5 unchanged sentences
Short-term investments
−Removed: Other receivable
Lease payments receivable –
27 unchanged sentences
Three months ended
+Added: Six months ended
Operating expenses:
3 unchanged sentences
Loss from operations
+Added: (12,757,202 )
+Added: (22,731,640 )
Other (expenses) income:
Interest/investment income, net
−Removed: Realized loss on short-term investments
−Removed: Unrealized loss on short-term investments
+Added: Realized gain (loss) on short-term investments
+Added: Unrealized gain on short-term investments
Total other (expenses) income
1 unchanged sentence
$ (4,122,592 )
+Added: $ (21,791,757 )
+Added: $ (6,808,657 )
Loss per common share –
3 unchanged sentences
accompanying notes are an integral part of these unaudited consolidated financial statements.
+Added: Relmada Therapeutics, Inc.
+Added: Consolidated Statements of Stockholders’
+Added: Six months ended June 30, 2020
+Added: Additional Paid-in
+Added: Balance - December 31, 2019
+Added: $ 235,522,746
+Added: $ (119,858,909 )
+Added: $ 115,678,294
+Added: Stock based compensation
+Added: Warrant exercised for cash
+Added: Cashless warrant exercise
+Added: Options exercised
+Added: (10,673,316 )
+Added: (10,673,316 )
+Added: Balance - March 31, 2020
+Added: (130,532,225 )
+Added: Stock based compensation
+Added: Warrant exercised for cash
+Added: Cashless warrant exercise
+Added: Options exercised
+Added: ATM offering, net of offering costs
+Added: (11,118,441 )
+Added: (11,118,441 )
+Added: Balance - June 30, 2020
+Added: $ 273,868,163
+Added: $ (141,650,666 )
+Added: $ 132,233,349
+Added: Six months ended June 30, 2019
+Added: Additional Paid-in
+Added: Balance - December 31, 2018
+Added: $ 106,280,950
+Added: $ (104,853,710 )
+Added: Stock-based compensation expense
+Added: Equity units issued for Cash
+Added: Shares relinquished
+Added: Balance - March 31, 2019
+Added: (107,539,775 )
+Added: Stock-based compensation expense
+Added: Equity units issued for Cash
+Added: Issuance of common stock for cashless exercises of warrants from consultants and Series A Preferred stock warrant holder
+Added: Balance - June 30, 2019
+Added: $ 119,265,938
+Added: $ (111,662,367 )
+Added: The accompanying notes are an integral part
+Added: of these unaudited consolidated financial statements.
Therapeutics, Inc.
Statements of Cash Flows
−Removed: Three months ended
+Added: Six months ended
Cash flows from operating activities
6 unchanged sentences
Realized loss on short-term investments
−Removed: Unrealized loss on short-term investments
+Added: Unrealized gain on short-term investments
Change in operating assets and liabilities:
17 unchanged sentences
Net cash provided by financing activities
−Removed: Net decrease in cash and cash equivalents
+Added: Net (decrease)/increase in cash and cash equivalents
(22,454,261 )
5 unchanged sentences
Cashless exercise of warrants for common stock
−Removed: accompanying notes are an integral part of these unaudited consolidated financial statements.
−Removed: Therapeutics, Inc.
−Removed: Statements of Stockholders’
−Removed: Three months ended March 31, 2020
−Removed: Additional Paid-in
−Removed: Balance - December 31, 2019
−Removed: $ 235,522,746
−Removed: $ (119,858,909 )
−Removed: $ 115,678,294
−Removed: Stock-based compensation expense
−Removed: Warrants exercised for cash
−Removed: Cashless warrant exercise
−Removed: Options exercised
−Removed: (10,673,316 )
−Removed: (10,673,316 )
−Removed: Balance - March 31, 2020
−Removed: $ 243,676,817
−Removed: $ (130,532,225 )
−Removed: $ 113,159,533
−Removed: Three months ended March
−Removed: Additional Paid-in
−Removed: Balance - December 31, 2018
−Removed: $ 106,280,950
−Removed: $ (104,853,710 )
−Removed: Stock-based compensation expense
−Removed: Equity units issued for Cash
−Removed: Shares relinquished
−Removed: Balance - March 31, 2019
−Removed: $ 108,005,928
−Removed: $ (107,539,775 )
+Added: Notes payable issued in connection with directors and officers insurance policies
accompanying notes are an integral part of these unaudited consolidated financial statements.
6 unchanged sentences
system (CNS) diseases and other disorders.
−Removed: October 7, 2019, our application to list our common stock on the NASDAQ Capital Market was approved.
−Removed: On October 10, 2019, our
−Removed: common stock began trading on Nasdaq under our existing symbol, “RLMD.”
−Removed: On December 19, 2019, the Board of Directors
−Removed: of the Company approved a change to its end of fiscal year from June 30 to December 31.
−Removed: The change in fiscal year became effective
−Removed: for the Company’s 2020 fiscal year, which began on January 1, 2020 and will end December 31, 2020.
+Added: On October 7, 2019, our application to list
+Added: our common stock on the NASDAQ Capital Market was approved.
+Added: On October 10, 2019, our common stock began trading on Nasdaq under
+Added: our existing symbol, “RLMD.”
+Added: On July 14, 2020, our common stock was uplisted to The Nasdaq Global Select Market and
+Added: continues to trade under the symbol “RLMD”.
+Added: December 19, 2019, the Board of Directors of the Company approved a change to its end of fiscal year from June 30 to December
+Added: The change in fiscal year became effective for the Company’s 2020 fiscal year, which began on January 1, 2020 and will
+Added: end December 31, 2020.
addition to the normal risks associated with a new business venture, there can be no assurance that the Company’s research
6 unchanged sentences
of Presentation
−Removed: The accompanying unaudited consolidated
−Removed: financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United
−Removed: States of America (U.S.
+Added: accompanying unaudited consolidated financial statements and related notes have been prepared in accordance with accounting principles
+Added: generally accepted in the United States of America (U.S.
GAAP) for interim unaudited consolidated financial information.
−Removed: Accordingly, they do not include all of
−Removed: the information and footnotes required by U.S.
+Added: they do not include all of the information and footnotes required by U.S.
GAAP for complete consolidated financial statements.
−Removed: The unaudited consolidated
−Removed: financial statements reflect all adjustments (consisting of normal recurring adjustments) which are, in the opinion of management,
−Removed: necessary for a fair statement of the results for the interim periods presented.
−Removed: Interim results are not necessarily indicative
−Removed: of the results for the full year.
−Removed: These unaudited consolidated financial statements should be read in conjunction with the audited
−Removed: consolidated financial statements of the Company for the six months ended December 31, 2019 and notes thereto contained in the
−Removed: Company’s Transition Report on Form 10-KT.
+Added: The unaudited consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) which are,
+Added: in the opinion of management, necessary for a fair statement of the results for the interim periods presented.
+Added: Interim results
+Added: are not necessarily indicative of the results for the full year.
+Added: These unaudited consolidated financial statements should be read
+Added: in conjunction with the audited consolidated financial statements of the Company for the six months ended December 31, 2019 and
+Added: notes thereto contained in the Company’s Transition Report on Form 10-KT.
On September 26, 2019, the Company’s
−Removed: Board of Directors approved a 1-for-4 reverse split of the Common Stock, which was effective on the NASDAQ Capital Market on September
−Removed: As a result of the reverse stock split, every 4 shares of issued and outstanding common stock were converted into 1
−Removed: share of issued and outstanding common stock, with all fractional shares rounded up to the nearest whole share, and the Company’s
+Added: Board of Directors approved a 1-for-4 reverse split of the Common Stock, which was effective on the OTC Markets on September 30,
+Added: As a result of the reverse stock split, every 4 shares of issued and outstanding common stock were converted into 1 share
+Added: of issued and outstanding common stock, with all fractional shares rounded up to the nearest whole share, and the Company’s
authorized share of common stock were reduced from 200,000,000 to 50,000,000 shares.
1 unchanged sentence
retroactively restated to reflect this reverse stock split.
−Removed: As shown in the accompanying financial statements, the Company
−Removed: incurred negative operating cash flows of $3,424,763 for the quarter ended March 31, 2020 and has an accumulated deficit of $130,532,225
−Removed: from inception through March 31, 2020.
−Removed: At March 31, 2020 the Company had cash and short term investments of approximately $115,000,000.
+Added: As shown in the accompanying financial
+Added: statements, the Company incurred negative operating cash flows of $8,378,419 for the six months ended June 30, 2020 and has an
+Added: accumulated deficit of $141,650,666 from inception through June 30, 2020.
+Added: At June 30, 2020 the Company had cash and short term
+Added: investments of approximately $134,087,800.
Relmada has funded its past operations
−Removed: through equity raises and most recently in 2019 raised net proceeds from the sale of common stock of $109,447,482 and $4,447,038
−Removed: through the exercise of warrants.
−Removed: The Company also raised an additional $3,115,193 during the three months ended March 31, 2020
−Removed: from the exercises of options and warrants.
+Added: through equity raises and most recently in 2020 raised net proceeds from the sale of common stock of $19,855,018 through our ATM
+Added: offering and $5,619,276 through the exercise of warrants.
+Added: The Company also raised an additional $530,643 during the six months
+Added: ended June 30, 2020 from the exercises of options.
Therapeutics, Inc.
1 unchanged sentence
2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
−Removed: Management believes that due to the recent
−Removed: equity raises completed and exercises of outstanding warrants and the current cash position on its balance sheet, it has obtained
−Removed: sufficient funding to continue ongoing operations for at least 12 months from the issuance of these unaudited consolidated quarterly
−Removed: financial statements.
−Removed: Since March 31, 2020 and to date, the Company has received approximately $1,516,400 in warrant and option
−Removed: exercises, which resulted in the Company having approximately $115,378,100 million in cash, cash equivalents, and short term investments
−Removed: at May 13, 2020.
−Removed: Based on its budgeted cash flow requirements, the Company believes these funds are sufficient to fund its ongoing
−Removed: operations for at least 12 months after the issuance of these unaudited consolidated quarterly financial statements.
−Removed: of the results of any ongoing clinical trial, the Company has control over its expenditures and has the ability to adjust spending
−Removed: accordingly based on the budgeted cash flow requirements developed and the excess cash on hand.
+Added: Management believes that due to the recent equity raises completed
+Added: and exercises of outstanding warrants and the current cash position on its balance sheet, it has obtained sufficient funding to
+Added: continue ongoing operations for at least 12 months from the issuance of these unaudited consolidated quarterly financial statements.
+Added: Since June 30, 2020 and to date, the Company has received approximately $1,230,000 in warrant exercises, which resulted in the
+Added: Company having approximately $131,549,600 million in cash, cash equivalents, and short term investments at August 5, 2020.
+Added: on its budgeted cash flow requirements, the Company believes these funds are sufficient to fund its ongoing operations for at least
+Added: 12 months after the issuance of these unaudited consolidated quarterly financial statements.
+Added: Regardless of the results of any ongoing
+Added: clinical trial, the Company has control over its expenditures and has the ability to adjust spending accordingly based on the budgeted
+Added: cash flow requirements developed and the excess cash on hand.
believes that their existing cash and cash equivalents will enable them to fund operating expenses and capital expenditure requirement
11 unchanged sentences
All significant intercompany accounts and transactions have been eliminated in consolidation.
−Removed: Risks and Uncertainties
−Removed: The pandemic caused by an outbreak of
−Removed: a new strain of coronavirus (COVID-19) has resulted, and is likely to continue to result, in significant national
−Removed: and global economic disruption and may adversely affect our business.
−Removed: Based on the Company’s current assessment, the Company
−Removed: does not expect any material impact on its long-term development timeline and its liquidity due to the worldwide spread of the
−Removed: COVID-19 virus.
−Removed: However, the Company is actively monitoring this situation and the possible effects on its financial condition,
−Removed: liquidity, operations, suppliers, industry, and workforce.
−Removed: The preparation of financial statements
−Removed: in conformity with U.S.
−Removed: GAAP requires management to make estimates and assumptions that affect the reported amounts of assets
−Removed: and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts
−Removed: of revenues and expenses for the reporting period.
−Removed: Actual results could differ from those estimates.
−Removed: The significant estimates
−Removed: are the valuation of stock-based compensation expenses and recorded amounts related to income taxes.
+Added: and Uncertainties
+Added: pandemic caused by an outbreak of a new strain of coronavirus (COVID-19) has resulted, and is likely to continue to result, in
+Added: significant national and global economic disruption and may adversely affect our business.
+Added: Based on the Company’s current
+Added: assessment, the Company does not expect any material impact on its long-term development timeline and its liquidity due to the
+Added: worldwide spread of the COVID-19 virus.
+Added: However, the Company is actively monitoring this situation and the possible effects on
+Added: its financial condition, liquidity, operations, suppliers, industry, and workforce.
+Added: preparation of financial statements in conformity with U.S.
+Added: GAAP requires management to make estimates and assumptions that affect
+Added: the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial
+Added: statements and the reported amounts of revenues and expenses for the reporting period.
+Added: Actual results could differ from those
+Added: The significant estimates are the valuation of stock-based compensation expenses and recorded amounts related to income
Therapeutics, Inc.
7 unchanged sentences
cash deposits at these institutions exceed federally insured limits.
−Removed: The Company’s investments consist
−Removed: entirely of mutual funds.
−Removed: The securities are measured at fair value based on the net asset value (“NAV”).
−Removed: has adopted Financial Accounting Standards Board (FASB) Accounting Standard Update (ASU) 2016-01, Financial Instruments, for the
−Removed: six months ended December 31, 2019 which requires substantially all equity investments in nonconsolidated entities to be measured
−Removed: at fair value with recurring changes recognized in earnings, except for those accounted for using equity method accounting.
−Removed: in fair value of the securities are recorded as part of other income on the consolidated statement of operations.
−Removed: Short term investment
−Removed: activity is presented in the investing activities section on the consolidated statement of cash flows.
+Added: Company’s investments consist entirely of mutual funds.
+Added: The securities are measured at fair value based on the net asset
+Added: The Company adopted Financial Accounting Standards Board (FASB) Accounting Standard Update (ASU) 2016-01, Financial
+Added: Instruments, for the six months ended December 31, 2019 which requires substantially all equity investments in nonconsolidated
+Added: entities to be measured at fair value with recurring changes recognized in earnings, except for those accounted for using equity
+Added: method accounting.
+Added: Changes in fair value of the securities are recorded as part of other income on the consolidated statement
+Added: of operations.
+Added: Short term investment activity is presented in the investing activities section on the consolidated statement of
related to filing and pursuing patent applications are recorded as general and administrative expense and expensed as incurred
6 unchanged sentences
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
−Removed: lease liabilities.
+Added: Company recognizes its leases with a term of greater than a year on the balance sheet by recording right-of-use assets and lease
Leases can be classified as either operating leases or finance leases.
−Removed: Operating leases will result in
−Removed: straight-line lease expense, while finance leases will result in front-loaded expense.
−Removed: The Company’s lease consists of
−Removed: an operating leases for office space.
−Removed: The Company does not recognize a lease liability or right-of-use asset on the balance
−Removed: sheet for short-term leases.
−Removed: Instead, the Company recognizes short-term lease payments as an expense on a straight-line basis
−Removed: over the lease term.
−Removed: A short-term lease is defined as a lease that, at the commencement date, has a lease term of 12 months
−Removed: or less and does not include an option to purchase the underlying asset that the lessee is reasonably certain to
+Added: Operating leases will result in straight-line
+Added: lease expense, while finance leases will result in front-loaded expense.
+Added: The Company’s lease consists of an operating leases
+Added: for office space.
+Added: The Company does not recognize a lease liability or right-of-use asset on the balance sheet for short-term leases.
+Added: Instead, the Company recognizes short-term lease payments as an expense on a straight-line basis over the lease term.
+Added: 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
+Added: to purchase the underlying asset that the lessee is reasonably certain to exercise.
Therapeutics, Inc.
2 unchanged sentences
Value of Financial Instruments
−Removed: The Company’s financial instruments
−Removed: primarily include cash, short term investments, and accounts payable.
−Removed: Due to the short-term nature of cash and accounts payable
−Removed: the carrying amounts of these assets and liabilities approximate their fair value.
+Added: Company’s financial instruments primarily include cash, short term investments, and accounts payable.
+Added: Due to the short-term
+Added: nature of cash and accounts payable the carrying amounts of these assets and liabilities approximate their fair value.
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
14 unchanged sentences
(supported by little or no market activity).
−Removed: The Company’s short-term investment instruments of $102,690,508
−Removed: at March 31, 2020 are classified using Level 1 inputs within the fair value hierarchy because they are valued using NAV.
−Removed: gains and losses are recorded in the consolidated statement of operations under other income.
−Removed: The Company recorded an unrealized
−Removed: loss of $934,919, included in other income for the three months ended March 31, 2020.
−Removed: Value on a Recurring Basis
−Removed: As required by Accounting Standard Codification
−Removed: (ASC) Topic No.
−Removed: 820 - 10 Fair Value Measurement , financial assets and liabilities are classified based on the lowest level
−Removed: of input that is significant to the fair value measurement.
−Removed: The Company’s assessment of the significance of a particular
−Removed: input to the fair value measurement requires judgment and may affect the valuation of the fair value of assets and liabilities
−Removed: and their placement within the fair value hierarchy levels.
−Removed: As of March 31, 2020 and December 31, 2019,
−Removed: there were no financial liabilities accounted for at fair value.
+Added: The Company’s short-term investment
+Added: instruments of $120,263,581 at June 30, 2020 are classified using Level 1 inputs within the fair value hierarchy because they
+Added: are valued using NAV.
+Added: Unrealized gains and losses are recorded in the consolidated statement of operations under other income.
+Added: The Company recorded an unrealized gain of $287,027 included in other income for the six months ended June 30, 2020.
Therapeutics, Inc.
13 unchanged sentences
realize the benefit, or that future deductibility is uncertain.
−Removed: As of March 31, 2020 and December 31, 2019, the Company had recognized
+Added: As of June 30, 2020 and December 31, 2019, the Company had recognized
a valuation allowance to the full extent of the Company’s net deferred tax assets since the likelihood of realization of
6 unchanged sentences
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 March 31, 2020 and December 31, 2019.
+Added: no liabilities recorded for uncertain tax positions at June 30, 2020 and December 31, 2019.
The open tax years, subject to potential
15 unchanged sentences
per Common Share
−Removed: loss per common share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders
−Removed: by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents.
−Removed: Diluted loss per common share attributable to common stockholders is computed by dividing the net loss attributable to common
−Removed: stockholders by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock
−Removed: Dilutive common stock equivalents are comprised of Class A convertible preferred stock, Series A preferred stock, restricted
−Removed: stock awards, options and warrants to purchase common stock.
−Removed: For all periods presented, there is no difference in the number of
−Removed: shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.
−Removed: the three months ended March 31, 2020 and 2019, the potentially dilutive securities that would be anti-dilutive due to the Company’s
+Added: Basic loss per common share attributable to
+Added: common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of
+Added: common shares outstanding for the period, without consideration for common stock equivalents.
+Added: Diluted loss per common share attributable
+Added: to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number
+Added: of common share equivalents outstanding for the period determined using the treasury-stock method.
+Added: Dilutive common stock equivalents
+Added: are comprised of options and warrants to purchase common stock.
+Added: For all periods presented, there is no difference in the number
+Added: of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.
+Added: the six months ended June 30, 2020 and 2019, the potentially dilutive securities that would be anti-dilutive due to the Company’s
net loss are not included in the calculation of diluted net loss per share attributable to common stockholders.
1 unchanged sentence
securities are as follows (in common stock equivalent shares):
−Removed: Three months ended
+Added: Six months ended
Stock options
12 unchanged sentences
We do not expect the adoption of ASU 2019-12 to have a material impact on our consolidated financial statements.
−Removed: Subsequent Events
−Removed: The Company’s management reviewed
−Removed: all material events through the date the financial statements were issued for subsequent event disclosure consideration.
+Added: In August 2018, FASB issued ASU 2018-13, Fair
+Added: Value Measurement –
+Added: Disclosure Framework (Topic 820).
+Added: The updated guidance improves the disclosure requirements on fair
+Added: value measurements, primarily associated with Level 3 fair value measurements and is effective for fiscal years, and interim periods
+Added: within those fiscal years, beginning December 15, 2019.
+Added: Early adoption is permitted upon issuance of the standard disclosures
+Added: modified or removed with a delay of adoption of the additional disclosures until their effective date.
+Added: The Company adopted this
+Added: standard effective January 1, 2020 and the standard did not have a significant impact on the Company’s financial statements.
+Added: In November 2018, FASB issued ASU 2018-18 –
+Added: Collaborative
+Added: Arrangements (Topic 808):
+Added: Clarifying the Interaction between Topic 808 and Topic 606 , which, among other things, provides guidance
+Added: on how to assess whether certain collaborative arrangement transactions should be accounted for under Topic 606.
+Added: The amendments
+Added: in the ASU are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with
+Added: early adoption permitted.
+Added: The Company adopted this standard on January 1, 2020 and the standard did not have a significant impact
+Added: on the Company’s financial statements.
+Added: Company’s management reviewed all material events through the date the financial statements were issued for subsequent event
+Added: disclosure consideration.
3 - PREPAID EXPENSES
5 unchanged sentences
accumulated depreciation
−Removed: Therapeutics, Inc.
−Removed: to Unaudited Consolidated Financial Statements
5 - ACCRUED EXPENSES
5 unchanged sentences
Legal settlement
+Added: Therapeutics, Inc.
+Added: to Unaudited Consolidated Financial Statements
6 - NOTES PAYABLE
−Removed: In June 2019, the Company entered into a note
−Removed: for approximately $364,200 in conjunction with a renewal of its director and officer insurance policy.
−Removed: The interest rate was 3.09%
+Added: June 2019, the Company entered into a note for approximately $364,200 in conjunction with a renewal of its director and officer
+Added: insurance policy.
+Added: The interest rate was 3.09% per annum.
The note matured on April 9, 2020.
−Removed: March 31, 2020 and December 31, 2019, the note payable outstanding balances were approximately $0 and $110,200, respectively.
+Added: June 30, 2020 and December 31, 2019, the note payable outstanding balances were approximately $0 and $110,200, respectively.
7 - STOCKHOLDERS’
On September 26, 2019, the Company’s
−Removed: Board of Directors approved a 1-for-4 reverse split of the Common Stock, which was effective on the NASDAQ Capital Market on September
+Added: Board of Directors approved a 1-for-4 reverse split of the Common Stock, which was effective on the OTC Markets on September 30,
As a result of the reverse stock split, every 4 shares of issued and outstanding common stock were converted into 1 share
3 unchanged sentences
retroactively restated to reflect this reverse stock split.
−Removed: During the three months ended March 31, 2020,
+Added: During the six months ended June 30,
2020, the Company issued 35,954 shares of common stock for cashless exercise of 49,196 warrants.
−Removed: The Company also issued 447,107 shares
−Removed: of common stock for cash exercises of warrants for proceeds of $3,042,173.
−Removed: During the three months ended March 31, 2020,
−Removed: the Company issued 2,434 shares of common stock for cash exercise of options for proceeds of $73,020.
−Removed: Options and Warrants
+Added: The Company also issued
+Added: 815,471 shares of common stock for cash exercises of warrants for proceeds of $5,619,276.
+Added: During the six months ended June 30, 2020,
+Added: the Company issued 115,715 shares of common stock for the exercise of options for proceeds of $530,643.
+Added: On May 15, 2020, the Company entered into an
+Added: Open Market Sale Agreement with Jefferies LLC, as sales agent (“Jefferies”), pursuant to which the Company may
+Added: offer and sell, from time to time, through Jefferies, shares of the Company’s common stock, having an aggregate offering
+Added: price of up to $75,000,000 .
+Added: The Company is not obligated to sell any shares under the agreement.
+Added: During the six months ended June
+Added: 30, 2020 the Company issued 427,700 shares of common stock for net cash proceeds of $19,900,000 million under the agreement.
In December 2014, the Board of Directors
−Removed: adopted and the shareholders approved Relmada’s 2014 Stock Option and Equity Incentive Plan, as amended (the Plan), which
−Removed: allows for the granting of common stock awards, stock appreciation rights, and incentive and nonqualified stock options to purchase
−Removed: shares of the Company’s common stock to designated employees, non-employee directors, and consultants and advisors.
−Removed: allowed for the granting of 5,152,942 options or stock awards.
−Removed: Stock options are exercisable generally
−Removed: for a period of 10 years from the date of grant and generally vest over four years.
−Removed: As of March 31, 2020, 1,155,086 shares were
−Removed: available for future grants under the Plan.
−Removed: As of March 31, 2020, no stock appreciation
−Removed: rights have been issued.
−Removed: The Company utilizes the Black-Scholes
−Removed: option pricing model to estimate the fair value of stock options and warrants.
−Removed: The price of common stock prior to the Company being
−Removed: public was determined from a third party valuation.
−Removed: The risk-free interest rate assumptions were based upon the observed interest
−Removed: rates appropriate for the expected term of the equity instruments.
−Removed: The expected dividend yield was assumed to be zero as the Company
−Removed: has not paid any dividends since its inception and does not anticipate paying dividends in the foreseeable future.
−Removed: volatility was based on historical volatility.
−Removed: The Company routinely reviews its calculation of volatility changes in future volatility,
−Removed: the Company’s life cycle, its peer group, and other factors.
−Removed: The Company uses the simplified method
−Removed: for share-based compensation to estimate the expected term for employee option awards for share-based compensation in its option-pricing
−Removed: On March 9, 2020, the Company awarded
−Removed: a total of 350,000 options to an employee with exercise price of $45.61 and a 10-year term vesting over 4-year period.
−Removed: have an aggregate fair value of $13.1 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 0.51% (2) expected life of 6.25 years, (3) expected volatility of 107%, and
−Removed: (4) zero expected dividends.
+Added: adopted and the shareholders approved Relmada’s 2014 Stock Option and Equity Incentive Plan, as amended (the “Plan”),
+Added: which allows for the granting of common stock awards, stock appreciation rights, and incentive and nonqualified stock options to
+Added: purchase shares of the Company’s common stock to designated employees, non-employee directors, and consultants and advisors.
+Added: The Plan allowed for the granting of 5,152,942 options or stock awards.
+Added: Stock options are exercisable generally for a period of 10 years
+Added: from the date of grant and generally vest over four years.
+Added: As of June 30, 2020, 1,018,367 shares were available for future grants
+Added: under the Plan.
+Added: of June 30, 2020, no stock appreciation rights have been issued.
+Added: The Company utilizes the Black-Scholes option pricing model
+Added: to estimate the fair value of stock options and warrants.
+Added: The risk-free interest rate assumptions were based upon the observed
+Added: interest rates appropriate for the expected term of the equity instruments.
+Added: The expected dividend yield was assumed to be zero
+Added: as the Company has not paid any dividends since its inception and does not anticipate paying dividends in the foreseeable future.
+Added: The expected volatility was based on historical volatility.
+Added: The Company routinely reviews its calculation of volatility changes
+Added: in future volatility, the Company’s life cycle, its peer group, and other factors.
+Added: Company uses the simplified method for share-based compensation to estimate the expected term for employee option awards for share-based
+Added: compensation in its option-pricing model.
+Added: 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
+Added: vesting over 4-year period.
+Added: The options have an aggregate fair value of $13.1 million calculated using the Black-Scholes option-pricing
+Added: Variables used in the Black-Scholes option-pricing model include:
+Added: (1) discount rate of 0.51% (2) expected life of 6.25
+Added: years, (3) expected volatility of 107%, and (4) zero expected dividends.
Therapeutics, Inc.
2 unchanged sentences
EQUITY (continued)
−Removed: On March 19, 2020, the Company awarded
+Added: 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
+Added: vesting over a 4-year period.
+Added: The options have an aggregate fair value of $2.3 million calculated using the Black-Scholes option-pricing
+Added: Variables used in the Black-Scholes option-pricing model include:
+Added: (1) discount rate of 0.83% (2) expected life of 6.25
+Added: years, (3) expected volatility of 108%, and (4) zero expected dividends.
+Added: 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
+Added: vesting over a 4-year period.
+Added: The options have an aggregate fair value of $4.0 million calculated using the Black-Scholes option-pricing
+Added: Variables used in the Black-Scholes option-pricing model include:
+Added: (1) discount rate of 0.67% (2) expected life of 6.25
+Added: years, (3) expected volatility of 108%, and (4) zero expected dividends.
+Added: On April 21, 2020, the Company awarded
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.
4 unchanged sentences
(4) zero expected dividends.
−Removed: On March 25, 2020, the Company awarded
−Removed: a total of 150,000 options to an employee with exercise price of $31.88 and a 10-year term vesting over a 4-year period.
+Added: On May 20, 2020, the Company awarded a
+Added: 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.
have an aggregate fair value of $5.6 million calculated using the Black-Scholes option-pricing model.
3 unchanged sentences
(4) zero expected dividends
−Removed: At March 31, 2020, the Company has unrecognized
+Added: At June 30, 2020, the Company has unrecognized
stock-based compensation expense of approximately $69,788,000 related to unvested stock options over the weighted average remaining
service period of 3.5 years.
−Removed: the three months ended March 31, 2020, the Company recognized additional compensation expense of approximately $1,500,000 related
−Removed: to acceleration of vesting and a nominal amount related to the modification of certain options in connection with the separation
−Removed: and settlement agreement with Dr.
+Added: During the six months
+Added: ended June 30, 2020, the Company recognized additional compensation expense of approximately $1.5 million related to acceleration
+Added: of vesting and a nominal amount related to the modification of certain options in connection with the separation and settlement
+Added: agreement with Dr.
Ottavio Vitolo (see note 8).
−Removed: summary of the changes in options during the three months ended March 31, 2020 is as follows:
+Added: summary of the changes in options during the six months ended June 30, 2020 is as follows:
Outstanding and expected to vest at December 31, 2019
−Removed: Outstanding and expected to vest at March 31, 2020
−Removed: Options exercisable at March 31, 2020
−Removed: summary of the changes in outstanding warrants during the three months ended March 31, 2020 is as follows:
+Added: Outstanding and expected to vest at June 30, 2020
+Added: Options exercisable at June 30, 2020
+Added: A summary of the changes in outstanding warrants during the
+Added: six months ended June 30, 2020 is as follows:
Outstanding and vested at December 31, 2019
−Removed: Outstanding and vested at March 31, 2020
+Added: Outstanding and vested at June 30, 2020
Therapeutics, Inc.
2 unchanged sentences
EQUITY (continued)
−Removed: At March 31, 2020 the Company had approximately
+Added: On April 1, 2020, the Company granted 120,000
+Added: warrants to consultants with exercise price of $31.59, a 5-year term and immediate vesting.
+Added: The warrants have an aggregated fair
+Added: value of $2.5 million that was calculated using the Black-Scholes option-pricing model.
+Added: Variables used in the Black-Scholes option-pricing
+Added: model include:
+Added: (1) discount rate of 0.26% (2) expected life of 2.5 years, (3) expected volatility of 118%, and (4) zero expected
+Added: On April 27, 2020, the Company granted
+Added: 2,000 warrants to a consultant with exercise price of $37.67, a 5-year term and immediate vesting.
+Added: The warrants have an aggregated
+Added: fair value of $48 thousand that was calculated using the Black-Scholes option-pricing model.
+Added: Variables used in the Black-Scholes
+Added: option-pricing model include:
+Added: (1) discount rate of 0.27% (2) expected life of 2.5 years, (3) expected volatility of 116%, and (4)
+Added: zero expected dividends.
+Added: At June 30, 2020 the Company had approximately
$103,000 of unrecognized compensation expense related to outstanding warrants.
−Removed: At March 31, 2020 and December 31, 2019,
−Removed: the aggregate intrinsic value of warrants vested and outstanding was approximately $85,466,000 and $115,731,000, respectively.
+Added: At June 30, 2020 and December 31,
+Added: 2019, the aggregate intrinsic value of warrants vested and outstanding was approximately $106,423,000 and $115,731,000,
+Added: 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 three months ended March 31, 2020 and 2019 (rounded to nearest $00):
+Added: for the six months ended June 30, 2020 and 2019 (rounded to nearest $00):
Research and development
General and administrative
−Removed: NOTE 8 - RELATED PARTY TRANSACTIONS
−Removed: Effective March 6, 2020, Dr.
−Removed: Vitolo entered
−Removed: into a Separation and Severance Agreement with the Company.
−Removed: Pursuant to the terms of the agreement, the Company agreed to pay Dr.
+Added: 8 - RELATED PARTY TRANSACTIONS
+Added: March 6, 2020, Dr.
+Added: Vitolo entered into a Separation and Severance Agreement with the Company.
+Added: Pursuant to the terms of the agreement,
+Added: the Company agreed to pay Dr.
Vitolo severance of $200,000 in accordance with his employment contract.
In addition, Dr.
−Removed: Vitolo’s options granted under
−Removed: the Company’s 2014 Stock Option and Equity Incentive Plan will continue to vest until September 6, 2020.
−Removed: have until March 6, 2021 to exercise his vested options and he shall be allowed to use a cashless exercise provision to exercise
−Removed: his vested options.
−Removed: The agreement also contains customary confidentiality, release, and non-disparagement provisions, and the Company
−Removed: agreed to pay accrued and unpaid salary, vacation time and attorneys fees totaling approximately $45,000.
−Removed: On March 9, 2020, the Company appointed
+Added: Vitolo’s
+Added: options granted under the Company’s 2014 Stock Option and Equity Incentive Plan will continue to vest until September 6,
+Added: Vitolo shall have until March 6, 2021 to exercise his vested options and he shall be allowed to use a cashless exercise
+Added: provision to exercise his vested options.
+Added: The agreement also contains customary confidentiality, release, and non-disparagement
+Added: provisions, and the Company agreed to pay accrued and unpaid salary, vacation time and attorney’s fees totaling approximately $45,000.
+Added: March 9, 2020, the Company appointed Dr.
Thomas Wessel as the Company’s Executive Vice President, Head of Research and Development.
−Removed: NOTE 9 - COMMITMENTS AND CONTINGENCIES
−Removed: License Agreements
−Removed: On August 20, 2007, the Company entered into
−Removed: a License Development and Commercialization Agreement with Wonpung Mulsan Co, a shareholder of the Company.
−Removed: Wonpung has exclusive
−Removed: territorial rights in countries it selects in Asia to market up to two drugs the Company is currently developing and a right of
−Removed: first refusal (ROFR) for up to an additional five drugs that the Company may develop in the future as defined in more detail in
−Removed: the license agreement.
−Removed: If the parties cannot agree to terms of a license agreement then the Company shall be able to engage in
−Removed: discussions with other potential licensors.
−Removed: As of March 2020, no discussions are active between the Company and Wonpung.
−Removed: The Company received an upfront license
−Removed: 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.
−Removed: The licensing terms for the ROFR products are subject to future negotiations and binding arbitration.
−Removed: The terms of each licensing
−Removed: agreement will expire on the earlier of any time from 15 years to 20 years after licensing or on the date of commercial availability
−Removed: of a generic product to such licensed product in the licensed territory.
−Removed: Third Party Licensor
+Added: 9 - COMMITMENTS AND CONTINGENCIES
+Added: On August 20, 2007, the Company
+Added: entered into a License Development and Commercialization Agreement with Wonpung Mulsan Co, a shareholder of the Company.
+Added: Wonpung has exclusive territorial rights in countries it selects in Asia to market up to two drugs the Company is currently
+Added: developing and a right of first refusal (“ROFR”) for up to an additional five drugs that the Company may develop
+Added: in the future as defined in more detail in the license agreement.
+Added: If the parties cannot agree to terms of a license agreement
+Added: then the Company shall be able to engage in discussions with other potential licensors.
+Added: As of July 2020, no discussions are
+Added: active between the Company and Wonpung.
+Added: 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
+Added: products it is currently developing.
+Added: The licensing terms for the ROFR products are subject to future negotiations and binding
+Added: The terms of each licensing agreement will expire on the earlier of any time from 15 years to 20 years after licensing
+Added: or on the date of commercial availability of a generic product to such licensed product in the licensed territory.
+Added: Therapeutics, Inc.
+Added: to Unaudited Consolidated Financial Statements
+Added: 9 - COMMITMENTS AND CONTINGENCIES (continued)
+Added: Party Licensor
Based upon a prior acquisition, the Company
−Removed: assumed an obligation to pay a third party (Dr.
+Added: assumed an obligation to pay third parties (Dr.
Inturrisi and Dr.
5 unchanged sentences
or (ii) up to 2% of net sales of sublicensee.
−Removed: The Company will also make milestone payments of up to $4
−Removed: or $2 million, for the first commercial sale of product in the field that has a single active pharmaceutical ingredient, and for
−Removed: the first commercial sale of product in the field of product that has more than one active pharmaceutical ingredient, respectively.
−Removed: As of March 31, 2020, the Company has not generated any revenue related to this license agreement.
−Removed: Therapeutics, Inc.
−Removed: to Unaudited Consolidated Financial Statements
−Removed: 9 - COMMITMENTS AND CONTINGENCIES (continued)
−Removed: January 2018, we entered into an Intellectual Property Assignment Agreement (the Assignment Agreement) and License Agreement
−Removed: (the License Agreement and together with the Assignment Agreement, the Agreements) with Dr.
+Added: The Company will also make milestone payments of up to $4 or
+Added: $2 million, for the first commercial sale of product in the field that has a single active pharmaceutical ingredient, and for the
+Added: first commercial sale of product in the field of product that has more than one active pharmaceutical ingredient, respectively.
+Added: As of June 30, 2020, the Company has not generated any revenue related to this license agreement.
+Added: In January 2018, we entered into an Intellectual
+Added: Property Assignment Agreement (the Assignment Agreement) and License Agreement (the License Agreement and together with the Assignment
+Added: Agreement, the Agreements) with Dr.
Inturrisi and Dr.
Paolo Manfredi (collectively, the Licensor).
−Removed: Pursuant to the Agreements, Relmada assigned its existing rights, including patents
−Removed: and patent applications, to d-methadone in the context of psychiatric use (the Existing Invention) to Licensor.
−Removed: Licensor then
−Removed: granted Relmada under the License Agreement a perpetual, worldwide, and exclusive license to commercialize the Existing Invention
−Removed: and certain further inventions regarding d-methadone in the context of other indications such as those contemplated above.
+Added: the Agreements, Relmada assigned its existing rights, including patents and patent applications, to d-methadone in the context
+Added: of psychiatric use (the Existing Invention) to Licensor.
+Added: Licensor then granted Relmada under the License Agreement a perpetual,
+Added: worldwide, and exclusive license to commercialize the Existing Invention and certain further inventions regarding d-methadone.
consideration of the rights granted to Relmada under the License Agreement, Relmada paid the Licensor an upfront, non-refundable
6 unchanged sentences
on net sales of licensed products covered under the License Agreement.
−Removed: Relmada will also pay Licensor tiered payments up to a
−Removed: maximum of 20%, and decreasing to 17.5%, and 15% in certain circumstances, of all consideration received by Relmada for sublicenses
−Removed: granted under the License Agreement.
+Added: Relmada will also pay Licensor tiered payments up to a maximum
+Added: of 20%, and decreasing to 17.5%, and 15% in certain circumstances, of all consideration received by Relmada for sublicenses granted
+Added: under the License Agreement.
time to time, the Company may become involved in lawsuits and other legal proceedings that arise in the course of business.
3 unchanged sentences
Brought by Former Officer
−Removed: On February 6, 2019, the Company entered into
−Removed: a settlement agreement in its previous dispute with Najib Babul, Relmada’s former President.
−Removed: Babul relinquished his 303,392
−Removed: shares in Relmada, signed a consulting contract and Relmada committed to a $500,000 initial payment and four subsequent payments
−Removed: of $250,000 on March 31, 2019, June 30, 2019, September 30, 2019 and December 31, 2019.
−Removed: The Company recorded a loss on the settlement
−Removed: of $1.1 million in the first quarter of 2019.
+Added: February 6, 2019, the Company entered into a settlement agreement in its previous dispute with Najib Babul, Relmada’s former
+Added: Babul relinquished his 303,392 shares in Relmada, signed a consulting contract and Relmada committed to a $500,000
+Added: initial payment and four subsequent payments of $250,000 on March 31, 2019, June 30, 2019, September 30, 2019 and December 31,
+Added: The Company recorded a loss on the settlement of $1.1 million in the first quarter of 2019.
Therapeutics, Inc.
4 unchanged sentences
the Company’s leases consist of one lease for their corporate headquarters, which is for a period of 12 months or less.
−Removed: accordance with ASU 2016-02, Leases, the Company has elected the practical expedient and recognizes rent expense evenly over the
+Added: accordance with ASC 842, Leases, the Company has elected the practical expedient and recognizes rent expense evenly over the 12
The monthly rent is approximately $13,800.
−Removed: For the three months ended March 31, 2020 and 2019, the Company recognized
−Removed: lease expense of approximately $41,600 and $23,200, respectively.
+Added: For the six months ended June 30, 2020 and 2019, the Company recognized lease
+Added: expense of approximately $83,000 and $46,800, respectively.
On June 8, 2017, the Company entered into an
1 unchanged sentence
Pursuant to the terms of the agreement, Actinium will continue to license
−Removed: the furniture, fixtures, equipment and tenant improvements located in the office (FFE) for a license fee of $7,529 per month until
−Removed: December 8, 2022.
−Removed: Actinium shall have at any time during the term of this agreement the right to purchase the FFE for $496,914,
−Removed: less any previously paid license fees.
+Added: the furniture, fixtures, equipment and tenant improvements located in its office (“FFE”) for a license fee of $7,529
+Added: per month until December 8, 2022.
+Added: Actinium shall have at any time during the term of this agreement the right to purchase the FFE
+Added: for $496,914, less any previously paid license fees.
The license of FFE qualifies as a sales-type lease.
−Removed: At inception, the Company derecognized
−Removed: the underlying assets of $493,452, recognized discounted lease payments receivable of $397,049 using the discount rate of 8.38%
−Removed: and recognized loss on sales-type lease of fixed assets of $96,403.
−Removed: For the three months ended March 31, 2020 and 2019, the Company
−Removed: recognized lease income of approximately $4,900 and $6,300, respectively.
−Removed: As of March 31, 2020, the balance of unearned interest
−Removed: income was approximately $27,200.
+Added: At inception, the Company
+Added: derecognized the underlying assets of $493,452, recognized discounted lease payments receivable of $397,049 using the discount
+Added: rate of 8.38% and recognized loss on sales-type lease of fixed assets of $96,403.
+Added: For the six months ended June 30, 2020 and 2019,
+Added: the Company recognized lease income of approximately $9,400 and $12,300, respectively.
+Added: As of June 30, 2020, the balance of unearned
+Added: interest income was approximately $22,700.
following tables sets forth our contractual obligations for the next five years and thereafter:
1 unchanged sentence
10 - SUBSEQUENT EVENTS
−Removed: to March 31, 2020, 257,441 outstanding warrants and options were exercised for total cash proceeds of approximately $1,516,400.
−Removed: These warrant exercises include 338 shares issued with a cashless exercise.
−Removed: On April 20, 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: On May 15, 2020, the Company entered into an Open Market Sale Agreement SM (the
−Removed: “Agreement”) with Jefferies LLC, as sales agent (“Jefferies”), pursuant to which the Company may offer
−Removed: and sell, from time to time, through Jefferies, shares of the Company’s common stock, par value $0.001 per share, having
−Removed: an aggregate offering price of up to $75,000,000.
+Added: Subsequent to June 30,
+Added: 2020, 172,093 outstanding warrants were exercised for total cash proceeds of approximately $1,230,000.
+Added: These warrant exercises
+Added: include 481 shares issued with a cashless exercise.
+Added: 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: On July 22, 2020, the Company awarded a
+Added: 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.
MANAGEMENT’S
50 unchanged sentences
results or changed expectations.
−Removed: Business Overview
Relmada Therapeutics, Inc.
(Relmada or the
−Removed: Company, we or us) (a Nevada corporation), is a clinical-stage biotechnology company focused on the development of d-methadone
−Removed: (dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist.
−Removed: d-methadone is a new chemical entity (NCE) that
−Removed: potentially addresses areas of high unmet medical need in the treatment of central nervous system (CNS) diseases and other disorders.
−Removed: NMDA receptors are present in many parts of
−Removed: the central nervous system and play important roles in regulating neuronal activity.
−Removed: We believe that dextromethadone acting as
−Removed: an NMDA receptor antagonist can have potential applications in a number of disease indications which mitigates risk and offers
−Removed: significant upside.
+Added: Company, we or us) (a Nevada corporation), is a clinical-stage biotechnology company focused on the development of REL-1017 (d-methadone
+Added: dextromethadone), an N-methyl-D-aspartate (NMDA) receptor antagonist.
+Added: d-methadone is a new chemical entity (NCE) that potentially
+Added: addresses areas of high unmet medical need in the treatment of central nervous system (CNS) diseases and other disorders.
+Added: receptors are present in many parts of the central nervous system and play important roles in regulating neuronal activity.
+Added: believe that dextromethadone acting as an NMDA receptor antagonist can have potential applications in a number of disease indications
+Added: which mitigates risk and offers significant upside.
On October 7, 2019, our application to list
2 unchanged sentences
on NASDAQ under the existing symbol, “RLMD”.
−Removed: On December 19, 2019, the Board of Directors
−Removed: of the Company approved a change to its end of fiscal year from June 30 to December 31.
−Removed: The change in fiscal year became effective
−Removed: for the Company’s 2020 fiscal year, which began on January 1, 2020 and will end December 31, 2020.
+Added: On July 14, 2020, our common stock was uplisted to The Nasdaq Global Select
+Added: Market and continues to trade under the symbol “RLMD.”
+Added: December 19, 2019, the Board of Directors of the Company approved a change to its end of fiscal year from June 30 to December
+Added: The change in fiscal year became effective for the Company’s 2020 fiscal year, which began on January 1, 2020 and will
+Added: end December 31, 2020.
Our lead product candidate, d-methadone, is
4 unchanged sentences
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 adequate antidepressant treatments with an antidepressant
+Added: major depressive disorder (MDD), who experienced an inadequate response to 1 to 3 treatments with an antidepressant medications.
In the REL-1017-202 study, 62 subjects, average
1 unchanged sentence
Scale (MADRS) score of 34.0 (severe depression), were randomized.
−Removed: Other demographic characteristics were balanced across all arms.
−Removed: After an initial screening period, subjects were randomized to one of three arms:
−Removed: placebo, REL-1017 25 mg or REL-1017 50 mg, in
−Removed: addition to stable background antidepressant therapy.
−Removed: Subjects in the REL-1017 treatment arms received one loading dose of either
−Removed: 75 mg (25 mg arm) or 100 mg (50 mg arm) of REL-1017.
−Removed: Subjects were treated inpatient for 7 days and discharged home at Day 9.
+Added: Demographic characteristics were balanced across all arms.
+Added: an initial screening period, subjects were randomized to one of three arms:
+Added: placebo, REL-1017 25 mg or REL-1017 50 mg, in addition
+Added: to stable background antidepressant therapy.
+Added: Subjects in the REL-1017 treatment arms received one loading dose of either 75 mg
+Added: (25 mg arm) or 100 mg (50 mg arm) of REL-1017.
+Added: Subjects were treated as inpatients for 7 days and discharged home at Day 9.
returned for follow-up visits at Day 14 and Day 21.
6 unchanged sentences
No differences were observed between the ITT and PPP analyses and results.
−Removed: We observed that subjects in both the REL-1017
−Removed: 25 mg and 50 mg treatment groups experienced statistically significant improvement on all efficacy measures tested as compared
−Removed: to subjects in the placebo group, including:
−Removed: the Montgomery-Asberg Depression Rating Scale (MADRS);
−Removed: the Clinical Global Impression
+Added: observed that subjects in both the REL-1017 25 mg and 50 mg treatment groups experienced statistically significant improvement
+Added: on all efficacy measures tested as compared to subjects in the placebo group, including:
+Added: the Montgomery-Asberg Depression Rating
+Added: Scale (MADRS);
+Added: the Clinical Global Impression –
Severity (CGI-S) scale;
the Clinical Global Impression –
−Removed: Improvement (CGI-I) scale;
−Removed: and the Symptoms of Depression
−Removed: Questionnaire (SDQ).
−Removed: Improvements on the MADRS endpoint appeared
−Removed: on Day 4 in both REL-1017 dose groups and continued through Day 7 and Day 14, seven days after treatment discontinuation, with
−Removed: P values< 0.03 and large effect sizes (a measure of quantifying the difference between two groups), ranging from 0.7 to 1.0.
+Added: (CGI-I) scale;
+Added: and the Symptoms of Depression Questionnaire (SDQ).
+Added: 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
+Added: treatment discontinuation, with P values< 0.03 and large effect sizes (a measure of quantifying the difference between two
+Added: groups), ranging from 0.7 to 1.0.
Similar findings emerged from the CGI-S and CGI-I scales.
1 unchanged sentence
Means Difference
+Added: LS Means Difference
Means Difference
Means Difference
−Removed: 25mg vs Placebo
−Removed: 50mg vs Placebo
+Added: REL-1017 25mg vs Placebo
+Added: REL-1017 50mg vs Placebo
= Least Squares;
d = Cohen’s effect size
−Removed: The study also confirmed the favorable tolerability profile
−Removed: of REL-1017, which was also observed in the Phase 1 studies.
−Removed: Subjects experienced mild and moderate adverse events (AEs), and no
−Removed: serious adverse events, without significant differences between placebo and treatment groups.
−Removed: The AEs observed in the Phase 2a
−Removed: clinical study were of the same nature as those observed in the Phase 1 clinical studies in d-Methadone, and there was no evidence
−Removed: of either treatment induced psychotomimetic and dissociative AEs or withdrawal signs and symptoms upon treatment discontinuation.
−Removed: Key Upcoming Anticipated Milestones
−Removed: We expect multiple key milestones over the
−Removed: next 12 months.
+Added: study also confirmed the favorable tolerability profile of REL-1017, which was also observed in the Phase 1 studies.
+Added: experienced mild and moderate adverse events (AEs), and no serious adverse events, without significant differences between placebo
+Added: and treatment groups.
+Added: The AEs observed in the Phase 2a clinical study were of the same nature as those observed in the Phase 1
+Added: clinical studies in d-Methadone, and there was no evidence of either treatment induced psychotomimetic and dissociative AEs or
+Added: withdrawal signs and symptoms upon treatment discontinuation.
+Added: Upcoming Anticipated Milestones
+Added: expect multiple key milestones over the next 12 months.
These include:
−Removed: Presentation of full details of the Phase 2 data for REL-1017.
−Removed: Feedback from the U.S.
−Removed: Food and Drug Administration (FDA) related
−Removed: to an End-of-Phase 2 meeting for the REL-1017 development by the end of the first half of 2020.
−Removed: We intend to focus the registrational
−Removed: plan for REL-1017 as an adjunctive treatment of MDD.
−Removed: Start of pivotal studies for REL-1017 as an
−Removed: adjunctive treatment of MDD in the second half of 2020.
−Removed: Start 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 based on the FDA’s feedback and other factors.
−Removed: NMDA receptors are present in many parts of
−Removed: the CNS and play important roles in regulating neuronal activity and promoting synaptic plasticity in brain areas important for
−Removed: cognitive functions such as executive function, learning and memory.
−Removed: Based on these premises, d-methadone could show benefits in
−Removed: several different CNS indications.
−Removed: d-Methadone Phase 1 Clinical Safety Studies
−Removed: The safety data from two Company-funded d-methadone
−Removed: Phase 1 clinical safety studies and a third study conducted by researchers at Memorial Sloan-Kettering Cancer Center indicate that
−Removed: d-methadone was well tolerated in both healthy subjects and cancer patients at all projected therapeutic doses tested.
+Added: of full details of the Phase 2 data for REL-1017.
+Added: of pivotal studies for REL-1017 as an adjunctive treatment of MDD in the second half of 2020.
+Added: of Phase 2 study in MDD.
+Added: We plan to start a Phase 2 MDD study in the second half of 2020, though development plans may change
+Added: based on the FDA’s feedback and other factors.
+Added: receptors are present in many parts of the CNS and play important roles in regulating neuronal activity and promoting synaptic
+Added: plasticity in brain areas important for cognitive functions such as executive function, learning and memory.
+Added: Based on these premises,
+Added: d-methadone could show benefits in several different CNS indications.
+Added: Phase 1 Clinical Safety Studies
+Added: safety data from two Company-funded d-methadone Phase 1 clinical safety studies and a third study conducted by researchers at
+Added: Memorial Sloan-Kettering Cancer Center indicate that d-methadone was well tolerated in both healthy subjects and cancer patients
+Added: at all projected therapeutic doses tested.
Corporate History and Background
9 unchanged sentences
anticipate generating revenues for the foreseeable future.
−Removed: We had net loss of approximately $10,673,300 for the three months ended
−Removed: March 31, 2020.
−Removed: At March 31, 2020, we have an accumulated deficit of approximately $130,532,200.
−Removed: strategy is to leverage our considerable industry experience, understanding of CNS markets and development expertise to identify,
−Removed: develop and commercialize product candidates with significant market potential that can fulfill unmet medical needs in the treatment
−Removed: of CNS diseases.
−Removed: We have assembled a management team along with both scientific and business advisors, including recognized experts
−Removed: in the fields of depression, with significant industry and regulatory experience to lead and execute the development and commercialization
−Removed: of d-methadone.
−Removed: plan to further develop d-methadone as our priority program.
−Removed: As the drug d-methadone is an NCE, the regulatory pathway required
−Removed: to support and NDA submission will consist of conducting a full clinical development program.
−Removed: We plan to also generate intellectual
−Removed: property (IP) that will further protect our products from competition.
−Removed: We will continue to prioritize our product development
−Removed: activities after taking into account the resources we have available, market dynamics and potential for adding value.
−Removed: believe that the market for addressing areas of high unmet medical need in the treatment of CNS diseases will continue to be large
−Removed: for the foreseeable future and that it will represent a sizable revenue opportunity for us.
−Removed: For example, the World Health Organization
−Removed: (WHO) has estimated that CNS diseases affect nearly 2 billion people globally, making up approximately 40% of total disease burden
−Removed: (based on disability adjusted life years), compared with 13% for cancer and 12% for cardiovascular disease.
+Added: We had net loss of $21,791,757 for the six months ended June 30, 2020.
+Added: At June 30, 2020, we have an accumulated deficit of $141,650,666.
+Added: Our strategy is to leverage our considerable
+Added: industry experience, understanding of CNS markets and development expertise to identify, develop and commercialize product candidates
+Added: with significant market potential that can fulfill unmet medical needs in the treatment of CNS diseases.
+Added: We have assembled a management
+Added: team along with both scientific and business advisors, including recognized experts in the fields of depression, with significant
+Added: industry and regulatory experience to lead and execute the development and commercialization of REL-1017.
+Added: We plan to further develop REL-1017 as our
+Added: priority program.
+Added: As the drug d-methadone is an NCE, the regulatory pathway required to support and NDA submission will consist
+Added: of conducting a full clinical development program.
+Added: We plan to also generate intellectual property (IP) that will further protect
+Added: our products from competition.
+Added: We will continue to prioritize our product development activities after taking into account the
+Added: resources we have available, market dynamics and potential for adding value.
+Added: Market Opportunity
+Added: We believe that the market for addressing areas
+Added: of high unmet medical need in the treatment of CNS diseases will continue to be large for the foreseeable future and that it will
+Added: represent a sizable revenue opportunity for us.
+Added: For example, the World Health Organization (WHO) has estimated that CNS diseases
+Added: affect nearly 2 billion people globally, making up approximately 40% of total disease burden (based on disability adjusted life
+Added: years), compared with 13% for cancer and 12% for cardiovascular disease.
The depression treatment market is segmented
9 unchanged sentences
(Johnson & Johnson).
−Removed: Property Portfolio and Market Exclusivity
−Removed: We have over 50 issued patents
−Removed: and pending patent applications related to dextromethadone (REL-1017) for multiple uses, including psychological and neurological
+Added: Intellectual Property Portfolio and Market
+Added: over 50 issued patents and pending patent applications related to REL-1017 for multiple uses, including psychological and neurological
We have also secured an Orphan Drug Designation from the FDA for d-methadone for “the treatment of postherpetic
−Removed: neuralgia”, which, upon NDA approval, carry 7-year FDA Orphan Drug marketing exclusivity.
−Removed: In the European Union, some of
−Removed: our products may be eligible up to 10 years of market exclusivity, which includes 8 years data exclusivity and 2 years market
−Removed: In addition to any granted patents, our products will be eligible for market exclusivity to run concurrently with
−Removed: the term of the patent for 5 years in the U.S.
+Added: neuralgia”, which, if pursed and upon potential NDA approval, would carry 7-year FDA Orphan Drug marketing exclusivity.
+Added: the European Union, some of our products may be eligible up to 10 years of market exclusivity, which includes 8 years data exclusivity
+Added: and 2 years market exclusivity.
+Added: In addition to any granted patents, REL-1017 will be eligible for market exclusivity to run concurrently
+Added: with the term of the patent for 5 years in the U.S.
(Hatch Waxman plus pediatric exclusivity) and up to 10 years of in the E.U.
−Removed: believe an extensive intellectual property estate of US and foreign patents and applications will protect our technology and products
−Removed: once our patent applications for our products are approved.
−Removed: Key Strengths
+Added: We believe an extensive intellectual property estate of US and foreign patents and applications, once approved, will protect our
+Added: technology and products.
We believe that the key elements for our market success include:
−Removed: Compelling lead product opportunity, d-methadone completed Phase
−Removed: 2 trial for the adjunctive treatment of MDD, including patients with TRD.
−Removed: Potential in additional multiple indications in underserved markets with large patient population, such as MDD, other affective disorders, and cognitive disorders.
+Added: Compelling lead product opportunity, REL-1017 completed Phase 2 trial for the adjunctive treatment of MDD.
+Added: Potential in multiple indications in underserved markets with large patient population, such as MDD, other affective disorders, and cognitive disorders.
Scientific support of leading experts:
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.
−Removed: Substantial IP portfolio
−Removed: and market protection:
+Added: Substantial IP portfolio and market protection:
approved and filed patent applications provide coverage beyond 2030.
2 unchanged sentences
maintained by the SEC at 100 F Street NE, Washington, D.C.
−Removed: September 26, 2019, our Board of Directors approved a 1-for-4 reverse split of our common stock, which was effective on the NASDAQ
−Removed: Capital Market on September 30, 2019.
−Removed: As a result of the reverse stock split, every 4 shares of issued and outstanding common
−Removed: stock were converted into 1 share of issued and outstanding common stock, with all fractional shares rounded up to the nearest
−Removed: whole share, and our authorized shares of common stock were reduced from 200,000,000 to 50,000,000 shares.
−Removed: share and per share amounts herein have been retroactively restated to reflect this reverse stock split.
+Added: On September 26, 2019, our Board of Directors
+Added: approved a 1-for-4 reverse split of our common stock, which was effective on the OTC Markets on September 30, 2019.
+Added: of the reverse stock split, every 4 shares of issued and outstanding common stock were converted into 1 share of issued and outstanding
+Added: common stock, with all fractional shares rounded up to the nearest whole share, and our authorized shares of common stock were
+Added: reduced from 200,000,000 to 50,000,000 shares.
+Added: All share and per share amounts herein have been retroactively
+Added: restated to reflect this reverse stock split.
of Operations
−Removed: the Three Months Ended March 31, 2020 versus March 31, 2019
+Added: the Three Months Ended June 30, 2020 versus June 30, 2019
+Added: and development
+Added: and administrative
+Added: Research and Development Expense
+Added: Research and development expense for the three months ended
+Added: 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
+Added: The increase was driven by an increase in study costs of $431,900, of which the majority pertained to completion of
+Added: 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
+Added: research and development employees and the related options granted to them.
+Added: and Administrative Expense
+Added: General and administrative expense for the three months ended
+Added: 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
+Added: The increase resulted from an increase in compensation costs of $484,700 as a result of hiring an additional employee;
+Added: an increase in stock-based compensation costs of $5,673,200 primarily related to warrant expenses from consultants of approximately
+Added: a net increase in other G&A expenses of $209,500 that pertained primarily to investor relations.
+Added: Income (Expense)
+Added: Interest / investment income was approximately $404,000 and
+Added: $13,100 for the three months ended June 30, 2020 and 2019, respectively.
+Added: Unrealized gain on short-term investments was approximately
+Added: $1,221,900 for the three months ended June 30, 2020.
+Added: Realized gain on short-term investments was approximately $12,800 for the
+Added: three months ended June 30, 2020.
+Added: All investments were classified as cash equivalents at June 30, 2019.
+Added: There was no unrealized
+Added: gain or loss or realized gain or loss at June 30, 2019.
+Added: The net loss for the Company for the three
+Added: months ended June 30, 2020 and 2019 was approximately $11,118,400 and $4,122,600, respectively.
+Added: The Company had loss per share
+Added: of basic and diluted $0.73 and $0.50 for the three months ended June 30, 2020 and 2019, respectively.
+Added: 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
+Added: valuation allowance against all deferred tax assets.
+Added: of Operations
+Added: the Six Months Ended June 30, 2020 versus June 30, 2019
Operating Expenses
−Removed: General and administrative
Research and development
−Removed: General and Administrative Expense
−Removed: General and administrative expense for
−Removed: the three months ended March 31, 2020 was approximately $5,466,700 compared to $1,426,100 for the three months ended March 31,
−Removed: 2019, an increase of approximately $4,040,000.
−Removed: The increase resulted from an increase in compensation costs of $948,600;
−Removed: in stock-based compensation costs of $2,934,400;
−Removed: an increase in other G&A expenses of $209,400 that pertained primarily to
−Removed: investor relations;
−Removed: an increase in professional service fees of $193,500;
−Removed: and an increase in patent legal fees of $27,000.
−Removed: increases were partially offset by a decrease in litigation fees of $272,300.
+Added: General and administrative
Research and Development Expense
−Removed: Research and development expense for the three
−Removed: months ended March 31, 2020 was approximately $4,507,800 compared to $1,276,000 for the three months ended March 31, 2019, an increase
+Added: Research and development expense for the six months ended June
+Added: 30, 2020 was approximately $9,831,700 compared to $4,345,800 for the six months ended June 30, 2019, an increase of approximately
+Added: The increase was driven by an increase in study costs of $1,298,700, of which the majority pertained to completion
+Added: of our Phase 2 study and manufacturing costs, as well as an increase in compensation costs of $4,187,200 which included the approximately
+Added: $2,936,100 of stock based compensation expense primarily related to the separation agreement with Ottavio Vitolo, the remaining
+Added: increase was a result of hiring 4 additional research and development employees and the related options granted to them.
+Added: General and Administrative Expense
+Added: General and administrative expense for the six months ended
+Added: 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
+Added: The increase resulted from an increase in compensation costs of $1,442,100, as a result of hiring additional employees
+Added: and their related bonuses;
+Added: an increase in stock-based compensation costs of $8,607,600 related to warrant expenses from consultants
of approximately $2,500,000;
−Removed: The increase was driven by an increase in study costs of $866,700, of which the majority pertained
−Removed: to completion of our Phase 2 study and manufacturing costs, as well as an increase in compensation costs of $2,365,100, which included
−Removed: the approximately $1,500,000 of stock based compensation expense related to the separation agreement with Ottavio Vitolo.
+Added: a net increase in other G&A expenses of $358,300 that pertained primarily to investor relations
+Added: and professional fees.
Other Income (Expense)
−Removed: Interest / investment income was approximately $407,600 and
−Removed: $15,900 for the three months ended March 31, 2020 and 2019, respectively.
−Removed: Unrealized loss on short-term investments was approximately
−Removed: $934,900 for the three months ended March 31, 2020.
−Removed: There was no unrealized gain or loss at March 31, 2019.
−Removed: Realized loss on short-term
−Removed: investments was approximately $171,600 for the three months ended March 31, 2020.
−Removed: There was no realized gain or loss at March 31,
−Removed: The net loss for the Company for the three
−Removed: months ended March 31, 2020 and 2019 was approximately $10,673,300 and $2,686,100 respectively.
+Added: Interest / investment income was approximately
+Added: $811,700 and $29,000 for the six months ended June 30, 2020 and 2019, respectively.
+Added: Unrealized gain on short-term investments was
+Added: approximately $287,000 for the six months ended June 30, 2020.
+Added: Realized loss on short-term investments was approximately $158,800
+Added: for the six months ended June 30, 2020.
+Added: All investments were classified as cash equivalents at June 30, 2019.
+Added: There was no unrealized
+Added: gain or loss or realized gain or loss at June 30, 2019.
+Added: The net loss for the Company for the six
+Added: months ended June 30, 2020 and 2019 was approximately $21,791,800 and $6,808,700 respectively.
The Company had loss per share
−Removed: of basic and diluted $0.72 and $0.36 for the three months ended March 31, 2020 and 2019, respectively.
−Removed: Company did not provide for income taxes for the three months ended March 31, 2020 and 2019, since there was a loss and a full
−Removed: valuation allowance against all deferred tax assets.
−Removed: As shown in the accompanying financial statements, the Company
−Removed: incurred negative operating cash flows of $3,424,763 for the quarter ended March 31, 2020 and has an accumulated deficit of $130,532,225
−Removed: from inception through March 31, 2020.
−Removed: Relmada has funded its past operations through
−Removed: equity raises and most recently in 2019 Relmada raised net proceeds from the sale of common stock of $109,447,482 and $4,447,038
+Added: of basic and diluted $1.45 and $0.86 for the six months ended June 30, 2020 and 2019, respectively.
+Added: 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
+Added: allowance against all deferred tax assets.
+Added: As shown in the accompanying financial statements,
+Added: the Company incurred negative operating cash flows of approximately $8,378,400 for the six months ended June 30, 2020 and has an
+Added: accumulated deficit of approximately $141,650,700 from inception through June 30, 2020.
+Added: At June 30, 2020 the Company had cash and
+Added: short term investments of approximately $134,087,800.
+Added: Relmada has funded its past operations through equity raises
+Added: 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
through the exercise of warrants.
−Removed: The Company also raised an additional $3,115,193 during the three months ended March 31, 2020
−Removed: from the exercise of options and warrants.
−Removed: believes that due to the recent equity raises completed and exercises of outstanding warrants and the current cash position on
−Removed: its balance sheet, it has obtained sufficient funding to continue ongoing operations for the at least 12 months from the issuance
−Removed: of the accompanying consolidated quarterly financial statements.
−Removed: Since March 31, 2020 and to date, the Company has received approximately
−Removed: $1,516,400 in warrant and option exercises, which resulted in the Company having approximately $115,378,100 million in cash, cash
−Removed: equivalents and short term investments at May 13, 2020.
−Removed: Based on its budgeted cash flow requirements, the Company believes these
−Removed: funds are sufficient to fund its ongoing operations for at least 12 months after the issuance of these consolidated quarterly financial
−Removed: The following table sets forth selected cash flow information for
−Removed: the periods indicated below:
−Removed: Three Months Ended
−Removed: Three Months Ended
+Added: The Company also raised an additional $530,643 during the six months ended June 30, 2020 from
+Added: the exercises of options.
+Added: Management believes that
+Added: due to the recent equity raises completed and exercises of outstanding warrants and the current cash position on its balance sheet,
+Added: it has obtained sufficient funding to continue ongoing operations for the at least 12 months from the issuance of the accompanying
+Added: consolidated quarterly financial statements.
+Added: Since June 30, 2020 and to date, the Company has received approximately $1,230,000
+Added: in warrant exercises, which resulted in the Company having approximately $131,549,600 million in cash, cash equivalents and short
+Added: term investments at August 5, 2020.
+Added: Based on its budgeted cash flow requirements, the Company believes these funds are sufficient
+Added: to fund its ongoing operations for at least 12 months after the issuance of these consolidated quarterly financial statements.
+Added: following table sets forth selected cash flow information for the periods indicated below:
+Added: Six Months Ended
+Added: Six Months Ended
Cash used in operating activities
−Removed: $ (3,424,763 )
−Removed: $ (2,011,929 )
Cash used in investing activities
−Removed: (23,632,215 )
Cash provided by financing activities
Net decrease in cash and cash equivalents
−Removed: $ (24,052,032 )
−Removed: For the three months ended March 31, 2020,
−Removed: cash used in operating activities was $3,424,763 primarily due to the net loss of $10,673,316, offset by prepaid expense of $177,855,
−Removed: accounts payable of $580,153, unrealized loss of $934,919, realized loss of $171,611, accrued expenses of $333,432, and non-cash
−Removed: stock compensation charges of $5,039,362.
−Removed: For the three months ended March 31, 2019,
−Removed: cash used in operating activities was $2,011,929 primarily due to the loss from operations for the three months ended March 31,
−Removed: 2019 of $2,686,065 off set by accounts payable of $721,220, prepaid expense of $329,872, and non-cash stock compensation expense
−Removed: of $394,692, offset by accrued expenses of 369,598 and shares relinquished in litigation of $394,410.
−Removed: For the three months ended March 31, 2020,
−Removed: cash used in investing activities was $23,632,215 related to the purchase and sale of short-term investments.
−Removed: For the three months
−Removed: ended March 31, 2019, no cash was used in investing activities.
+Added: For the six months ended June 30, 2020, cash used in operating
+Added: 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,
+Added: prepaid expense of $183,329, accounts payable of $442,506, unrealized gain of $287,027, realized loss of $158,801, and accrued
+Added: expenses of $535,997.
+Added: For the six months ended June 30, 2019,
+Added: cash used in operating activities was $5,679,009 primarily due to the loss from operations for the six months ended June 30, 2019
+Added: of $6,808,657 off set by accounts payable of $565,469 prepaid expense of $381,124, and non-cash stock compensation expense of
+Added: $798,151, offset by accrued expenses of $72,692 and shares relinquished in litigation of $394,410.
+Added: For the six months ended June 30, 2020, cash
+Added: used in investing activities was $39,970,532 related to the net purchase and sale of short-term investments.
+Added: For the six months
+Added: ended June 30, 2020, no cash was used in investing activities.
Net cash provided by financing activities for
−Removed: the three months ended March 31, 2020 was $3,004,946 due to proceeds from options exercised for common stock of $73,020 and proceeds
−Removed: from warrants exercised for common stock of $3,042,173, partially offset by payments of notes payable of 110,247.
−Removed: Net cash provided
−Removed: by financing activities for the three months ended March 31, 2019 was $1,639,031 primarily due to proceeds from the issuance of
−Removed: common stock of $1,725,000 partially offset by payments of notes payable of $85,969.
−Removed: Effects of Inflation
−Removed: Our assets are primarily monetary, consisting
−Removed: of cash and cash equivalents.
−Removed: Because of their liquidity, these assets are not directly affected by inflation.
−Removed: Because we intend
−Removed: to retain and continue to use our equipment, we believe that the incremental inflation related to replacement costs of such items
−Removed: will not materially affect our operations.
−Removed: However, the rate of inflation affects our expenses, such as those for employee compensation
−Removed: and contract services, which could increase our level of expenses and the rate at which we use our resources.
+Added: the six months ended June 30, 2020 was $25,894,690 due to proceeds from options exercised for common stock of $530,643, proceeds
+Added: from warrants exercised for common stock of $5,619,276, and sales of common stock of $19,855,018, partially offset by payments
+Added: of notes payable of $110,247.
+Added: Net cash provided by financing activities for the six months ended June 30, 2019 was $12,468,812
+Added: primarily due to proceeds from the sale of common stock of $12,583,550 partially offset by payments of notes payable of $114,738.
+Added: assets are primarily monetary, consisting of cash and cash equivalents.
+Added: Because of their liquidity, these assets are not directly
+Added: affected by inflation.
+Added: Because we intend to retain and continue to use our equipment, we believe that the incremental inflation
+Added: related to replacement costs of such items will not materially affect our operations.
+Added: However, the rate of inflation affects our
+Added: expenses, such as those for employee compensation and contract services, which could increase our level of expenses and the rate
+Added: at which we use our resources.
Sheet Arrangements
2 unchanged sentences
have been established for the purpose of facilitating off-balance sheet arrangements or other contractually limited purposes.
−Removed: As of March 31, 2020 and December 31, 2019, we were not involved in any SPE transactions.
−Removed: Commitments 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
+Added: As of June 30, 2020 and December 31, 2019, we were not involved in any SPE transactions.
and Contingencies
−Removed: To our knowledge there have been no material changes to the risk factors that were previously disclosed in
−Removed: the Company’s Annual Report on Form 10-KT for the six months ended December 31, 2019.
−Removed: Additional risks and
−Removed: uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our
−Removed: business, financial condition and/or operating results.
+Added: 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
+Added: Contingencies.
+Added: To our knowledge there have been no material changes to the risk factors that were previously disclosed in the
+Added: Company’s Annual Report on Form 10-KT for the six months ended December 31, 2019.
+Added: Additional risks and uncertainties
+Added: not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial
+Added: condition and/or operating results.
Accounting Policies and Estimates
5 unchanged sentences
GAAP accounting
−Removed: standards effective as of September 30, 2018 have been taken into consideration in preparing the unaudited consolidated financial
−Removed: The preparation of unaudited consolidated financial statements requires estimates and assumptions that affect the
−Removed: reported amounts of assets, liabilities, expenses and related disclosures.
−Removed: Some of those estimates are subjective and complex,
−Removed: and, consequently, actual results could differ from those estimates.
−Removed: The following accounting policies and estimates have been
−Removed: highlighted as significant because changes to certain judgments and assumptions inherent in these policies could affect our consolidated
−Removed: financial statements:
+Added: standards effective as of June 30, 2020 have been taken into consideration in preparing the unaudited consolidated financial statements.
+Added: The preparation of unaudited consolidated financial statements requires estimates and assumptions that affect the reported amounts
+Added: of assets, liabilities, expenses and related disclosures.
+Added: Some of those estimates are subjective and complex, and, consequently,
+Added: actual results could differ from those estimates.
+Added: The following accounting policies and estimates have been highlighted as significant
+Added: because changes to certain judgments and assumptions inherent in these policies could affect our consolidated financial statements:
and development expenses, and
11 unchanged sentences
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.