exercised for common stock of $636,518, partially offset by
+Added: payments of notes payable of $110,247.
+Added: Net cash provided by financing activities
+Added: for the nine months ended September 30, 2019 was $13,636,282 due to sales of common stock of $13,409,299 and proceeds from warrants
+Added: exercised for common stock of $450,000, partially offset by payments of notes payable of $223,017.
+Added: Effects of Inflation
+Added: Our assets are primarily monetary, consisting
+Added: of cash and cash equivalents.
+Added: Because of their liquidity, these assets are not directly affected by inflation.
+Added: Because we intend
+Added: to retain and continue to use our equipment, we believe that the incremental inflation related to replacement costs of such items
+Added: will not materially affect our operations.
+Added: However, the rate of inflation affects our expenses, such as those for employee compensation
+Added: and contract services, which could increase our level of expenses and the rate at which we use our resources.
+Added: Off-Balance Sheet Arrangements
+Added: As part of our ongoing business, we do
+Added: not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities
+Added: often referred to as structured finance or special purpose entities (SPEs), which would have been established for the purpose of
+Added: facilitating off-balance sheet arrangements or other contractually limited purposes.
+Added: As of September 30, 2020 and December 31,
+Added: 2019, we were not involved in any SPE transactions.
+Added: Commitments and Contingencies
+Added: Please refer to Note 12 in our Annual Report
+Added: on Form 10-KT for the six months ended December 31, 2019 under the heading Commitments and Contingencies.
+Added: To our knowledge there
+Added: have been no material changes to the risk factors that were previously disclosed in the Company’s Annual Report on Form 10-KT
+Added: for the six months ended December 31, 2019.
+Added: Additional risks and uncertainties not currently known to us or that we currently
+Added: deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.
+Added: Critical Accounting Policies and Estimates
+Added: A critical accounting policy is one that
+Added: is both important to the portrayal of a company’s financial condition and results of operations and requires management’s
+Added: most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that
+Added: are inherently uncertain.
+Added: Our unaudited consolidated financial statements
+Added: are presented in accordance with U.S.
GAAP, and all applicable U.S.
−Removed: GAAP accounting
−Removed: standards effective as of June 30, 2020 have been taken into consideration in preparing the unaudited consolidated financial statements.
−Removed: The preparation of unaudited consolidated financial statements requires estimates and assumptions that affect the reported amounts
−Removed: of assets, liabilities, expenses and related disclosures.
−Removed: Some of those estimates are subjective and complex, and, consequently,
−Removed: actual results could differ from those estimates.
−Removed: The following accounting policies and estimates have been highlighted as significant
−Removed: because changes to certain judgments and assumptions inherent in these policies could affect our consolidated financial statements:
−Removed: and development expenses, and
−Removed: compensation expenses
−Removed: base our estimates, to the extent possible, on historical experience.
−Removed: Historical information is modified as appropriate based
−Removed: on current business factors and various assumptions that we believe are necessary to form a basis for making judgments about the
−Removed: carrying value of assets and liabilities.
−Removed: We evaluate our estimates on an on-going basis and make changes when necessary.
−Removed: results could differ from our estimates.
−Removed: AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
−Removed: have been no material changes to our exposures to market risks as disclosed under the heading “Quantitative and Qualitative
−Removed: Disclosures About Market Risks”
+Added: GAAP accounting standards effective as of September 30, 2020
+Added: have been taken into consideration in preparing the unaudited consolidated financial statements.
+Added: The preparation of unaudited consolidated
+Added: financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and related
+Added: Some of those estimates are subjective and complex, and, consequently, actual results could differ from those estimates.
+Added: The following accounting policies and estimates have been highlighted as significant because changes to certain judgments and assumptions
+Added: inherent in these policies could affect our consolidated financial statements:
+Added: Research and development expenses, and
+Added: Stock-based compensation expenses
+Added: We base our estimates, to the extent possible,
+Added: on historical experience.
+Added: Historical information is modified as appropriate based on current business factors and various assumptions
+Added: that we believe are necessary to form a basis for making judgments about the carrying value of assets and liabilities.
+Added: our estimates on an on-going basis and make changes when necessary.
+Added: Actual results could differ from our estimates.
+Added: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
+Added: There have been no material changes to
+Added: our exposures to market risks as disclosed under the heading “Quantitative and Qualitative Disclosures About Market Risks”
in the annual MD&A contained in our Form 10-KT for the six months ended December 31, 2019.
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.