Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 09, 2022 | |
Document Information Line Items | ||
Entity Registrant Name | Relmada Therapeutics, Inc. | |
Trading Symbol | RLMD | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 30,060,518 | |
Amendment Flag | false | |
Entity Central Index Key | 0001553643 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 000-55347 | |
Entity Incorporation, State or Country Code | NV | |
Entity Tax Identification Number | 45-5401931 | |
Entity Address, Address Line One | 2222 Ponce de Leon | |
Entity Address, Address Line Two | Floor 3 | |
Entity Address, City or Town | Coral Gables | |
Entity Address, State or Province | FL | |
Entity Address, Postal Zip Code | 33134 | |
City Area Code | (786) | |
Local Phone Number | 629-1376 | |
Title of 12(b) Security | Common stock, $0.001 par value per share | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 37,260,866 | $ 44,443,439 |
Short-term investments | 174,694,211 | 167,466,167 |
Lease payments receivable – short term | 42,234 | 86,377 |
Prepaid expenses | 3,483,744 | 11,301,535 |
Other current assets | 256,192 | |
Total current assets | 215,737,247 | 223,297,518 |
Other assets | 35,238 | 28,293 |
Total assets | 215,772,485 | 223,325,811 |
Commitments and Contingencies (See Note 7) | ||
Current liabilities: | ||
Accounts payable | 7,539,686 | 11,192,502 |
Accrued expenses | 11,381,468 | 3,868,423 |
Total current liabilities | 18,921,154 | 15,060,925 |
Stockholders’ Equity: | ||
Preferred stock, $0.001 par value, 200,000,000 shares authorized, none issued and outstanding | ||
Class A convertible preferred stock, $0.001 par value, 3,500,000 shares authorized, none issued and outstanding | ||
Common stock, $0.001 par value, 150,000,000 shares authorized, 30,024,594 and 27,740,147 shares issued and outstanding, respectively | 30,025 | 27,740 |
Additional paid-in capital | 581,569,169 | 513,304,258 |
Accumulated deficit | (384,747,863) | (305,067,112) |
Total stockholders’ equity | 196,851,331 | 208,264,886 |
Total liabilities and stockholders’ equity | $ 215,772,485 | $ 223,325,811 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Preferred stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 200,000,000 | 200,000,000 |
Preferred stock, shares issued | ||
Preferred stock, shares outstanding | ||
Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 30,024,594 | 27,740,147 |
Common stock, shares outstanding | 30,024,594 | 27,740,147 |
Class A Convertible Preferred Stock | ||
Preferred stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 3,500,000 | 3,500,000 |
Preferred stock, shares issued | ||
Preferred stock, shares outstanding |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 30,912,671 | $ 17,331,507 | $ 55,925,524 | $ 31,353,734 |
General and administrative | 14,599,401 | 9,130,373 | 27,883,971 | 17,513,349 |
Total operating expenses | 45,512,072 | 26,461,880 | 83,809,495 | 48,867,083 |
Loss from operations | (45,512,072) | (26,461,880) | (83,809,495) | (48,867,083) |
Other (expenses) income: | ||||
Gain on settlement of fees | 6,351,606 | 6,351,606 | ||
Interest/investment income, net | 387,333 | 322,807 | 717,282 | 742,781 |
Realized (loss) gain on short-term investments | 24,502 | (123,590) | 9,480 | (176,379) |
Unrealized loss on short-term investments | (1,186,337) | (289,281) | (2,949,624) | (466,444) |
Total other (expenses) income | 5,577,104 | (90,064) | 4,128,744 | 99,958 |
Net loss | $ (39,934,968) | $ (26,551,944) | $ (79,680,751) | $ (48,767,125) |
Loss per common share – basic and diluted (in Dollars per share) | $ (1.33) | $ (1.56) | $ (2.73) | $ (2.9) |
Weighted average number of common shares outstanding – basic and diluted (in Shares) | 29,935,895 | 17,054,646 | 29,168,511 | 16,814,991 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parentheticals) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement [Abstract] | ||||
Loss per common share – basic and diluted | $ (1.33) | $ (1.56) | $ (2.73) | $ (2.90) |
Weighted average number of common shares outstanding – basic and diluted | 29,935,895 | 17,054,646 | 29,168,511 | 16,814,991 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders’ Equity - USD ($) | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2020 | $ 16,333 | $ 284,881,716 | $ (179,315,303) | $ 105,582,746 |
Balance (in Shares) at Dec. 31, 2020 | 16,332,939 | |||
Stock based compensation | 5,851,284 | 5,851,284 | ||
Warrant exercised for cash | $ 273 | 1,460,233 | 1,460,506 | |
Warrant exercised for cash (in Shares) | 273,491 | |||
Options exercised for cash | $ 142 | 467,631 | 467,773 | |
Options exercised for cash (in Shares) | 141,625 | |||
Net loss | (22,215,181) | (22,215,181) | ||
Balance at Mar. 31, 2021 | $ 16,748 | 292,660,864 | (201,530,484) | 91,147,128 |
Balance (in Shares) at Mar. 31, 2021 | 16,748,055 | |||
Balance at Dec. 31, 2020 | $ 16,333 | 284,881,716 | (179,315,303) | 105,582,746 |
Balance (in Shares) at Dec. 31, 2020 | 16,332,939 | |||
Net loss | (48,767,125) | |||
Balance at Jun. 30, 2021 | $ 17,469 | 324,917,516 | (228,082,428) | 96,852,557 |
Balance (in Shares) at Jun. 30, 2021 | 17,468,819 | |||
Balance at Mar. 31, 2021 | $ 16,748 | 292,660,864 | (201,530,484) | 91,147,128 |
Balance (in Shares) at Mar. 31, 2021 | 16,748,055 | |||
Stock based compensation | 8,268,376 | 8,268,376 | ||
ATM offering, net | $ 652 | 23,457,398 | 23,458,050 | |
ATM offering, net (in Shares) | 651,674 | |||
Warrant exercised for cash | $ 62 | 481,387 | 481,449 | |
Warrant exercised for cash (in Shares) | 62,059 | |||
Options exercised for cash | $ 7 | 49,491 | 49,498 | |
Options exercised for cash (in Shares) | 7,031 | |||
Net loss | (26,551,944) | (26,551,944) | ||
Balance at Jun. 30, 2021 | $ 17,469 | 324,917,516 | (228,082,428) | 96,852,557 |
Balance (in Shares) at Jun. 30, 2021 | 17,468,819 | |||
Balance at Mar. 31, 2021 | $ 16,748 | 292,660,864 | (201,530,484) | 91,147,128 |
Balance (in Shares) at Mar. 31, 2021 | 16,748,055 | |||
Stock based compensation | 12,295,016 | 12,295,016 | ||
Warrant exercised for cash | $ 91 | 595,259 | 595,350 | |
Warrant exercised for cash (in Shares) | 91,058 | |||
Balance at Jun. 30, 2022 | $ 30,025 | 581,569,169 | (384,747,863) | 196,851,331 |
Balance (in Shares) at Jun. 30, 2022 | 30,024,594 | |||
Balance at Dec. 31, 2021 | $ 27,740 | 513,304,258 | (305,067,112) | 208,264,886 |
Balance (in Shares) at Dec. 31, 2021 | 27,740,147 | |||
Stock based compensation | 11,930,681 | 11,930,681 | ||
ATM offering, net | $ 1,610 | 29,581,932 | 29,583,542 | |
ATM offering, net (in Shares) | 1,609,343 | |||
Warrant exercised for cash | $ 33 | 299,973 | 300,006 | |
Warrant exercised for cash (in Shares) | 33,334 | |||
Options exercised for cash | $ 20 | 64,780 | 64,800 | |
Options exercised for cash (in Shares) | 20,000 | |||
Net loss | (39,745,783) | (39,745,783) | ||
Balance at Mar. 31, 2022 | $ 29,403 | 555,181,624 | (344,812,895) | 210,398,132 |
Balance (in Shares) at Mar. 31, 2022 | 29,402,824 | |||
Balance at Dec. 31, 2021 | $ 27,740 | 513,304,258 | (305,067,112) | 208,264,886 |
Balance (in Shares) at Dec. 31, 2021 | 27,740,147 | |||
Net loss | (79,680,751) | |||
Balance at Jun. 30, 2022 | $ 30,025 | 581,569,169 | (384,747,863) | 196,851,331 |
Balance (in Shares) at Jun. 30, 2022 | 30,024,594 | |||
Balance at Mar. 31, 2022 | $ 29,403 | 555,181,624 | (344,812,895) | 210,398,132 |
Balance (in Shares) at Mar. 31, 2022 | 29,402,824 | |||
ATM offering, net | $ 485 | 13,144,572 | 13,145,057 | |
ATM offering, net (in Shares) | 484,900 | |||
Cashless option exercised | $ 46 | 352,698 | 352,744 | |
Cashless option exercised (in Shares) | 45,812 | |||
Net loss | (39,934,968) | (39,934,968) | ||
Balance at Jun. 30, 2022 | $ 30,025 | $ 581,569,169 | $ (384,747,863) | $ 196,851,331 |
Balance (in Shares) at Jun. 30, 2022 | 30,024,594 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (79,680,751) | $ (48,767,125) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 1,258 | |
Stock-based compensation | 24,225,697 | 14,119,660 |
Gain on settlement of fees | (6,351,606) | |
Realized loss (gain) on short-term investments | (9,480) | 176,379 |
Unrealized loss on short-term investments | 2,949,624 | 466,444 |
Change in operating assets and liabilities: | ||
Lease payment receivable | 44,143 | 38,899 |
Other current assets | (256,192) | |
Prepaid expenses and other assets | 7,810,846 | (645,690) |
Accounts payable | 2,698,790 | 2,109,447 |
Accrued expenses | 7,513,045 | (796,162) |
Net cash used in operating activities | (41,055,884) | (33,296,890) |
Cash flows from investing activities | ||
Purchase of short-term investments | (33,412,425) | (56,872,459) |
Sale of short-term investments | 23,244,237 | 66,426,021 |
Net cash (used in) provided by investing activities | (10,168,188) | 9,553,562 |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net | 42,728,599 | 23,458,050 |
Proceeds from options exercised for common stock | 417,544 | 517,271 |
Proceeds from warrants exercised for common stock | 895,356 | 1,941,955 |
Net cash provided by financing activities | 44,041,499 | 25,917,276 |
Net (decrease)/increase in cash and cash equivalents | (7,182,573) | 2,173,948 |
Cash and cash equivalents at beginning of the period | 44,443,439 | 2,495,397 |
Cash and cash equivalents at end of the period | 37,260,866 | 4,669,345 |
Cash paid during the period for: | ||
Interest | ||
Income Tax |
Business
Business | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
BUSINESS | NOTE 1 - BUSINESS Relmada Therapeutics, Inc. (Relmada or the Company) (a Nevada corporation), is a clinical-stage, publicly traded biotechnology company focused on the development of esmethadone (d-methadone, dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist. Esmethadone is a New Chemical Entity (NCE) that potentially addresses areas of high unmet medical need in the treatment of central nervous system (CNS) diseases and other disorders. In addition to the normal risks associated with a new business venture, there can be no assurance that the Company’s research and development will be successfully completed or that any product will be approved or commercially viable. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, and compliance with the Food and Drug Administration (FDA) and other governmental regulations and approval requirements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying unaudited condensed consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim unaudited condensed consolidated financial information. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete consolidated financial statements. The unaudited condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) which are, in the opinion of management, necessary for a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements of the Company for the year ended December 31, 2021 and notes thereto contained in the Company’s Annual Report on Form 10-K. Liquidity As shown in the accompanying unaudited condensed consolidated financial statements, the Company incurred negative operating cash flows of $41,055,884 for the six months ended June 30, 2022 and has an accumulated deficit of $384,747,863 from inception through June 30, 2022. Relmada has funded its past operations through equity raises and most recently in the six months ended June 30, 2022, the Company raised net proceeds of $42,728,599 from the sale of common stock through our at-the-market (ATM) equity offering, $417,544 through the exercise of options and $895,356 through the exercise of warrants. On April 8, 2022, we raised net proceeds of $13,145,057 from the sale of common stock through our ATM equity offering. On April 6, 2022, we entered into a new Open Market Sale Agreement with Jefferies, as sales agent, pursuant to which we may offer and sell, from time to time, through Jefferies, shares of our common stock, having an aggregate offering price of up to $100,000,000. We are not obligated to sell any shares under the agreement. Management believes that the Company’s existing cash and cash equivalents will enable it to fund operating expenses and capital expenditure requirements for at least 12 months from the issuance of these unaudited condensed consolidated quarterly financial statements. Beyond that point management will evaluate the size and scope of any subsequent trials that will affect the timing of additional financings through public or private sales of equity or debt securities or from bank or other loans or through strategic collaboration and/or licensing agreements. Any such expenditures related to any subsequent clinical trials will not be incurred until such additional financing is raised. Further, additional financing related to subsequent clinical trials does not affect the Company’s conclusion that based on the cash on hand and the budgeted cash flow requirements, the Company has sufficient funds to maintain operations for at least 12 months from the issuance of these unaudited condensed consolidated financial statements. Principles of Consolidation The unaudited condensed consolidated financial statements include the Company’s accounts and those of the Company’s wholly-owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. Risks and Uncertainties The ongoing pandemic may adversely affect our business. Based on the Company’s current assessment, the Company does not expect any material impact on its long-term development timeline and its liquidity due to the worldwide spread of the coronavirus (COVID-19). However, the Company is actively monitoring this situation and the possible effects on its financial condition, liquidity, operations, suppliers, industry, and workforce. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Actual results could differ from those estimates. The significant estimates are stock-based compensation expenses and recorded amounts related to income taxes. Cash and Cash Equivalents The Company considers cash deposits and all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. The Company’s cash deposits are held at two high-credit-quality financial institutions. The Company’s cash balance of $37,260,866 at June 30, 2022 at these institutions exceed the federally insured limits. Short-term Investments The Company’s investments consist entirely of mutual funds. The securities are measured at fair value based on the net asset value (NAV). Substantially all equity investments are nonconsolidated entities to be measured at fair value with recurring changes recognized in earnings, except for those accounted for using equity method accounting. Changes in fair value of the securities are recorded as part of other income on the unaudited condensed consolidated statement of operations. Short term investment activity is presented in the investing activities section on the unaudited condensed consolidated statement of cash flows. Short-term investments at June 30, 2022 consisted of mutual funds with a fair value of $174,694,211. Patents Costs related to filing and pursuing patent applications are recorded as general and administrative expense and expensed as incurred since recoverability of such expenditures is uncertain. Leases The Company recognizes its leases with a term of greater than a year on the balance sheet by recording right-of-use assets and lease liabilities. Leases can be classified as either operating leases or finance leases. Operating leases will result in straight-line lease expense, while finance leases will result in front-loaded expense. The Company’s lease consists of an operating lease for office space. The Company does not recognize a lease liability or right-of-use asset on the balance sheet for short-term leases. Instead, the Company recognizes short-term lease payments as an expense on a straight-line basis over the lease term. A short-term lease is defined as a lease that, at the commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. Other Current Assets The Company recognizes other current assets as a transaction that will be converted into cash within a year on the balance sheet. The Company’s other current assets consist entirely of unsettled funds from an option exercise on June 30, 2022. Fair Value of Financial Instruments The Company’s financial instruments primarily include cash, short term investments, and accounts payable. Due to the short-term nature of cash and accounts payable the carrying amounts of these assets and liabilities approximate their fair value. Fair value is defined as the price that would be received to sell an asset, or paid to transfer a liability (an exit price), in an orderly transaction between market participants at the reporting date. A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. The fair value hierarchy is as follows: Level 1 Inputs – Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 Inputs – Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. These might include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (such as interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market data by correlation or other means. Level 3 Inputs – Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (supported by little or no market activity). As required by Accounting Standard Codification (ASC) Topic No. 820 – 10 Fair Value Measurement The Company’s short-term investment instruments of $174,694,211 at June 30, 2022 consist of mutual funds, bank deposits and money market funds and are classified using Level 1 inputs within the fair value hierarchy because the value is based on quoted prices in active markets. Unrealized gains and losses are recorded in the condensed consolidated statement of operations under other income. The Company recorded unrealized loss of $1,186,337 and $2,949,624 included in other income for the three and six months ended June 30, 2022, respectively. The Company recorded unrealized losses of $289,281 and $466,444 included in other income for the three and six months ended June 30, 2021, respectively. Income Taxes The Company accounts for income taxes using the asset and liability method. Accordingly, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in the tax rate is recognized in income or expense in the period that the change is effective. Tax benefits are recognized when it is probable that the deduction will be sustained. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will either expire before the Company is able to realize the benefit, or that future deductibility is uncertain. As of June 30, 2022 and December 31, 2021, the Company had recognized a valuation allowance to the full extent of the Company’s net deferred tax assets since the likelihood of realization of the benefit does not meet the more likely than not threshold. The Company files a U.S. Federal income tax return and various state returns. Uncertain tax positions taken on the Company’s tax returns will be accounted for as liabilities for unrecognized tax benefits. The Company will recognize interest and penalties, if any, related to unrecognized tax benefits in general and administrative expenses in the statements of operations. There were no liabilities recorded for uncertain tax positions at June 30, 2022 and December 31, 2021. The open tax years, subject to potential examination by the applicable taxing authority, for the Company are from June 30, 2018 forward. Research and Development Research and development costs primarily consist of research contracts for the advancement of product development, salaries and benefits, stock-based compensation, and consultants. The Company expenses all research and development costs in the period incurred. The Company makes an estimate of costs in relation to clinical study contracts. The Company analyzes the progress of studies, including the progress of clinical studies and phases, invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. Stock-Based Compensation The Company measures the cost of employee and non-employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period during which an employee is required to provide service in exchange for the award - the requisite service period. The grant-date fair value of employee share options is estimated using the Black-Scholes option pricing model adjusted for the unique characteristics of those instruments. Net Loss per Common Share Basic loss per common share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted loss per common share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of options and warrants to purchase common stock. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss in each period. For the six months ended June 30, 2022 and 2021, the potentially dilutive securities that would be anti-dilutive due to the Company’s net loss are not included in the calculation of diluted net loss per share attributable to common stockholders. The anti-dilutive securities are as follows (in common stock equivalent shares): Six months ended June 30, June 30, Stock options 10,427,310 5,158,956 Common stock warrants 3,084,385 2,755,083 Total 13,511,695 7,914,039 Recent Accounting Pronouncements In November 2021, the FASB issued ASU 2021-10, “ Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance In October 2021, the FASB issued ASU 2021-08, “ Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) Subsequent Events The Company’s management reviewed all material events through the date the financial statements were issued for subsequent event disclosure consideration. |
Prepaid Expenses
Prepaid Expenses | 6 Months Ended |
Jun. 30, 2022 | |
Prepaid Expenses [Abstract] | |
PREPAID EXPENSES | NOTE 3 - PREPAID EXPENSES Prepaid expenses consisted of the following (rounded to nearest $00): June 30, December 31, Insurance $ 643,300 $ 353,300 Research and Development 2,624,600 10,708,800 Legal 11,000 11,000 Other 204,800 228,400 Total $ 3,483,700 $ 11,301,500 |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | NOTE 4 - ACCRUED EXPENSES Accrued expenses consisted of the following (rounded to nearest $00): June 30, December 31, Research and development $ 9,799,100 $ 1,928,000 Professional fees 111,800 168,000 Accrued bonus 780,400 1,191,000 Accrued vacation 572,000 450,400 Other 118,200 131,000 Total $ 11,381,500 $ 3,868,400 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS' EQUITY | NOTE 5 - STOCKHOLDERS’ EQUITY Common Stock During the six months ended June 30, 2022, the Company issued 124,392 shares of common stock, for cash exercises of warrants for proceeds of $895,356. During the six months ended June 30, 2022, the Company issued 65,812 shares of common stock for cash exercises of options for proceeds of $417,544. On May 15, 2020, the Company entered into an Open Market Sale Agreement with Jefferies LLC, as sales agent (“Jefferies”), pursuant to which the Company 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 was not obligated to sell any shares under the agreement. During the six months ended June 30, 2022, the Company issued 2,094,243 shares of common stock for net cash proceeds of $42,728,599 under the agreement. Options and Warrants In December 2014, the Board of Directors adopted and Company’s shareholders approved Relmada’s 2014 Stock Option and Equity Incentive Plan, as amended (the “Plan”), which allows for the granting of 5,152,942 common stock awards, stock appreciation rights, and incentive and nonqualified stock options to purchase shares of the Company’s common stock to designated employees, non-employee directors, and consultants and advisors. In May 2021, the Company’s Board of Directors adopted and shareholders approved Relmada’s 2021 Equity Incentive Plan which allows for the granting of 1,500,000 options or stock awards. In May 2022, the Company’s Board of Directors adopted and Shareholders approved an amendment to the 2021 Equity Incentive Plan to increase the shares of the Company’s common stock available for issuance thereunder by 3,900,000 shares. Stock options are exercisable generally for a period of 10 years from the date of grant and generally vest over four years. As of June 30, 2022, there were 125,632 shares available for future grants under the combined Equity Incentive Plans. As of June 30, 2022, no stock appreciation rights have been issued. The Company utilizes the Black-Scholes option pricing model to estimate the fair value of stock options and warrants. The risk-free interest rate assumptions were based upon the observed interest rates appropriate for the expected term of the equity instruments. The expected dividend yield was assumed to be zero as the Company has not paid any dividends since its inception and does not anticipate paying dividends in the foreseeable future. The expected volatility was based on historical volatility. The Company routinely reviews its calculation of volatility changes in future volatility, the Company’s life cycle, its peer group, and other factors. The Company uses the simplified method for share-based compensation to estimate the expected term for equity awards for share-based compensation in its option-pricing model. On January 1, 2022, 50,000 options were issued to a consultant with an exercise price of $22.53 and a 10-year term, vesting over a 1-year period. The options granted include performance vesting based on the Company’s achievement of performance metrics. The options have an aggregate fair value of $847,583, calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 1.53% (2) expected life of 5.5 years, (3) expected volatility of 96%, and (4) zero expected dividends. From January 1, 2022 through March 14, 2022, 110,000 options were issued to various consultants with an exercise price ranging from $18.00 to $21.46 and a 10-year term, vesting over a 4-year period. The options granted include time-based vesting grants. The options have an aggregate fair value of approximately $1.6 million, calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 1.53 – 2.00% (2) expected life of 6.25 years, (3) expected volatility of 98%, and (4) zero expected dividends. On March 28, 2022, the Company awarded a total of 15,000 options to an employee with an exercise price of $25.76 and a 10-year term vesting over a 4-year period. The options granted include time-based vesting grants. The options have an aggregate fair value of $307,845 calculated using the Black Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 2.55% (2) expected life of 6.25 years, (3) expected volatility of 98%, and (4) zero expected dividends. From April 25, 2022 through May 5, 2022, 260,000 options were issued to various consultants with an exercise price ranging from $22.40 to $25.52 and a 10-year term, vesting over a 4-year period. The options granted include time-based vesting grants. The options have an aggregate fair value of approximately $4.6 million, calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 2.85 – 3.04% (2) expected life of 6.25 years, (3) expected volatility of 95%, and (4) zero expected dividends. At June 30, 2022, the Company has unrecognized stock-based compensation expense of approximately $122.7 million related to unvested stock options over the weighted average remaining service period of 2.51 years. Options A summary of the changes in options during the six months ended June 30, 2022 is as follows: Number of Weighted Weighted Aggregate Outstanding and expected to vest at December 31, 2021 10,330,622 $ 22.52 9.00 $ 46,088,534 Granted 435,000 $ 21.65 9.75 $ - Exercised (65,812 ) $ 6.34 - $ - Forfeited (272,500 ) $ 29.30 - $ - Outstanding and expected to vest at June 30, 2022 10,427,310 $ 22.41 8.60 $ 19,951,999 Options exercisable at June 30, 2022 3,252,058 $ 21.43 7.30 $ 18,294,480 Warrants A summary of the changes in outstanding warrants during the six months ended June 30, 2022 is as follows: Number of Weighted Outstanding and vested at December 31, 2021 3,208,777 $ 16.45 Granted - $ - Exercised (124,392 ) $ 7.20 Outstanding at June 30, 2022 3,084,385 $ 16.82 Vested at June 30, 2022 2,763,948 $ 14.93 At June 30, 2022, the Company had approximately $7.7 million of unrecognized compensation expense related to outstanding warrants. At June 30, 2022, the aggregate intrinsic value of warrants vested and outstanding was approximately $22.9 million. Stock -based compensation by class of expense The following summarizes the components of stock-based compensation expense which includes stock options and warrants in the unaudited consolidated statements of operations for the six months ended June 30, 2022 and 2021 (rounded to nearest $00): Six Months Six Months Research and development $ 2,494,800 $ 2,506,700 General and administrative 21,730,900 11,613,000 Total $ 24,225,700 $ 14,119,700 |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2022 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 6 - RELATED PARTY TRANSACTIONS Effective March 6, 2020, Dr. Ottavio Vitolo, the Company’s Chief Medical Officer and Head of Research and Development, entered into a Separation and Severance Agreement with the Company. 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. Vitolo’s options granted under the Company’s 2014 Stock Option and Equity Incentive Plan continued to vest until September 6, 2020. Dr. Vitolo had until March 6, 2021 to exercise his vested options and he was allowed to use a cashless exercise provision to exercise his vested options. Dr. Vitolo exercised 126,562 options during 2020 and the remaining options expired on March 6, 2021. The agreement also contains customary confidentiality, release, and non-disparagement provisions, and the Company paid accrued and unpaid salary, vacation time and attorney’s fees totaling approximately $45,000. Effective December 31, 2020, Dr. Thomas Wessel, the Company’s Executive Vice President, Head of Research and Development, entered into a Separation and Severance Agreement with the Company. Pursuant to the terms of the agreement, the Company agreed to pay Dr. Wessel severance of $237,500 in accordance with his employment contract. In addition, Dr. Wessel’s options granted under the Company’s 2014 Stock Option and Equity Incentive Plan continue to vest until June 30, 2021. Dr. Wessel had until December 31, 2021 to exercise his vested options and he was allowed to use a cashless exercise provision to exercise his vested options. All of Dr. Wessel’s options expired on December 31, 2021. The agreement also contains customary confidentiality, release, and non-disparagement provisions, and the Company paid accrued vacation time totaling approximately $28,940. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 7 - COMMITMENTS AND CONTINGENCIES License Agreements Wonpung On August 20, 2007, the Company entered into a License Development and Commercialization Agreement with Wonpung Mulsan Co, a shareholder of the Company. Wonpung has exclusive territorial rights in countries it selects in Asia to market up to two drugs the Company was developing at the time of the signing of the agreement and a right of first refusal (“ROFR”) for up to an additional five drugs that the Company may develop in the future as defined in more detail in the license agreement. If the parties cannot agree to terms of a license agreement then the Company shall be able to engage in discussions with other potential licensors. As of June 30, 2022, no discussions are active between the Company and Wonpung. The 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 products it was developing at the time of the signing of the agreement. The licensing terms for the ROFR products are subject to future negotiations and binding arbitration. The terms of each licensing agreement will expire on the earlier of any time from 15 years to 20 years after licensing or on the date of commercial availability of a generic product to such licensed product in the licensed territory. Third Party Licensor Based upon a prior acquisition, the Company assumed an obligation to pay third parties (Dr. Charles E. Inturrisi and Dr. Paolo Manfredi – see below): (A) royalty payments up to 2% on net sales of licensed products that are not sold by sublicensee and (B) on each and every sublicense earned royalty payment received by licensee from its sublicensee on sales of license product by sublicensee, the higher of (i) 20% of the royalties received by licensee; or (ii) up to 2% of net sales of sublicensee. The Company will also make milestone payments of up to $4 or $2 million, for the first commercial sale of product in the field that has a single active pharmaceutical ingredient, and for the first commercial sale of product in the field of product that has more than one active pharmaceutical ingredient, respectively. As of June 30, 2022, the Company has not generated any revenue related to this license agreement. Inturrisi / Manfredi In January 2018, we entered into an Intellectual Property Assignment Agreement (the Assignment Agreement) and License Agreement (the License Agreement and together with the Assignment Agreement, the Agreements) with Dr. Charles E. Inturrisi and Dr. Paolo Manfredi (collectively, the Licensor). Pursuant to the Agreements, Relmada assigned its existing rights, including patents and patent applications, to esmethadone in the context of psychiatric use (the Existing Invention) to Licensor. Licensor then granted Relmada under the License Agreement a perpetual, worldwide, and exclusive license to commercialize the Existing Invention and certain further inventions regarding esmethadone, in the context of other indications such as those contemplated above. In consideration of the rights granted to Relmada under the License Agreement, Relmada paid the Licensor an upfront, non-refundable license fee of $180,000. Additionally, Relmada will pay Licensor $45,000 every three months until the earliest to occur of the following events: (i) the first commercial sale of a licensed product anywhere in the world, (ii) the expiration or invalidation of the last to expire or be invalidated of the patent rights anywhere in the world, or (iii) the termination of the License Agreement. Relmada will also pay Licensor tiered royalties with a maximum rate of 2%, decreasing to 1.75%, and 1.5% in certain circumstances, on net sales of licensed products covered under the License Agreement. Relmada will also pay Licensor tiered payments up to a maximum of 20%, and decreasing to 17.5%, and 15% in certain circumstances, of all consideration received by Relmada for sublicenses granted under the License Agreement. As of June 30, 2022, no events have occurred, and the Company continues to pay Licensor $45,000 every three months. Arbormentis, LLC On July 16, 2021, the Company entered into a License Agreement with Arbormentis, LLC, a privately held Delaware limited liability company, by which the Company acquired development and commercial rights to a novel psilocybin and derivate program from Arbormentis, LLC, worldwide excluding the countries of Asia. The Company will collaborate with Arbormentis, LLC on the development of new therapies targeting neurological and psychiatric disorders, leveraging its understanding of neuroplasticity, and focusing on this emerging new class of drugs targeting the neuroplastogen mechanism of action. Under the terms of the License Agreement, the Company paid Arbormentis, LLC an upfront fee of $12.7 million, consisting of a mix of cash and warrants to purchase the Company’s common stock, in addition to potential milestone payments totaling up to approximately $160 million related to pre-specified development and commercialization milestones. Arbormentis, LLC is also eligible to receive a low single digit royalty on net sales of any commercialized therapy resulting from this agreement. The license agreement is terminable by the Company but is perpetual and not terminable by the licensor absent material breach of its terms by the Company. The new licensed program stems from an international collaboration among U.S., European and Swiss scientists that has focused on the discovery and development of compounds that may promote neural plasticity. Dr. Paolo Manfredi, Relmada’s Acting Chief Scientific Officer and co-inventor of REL-1017, and Dr. Marco Pappagallo, Relmada’ s Acting Chief Medical Officer, are among the scientists affiliated with Arbormentis, LLC. Legal From time to time, the Company may become involved in lawsuits and other legal proceedings that arise in the course of business. Litigation is subject to inherent uncertainties, and it is not possible to predict the outcome of litigation with total confidence. The Company is currently not aware of any legal proceedings or potential claims against it whose outcome would be likely, individually or in the aggregate, to have a material adverse effect on the Company’s business, financial condition, operating results, or cash flows. Leases and Sublease On August 1, 2021, the Company relocated its corporate headquarters to 2222 Ponce de Leon, Floor 3, Coral Gables, FL 33134, pursuant to a lease agreement with monthly rent of approximately $11,000. The lease period was for five months. The lease agreement expired on December 31, 2021 and was renewed for the calendar year 2022 with monthly rent of approximately $9,000. The Company’s previous lease at 880 Third Avenue, 12 th Leases On June 8, 2017, the Company entered into an Amended and Restated License Agreement with Actinium Pharmaceuticals, Inc. Pursuant to the terms of the agreement, Actinium will continue to license the furniture, fixtures, equipment and tenant improvements located in its office (FFE) for a license fee of $7,529 per month until December 8, 2022. Actinium shall have at any time during the term of this agreement the right to purchase the FFE for $496,914, less any previously paid license fees. On July 7, 2022, Actinium exercised their right to purchase the FFE for $52,698. The license of FFE qualified as a sales-type lease. At inception, the Company derecognized the underlying assets of $493,452, recognized discounted lease payments receivable of $397,049 using the discount rate of 8.38% and recognized loss on sales-type lease of fixed assets of $96,403. For the six months ended June 30, 2022 and 2021, the Company recognized lease income of approximately $2,500 and $6,300, respectively. As of June 30, 2022, there was no unearned interest income as a result of the exercised right to purchase. |
Other Post-Retirement Benefit P
Other Post-Retirement Benefit Plan | 6 Months Ended |
Jun. 30, 2022 | |
Retirement Benefits [Abstract] | |
OTHER POST-RETIREMENT BENEFIT PLAN | NOTE 8 - OTHER POST-RETIREMENT BENEFIT PLAN Relmada participates in a multiemployer 401(k) plan that permits eligible employees to contribute funds on a pretax basis subject to maximum allowed under federal tax provisions. The Company matches 100% of the first 3% of employee contributions, plus 50% of employee contributions that exceed 3% but do not exceed 5%. The employees choose an amount from various investment options for both their contributions and the Company’s matching contribution. The Company’s contribution expense was approximately $62,800 and $78,800 for the six months ended June 30, 2022 and 2021, respectively. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 9 - SUBSEQUENT EVENTS On July 1, 2022, 150,000 options were granted to a consultant with an exercise price of $18.30. Subsequent to June 30, 2022, 17,886 outstanding options were exercised for total cash proceeds of $286,176. Subsequent to June 30, 2022, 18,038 outstanding warrants were exercised for total cash proceeds of $129,478. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim unaudited condensed consolidated financial information. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete consolidated financial statements. The unaudited condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) which are, in the opinion of management, necessary for a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements of the Company for the year ended December 31, 2021 and notes thereto contained in the Company’s Annual Report on Form 10-K. |
Liquidity | Liquidity As shown in the accompanying unaudited condensed consolidated financial statements, the Company incurred negative operating cash flows of $41,055,884 for the six months ended June 30, 2022 and has an accumulated deficit of $384,747,863 from inception through June 30, 2022. Relmada has funded its past operations through equity raises and most recently in the six months ended June 30, 2022, the Company raised net proceeds of $42,728,599 from the sale of common stock through our at-the-market (ATM) equity offering, $417,544 through the exercise of options and $895,356 through the exercise of warrants. On April 8, 2022, we raised net proceeds of $13,145,057 from the sale of common stock through our ATM equity offering. On April 6, 2022, we entered into a new Open Market Sale Agreement with Jefferies, as sales agent, pursuant to which we may offer and sell, from time to time, through Jefferies, shares of our common stock, having an aggregate offering price of up to $100,000,000. We are not obligated to sell any shares under the agreement. Management believes that the Company’s existing cash and cash equivalents will enable it to fund operating expenses and capital expenditure requirements for at least 12 months from the issuance of these unaudited condensed consolidated quarterly financial statements. Beyond that point management will evaluate the size and scope of any subsequent trials that will affect the timing of additional financings through public or private sales of equity or debt securities or from bank or other loans or through strategic collaboration and/or licensing agreements. Any such expenditures related to any subsequent clinical trials will not be incurred until such additional financing is raised. Further, additional financing related to subsequent clinical trials does not affect the Company’s conclusion that based on the cash on hand and the budgeted cash flow requirements, the Company has sufficient funds to maintain operations for at least 12 months from the issuance of these unaudited condensed consolidated financial statements. |
Principles of Consolidation | Principles of Consolidation The unaudited condensed consolidated financial statements include the Company’s accounts and those of the Company’s wholly-owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. |
Risks and Uncertainties | Risks and Uncertainties The ongoing pandemic may adversely affect our business. Based on the Company’s current assessment, the Company does not expect any material impact on its long-term development timeline and its liquidity due to the worldwide spread of the coronavirus (COVID-19). However, the Company is actively monitoring this situation and the possible effects on its financial condition, liquidity, operations, suppliers, industry, and workforce. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Actual results could differ from those estimates. The significant estimates are stock-based compensation expenses and recorded amounts related to income taxes. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers cash deposits and all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. The Company’s cash deposits are held at two high-credit-quality financial institutions. The Company’s cash balance of $37,260,866 at June 30, 2022 at these institutions exceed the federally insured limits. |
Short-term Investments | Short-term Investments The Company’s investments consist entirely of mutual funds. The securities are measured at fair value based on the net asset value (NAV). Substantially all equity investments are nonconsolidated entities to be measured at fair value with recurring changes recognized in earnings, except for those accounted for using equity method accounting. Changes in fair value of the securities are recorded as part of other income on the unaudited condensed consolidated statement of operations. Short term investment activity is presented in the investing activities section on the unaudited condensed consolidated statement of cash flows. Short-term investments at June 30, 2022 consisted of mutual funds with a fair value of $174,694,211. |
Patents | Patents Costs related to filing and pursuing patent applications are recorded as general and administrative expense and expensed as incurred since recoverability of such expenditures is uncertain. |
Leases | Leases The Company recognizes its leases with a term of greater than a year on the balance sheet by recording right-of-use assets and lease liabilities. Leases can be classified as either operating leases or finance leases. Operating leases will result in straight-line lease expense, while finance leases will result in front-loaded expense. The Company’s lease consists of an operating lease for office space. The Company does not recognize a lease liability or right-of-use asset on the balance sheet for short-term leases. Instead, the Company recognizes short-term lease payments as an expense on a straight-line basis over the lease term. A short-term lease is defined as a lease that, at the commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. |
Other Current Assets | Other Current Assets The Company recognizes other current assets as a transaction that will be converted into cash within a year on the balance sheet. The Company’s other current assets consist entirely of unsettled funds from an option exercise on June 30, 2022. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s financial instruments primarily include cash, short term investments, and accounts payable. Due to the short-term nature of cash and accounts payable the carrying amounts of these assets and liabilities approximate their fair value. Fair value is defined as the price that would be received to sell an asset, or paid to transfer a liability (an exit price), in an orderly transaction between market participants at the reporting date. A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. The fair value hierarchy is as follows: Level 1 Inputs – Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 Inputs – Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. These might include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (such as interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market data by correlation or other means. Level 3 Inputs – Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (supported by little or no market activity). As required by Accounting Standard Codification (ASC) Topic No. 820 – 10 Fair Value Measurement The Company’s short-term investment instruments of $174,694,211 at June 30, 2022 consist of mutual funds, bank deposits and money market funds and are classified using Level 1 inputs within the fair value hierarchy because the value is based on quoted prices in active markets. Unrealized gains and losses are recorded in the condensed consolidated statement of operations under other income. The Company recorded unrealized loss of $1,186,337 and $2,949,624 included in other income for the three and six months ended June 30, 2022, respectively. The Company recorded unrealized losses of $289,281 and $466,444 included in other income for the three and six months ended June 30, 2021, respectively. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method. Accordingly, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in the tax rate is recognized in income or expense in the period that the change is effective. Tax benefits are recognized when it is probable that the deduction will be sustained. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will either expire before the Company is able to realize the benefit, or that future deductibility is uncertain. As of June 30, 2022 and December 31, 2021, the Company had recognized a valuation allowance to the full extent of the Company’s net deferred tax assets since the likelihood of realization of the benefit does not meet the more likely than not threshold. The Company files a U.S. Federal income tax return and various state returns. Uncertain tax positions taken on the Company’s tax returns will be accounted for as liabilities for unrecognized tax benefits. The Company will recognize interest and penalties, if any, related to unrecognized tax benefits in general and administrative expenses in the statements of operations. There were no liabilities recorded for uncertain tax positions at June 30, 2022 and December 31, 2021. The open tax years, subject to potential examination by the applicable taxing authority, for the Company are from June 30, 2018 forward. |
Research and Development | Research and Development Research and development costs primarily consist of research contracts for the advancement of product development, salaries and benefits, stock-based compensation, and consultants. The Company expenses all research and development costs in the period incurred. The Company makes an estimate of costs in relation to clinical study contracts. The Company analyzes the progress of studies, including the progress of clinical studies and phases, invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. |
Stock-Based Compensation | Stock-Based Compensation The Company measures the cost of employee and non-employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period during which an employee is required to provide service in exchange for the award - the requisite service period. The grant-date fair value of employee share options is estimated using the Black-Scholes option pricing model adjusted for the unique characteristics of those instruments. |
Net Loss per Common Share | Net Loss per Common Share Basic loss per common share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted loss per common share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of options and warrants to purchase common stock. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss in each period. For the six months ended June 30, 2022 and 2021, the potentially dilutive securities that would be anti-dilutive due to the Company’s net loss are not included in the calculation of diluted net loss per share attributable to common stockholders. The anti-dilutive securities are as follows (in common stock equivalent shares): Six months ended June 30, June 30, Stock options 10,427,310 5,158,956 Common stock warrants 3,084,385 2,755,083 Total 13,511,695 7,914,039 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2021, the FASB issued ASU 2021-10, “ Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance In October 2021, the FASB issued ASU 2021-08, “ Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) |
Subsequent Events | Subsequent Events The Company’s management reviewed all material events through the date the financial statements were issued for subsequent event disclosure consideration. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Schedule of anti-dilutive securities | Six months ended June 30, June 30, Stock options 10,427,310 5,158,956 Common stock warrants 3,084,385 2,755,083 Total 13,511,695 7,914,039 |
Prepaid Expenses (Tables)
Prepaid Expenses (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Prepaid Expenses [Abstract] | |
Schedule of prepaid expenses | June 30, December 31, Insurance $ 643,300 $ 353,300 Research and Development 2,624,600 10,708,800 Legal 11,000 11,000 Other 204,800 228,400 Total $ 3,483,700 $ 11,301,500 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | June 30, December 31, Research and development $ 9,799,100 $ 1,928,000 Professional fees 111,800 168,000 Accrued bonus 780,400 1,191,000 Accrued vacation 572,000 450,400 Other 118,200 131,000 Total $ 11,381,500 $ 3,868,400 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Schedule of summary changes in outstanding warrants | Number of Weighted Weighted Aggregate Outstanding and expected to vest at December 31, 2021 10,330,622 $ 22.52 9.00 $ 46,088,534 Granted 435,000 $ 21.65 9.75 $ - Exercised (65,812 ) $ 6.34 - $ - Forfeited (272,500 ) $ 29.30 - $ - Outstanding and expected to vest at June 30, 2022 10,427,310 $ 22.41 8.60 $ 19,951,999 Options exercisable at June 30, 2022 3,252,058 $ 21.43 7.30 $ 18,294,480 |
Schedule of the changes in outstanding warrants | Number of Weighted Outstanding and vested at December 31, 2021 3,208,777 $ 16.45 Granted - $ - Exercised (124,392 ) $ 7.20 Outstanding at June 30, 2022 3,084,385 $ 16.82 Vested at June 30, 2022 2,763,948 $ 14.93 |
Schedule of stock-based compensation expense | Six Months Six Months Research and development $ 2,494,800 $ 2,506,700 General and administrative 21,730,900 11,613,000 Total $ 24,225,700 $ 14,119,700 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Aug. 08, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Accumulated deficit | $ (41,055,884) | $ (41,055,884) | |||
Net proceeds from sale of stock | $ 13,145,057 | 42,728,599 | |||
Exercise of warrants | 895,356 | ||||
Aggregate offering price | $ 100,000,000 | ||||
Cash | 37,260,866 | 37,260,866 | |||
Short-term investments fair value | 174,694,211 | 174,694,211 | |||
Short-term investment instrument | 174,694,211 | 174,694,211 | |||
Unrealized loss on short-term investments | (1,186,337) | $ (289,281) | (2,949,624) | $ (466,444) | |
Common Stock [Member] | |||||
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Equity offering | 417,544 | 417,544 | |||
Liquidity [Member] | |||||
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Accumulated deficit | $ 384,747,863 | $ 384,747,863 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of anti-dilutive securities - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 13,511,695 | 7,914,039 |
Stock options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 10,427,310 | 5,158,956 |
Common stock warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 3,084,385 | 2,755,083 |
Prepaid Expenses (Details) - Sc
Prepaid Expenses (Details) - Schedule of prepaid expenses - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Schedule of prepaid expenses [Abstract] | ||
Insurance | $ 643,300 | $ 353,300 |
Research and Development | 2,624,600 | 10,708,800 |
Legal | 11,000 | 11,000 |
Other | 204,800 | 228,400 |
Total | $ 3,483,700 | $ 11,301,500 |
Accrued Expenses (Details) - Sc
Accrued Expenses (Details) - Schedule of accrued expenses - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Schedule of accrued expenses [Abstract] | ||
Research and development | $ 9,799,100 | $ 1,928,000 |
Professional fees | 111,800 | 168,000 |
Accrued bonus | 780,400 | 1,191,000 |
Accrued vacation | 572,000 | 450,400 |
Other | 118,200 | 131,000 |
Total | $ 11,381,500 | $ 3,868,400 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 1 Months Ended | 2 Months Ended | 6 Months Ended | ||||||
May 05, 2022 | Jan. 02, 2022 | May 15, 2020 | Mar. 28, 2022 | Mar. 14, 2022 | Jun. 30, 2022 | May 31, 2022 | May 31, 2021 | Dec. 31, 2014 | |
Stockholders' Equity (Details) [Line Items] | |||||||||
Shares of common stock (in Shares) | 2,094,243 | 124,392 | |||||||
Exercise of warrants (in Dollars) | $ 895,356 | ||||||||
Net cash proceeds (in Dollars) | $ 42,728,599 | ||||||||
Granting to option or stock awards (in Shares) | 1,500,000 | 5,152,942 | |||||||
Available shares to be issued (in Shares) | 3,900,000 | ||||||||
Stock options exercisable Period | 10 years | ||||||||
Vesting period | 4 years | ||||||||
Shares available (in Shares) | 125,632 | ||||||||
Term year | 2 years 6 months 3 days | ||||||||
Unrecognized stock-based compensation expense (in Dollars) | $ 122,700,000 | ||||||||
Unrecognized compensation expense related to outstanding warrants (in Dollars) | 7,700,000 | ||||||||
Aggregate intrinsic value of warrants vested and outstanding (in Dollars) | $ 22,900,000 | ||||||||
Common Stock [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Shares of common stock (in Shares) | 65,812 | ||||||||
Exercise of warrants (in Dollars) | $ 417,544 | ||||||||
Employee [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Total warrants shares (in Shares) | 15,000 | ||||||||
Exercise price per share (in Dollars per share) | $ 25.76 | ||||||||
Term year | 10 years | ||||||||
Vesting period | 4 years | ||||||||
Aggregate fair value of options (in Dollars) | $ 307,845 | ||||||||
Discount rate | 2.55% | ||||||||
Expected life term | 6 years 3 months | ||||||||
Expected volatility rate | 98% | ||||||||
Expected dividends rate | 0% | ||||||||
Consultants [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Total warrants shares (in Shares) | 260,000 | 50,000 | 110,000 | ||||||
Exercise price per share (in Dollars per share) | $ 22.53 | ||||||||
Term year | 10 years | 10 years | 10 years | ||||||
Vesting period | 4 years | 1 year | 4 years | ||||||
Aggregate fair value of options (in Dollars) | $ 4,600,000 | $ 847,583 | $ 1,600,000 | ||||||
Discount rate | 1.53% | 1.53% | |||||||
Expected life term | 6 years 3 months | 5 years 6 months | 6 years 3 months | ||||||
Expected volatility rate | 95% | 96% | 2% | ||||||
Expected dividends rate | 0% | 0% | 0% | ||||||
Expected volatility rate | 98% | ||||||||
Consultants [Member] | Minimum [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Exercise price per share (in Dollars per share) | $ 18 | ||||||||
Discount rate | 2.85% | ||||||||
Exercise price (in Dollars per share) | $ 22.4 | ||||||||
Consultants [Member] | Maximum [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Exercise price per share (in Dollars per share) | $ 21.46 | ||||||||
Discount rate | 3.04% | ||||||||
Exercise price (in Dollars per share) | $ 25.52 | ||||||||
Jefferies LLC [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Aggregate of offering price (in Dollars) | $ 75,000,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Schedule of changes in options outstanding - Options [Member] - USD ($) | 6 Months Ended | |
Dec. 31, 2021 | Jun. 30, 2022 | |
Stockholders' Equity (Details) - Schedule of changes in options outstanding [Line Items] | ||
Number of Options, Outstanding and expected to vest, Beginning balance | 10,330,622 | |
Weighted Average Exercise Price Per Share, Outstanding and expected to vest - Beginning balance | $ 22.52 | |
Weighted Average Remaining Contractual Term (Years), Beginning balance | 9 years | |
Aggregate Intrinsic Value, Outstanding and expected to vest - Beginning balance | $ 46,088,534 | |
Number of Options, Granted | 435,000 | |
Weighted Average Exercise Price Per Share, Granted | $ 21.65 | |
Weighted Average Remaining Contractual Term (Years), Granted | 9 years 9 months | |
Number of Options, Exercised | (65,812) | |
Weighted Average Exercise Price Per Share, Exercised | $ 6.34 | |
Weighted Average Remaining Contractual Term (Years), Exercised | ||
Aggregate Intrinsic Value, Outstanding and expected to vest, Exercised | ||
Number of Options, Forfeited | (272,500) | |
Weighted Average Exercise Price Per Share, Forfeited | $ 29.3 | |
Weighted Average Remaining Contractual Term (Years), Forfeited | ||
Aggregate Intrinsic Value, Outstanding and expected to vest, Forfeited | ||
Number of Options, Outstandin and expected to vest, Ending balance | 10,427,310 | |
Weighted Average Exercise Price Per Share, Outstandin and expected to vest, Ending balance | $ 22.41 | |
Weighted Average Remaining Contractual Term (Years), Ending balance | 8 years 7 months 6 days | |
Aggregate Intrinsic Value, Outstandin and expected to vest, Ending balance | $ 19,951,999 | |
Number of Options, Options exercisable | 3,252,058 | |
Weighted Average Exercise Price Per Share, Options exercisable | $ 21.43 | |
Weighted Average Remaining Contractual Term (Years), Options exercisable | 7 years 3 months 18 days | |
Aggregate Intrinsic Value, Options exercisable | $ 18,294,480 |
Stockholders' Equity (Details_2
Stockholders' Equity (Details) - Schedule of the changes in outstanding warrants - Warrants [Member] | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Stockholders' Equity (Details) - Schedule of the changes in outstanding warrants [Line Items] | |
Number of Shares, Outstanding and vested, Beginning balance | shares | 3,208,777 |
Weighted Average Exercise Price Per Share, Outstanding and vested, Beginning balance | $ / shares | $ 16.45 |
Number of Shares, Granted | shares | |
Weighted Average Exercise Price Per Share, Granted | $ / shares | |
Number of Shares, Exercised | shares | (124,392) |
Weighted Average Exercise Price Per Share, Exercised | $ / shares | $ 7.2 |
Number of Shares, Outstanding and vested, Ending balance | shares | 3,084,385 |
Weighted Average Exercise Price Per Share, Outstanding and vested, Ending balance | $ / shares | $ 16.82 |
Number of Shares, Warrants Vested | shares | 2,763,948 |
Weighted Average Exercise Price Per Share, Warrants Vested | $ / shares | $ 14.93 |
Stockholders' Equity (Details_3
Stockholders' Equity (Details) - Schedule of stock-based compensation expense - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 24,225,700 | $ 14,119,700 |
Research and development [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 2,494,800 | 2,506,700 |
General and administrative [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 21,730,900 | $ 11,613,000 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 1 Months Ended | 6 Months Ended | ||
Mar. 06, 2021 | Mar. 06, 2020 | Dec. 31, 2020 | Jun. 30, 2022 | |
Dr. Vitolo [Member] | ||||
Related Party Transactions (Details) [Line Items] | ||||
Severance fees | $ 200,000 | |||
Exercise price (in Shares) | 126,562 | |||
Attorneys fees | $ 45,000 | |||
Dr.Wessel [Member] | ||||
Related Party Transactions (Details) [Line Items] | ||||
Severance fees | $ 237,500 | |||
Paid accrued vacation | $ 28,940 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 6 Months Ended | ||||
Aug. 01, 2021 | Jul. 16, 2021 | Jun. 08, 2017 | Jun. 30, 2022 | Jun. 30, 2021 | |
Commitments and Contingencies (Details) [Line Items] | |||||
Pay licensor | $ 45,000 | ||||
License agreement, description | the Company paid Arbormentis, LLC an upfront fee of $12.7 million, consisting of a mix of cash and warrants to purchase the Company’s common stock, in addition to potential milestone payments totaling up to approximately $160 million related to pre-specified development and commercialization milestones. Arbormentis, LLC is also eligible to receive a low single digit royalty on net sales of any commercialized therapy resulting from this agreement. The license agreement is terminable by the Company but is perpetual and not terminable by the licensor absent material breach of its terms by the Company. | ||||
Rent amount | $ 11,000 | ||||
Lease period | 5 months | ||||
Lease agreement expiry date | Dec. 31, 2021 | ||||
Rent | $ 9,000 | ||||
Lease expense | 44,000 | $ 38,700 | |||
Lease income | $ 2,500 | $ 6,300 | |||
Licensing Agreements [Member] | |||||
Commitments and Contingencies (Details) [Line Items] | |||||
Description of rights granted to license agreement | In consideration of the rights granted to Relmada under the License Agreement, Relmada paid the Licensor an upfront, non-refundable license fee of $180,000. Additionally, Relmada will pay Licensor $45,000 every three months until the earliest to occur of the following events: (i) the first commercial sale of a licensed product anywhere in the world, (ii) the expiration or invalidation of the last to expire or be invalidated of the patent rights anywhere in the world, or (iii) the termination of the License Agreement. Relmada will also pay Licensor tiered royalties with a maximum rate of 2%, decreasing to 1.75%, and 1.5% in certain circumstances, on net sales of licensed products covered under the License Agreement. Relmada will also pay Licensor tiered payments up to a maximum of 20%, and decreasing to 17.5%, and 15% in certain circumstances, of all consideration received by Relmada for sublicenses granted under the License Agreement. | ||||
Licensing Agreements [Member] | Minimum [Member] | |||||
Commitments and Contingencies (Details) [Line Items] | |||||
Term of licensing agreement | 15 years | ||||
Licensing Agreements [Member] | Maximum [Member] | |||||
Commitments and Contingencies (Details) [Line Items] | |||||
Term of licensing agreement | 20 years | ||||
FFE [Member] | |||||
Commitments and Contingencies (Details) [Line Items] | |||||
Description of lease agreement | Actinium will continue to license the furniture, fixtures, equipment and tenant improvements located in its office (FFE) for a license fee of $7,529 per month until December 8, 2022. Actinium shall have at any time during the term of this agreement the right to purchase the FFE for $496,914, less any previously paid license fees. On July 7, 2022, Actinium exercised their right to purchase the FFE for $52,698. The license of FFE qualified as a sales-type lease. At inception, the Company derecognized the underlying assets of $493,452, recognized discounted lease payments receivable of $397,049 using the discount rate of 8.38% and recognized loss on sales-type lease of fixed assets of $96,403. | ||||
Wonpung [Member] | Licensing Agreements [Member] | |||||
Commitments and Contingencies (Details) [Line Items] | |||||
License agreement | $ 1,500,000 | ||||
Net sales rate | 12% | ||||
Wonpung [Member] | Business Combination [Member] | Licensing Agreements [Member] | |||||
Commitments and Contingencies (Details) [Line Items] | |||||
Business acquisition, description | (A) royalty payments up to 2% on net sales of licensed products that are not sold by sublicensee and (B) on each and every sublicense earned royalty payment received by licensee from its sublicensee on sales of license product by sublicensee, the higher of (i) 20% of the royalties received by licensee; or (ii) up to 2% of net sales of sublicensee. The Company will also make milestone payments of up to $4 or $2 million, for the first commercial sale of product in the field that has a single active pharmaceutical ingredient, and for the first commercial sale of product in the field of product that has more than one active pharmaceutical ingredient, respectively. As of June 30, 2022, the Company has not generated any revenue related to this license agreement. |
Other Post-Retirement Benefit_2
Other Post-Retirement Benefit Plan (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Retirement Benefits [Abstract] | ||
Employee contributions, description | The Company matches 100% of the first 3% of employee contributions, plus 50% of employee contributions that exceed 3% but do not exceed 5%. | |
Employee contribution expense | $ 62,800 | $ 78,800 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 6 Months Ended | |
Jul. 01, 2022 | Jun. 30, 2022 | |
Subsequent Events (Details) [Line Items] | ||
Granted options | 150,000 | |
Exercise price | $ 18.3 | |
Outstanding options | 17,886 | |
Cash proceeds | $ 286,176 | |
Warrant [Member] | ||
Subsequent Events (Details) [Line Items] | ||
Outstanding options | 18,038 | |
Cash proceeds | $ 129,478 |