COVER
COVER - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 24, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-37797 | ||
Entity Registrant Name | 9 METERS BIOPHARMA, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 27-3948465 | ||
Entity Address, Address Line One | 4509 Creedmoor Road | ||
Entity Address, Address Line Two | Suite 201 | ||
Entity Address, City or Town | Raleigh | ||
Entity Address, State or Province | NC | ||
Entity Address, Postal Zip Code | 27612 | ||
City Area Code | 919 | ||
Local Phone Number | 275-1933 | ||
Title of 12(b) Security | Common Stock $0.0001 Par Value | ||
Trading Symbol | NMTR | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 67.2 | ||
Entity Common Stock, Shares Outstanding (in shares) | 14,336,356 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE The information required by Part III of this Annual Report on Form 10-K, to the extent not set forth herein, is incorporated herein by reference from the registrant’s definitive proxy statement relating to the Annual Meeting of Stockholders to be held in 2023, which definitive proxy statement shall be filed with the Securities and Exchange Commission within 120 days after the end of the fiscal year to which this Annual Report on Form 10-K relates. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001551986 |
AUDIT INFORMATION
AUDIT INFORMATION | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Firm ID | 199 |
Auditor Name | Mayer Hoffman McCann P.C. |
Auditor Location | San Diego, California |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 | |
Current assets: | |||
Cash and cash equivalents | $ 12,646,282 | $ 46,993,285 | |
Prepaid expenses and other current assets | 3,358,917 | 2,991,948 | |
Restricted cash | 17,012,650 | 0 | |
Total current assets | 33,017,849 | 49,985,233 | |
Property and equipment, net | 10,413 | 16,094 | |
Right-of-use asset | 112,302 | 166,618 | |
Other assets | 7,280 | 5,580 | |
Total assets | 33,147,844 | 50,173,525 | |
Current liabilities: | |||
Accounts payable | 5,053,073 | 2,434,452 | |
Accrued expenses | 4,379,773 | 5,967,822 | |
Convertible note payable, net | 19,616,313 | 0 | |
Derivative liability | 1,585,000 | 0 | |
Lease liability, current portion | 61,746 | 54,796 | |
Total current liabilities | 30,695,905 | 8,457,070 | |
Lease liability, net of current portion | 51,396 | 113,142 | |
Total liabilities | 30,747,301 | 8,570,212 | |
Commitments and contingencies (Note 11) | |||
Stockholders’ equity: | |||
Preferred stock $0.0001 par value per share, 10,000,000 shares authorized as of December 31, 2022 and 2021; 0 shares issued and outstanding as of December 31, 2022 and 2021 | 0 | 0 | |
Common stock $0.0001 par value per share, 550,000,000 shares authorized as of December 31, 2022 and 2021, 13,036,356 and 12,911,776 shares issued and outstanding as of December 31, 2022 and 2021, respectively | 1,304 | 1,291 | |
Additional paid-in capital | [1] | 215,006,321 | 210,442,689 |
Accumulated deficit | (212,607,082) | (168,840,667) | |
Total stockholders’ equity | 2,400,543 | 41,603,313 | |
Total liabilities and stockholders’ equity | $ 33,147,844 | $ 50,173,525 | |
[1] 1 Amounts have been retroactively restated to reflect the 1-for-20 reverse stock split effected on October 17, 2022 (see Note 1) |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) | Dec. 31, 2022 $ / shares shares | Dec. 31, 2021 $ / shares shares |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 |
Preferred stock authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock issued (in shares) | 0 | 0 |
Preferred stock outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 |
Common stock authorized (in shares) | 550,000,000 | 550,000,000 |
Common stock issued (in shares) | 13,036,356 | 12,911,776 |
Common stock outstanding (in shares) | 13,036,356 | 12,911,776 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | ||
Operating expenses: | |||
Research and development | $ 31,008,151 | $ 21,995,291 | |
Acquired in-process research and development | 0 | 5,103,753 | |
General and administrative | 11,008,900 | 9,662,875 | |
Total operating expenses | 42,017,051 | 36,761,919 | |
Loss from operations | (42,017,051) | (36,761,919) | |
Other income (expense): | |||
Interest income | 501,228 | 22,707 | |
Interest expense | (2,667,289) | (47,188) | |
Loss on extinguishment of convertible note payable | (20,303) | 0 | |
Change in fair value of derivative liability | 437,000 | 7,000 | |
Total other income (expense), net | (1,749,364) | (17,481) | |
Loss before income taxes | (43,766,415) | (36,779,400) | |
Income tax benefit | 0 | 0 | |
Net loss | $ (43,766,415) | $ (36,779,400) | |
Net loss per common share, basic (in dollars per share) | [1] | $ (3.38) | $ (3.03) |
Net loss per common share, diluted (in dollars per share) | [1] | $ (3.38) | $ (3.03) |
Weighted-average common shares, basic (in shares) | [1] | 12,955,577 | 12,155,429 |
Weighted-average common shares, diluted (in shares) | [1] | 12,955,577 | 12,155,429 |
[1] 1 Amounts have been retroactively restated to reflect the 1-for-20 reverse stock-split effected on October 17, 2022 (see Note 1) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT) - USD ($) | Total | Common Stock | Additional Paid-in Capital | [1] | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2020 | 10,231,454 | ||||
Beginning balance at Dec. 31, 2020 | $ 32,142,113 | $ 1,023 | $ 164,202,357 | $ (132,061,267) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock (in shares) | 1,850,861 | ||||
Issuance of common stock | 37,218,588 | $ 185 | 37,218,403 | ||
Vesting of RSUs (in shares) | 10,185 | ||||
Vesting of RSUs | 0 | $ 1 | (1) | ||
Share-based compensation | 2,413,000 | 2,413,000 | |||
Stock issuance costs | (2,901,123) | (2,901,123) | |||
Exercise of warrants (in shares) | 777,344 | ||||
Exercise of warrants | 9,163,174 | $ 78 | 9,163,096 | ||
Exercise of stock options (in shares) | 41,932 | ||||
Exercise of stock options | 346,961 | $ 4 | 346,957 | ||
Net loss | $ (36,779,400) | (36,779,400) | |||
Ending balance (in shares) at Dec. 31, 2021 | 12,911,776 | 12,911,776 | |||
Ending balance at Dec. 31, 2021 | $ 41,603,313 | $ 1,291 | 210,442,689 | (168,840,667) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock (in shares) | 68,861 | ||||
Issuance of common stock | 500,000 | $ 7 | 499,993 | ||
Share-based compensation | 3,938,000 | 3,938,000 | |||
Settlement of convertible debt and accrued interest (in shares) | 55,719 | ||||
Settlement of convertible debt and accrued interest | 125,645 | $ 6 | 125,639 | ||
Net loss | $ (43,766,415) | (43,766,415) | |||
Ending balance (in shares) at Dec. 31, 2022 | 13,036,356 | 13,036,356 | |||
Ending balance at Dec. 31, 2022 | $ 2,400,543 | $ 1,304 | $ 215,006,321 | $ (212,607,082) | |
[1] 1 Amounts have been retroactively restated to reflect the 1-for-20 reverse stock split effected on October 17, 2022 (see Note 1) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (43,766,415) | $ (36,779,400) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation | 3,938,000 | 2,413,000 |
Amortization of debt discount | 1,831,607 | 43,983 |
Depreciation | 8,523 | 7,573 |
Acquired in-process research and development | 0 | 2,610,588 |
Change in fair value of derivative liability | (437,000) | (7,000) |
Non-cash payment of milestone fees | 500,000 | 0 |
Loss on extinguishment of convertible note payable | 20,645 | 0 |
Changes in operating assets and liabilities, net of acquisition: | ||
Prepaid expenses and other assets | (368,669) | (1,991,361) |
Accounts payable | 2,618,621 | 1,054,504 |
Accrued expenses and other liabilities | (1,588,529) | 3,170,326 |
Accrued interest | 0 | (488) |
Net cash used in operating activities | (37,243,217) | (29,478,275) |
Cash flows from investing activities | ||
Purchase of property and equipment | (2,842) | (12,476) |
Purchase of in-process research and development, net of assets acquired | 0 | (2,493,165) |
Maturity of restricted deposit | 0 | 75,000 |
Net cash used in investing activities | (2,842) | (2,430,641) |
Cash flows from financing activities | ||
Borrowings from convertible notes | 21,000,000 | 0 |
Payments of debt issuance costs | (1,088,294) | 0 |
Payments of convertible notes | 0 | (58,199) |
Proceeds from issuance of common stock and warrants | 0 | 34,500,000 |
Proceeds from the exercise of stock options | 0 | 346,961 |
Proceeds from the exercise of warrants | 0 | 9,163,174 |
Payment of offering costs | 0 | (2,901,123) |
Net cash provided by financing activities | 19,911,706 | 41,050,813 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (17,334,353) | 9,141,897 |
Cash, cash equivalents and restricted cash as of beginning of year | 46,993,285 | 37,851,388 |
Cash, cash equivalents and restricted cash as of end of year | 29,658,932 | 46,993,285 |
Supplemental disclosure of cash flow information | ||
Cash paid during the year for interest | 835,038 | 569 |
Supplemental disclosure of non-cash financing activities | ||
Settlement of convertible notes and accrued interest with common stock | 105,342 | 0 |
Non-cash issuance of common stock with asset acquisition | 0 | 2,610,588 |
Issuance of common stock for settlement of accounts payable | 0 | 108,000 |
Non-cash addition of derivative liability | 2,022,000 | 0 |
Reconciliation to consolidated balance sheets: | ||
Cash and cash equivalents | 12,646,282 | 46,993,285 |
Restricted cash included in current assets | 17,012,650 | 0 |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | $ 29,658,932 | $ 46,993,285 |
CONSOLIDATED STATEMENTS OF OP_2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical)) | Oct. 17, 2022 |
Income Statement [Abstract] | |
Reverse stock split ratio | 0.05 |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT) (Parenthetical) | Oct. 17, 2022 |
Statement of Stockholders' Equity [Abstract] | |
Reverse stock split ratio | 0.05 |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Business Description 9 Meters Biopharma, Inc. (the “Company”) is a clinical-stage company pioneering novel treatments for people with rare digestive diseases, gastrointestinal conditions with unmet needs, and debilitating disorders in which the biology of the gut is a contributing factor. The Company’s pipeline includes drug candidate vurolenatide, a proprietary long-acting GLP-1 agonist for the orphan-designated disease short bowel syndrome (“SBS”), and a robust pipeline of early-stage candidates for undisclosed rare diseases and/or unmet needs. On October 17, 2022, the Company effected a 1-for-20 reverse stock split (the “Reverse Stock Split”). The Reverse Stock Split did not change the number of authorized shares of capital stock or cause an adjustments to the par value of the Company’s capital stock. The Company has retroactively restated the consolidated financial statements to reflect the effect of the reverse stock split made effective on October 17, 2022. Additionally, pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable and outstanding to the Company’s stock options and warrants. The number of shares authorized for issuance pursuant to the Company’s equity incentive plans have been adjusted proportionately to reflect the reverse stock split. The Company retroactively restated such adjustment in the notes to the consolidated financial statements for the years ended December 31, 2022 and 2021. Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The Company’s financial position, results of operations and cash flows are presented in U.S. Dollars. Basis of Consolidation The accompanying consolidated financial statements reflect the operations of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Shelf Registration Filing On October 2, 2020, the Company filed a shelf registration statement that was declared effective on October 9, 2020 (the “Shelf Registration Statement”). Pursuant to the Shelf Registration Statement, the Company may from time to time offer, issue and sell in one or more offerings of various types of securities up to an aggregate dollar amount of $200 million. On July 22, 2020, the Company filed a prospectus supplement and associated sales agreement (the “Sales Agreement”) related to an “at-the-market” offering pursuant to which the Company may sell, from time to time, common stock with an aggregate offering price of up to $40 million through Truist Securities, Inc., previously SunTrust Robinson Humphrey (“Truist”), as sales agent, for general corporate purposes (the “2020 ATM”). In October 2020, the Company entered into an amendment to the Sales Agreement to reflect the termination of the prior registration statement and effectiveness of the Shelf Registration Statement. During the years ended December 31, 2022 and 2021, the Company did not sell any shares under the Sales Agreement. April 2021 Offering On March 30, 2021, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Citigroup Global Markets, Inc., William Blair & Company, L.L.C. and Truist, as representatives of the several underwriters named therein (the “Underwriters”), in connection with the public offering of 1,500,000 shares of the Company’s common stock at a price of $20.00 per share, less underwriting discounts and commissions (the “April 2021 Offering”). Pursuant to the terms of the Underwriting Agreement, the Company granted the Underwriters a 30-day option to purchase up to an additional 225,000 shares of common stock at the same price, which the Underwriters exercised in full on March 31, 2021. On April 5, 2021, upon closing of the April 2021 Offering, the Company received net proceeds of approximately $31.5 million after deducting underwriting discounts and commissions and offering expenses. The shares issued in the April 2021 Offering were registered and sold under the Shelf Registration Statement. Of the shares of common stock issued in the April 2021 Offering, the Company’s Chief Executive Officer, then-current Chief Financial Officer and Chairman of the Board of Directors purchased an aggregate of 22,500 shares at the public offering price and on the same terms as the other purchasers in the offering. The underwriters received the same underwriting discount on the shares purchased by the Company’s Chief Executive Officer, then-current Chief Financial Officer and Chairman of the Board of Directors. Business Risks The Company faces risks, including those associated with biopharmaceutical companies whose products are in various stages of development. These risks include, among others, risks related to the inability of the Company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs, including in light of current stock market conditions; risks related to the Company’s ability to successfully implement its strategic plans; uncertainties associated with the clinical development and regulatory approval of product candidates, including reliance on blinded data; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom, including the Company’s reliance on its lead product candidate; risks related to the failure to realize any value from product candidates and preclinical programs being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; intellectual property risks; delays in enrollment and timing of clinical trials; risks related to leveraging the Company by borrowing money under the debt facility and compliance with its terms; uncertainties regarding the effect of the reverse stock split and our continued listing on Nasdaq; reliance on collaborators; reliance on research and development partners; risks related to cybersecurity and data privacy; risks related to the COVID-19 pandemic and risks associated with acquiring and developing additional compounds. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and disclosures made in the accompanying notes to the financial statements. Areas of the financial statements where estimates may have the most significant effect include fair value measurements, acquired in-process research and development, accrued expenses, share-based compensation, and management’s assessment of the Company’s ability to continue as a going concern. The Company considered the impact of the COVID-19 pandemic on its estimates and assumptions, and concluded there was not a material impact to its consolidated financial statements as of and for the years ended December 31, 2022 and 2021. Changes in the facts or circumstances underlying these estimates could result in material changes and actual results could differ from these estimates. Concentration of Credit Risk Financial instruments which potentially subject the Company to concentration of credit risk consist of cash and cash equivalents. While cash held by financial institutions may at times exceed federally insured limits, management believes that no material credit or market risk exposure exists due to the high quality of the financial institutions. The Company has not experienced any losses on such accounts. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash and cash equivalents. Cash equivalents are stated at cost and consist primarily of money market accounts and commercial paper. Restricted Cash The terms of the 2022 Convertible Note further described in Note 6—Debt require the Company to maintain a minimum liquidity balance of 80% of then-outstanding principal. The restricted amount is maintained in a reserve account with the Company’s financial banking institution, and funds are periodically released from restriction as the balance of outstanding principal decreases. In accordance with the terms of the note, upon fulfillment of certain conditions, the cash held in reserve pursuant to the minimum liquidity requirement will be further reduced to a minimum amount equal to the greater of (i) the total outstanding principal amount less 7.5% of the Company’s total market capitalization and (ii) 50% of the total outstanding principal. As of December 31, 2022, there was approximately $16.9 million classified as restricted cash under the convertible note. Additionally, under the terms of the lease agreement further described in Note 11—Commitments and Contingencies, we are required to maintain a letter of credit as security for performance of lease obligations over the life of the lease. Accordingly, there is approximately $0.1 million classified as restricted cash under the letter of credit. As certain conditions are met, including the passage of time, the amount will be reduced to a minimum of $23,600, or the equivalent of approximately one month’s rent. Property and Equipment The Company records property and equipment at cost. Improvements and betterments that add new functionality or extend the useful life of the asset are capitalized, while general repairs and maintenance are expensed as incurred. The Company depreciates its property and equipment over the estimated useful lives of the assets, typically three years, using the straight-line method. Leasehold improvements are amortized over the lesser of their estimated useful lives or the lives of the underlying leases, whichever is shorter. Depreciation and amortization expense for property and equipment and leasehold improvements has been included in general and administrative expenses in the accompanying statements of operations and comprehensive loss. Accrued Expenses The Company incurs periodic expenses such as research and development, licensing fees, salaries and benefits and professional fees. The Company is required to estimate its expenses resulting from obligations under contracts with clinical research organizations, vendors and consulting agreements that have been incurred by the Company prior to being invoiced. This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. The majority of the Company’s service providers invoice monthly in arrears for services performed or when contractual milestones are met. The Company estimates accrued expenses as of each balance sheet date based on facts and circumstances known at that time. Accrued expenses consisted of the following: December 31, 2022 2021 Accrued compensation and benefits $ 427,196 $ 1,633,295 Accrued clinical expenses 3,833,282 4,228,048 Other accrued expenses 119,295 106,479 Total $ 4,379,773 $ 5,967,822 Derivative Liability The Company accounts for derivative instruments in accordance with ASC 815, Derivative and Hedging, which establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the consolidated balance sheet at fair value. The Company’s derivative financial instruments consisted of embedded features in the Company’s convertible notes. The embedded derivatives include provisions that provide the noteholder with certain conversion and put rights at various conversion or redemption values as well as certain call options for the Company. See Note 6—Debt for further details. Research and Development Research and development expenses consist of costs incurred to further the Company’s research and development activities and include salaries and related employee benefits, manufacturing of pharmaceutical active ingredients and drug products, costs associated with clinical trials, nonclinical activities, regulatory activities, research-related overhead expenses and fees paid to expert consultants, external service providers and contract research organizations which conduct certain research and development activities on behalf of the Company. Costs incurred in the research and development of products are charged to research and development expense as incurred. Costs for preclinical studies and clinical trial activities are recognized based on an evaluation of the vendors’ progress towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided by vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services were performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of trials, or the services completed. The estimates of accrued expenses as of each balance sheet date are based on the facts and circumstances known at the time. Although the Company does not expect its estimates to be materially different from amounts incurred, the Company’s estimates and assumptions for clinical trial costs could differ significantly from actual costs incurred, which could result in increases or decreases in research and development expenses in future periods when actual results are known. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the goods have been received or when the activity is performed, rather than when payment is made. Acquired In-process Research and Development The Company has acquired, and may in the future acquire, rights to develop and commercialize new drug candidates and/or other in-process research and development assets. The up-front acquisition payments, as well as future milestone payments that are deemed probable to achieve and do not meet the definition of a derivative, are expensed as acquired in-process research and development provided that the drug has not achieved regulatory approval for marketing, and, absent obtaining such approval, have no alternative future use. Concentration of Manufacturing Risk The Company relies on a small number of third-party CMOs for the manufacturing of drug product candidates for the Company’s research and development activities, including supply of clinical trial drug supply. Significant delays or interruption in the supply of materials necessary to manufacture the Company’s product candidates could adversely affect the Company’s research and development activities. For the year ended December 31, 2022, one CMO accounted for 21% of the Company’s purchases and there was approximately $2.7 million in outstanding accounts payable to this CMO as of December 31, 2022. Share-Based Compensation The Company recognizes share-based compensation expense for grants of stock options based on the grant-date fair value of those awards using the Black-Scholes option-pricing model. Share-based compensation expense is generally recognized on a straight-line basis over the requisite service period for awards with time-based vesting. For awards with performance conditions, compensation cost is recognized from the time achievement of the performance criteria is probable over the expected term. Share-based compensation expense includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Under the Black-Scholes option-pricing model, fair value is calculated based on assumptions with respect to: • Expected dividend yield. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on the Company’s common stock. • Expected stock price volatility. Due to limited trading history as a public company, the expected volatility is derived from the average historical volatilities of publicly traded companies within the Company’s industry that the Company considers to be comparable to the Company’s business over a period approximately equal to the expected term. In evaluating comparable companies, the Company considers factors such as industry, stage of life cycle, financial leverage, size and risk profile. • Risk-free interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to the expected term. • Expected term. The expected term represents the period that the stock-based awards are expected to be outstanding. Due to limited history of stock option exercises, the Company estimates the expected term of employee stock options with service conditions based on the simplified method, which calculates the expected term as the average of the time-to-vesting and the contractual life of the options. Pursuant to Accounting Standards Update (“ASU”) 2018-07, the Company has elected to use the contractual life of the option as the expected term for non-employee options. The expected term for performance options is the longer of the explicit or implicit service period. Periodically, the Company’s Board of Directors (the “Board”) may approve the grant of restricted stock units (“RSUs”) pursuant to the Company’s stock incentive plans, which represent the right to receive shares of the Company’s common stock based on terms of the agreement. The fair value of RSUs is recognized as share-based compensation expense generally on a straight-line basis over the service period, net of estimated forfeitures. The grant date fair value of an RSU represents the closing price of the Company’s common stock on the date of grant. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined based on the differences between the consolidated financial statements and the tax basis of assets and liabilities using the enacted tax rates in effect for the year in which the differences are expected to reverse. Net deferred tax assets are recognized to the extent the Company’s management believes these assets will more likely than not be realized. In making such determination, management considers all positive and negative evidence, including reversals of existing temporary differences, projected future taxable income, tax planning strategies and recent financial operations. A valuation allowance is recorded to reduce the deferred tax assets reported if, based on the weight of the evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Management periodically reviews its deferred tax assets for recoverability and its estimates and judgments in assessing the need for a valuation allowance. The Company recognizes a tax benefit from uncertain positions when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits of the position. Income tax positions must meet a more-likely-than-not recognition threshold to be recognized. Fair Value of Financial Instruments Fair value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction between market participants at the measurement date. U.S. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). Financial instruments recorded in the accompanying consolidated balance sheets are categorized based on the inputs to valuation techniques as follows: • Level 1 — defined as observable inputs based on unadjusted quoted prices for identical instruments in active markets; • Level 2 — defined as inputs other than Level 1 that are either directly or indirectly observable in the marketplace for identical or similar instruments in markets that are not active; and • Level 3 — defined as unobservable inputs in which little or no market data exists where valuations are derived from techniques in which one or more significant inputs are unobservable. The fair value of the embedded derivatives issued in connection with the 2022 Convertible Note and 2020 Convertible Note, further described in Note 6—Debt, were determined by using a Monte Carlo simulation technique (“MCS”) to value the embedded derivatives associated with each note. As part of the MCS valuation, a discounted cash flow (“DCF”) model was used to value the debt on a stand-alone basis and determine the discount rate to utilize in both the DCF and MCS models. The significant estimates used in the DCF model include the time to maturity of the convertible debt and calculated discount rate, which includes an estimate of the Company’s specific risk premium. The MCS methodology calculates the theoretical value of an option based on certain parameters, including: (i) the threshold of exercising the option, (ii) the price of the underlying security, (iii) the time to expiration, or expected term, (iv) the expected volatility of the underlying security, (v) the risk-free rate, (vi) the number of paths, and (vii) an estimated probability of subsequent financing as defined in the 2022 Convertible Note. The Company estimated a probability of subsequent financing of 90% and 60% as of July 15, 2022 and December 31, 2022, respectively. On January 12, 2023, the Company amended the 2022 Convertible Note to among other things remove the subsequent financing requirement further described in Note 12—Subsequent Events. These valuation techniques involve management’s estimates and judgment based on unobservable inputs and are classified in Level 3. The fair value estimates may not be indicative of the amounts that would be realized in a market exchange. Additionally, there may be inherent uncertainties or changes in the underlying assumptions used, which could significantly affect the current or future fair value estimates. Generally, a significant increase (decrease) in the probability of subsequent financing would have resulted in a significantly lower (higher) fair value measurement; however, changes in other inputs such as expected term and price of the underlying common stock will have a directionally opposite impact on fair value measurement. The table below summarizes the valuation inputs into the MCS model for the derivative liabilities associated with the 2022 Convertible Note on the date of issuance July 15, 2022 and period end as of December 31, 2022. Derivative Liability 2022 Convertible Note July 15, December 31, 2022 2022 Discount rate 24 % 20.1 % Expected stock price volatility 102.5 % 100 % Risk-free interest rate 3.1 % 4.2 % Expected term 3.0 years 2.5 years Price of the underlying common stock $ 4.87 $ 1.26 The following table summarize the fair value hierarchy of financial liabilities measured at fair value as of December 31, 2022. December 31, 2022 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Total Derivative liability $ — $ — $ (1,585,000) $ (1,585,000) Commercial paper — 6,965,646 — 6,965,646 Total liabilities at fair value $ — $ 6,965,646 $ (1,585,000) $ 5,380,646 The following table summarizes the changes in fair value of the derivative liability classified in Level 3. Gains and losses reported in this table include changes in fair value that are attributable to unobservable inputs. Year Ended December 31, 2022 Beginning balance $ — Issuance of derivative liability (the 2022 Convertible Note) 2,022,000 Change in fair value of derivative liabilities (437,000) Ending balance $ 1,585,000 The amount of total gains (losses) for the period included in earnings attributable to the change in unrealized gains (losses) relating to the fair value liabilities still held at the end of the period $ 437,000 The cumulative unrealized gain relating to the change in fair value of the derivative liability ASC 820, Fair Value Measurement and Disclosures requires all entities to disclose the fair value of financial instruments, both assets and liabilities, for which it is practicable to estimate fair value. As of December 31, 2022 and 2021, the recorded values of cash and cash equivalents, restricted cash, accounts payable, accrued expenses and convertible notes payable approximated their fair values due to the short-term nature of the instruments. Deferred Offering Costs Deferred offering costs consist principally of legal, accounting and underwriters’ fees related to offerings or the Company’s Shelf Registration Statement. Offering costs incurred prior to an offering are initially capitalized and then subsequently reclassified to additional paid-in capital upon completion of the offering. If the equity offering is not completed, any costs deferred will be expensed immediately upon termination of the offering. Patent Costs Costs associated with the submission of patent applications are expensed as incurred given the uncertainty of the future economic benefits of the patents. Patent and patent related legal and administrative costs included in general and administrative expenses were approximately $499,000 and $470,000 for the years ended December 31, 2022 and 2021, respectively. Net Loss Per Share The Company calculates net loss per share as a measurement of the Company’s performance while giving effect to all potentially dilutive shares that were outstanding during the reporting period. Because the Company had a net loss for all periods presented, the inclusion of common stock options or other similar instruments would be anti-dilutive. Therefore, the weighted-average shares outstanding used to calculate both basic and diluted net loss per share are the same. For the years ended December 31, 2022 and 2021, 13.6 million and 2.2 million shares, respectively, underlying potentially dilutive warrants and stock options issued and outstanding, and shares of common stock expected to be issued under our convertible note, have been excluded from the computation of diluted weighted-average shares outstanding because the effect would be anti-dilutive. The potentially dilutive securities consisted of the following: Year Ended December 31, 2022 2021 Options outstanding under the 2015 Stock Incentive Plan 179,630 265,067 Options outstanding under the 2012 Omnibus Incentive Plan, as amended 1,192,233 730,377 Options outstanding under the 2022 Stock Incentive Plan 36,880 — Options outstanding under the Option Grant Agreements granted to RDD Employees 49,295 49,295 Warrants outstanding at an exercise price of $50.80 112 112 Warrants outstanding at an exercise price of $63.60 5,702 5,702 Warrants outstanding at an exercise price of $11.7880 1,146,397 1,146,397 Shares issuable upon conversion of convertible debt (Note 6) 10,972,500 — Total 13,582,749 2,196,950 Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. The Company is required to record all components of comprehensive loss in the consolidated financial statements in the period in which they are recognized. Net loss and other comprehensive loss, including unrealized gains and losses on investments are reported, net of their related tax effect, to arrive at a comprehensive loss. For the years ended December 31, 2022 and 2021, comprehensive loss was equal to net loss. Segments Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company operates and manages its business as one operating segment and the Company’s primary operations are in North America. Recently Issued Accounting Standards Accounting Pronouncements Adopted In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity |
LIQUIDITY AND GOING CONCERN
LIQUIDITY AND GOING CONCERN | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LIQUIDITY AND GOING CONCERN | LIQUIDITY AND GOING CONCERN The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. As of December 31, 2022, the Company has unrestricted cash and cash equivalents of approximately $12.6 million. In March 2023, the Company received net proceeds of approximately $4.4 million from the closing of a registered direct offering further described in Note 12—Subsequent Events. Without additional sources of funding, the Company’s unrestricted cash and cash equivalents at December 31, 2022, combined with the net proceeds from the March 2023 Offering, are not sufficient for the Company to continue as a going concern for a period of at least one year from the date of filing this Annual Report on Form 10-K. The Company expects to incur substantial losses in the future as it progresses its current product pipeline, seeks regulatory approval for product candidates and prepares for commercialization.Based on the Company’s limited operating history, recurring negative cash flows from operations, current plans and available resources, the Company will need substantial additional funding to support future operating activities. The Company has concluded that the prevailing conditions and ongoing liquidity risks faced by the Company raise substantial doubt about the Company’s ability to continue as a going concern for at least one year following the date these financial statements are issued. The accompanying consolidated financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern.The Company may seek to raise additional funding through dilutive and non-dilutive financings. There can be no assurance that the Company will be able to obtain additional capital on terms acceptable to the Company, on a timely basis or at all. The failure to obtain sufficient additional funding could adversely affect the Company’s ability to achieve its business objectives and product development timelines and could have a material adverse effect on the Company’s results of operations. |
MERGER AND ACQUISITION
MERGER AND ACQUISITION | 12 Months Ended |
Dec. 31, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
MERGER AND ACQUISITION | MERGER AND ACQUISITION Lobesity Acquisition On July 19, 2021, the Company closed an asset purchase agreement (the “Lobesity Asset Purchase Agreement”) with Lobesity LLC (“Lobesity”) pursuant to which the Company acquired global development rights to a proprietary and highly specific humanized monoclonal antibody that targets glucose-dependent insulinotropic polypeptide, as well as related intellectual property (the “Lobesity Acquisition”). The consideration for the Lobesity Acquisition at closing consisted of $2.3 million in cash and 120,861 shares of unregistered common stock plus the right to contingent payments including certain potential worldwide regulatory and clinical milestone payments totaling $45.5 million for a single indication (with the total amount payable, if multiple indications are developed, not to exceed $58.0 million), global sales-related milestone payments totaling up to $50.0 million, and, subject to certain adjustments, a mid-single digit royalty on worldwide net sales. To satisfy the Company’s post-closing rights to indemnification under the Asset Purchase Agreement, 30,216 of the shares issued to Lobesity were subject to holdback restrictions for 18 months following closing of the transaction. The Company’s right to indemnification will be satisfied through the recovery of these shares or paid in cash by Lobesity. Accounting Treatment The Lobesity Acquisition was accounted for as an asset acquisition under ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business . The net tangible and intangible assets acquired, and liabilities assumed in connection with the transaction were recorded at their estimated fair values on the date of acquisition. The excess of purchase price over fair value of identified assets acquired and liabilities assumed was expensed as in-process research and development. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | PROPERTY AND EQUIPMENTProperty and equipment consisted of the following as of December 31, 2022 and 2021: December 31, 2022 2021 Furniture and fixtures $ 11,552 $ 11,552 Computer equipment 46,420 43,578 Leasehold improvements 29,994 29,994 Property and equipment, gross $ 87,966 $ 85,124 Less: Accumulated depreciation (77,553) (69,030) Property and equipment, net $ 10,413 $ 16,094 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | RELATED PARTY TRANSACTIONS Master Services Agreement Michael Rice, a member of our Board since March 2021, is a Founding Partner of LifeSci Advisors, LLC and LifeSci Communications, LLC. Prior to his becoming a director, on April 1, 2020, the Company entered into a master services agreement with both LifeSci Advisors, LLC and LifeSci Communications, LLC, to provide investor relations and public relations services, respectively. The Company incurred expenses of approximately $0.3 million with LifeSci Advisors, LLC during the years ended December 31, 2022 and 2021, and approximately $0.2 million and $0.3 million with LifeSci Communications, LLC during the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, the Company had less than $0.1 million in outstanding accounts payable due to LifeSci Advisors, LLC. Equity Financing Pursuant to the Underwriting Agreement in connection with the April 2021 Offering, the Company issued an aggregate of 1,725,000 shares of common stock at a price of $20.00 per share. Of the shares issued in the April 2021 Offering, the Company’s Chief Executive Officer, then-current Chief Financial Officer and Chairman of the Board of Directors purchased an aggregate of 22,500 shares at the public offering price and on the same terms as the other purchasers in the April 2021 Offering. The underwriters received the same underwriting discount on the shares purchased by the Company’s Chief Executive Officer, then-current Chief Financial Officer and Chairman of the Board of Directors as the other shares sold in the offering. The aggregate purchase price of the common stock shares issued to the Company’s Chief Executive Officer, then-current Chief Financial Officer and Chairman of the Board was $450,000. |
DEBT
DEBT | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
DEBT | DEBT 2020 Convertible Note On January 10, 2020, the Company entered into a securities purchase agreement and unsecured convertible promissory note in the principal amount of $2,750,000 (the “2020 Convertible Note”). The holder of the 2020 Convertible Note could elect to convert all or a portion of the note, at any time from time to time into the Company’s common stock at a conversion price of $65.00 per share, as adjusted by the Reverse Stock Split effected October 17, 2022. The purchase price of the 2020 Convertible Note was $2,500,000 and carried an original issuance discount of $250,000, which was included in the principal amount of the 2020 Convertible Note. The various conversion and redemption features contained in the 2020 Convertible Note were embedded derivative instruments, which were recorded as a debt discount and derivative liability at the issuance date at their estimated fair value of $0.4 million. Amortization of the debt discount and accretion of the original issuance discount (“OID”) for the 2020 Convertible Note recorded as interest expense was approximately $44,000 for the year ended December 31, 2021. There was no interest expense incurred under the 2020 Convertible Note during the year ended December 31, 2022. The 2020 Convertible Note bore interest at the rate of 10% per annum, compounding on a daily basis. During the year ended December 31, 2021, the Company paid the remaining balance of principal and interest of approximately $0.1 million in cash. 2022 Convertible Note On June 30, 2022, the Company entered into a securities purchase agreement (the “Purchase Agreement”) for the purchase of senior secured convertible notes with an institutional investor (the “Holder”). The purchase price of the initial note issued on July 15, 2022 and maturing July 1, 2025, is $21.0 million (the “2022 Convertible Note”), and carries an OID of 5% or $1.1 million, with an option for the Company to issue additional convertible notes to the Holder with principal amounts of up to an aggregate of $70.0 million, subject to certain limitations. The 2022 Convertible Note bears interest equal to the three-month benchmark rate plus 5% (with a floor of 6% and 18% upon default). The Company paid debt issuance costs of approximately $1.1 million during the year ended December 31, 2022. The Company’s accounting policy is to amortize the debt discount and OID over the estimated life of the debt, which is approximately 2.5 years for the 2022 Convertible Note. On November 7, 2022, the Company amended and restated the 2022 Convertible Note (the “Amended 2022 Note”) in order to, among other things, reduce the minimum liquidity requirement from 110% of the outstanding principal amount to 80% of the outstanding principal amount, which released approximately $6.3 million from restricted cash upon the effective date of the Amended 2022 Note. Additionally, the Amended 2022 Note removed the provisions related to accelerated principal payments and instead established scheduled equity amortization payments beginning in November 2022. On the first day of each month through June 1, 2023, the Company will make an amortization payment equal to $1.68 million, to be paid in shares of the Company’s common stock (unless the Company elects to pay in cash), to the Holder, subject to certain conditions, including the equity conditions (as defined in the original 2022 Convertible Note). Such amortization payment may be optionally decreased by the Company, or if agreed to in writing by the Holder and the Company, increased. On the first day of each month on or after July 1, 2023, the Company will make an amortization payment equal to $882,000 in cash (unless the Company elects to pay in shares of common stock, subject to certain conditions, including the equity conditions). Such amortization payment may be optionally increased by the Company, if agreed to in writing by the Holder and the Company. The Amended 2022 Note also amends the definitions of the Conversion Floor Price, Subsequent Financing, Subsequent Financing Requirement and Required Reserve Amount. The Amended 2022 Note was accounted for as a debt modification and represents the same indebtedness represented by the Original 2022 Convertible Note. Additionally, the Company and the Holder also amended the Securities Purchase Agreement to replace the form of note with a form of note substantially similar to the Amended 2022 Note, which the Company may use to issue, at the Company’s option, additional notes to the Holder with principal amounts of up to an aggregate of $70.0 million, subject to certain limitations. The Amended 2022 Note ranks senior to all outstanding and future indebtedness of the Company and its subsidiaries over the three-year term. The Amended 2022 Note also contains customary affirmative and negative covenants, including limitations on incurring indebtedness, the creation of additional liens on the Company’s assets, and entering into investments, as well as a subsequent financing requirement to raise at least $25.0 million by March 31, 2023, and a minimum liquidity requirement to maintain 80% of the outstanding principal in a restricted cash account. The Company is required to have shares reserved of at least 200% of then outstanding principal and accruable interest divided by the Holder’s conversion rate. The Holder can elect to convert at the Holder’s conversion rate of $7.06 per share, subject to certain adjustments, including but not limited to, the issuance of certain rights, options or warrants. The Company can elect to make principal or interest payments in common stock instead of cash at an amount equal to 92% of the lowest daily volume weighted-average price (“VWAP”) of the Company’s common stock during the three-trading day period immediately prior to payment date, which cannot be less than the floor price of $2.00 per share. The Holder can redeem the Amended 2022 Note in cash upon (i) a “fundamental change”, as defined in the Amended 2022 Note, (ii) cessation of vurolenatide clinical development while the Company’s total market capitalization is less than $100 million for a period of five consecutive days (the “Clinical Development Cessation”), (iii) an event of default as defined in the Amended 2022 Note, or (iv) if the resale registration statement is withdrawn. The Holder’s cash redemption price ranges from 5% to 15% of then-outstanding principal and unpaid interest. If the Holder redeemed the Amended 2022 Note at December 31, 2022 under the redemption options (i) through (iii) above, the Company would settle the Amended 2022 Note in cash at a price of approximately $24.0 million. Redemption option (iv) would result in a cash redemption payment of approximately $21.9 million. The Company can elect to redeem the Amended 2022 Note in cash at an amount equal to the greater of (A) the “fixed conversion value”, as defined in the Amended 2022 Note, plus accrued and unpaid interest and (B) if before the first year anniversary of the issuance date, 125% of then-outstanding principal and interest. If the Company elected to redeem the Amended 2022 Note as of December 31, 2022, the Company would have settled the Amended 2022 Note in cash for approximately $26.1 million. Events of defaults include, but are not limited to, failure to make timely payments, failure to maintain the minimum liquidity requirement, failure to timely deliver certain notices (including notice of a fundamental change or the Clinical Development Cessation) and filing for bankruptcy. There were no events of default during the year ended December 31, 2022. The Company made principal and interest payments in equity of $0.1 million, which was settled with 55,719 shares of the Company’s common stock at a weighted-average conversion price of $1.89. In addition, the Company paid interest payments in cash of approximately $0.8 million. The various conversion and redemption features contained in the Amended 2022 Note are embedded derivative instruments, which were recorded as a debt discount and derivative liability at the issuance date at their estimated fair value of $2.0 million. Amortization of the debt discount and accretion of the OID for the Amended 2022 Note, recorded as interest expense using an effective interest rate of 24.7%, was approximately $1.8 million for the year ended December 31, 2022. The unamortized discount and OID is approximately $2.3 million, which is expected to be amortized over approximately 1.3 years. The Amended 2022 Note, which is classified as current as of December 31, 2022, consisted of: December 31, 2022 Convertible notes payable, net $ 22,050,000 Less: principal payments of debt (105,000) Less: unamortized debt discount and OID (2,328,687) Total convertible notes payable, net $ 19,616,313 |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of License Agreements [Abstract] | |
LICENSE AGREEMENTS | LICENSE AGREEMENTS Alba License During 2016, the Company entered into a license agreement (the “Alba License”) with Alba Therapeutics Corporation (“Alba”) to obtain the rights to certain intellectual property relating to larazotide acetate and related compounds. Upon execution of the Alba License, the Company paid Alba a non-refundable license fee of $0.5 million. In addition, the Company is required to make milestone payments to Alba upon the achievement of certain clinical and regulatory milestones totaling up to $1.5 million and payments upon regulatory approval and commercial sales of a licensed product totaling up to $150 million, which is based on sales ranging from $100 million to $1.5 billion. Upon the Company paying Alba $2.5 million for the first commercial sale of a licensed product, the Alba License becomes perpetual and irrevocable. Upon the achievement of net sales in a year exceeding $1.5 billion, the Alba License also becomes free of milestone fees. The Alba License provides Alba with certain termination rights, including failure of the Company to use Commercially Reasonable Efforts (as defined in the Alba License) to develop the licensed products. Amunix Licenses In connection with the acquisition of Naia Rare Diseases, Inc. (the “Naia Acquisition”), the Company entered into two amended and restated license agreements with Amunix Pharmaceuticals, Inc. (“Amunix”), pursuant to which the Company received an exclusive, worldwide, royalty-bearing license, with rights of sublicense, to lead molecules GLP-1 and GLP-2 along with a related XTEN sequence and other intellectual property referenced therein (the “Amunix Licenses”). Also in connection with the Naia Acquisition, the Company entered into an amended and restated license agreement with Cedars-Sinai Medical Center (“Cedars”), pursuant to which the Company licensed the rights to GLP-1 Agonist for the treatment of SBS (the “Cedars License”). As consideration under the Amunix License for GLP-1, the Company agreed to pay Amunix certain royalty payments and (i) $70.4 million in milestone payments upon achievement of future development and sales milestones in the U.S. and major EU countries, (ii) $20.5 million in milestone payments upon achievement of future development and sales milestones in China and certain related territories, and (iii) $20.5 million in milestone payments upon achievement of future development and sales milestones in South Korea and certain other East Asian countries. As consideration under the Amunix License for GLP-2, the Company agreed to pay Amunix certain royalty payments and $60.1 million in milestone payments upon achievement of future development and sales milestones in the U.S. and major EU countries. As consideration under the Cedars License, the Company agreed to pay Cedars certain royalty payments and approximately $9.4 million in milestone payments upon achievement of future development and sales milestones. MHS License One of the assets acquired in the Lobesity Acquisition was an amended and restated technology license agreement with MHS Care-Innovation LLC (“MHS”), pursuant to which the Company received an exclusive, worldwide license, with rights to sublicense, to certain patent and other intellectual property rights concerning a proprietary and highly specific humanized monoclonal antibody that targets glucose-dependent insulinotropic polypeptide (the “MHS License”). The MHS License does not require the payment of any future milestone payments or royalties to MHS, since it was originally entered into with Lobesity in exchange for the issuance of certain equity securities and a grant of certain related rights to Lobesity, all of which occurred prior to the closing of the Lobesity Acquisition. As consideration for the assets purchased in the Lobesity Acquisition (including but not limited to the MHS License), the Company is obligated to pay Lobesity (i) potential worldwide regulatory and clinical milestone payments totaling $45.5 million for a single indication (with the total amount payable, if multiple indications are developed, not to exceed $58.0 million), (ii) up to $50.0 million in global sales-related milestone payments, and (iii) subject to certain adjustments, a mid-single digit royalty on worldwide net sales. EBRIS Collaboration On August 6, 2021, the Company announced a collaboration with the European Biomedical Research Institute of Salerno, Italy (“EBRIS”) to study larazotide for the treatment of multisystem inflammatory syndrome in children (“MIS-C”). In connection with this collaboration, the Company paid a milestone fee of $0.5 million upon IND approval for MIS-C. Following receipt of a Study May Proceed letter from the FDA under the Investigator IND, EBRIS initiated a Phase 2a study in MIS-C during the fourth quarter of 2021. The ongoing Phase 2a study is a randomized, double-blind, placebo-controlled study. On April 11, 2022, the Company entered into an exclusive license agreement (the “EBRIS License Agreement”) with EBRIS pursuant to which the Company granted to EBRIS an exclusive license to study the Company’s product incorporating larazotide as its sole active pharmaceutical ingredient (the “Product”) for the treatment of MIS-C and potentially, multisystem inflammatory syndrome in adults (“MIS-A”). In turn, the Company will have an option to license from EBRIS any new intellectual property resulting from such development for purposes of developing, manufacturing, or commercializing products incorporating larazotide or any analog or derivative thereof for the treatment of MIS-C or MIS-A (the “Option”). Pursuant to the EBRIS License Agreement, the Company issued to EBRIS shares of common stock valued at $0.5 million (consisting of 43,708 shares of unregistered common stock priced at the Company’s 20-day VWAP as of the date of closing), plus the Company will pay EBRIS $0.5 million in cash in connection with final database lock of the ongoing Phase II clinical trial for the treatment of MIS-C. Upon the readout of the top-line data and an FDA agreed upon path forward to further develop the compound in MIS-C, the Company may exercise the Option for an upfront fee of $1.0 million. In addition, the EBRIS License Agreement contemplates certain contingent payments, including development milestone payments, sales-related milestone payments, and subject to certain adjustments, a low-single digit royalty on net sales in the United States of products incorporating larazotide or any analog or derivative thereof that (i) are covered by any patent rights licensed from EBRIS pursuant to the exercise of the Option, or whose regulatory approval for MIS-C or MIS-A relied on data generated by EBRIS, and (ii) sold pursuant to prescriptions for use in treating MIS-C and MIS-A. Of note, each such payment is payable, at the option of the Company, in cash or unregistered shares of the Company’s common stock. The Company has the right to exercise the Option until three months following the later of (i) the end of the Development Term (as defined in the EBRIS License Agreement) or (ii) the delivery by EBRIS to the Company of the material Know-How (as defined in the EBRIS License Agreement) and final study reports with respect to the clinical trials conducted by EBRIS under the EBRIS License Agreement (the “Option Expiration Date”). Unless earlier terminated, the term of the EBRIS License Agreement will continue (i) if the Company does not exercise the Option, until the Option Expiration Date or (ii) if the Company exercises the Option, on a product-by-product and country-by-country basis, until the expiration of the Company’s royalty obligations for each product in a particular country. Following the Option Expiration Date, the EBRIS License Agreement may be terminated by the Company for convenience upon two months’ prior written notice to EBRIS. The EBRIS License Agreement may be terminated by either party upon (i) a material breach by the other party (subject to prior written notice and an opportunity to cure during a customary cure period), (ii) certain insolvency events, including bankruptcy proceedings, or (iii) prior to the Option Expiration Date, written notice that, as reasonably determined in good faith by the terminating party, termination is necessary to protect the health or safety of trial participants. Additionally, the EBRIS License Agreement will automatically terminate if the Alba License terminates during the Development Term and we do not obtain sufficient rights in the relevant Alba intellectual property to enable the corresponding rights granted to EBRIS to continue following such termination. The EBRIS License Agreement includes standard and customary provisions regarding, among other things, compliance with laws and regulations, confidentiality, intellectual property, representations and warranties, indemnification, and insurance. Milestone Fees |
STOCKHOLDERS' EQUITY (DEFICIT)
STOCKHOLDERS' EQUITY (DEFICIT) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
STOCKHOLDERS' EQUITY (DEFICIT) | STOCKHOLDERS’ EQUITY (DEFICIT) The Company’s amended and restated certificate of incorporation, as amended, authorizes 560 million shares of capital stock, par value $0.0001 per share, of which 550 million shares are designated as common stock and 10 million shares are designated as preferred stock. Preferred Stock The Company’s amended and restated certificate of incorporation, as amended, authorizes the Board to issue preferred stock in one or more classes or one or more series within any class from time to time. Voting powers, designations, preferences, qualifications, limitations, restrictions or other rights will be determined by the Board at that time. There were no shares of preferred stock issued and outstanding as of December 31, 2022 and 2021. Common Stock The holders of the Company’s common stock (i) have equal ratable rights to dividends from funds legally available, therefore, when, as and if declared by the Board; (ii) are entitled to share in all the Company’s assets available for distribution to holders of common stock upon liquidation, dissolution or winding up of the Company’s affairs; (iii) do not have preemptive, subscription or conversion rights (and there are no redemption or sinking fund provisions or rights); and (iv) are entitled to one non-cumulative vote per share on all matters on which stockholders may vote. There were 13,036,356 and 12,911,776 shares of common stock outstanding as of December 31, 2022 and 2021, respectively. The Company had reserved shares of common stock for future issuance as follows: December 31, 2022 2021 Outstanding stock options 1,458,038 1,044,739 Warrants to purchase common stock 1,152,211 1,152,211 Shares reserved for issuance upon conversion of convertible debt (Note 6) 27,717,921 — For possible future issuance under the Company's incentive plans 565,120 273,940 Total common shares reserved for future issuance 30,893,290 2,470,890 |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
SHARE-BASED COMPENSATION | SHARE-BASED COMPENSATION The Company has three stock option plans in existence: the 9 Meters Biopharma, Inc. 2022 Stock Incentive Plan (the “2022 Plan”), the 2012 Omnibus Incentive Plan, as amended (the “Omnibus Plan”) and the Innovate 2015 Stock Incentive Plan (the “Private Innovate Plan”). In addition, the Company assumed 50,714 options in accordance with the terms of the merger agreement with RDD Pharma, Ltd. (the “RDD Merger Agreement”). The Company’s stock options typically vest over a period of three Private Innovate Plan As of December 31, 2022, there were 179,630 stock options outstanding under the Private Innovate Plan. Since 2018, the Company has not issued, and does not intend to issue, any additional awards from the Private Innovate Plan. The following table summarizes stock option activity under the Private Innovate Plan: Number of Weighted-Average Aggregate Weighted-Average Outstanding at December 31, 2021 265,067 $ 33.80 $ 837,459 2.7 Options granted — — — Options forfeited (85,437) 41.76 — Options exercised — — — Outstanding at December 31, 2022 179,630 29.88 — 2.7 Exercisable at December 31, 2022 179,630 29.88 — 2.7 Vested and expected to vest at December 31, 2022 179,630 $ 29.88 $ — 2.7 There were no options granted under the Private Innovate Plan during the years ended December 31, 2022 and 2021. The total intrinsic value of options exercised was approximately $635,000 during the year ended December 31, 2021. There were no options exercised during the year ended December 31, 2022. The total fair value of stock option awards vested during the year ended December 31, 2021 under the Private Innovate Plan was approximately $49,000. There were no stock options vested during the year ended December 31, 2022 under the Private Innovate Plan. As of December 31, 2022, there was no unrecognized compensation cost related to unvested stock-based compensation arrangements under the Private Innovate Plan. The Private Innovate Plan provides for accelerated vesting under certain change-of-control transactions, if approved by the Board. On April 23, 2021, the Board approved the extension of the exercise periods of certain option holders’ vested options for an additional twelve months. Pursuant to the Board’s approval, options to purchase 85,414 shares of the Company’s common stock were extended and the Company recognized an additional $0.3 million in non-cash stock compensation expense related to the modification during the year ended December 31, 2021. All other terms of the options remained unchanged. Omnibus Plan The shares reserved for issuance under the Omnibus Plan automatically increase on the first day of each calendar year beginning in 2019 and ending in 2022 by an amount equal to the lesser of (i) five percent of the number of shares of common stock outstanding as of December 31st of the immediately preceding calendar year or (ii) such lesser number of shares of common stock as determined by the Board (the “Evergreen Provision”). On January 1, 2022, the number of shares of common stock available under the Omnibus Plan automatically increased by 645,589 shares, pursuant to the Evergreen Provision. The Board elected to forgo the increase from the Evergreen Provision that would have increased the option pool by 5% of the shares of common stock outstanding on January 1, 2021. As of December 31, 2022, there were options to purchase 1,192,233 shares of the Company’s common stock outstanding under the Omnibus Plan. Upon its approval, the 2022 Plan superseded and replaced the Omnibus Plan, which expired by its terms on April 30, 2022. No new awards can be granted under the Omnibus Plan after its expiration, but any awards outstanding under the Omnibus Plan remain subject to the terms of the Omnibus Plan. Upon approval of the 2022 Plan, any shares subject to outstanding awards under the Omnibus Plan that subsequently expire, terminate or are surrendered or forfeited for any reason without issuance of shares will automatically become available under the 2022 Plan. The range of assumptions used in estimating the fair value of the options granted under the Omnibus Plan using the Black-Scholes option pricing model for the periods presented were as follows: Year Ended December 31, 2022 2021 Expected dividend yield 0% 0% Expected stock-price volatility 79% 68% - 85% Risk-free interest rate 1.4% - 1.9% 0.1% - 1.1% Expected term of options (in years) 6.1 2.3 - 6.1 The following table summarizes stock option activity under the Omnibus Plan: Number of Weighted-Average Aggregate Weighted-Average Outstanding at December 31, 2021 730,377 $ 23.70 $ 2,296,720 8.5 Options granted 470,631 14.71 Options forfeited (8,775) 14.80 Options exercised — — Outstanding at December 31, 2022 1,192,233 20.22 — 8.1 Exercisable at December 31, 2022 519,256 23.78 — 7.4 Vested and expected to vest at December 31, 2022 1,153,870 $ 20.32 $ — 8.1 The weighted-average grant date fair value of options granted under the Omnibus Plan was $9.89 and $18 during the years ended December 31, 2022 and 2021, respectively. The total intrinsic value of options exercised was approximately $39,000 during the year ended December 31, 2021. There were no options exercised during the year ended December 31, 2022. The total fair value of stock option awards vested under the Omnibus Plan was approximately $3.7 million and $0.8 million during the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, there was approximately $6.5 million of total unrecognized compensation cost related to unvested stock-based compensation arrangements under the Omnibus Plan. This cost is expected to be recognized over a weighted-average period of 2.6 years. The Omnibus Plan provides for accelerated vesting, if approved by the Company’s Board. During the year ended December 31, 2022, in accordance with the separation and consulting agreement entered into with our former Chief Financial Officer, the Company accelerated the vesting of all remaining unvested options and extended the exercise period to ten years from the issuance date. During the year ended December 31, 2021, the Board approved the acceleration and extension of unvested options held by a former board member whose term on the Board was expiring. The Company recognized additional non-cash stock compensation expense related to modifications of $1.1 million and $0.1 million during the years ended December 31, 2022 and 2021, respectively. There were no RSUs granted during the year ended December 31, 2022 and 2021 and there were no unvested RSUs as of December 31, 2022. The Company recognized share-based compensation expense for RSUs of approximately $0.2 million during the year ended December 31, 2021. There was no share-based compensation expense for RSUs during the year ended December 31, 2022. 2022 Stock Incentive Plan The 2022 Plan was approved by the Company’s stockholders on June 22, 2022. The 2022 Plan provides for the grant of stock options, stock appreciation rights, restricted stock, restricted stock units, dividend equivalent rights, or other stock awards. Upon adoption of the 2022 Plan, there were 600,000 shares of the Company’s common stock reserved for issuance. The 2022 Plan will be increased by the number of shares underlying any option awarded under the Omnibus Plan that expires, terminates or is canceled without issuance. As of December 31, 2022, there were 565,120 shares available for issuance under the 2022 Plan. The range of assumptions used in estimating the fair value of the options granted under the 2022 Plan using the Black-Scholes option pricing model for the periods presented were as follows: Year Ended December 31, 2022 2021 Expected dividend yield —% — Expected stock-price volatility 79% - 81% — Risk-free interest rate 3.0% - 3.2% — Expected term of options (in years) 5.8 - 6.0 — The following table summarizes stock option activity under the 2022 Plan: Number of Weighted-Average Aggregate Weighted-Average Outstanding at December 31, 2021 — $ — $ — — Options granted 36,880 5.27 Options forfeited — — Options exercised — — Outstanding at December 31, 2022 36,880 $ 5.27 $ — 9.5 Exercisable at December 31, 2022 5,940 $ 5.29 $ — 9.5 Vested and expected to vest at December 31, 2022 34,927 $ 5.27 $ — 9.5 The weighted-average grant date fair value of options granted under the 2022 Plan was $3.64 during the year ended December 31, 2022. There were no options granted under the 2022 Plan during the year ended December 31, 2021. There were no options exercised under the 2022 Plan during the year ended December 31, 2022. The total fair value of stock options vested under the 2022 Plan was approximately $22,000 during the year ended December 31, 2022. As of December 31, 2022, there was approximately $0.1 million of total unrecognized compensation cost related to unvested stock-based compensation arrangements under the 2022 Plan which is expected to be recognized over a weighted-average period of 2.5 years. RDD Option Grants Pursuant to the RDD Merger Agreement, the Company assumed option grant agreements for 50,714 option grant agreements awarded to RDD employees upon consummation of the merger with RDD (the “RDD Options”) on April 30, 2020. All of the RDD Options are fully vested as of December 31, 2022 and there were no RDD Options granted during the years ended December 31, 2022 and 2021. The total intrinsic value of RDD Options exercised was approximately $27,000 during the year ended December 31, 2021. There were no RDD Options exercised during the year ended December 31 2022. The following table summarizes stock option activity for the RDD Options: Number of Weighted-Average Aggregate Weighted-Average Outstanding at December 31, 2021 49,295 $ 12.60 $ 343,486 3.3 Options granted — Options forfeited — Options exercised — Outstanding at December 31, 2022 49,295 $ 12.60 $ 8,269 2.3 Exercisable at December 31, 2022 49,295 $ 12.60 $ 8,269 2.3 Share-based Compensation Expense Total share-based compensation expense recognized in the accompanying consolidated statements of operations and comprehensive loss was as follows: Year Ended December 31, 2022 2021 Research and development $ 950,000 $ 773,000 General and administrative 2,988,000 1,640,000 Total share-based compensation $ 3,938,000 $ 2,413,000 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES No provision for federal and state income tax expense has been recorded for the years ended December 31, 2022 and 2021 due to the valuation allowance recorded against the net deferred tax asset and recurring losses. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and deferred tax liabilities are as follows: December 31, 2022 2021 Domestic tax loss and contribution carryforwards $ 21,419,800 $ 18,656,500 Foreign tax loss carryforwards 4,531,900 5,134,700 Tax credits 3,718,100 2,534,600 Share-based compensation 3,908,000 3,647,100 Intangible assets 2,957,100 3,096,800 Accrued expenses 114,300 371,200 Section 174 - capitalized research and development 5,940,400 — Research and development expenses — 20,500 Other 19,200 5,900 Valuation allowance (42,608,800) (33,467,300) Total deferred tax assets, noncurrent $ — $ — The Company has established a valuation allowance against its deferred tax assets due to the uncertainty surrounding the realization of such assets. During the years ended December 31, 2022 and 2021, the valuation allowance increased by $9,764,900 and $6,265,600, respectively. The reasons for the difference between actual income tax expense (benefit) for the years ended December 31, 2022 and 2021, and the amount computed by applying the statutory federal income tax rate to losses before income tax (benefit) are as follows: 2022 2021 Amount % of Pretax Amount % of Pretax Income tax benefit at statutory rate $ (9,190,900) 21.0 % $ (7,726,800) 21.0 % State income taxes, net of federal tax benefit (41,000) 0.1 % (27,900) 0.1 % Non-deductible expenses 314,900 (0.7) % 4,500 — % Credits (1,210,000) 2.7 % (1,176,500) 3.2 % Foreign rate differential 3,100 — % 2,400 — % Change in state tax rate (8,500) — % 1,764,100 (4.8) % Other 367,500 (0.8) % 894,600 (2.5) % Change in valuation allowance 9,764,900 (22.3) % 6,265,600 (17.0) % Income tax benefit $ — — % $ — — % As of December 31, 2022, the Company had net operating loss carryforwards for federal, state and foreign income tax purposes of $101.8 million, $102.1 million and $19.7 million respectively. Federal loss carryforwards of $3.6 million begin to expire in 2034 and $98.3 million of the federal losses carryforward indefinitely. The state loss carryforwards of $102.0 million begin to expire in 2029 and $0.1 million carryforward indefinitely. Foreign net operating losses carry forward indefinitely, and may be subject to limitation. As of December 31, 2022, the Company had contribution carryforwards of $10,300, which begin to expire in 2023. In addition, as of December 31, 2022, the Company has federal research and development credits of $3.7 million which begin to expire in 2038. Starting in 2022, the Company has federal capital loss carryforwards of $33,100, which carryforward indefinitely for foreign tax purposes. The Company acquired a subsidiary in Israel during the year ended December 31, 2020. However, the subsidiary has a history of book losses and as such, has no undistributed earnings. The Tax Cuts and Jobs Act subjects a US shareholder to tax on global intangible low-taxed income (GILTI) earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income, states that an entity can make an accounting policy election to either recognized deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. The Company has elected to account for GILTI in the year the tax is incurred. The Company has a GILTI inclusion in 2022 and 2021 and an overall net operating loss; therefore, no GILTI tax has been recorded for the years ended December 31, 2022 and 2021. The Internal Revenue Code of 1986, as amended, contains provisions which limit the ability to utilize the net operating loss and tax credit carryforwards in the case of certain events, including significant changes in ownership interests. If the Company’s net operating loss and tax credit carryforwards are limited, and the Company has taxable income which exceeds the permissible yearly net operating loss and tax credit carryforwards, the Company would incur a federal income tax liability even though net operating loss and tax credit carryforwards would be available in future years. As of December 31, 2022 and 2021, the Company had no unrecognized tax benefits and does not anticipate a significant change in total unrecognized tax benefits within the next 12 months. The Company is subject to United States federal income tax and income tax in multiple state jurisdictions. The Company has analyzed its filing positions in all federal and state jurisdictions where it is required to file income tax returns, as well as open tax years in these jurisdictions. The Company is subject to United States federal, state and local tax examinations by tax authorities for all years of operation. No income tax returns are under examination by taxing authorities at this time. The Company’s policy for recording interest and penalties is to record them as a component of interest expense and general and administrative expenses, respectively. During December 31, 2022 and 2021, the Company did not record any interest and penalties related to uncertain tax positions. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Employment Agreements The Company has entered into executive employment agreements with the executives (the “Executive Employment Agreements”). The Executive Employment Agreements provide an annual base salary and the opportunity to participate in the Company’s equity compensation, employee benefit and bonus plans once they are established and approved by the Board. The Executive Employment Agreements contain severance provisions if such executive is terminated under certain conditions that would provide the executive with up to 12 months of their base salary and up to 12 months of continuation of health insurance benefits. Additionally, if the Company’s Chief Executive Officer is terminated under certain conditions or resigns for good reason within 12 months of a “change in control,” the Chief Executive Officer will be eligible to receive 18 months of his then-current salary, the amount of his target year-end annual non-equity incentive award, and accelerated vesting of all of his unvested options and restricted stock unit awards. Periodically, the Company enters into separation and general release agreements with former executives of the Company that include separation benefits consistent with the former executives’ employment agreements. The Company recognized severance expense totaling approximately $0.4 million during the year ended December 31, 2021, which was paid in equal installments over 12 months from the date of separation. There was no accrued severance obligation as of December 31, 2022. Office Leases In July 2020, the Company entered into a 4-year lease for office space that expires on September 30, 2024 (the “Original Lease”). Base annual rent is $72,000, or $6,000 per month over the 4-year term. The Original Lease contains a 3-year renewal option. The Company recorded a right of use asset of $233,206 and an operating lease liability of $233,206 at the inception of the Original Lease in July 2020. The Company estimated the present value of the lease payments over the remaining term of the lease using a discount rate of 12%, which represented the Company’s estimated incremental borrowing rate. The renewal options were excluded from the lease payments as the Company concluded the exercise of the option was not considered reasonably certain. Operating lease cost under ASC 842 was approximately $71,520 for the years ended December 31, 2022 and 2021. Operating lease cost is included in general and administrative expenses on the accompanying consolidated statement of operations and comprehensive loss. The total cash paid for amounts included in the measurement of the operating lease liability and reported within operating activities was less than $0.1 million during the year ended December 31, 2022. Future minimum payments under the Company’s lease liability were as follows: Year ending December 31, Operating Leases 2023 $ 72,000 2024 54,000 Total lease payment 126,000 Less: imputed interest (12,858) Total $ 113,142 On October 3, 2022, the Company entered into a lease agreement (the “2023 Lease”) for its new headquarters in Raleigh, North Carolina. The landlord is required to make improvements to the facility before commencement of the 2023 Lease, which is expected to commence on or around April 1, 2023, for a term of 126 months (the “Initial Term”) and provides for rent abatement for the first six months of the Initial Term. Beginning on the seventh month of the Initial Term, base rent payments are approximately $24,000 per month ($38 per square foot), and increase each year, up to approximately $31,000 per month during the last six months of the Initial Term. The 2023 Lease may be extended for a period of five years at the option of the Company. The 2023 Lease also contains a tenant improvement allowance of $0.7 million. In accordance with ASC 842, Leases , the Company concluded that it does not control the underlying asset being constructed. As such, there is no impact to the Company’s consolidated financial statements for the year ended December 31, 2022. Under the terms of the 2023 Lease, the Company is required to maintain a letter of credit as security for performance of lease obligations over the life of the lease. Accordingly, there is approximately $0.1 million classified as restricted cash under the letter of credit. As certain conditions are met, including the passage of time, the amount will be reduced to a minimum of $23,600, or the equivalent of approximately one month’s rent. Legal From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. Periodically, the Company reviews the status of significant matters, if any exist, and assesses its potential financial exposure. If the potential loss from any claim or legal claim is considered probable and the amount can be estimated, the Company accrues a liability for the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict; therefore, accruals are based on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS 1st Amendment to Amended 2022 Note On January 12, 2023, the Company and the Holder agreed to amend the Amended 2022 Note (the “Amendment”, and together with the Amended 2022 Note, the “Amended A&R Note”) in order to reduce the outstanding principal amount to approximately $4.95 million in exchange for $16.8 million of restricted cash. In connection with the reduction of the outstanding principal amount, the Amendment also reduces the minimum liquidity requirement to no less than $0.5 million. Additionally, the definition of Conversion Floor Price was amended and relieves the Company of the requirement to raise $25 million by March 31, 2023. The Amended A&R Note is classified as current on the consolidated balance sheet as of December 31, 2022. Except as set forth herein, the material terms of the Amended A&R Note are otherwise substantially similar to the Amended 2022 Note described in Note 6—Debt. March 2023 Offering On March 13, 2023, the Company entered into a securities purchase agreement (the “2023 Purchase Agreement”) with an institutional investor for the issuance and sale of 1,300,000 shares of the Company’s common stock, par value $0.0001 (the “Shares”), pre-funded warrants to purchase up to 1,825,000 shares of the Company’s common stock (the “Pre-Funded Warrants”), and accompanying warrants to purchase up to 6,250,000 shares of the Company’s common stock (the “Common Warrants”). The Shares and accompanying Common Warrants were sold at an offering price of $1.60 and the Pre-Funded Warrants and accompanying Common Warrants were sold at an offering price of $1.5999. The offering closed on March 15, 2023. The net proceeds to the Company were approximately $4.4 million, after deducting placement agent fees and other offering expenses. The Common Warrants have an exercise price equal to $1.35, are immediately exercisable and have a term of 3.5 years following the initial issuance date. The Pre-Funded Warrants have an exercise price of $0.0001 per share, are immediately exercisable and can be exercised at any time after the issuance date until such Pre-Funded Warrants are exercised in full. In addition, the Company granted the placement agent warrants to purchase up to 187,500 shares of the Company’s common stock (the “Placement Agent Warrants”). The terms of the Placement Agent Warrants are substantially the same as the terms of the Common Warrants, except the Placement Agent Warrants have an exercise price of $2.00 per share. Workforce Reduction |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The Company’s financial position, results of operations and cash flows are presented in U.S. Dollars. |
Basis of Consolidation | Basis of ConsolidationThe accompanying consolidated financial statements reflect the operations of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Business Risks | Business Risks |
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 amounts reported in the financial statements and disclosures made in the accompanying notes to the financial statements. Areas of the financial statements where estimates may have the most significant effect include fair value measurements, acquired in-process research and development, accrued expenses, share-based compensation, and management’s assessment of the Company’s ability to continue as a going concern. The Company considered the impact of the COVID-19 pandemic on its estimates and assumptions, and concluded there was not a material impact to its consolidated financial statements as of and for the years ended December 31, 2022 and 2021. Changes in the facts or circumstances underlying these estimates could result in material changes and actual results could differ from these estimates. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments which potentially subject the Company to concentration of credit risk consist of cash and cash equivalents. While cash held by financial institutions may at times exceed federally insured limits, management believes that no material credit or market risk exposure exists due to the high quality of the financial institutions. The Company has not experienced any losses on such accounts. |
Cash and Cash Equivalents | Cash and Cash EquivalentsThe Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash and cash equivalents. Cash equivalents are stated at cost and consist primarily of money market accounts and commercial paper. |
Property and Equipment | Property and Equipment The Company records property and equipment at cost. Improvements and betterments that add new functionality or extend the useful life of the asset are capitalized, while general repairs and maintenance are expensed as incurred. The Company depreciates its property and equipment over the estimated useful lives of the assets, typically three years, using the straight-line method. Leasehold improvements are amortized over the lesser of their estimated useful lives or the lives of the underlying leases, whichever is shorter. Depreciation and amortization expense for property and equipment and leasehold improvements has been included in general and administrative expenses in the accompanying statements of operations and comprehensive loss. |
Accrued Expenses | Accrued Expenses The Company incurs periodic expenses such as research and development, licensing fees, salaries and benefits and professional fees. The Company is required to estimate its expenses resulting from obligations under contracts with clinical research organizations, vendors and consulting agreements that have been incurred by the Company prior to being invoiced. This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. The majority of the Company’s service providers invoice monthly in arrears for services performed or when contractual milestones are met. The Company estimates accrued expenses as of each balance sheet date based on facts and circumstances known at that time. |
Derivative Liability | Derivative Liability The Company accounts for derivative instruments in accordance with ASC 815, Derivative and Hedging, which establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the consolidated balance sheet at fair value. The Company’s derivative financial instruments consisted of embedded features in the Company’s convertible notes. The embedded derivatives include provisions that provide the noteholder with certain conversion and put rights at various conversion or redemption values as well as certain call options for the Company. See Note 6—Debt for further details. |
Research and Development | Research and Development Research and development expenses consist of costs incurred to further the Company’s research and development activities and include salaries and related employee benefits, manufacturing of pharmaceutical active ingredients and drug products, costs associated with clinical trials, nonclinical activities, regulatory activities, research-related overhead expenses and fees paid to expert consultants, external service providers and contract research organizations which conduct certain research and development activities on behalf of the Company. Costs incurred in the research and development of products are charged to research and development expense as incurred. Costs for preclinical studies and clinical trial activities are recognized based on an evaluation of the vendors’ progress towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided by vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services were performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of trials, or the services completed. The estimates of accrued expenses as of each balance sheet date are based on the facts and circumstances known at the time. Although the Company does not expect its estimates to be materially different from amounts incurred, the Company’s estimates and assumptions for clinical trial costs could differ significantly from actual costs incurred, which could result in increases or decreases in research and development expenses in future periods when actual results are known. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the goods have been received or when the activity is performed, rather than when payment is made. |
Acquired In-process Research and Development | Acquired In-process Research and Development The Company has acquired, and may in the future acquire, rights to develop and commercialize new drug candidates and/or other in-process research and development assets. The up-front acquisition payments, as well as future milestone payments that are deemed probable to achieve and do not meet the definition of a derivative, are expensed as acquired in-process research and development provided that the drug has not achieved regulatory approval for marketing, and, absent obtaining such approval, have no alternative future use. |
Concentration of Manufacturing Risk | Concentration of Manufacturing RiskThe Company relies on a small number of third-party CMOs for the manufacturing of drug product candidates for the Company’s research and development activities, including supply of clinical trial drug supply. Significant delays or interruption in the supply of materials necessary to manufacture the Company’s product candidates could adversely affect the Company’s research and development activities. |
Share-Based Compensation | Share-Based Compensation The Company recognizes share-based compensation expense for grants of stock options based on the grant-date fair value of those awards using the Black-Scholes option-pricing model. Share-based compensation expense is generally recognized on a straight-line basis over the requisite service period for awards with time-based vesting. For awards with performance conditions, compensation cost is recognized from the time achievement of the performance criteria is probable over the expected term. Share-based compensation expense includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Under the Black-Scholes option-pricing model, fair value is calculated based on assumptions with respect to: • Expected dividend yield. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on the Company’s common stock. • Expected stock price volatility. Due to limited trading history as a public company, the expected volatility is derived from the average historical volatilities of publicly traded companies within the Company’s industry that the Company considers to be comparable to the Company’s business over a period approximately equal to the expected term. In evaluating comparable companies, the Company considers factors such as industry, stage of life cycle, financial leverage, size and risk profile. • Risk-free interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to the expected term. • Expected term. The expected term represents the period that the stock-based awards are expected to be outstanding. Due to limited history of stock option exercises, the Company estimates the expected term of employee stock options with service conditions based on the simplified method, which calculates the expected term as the average of the time-to-vesting and the contractual life of the options. Pursuant to Accounting Standards Update (“ASU”) 2018-07, the Company has elected to use the contractual life of the option as the expected term for non-employee options. The expected term for performance options is the longer of the explicit or implicit service period. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined based on the differences between the consolidated financial statements and the tax basis of assets and liabilities using the enacted tax rates in effect for the year in which the differences are expected to reverse. Net deferred tax assets are recognized to the extent the Company’s management believes these assets will more likely than not be realized. In making such determination, management considers all positive and negative evidence, including reversals of existing temporary differences, projected future taxable income, tax planning strategies and recent financial operations. A valuation allowance is recorded to reduce the deferred tax assets reported if, based on the weight of the evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Management periodically reviews its deferred tax assets for recoverability and its estimates and judgments in assessing the need for a valuation allowance. The Company recognizes a tax benefit from uncertain positions when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits of the position. Income tax positions must meet a more-likely-than-not recognition threshold to be recognized. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction between market participants at the measurement date. U.S. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). Financial instruments recorded in the accompanying consolidated balance sheets are categorized based on the inputs to valuation techniques as follows: • Level 1 — defined as observable inputs based on unadjusted quoted prices for identical instruments in active markets; • Level 2 — defined as inputs other than Level 1 that are either directly or indirectly observable in the marketplace for identical or similar instruments in markets that are not active; and • Level 3 — defined as unobservable inputs in which little or no market data exists where valuations are derived from techniques in which one or more significant inputs are unobservable. The fair value of the embedded derivatives issued in connection with the 2022 Convertible Note and 2020 Convertible Note, further described in Note 6—Debt, were determined by using a Monte Carlo simulation technique (“MCS”) to value the embedded derivatives associated with each note. As part of the MCS valuation, a discounted cash flow (“DCF”) model was used to value the debt on a stand-alone basis and determine the discount rate to utilize in both the DCF and MCS models. The significant estimates used in the DCF model include the time to maturity of the convertible debt and calculated discount rate, which includes an estimate of the Company’s specific risk premium. The MCS methodology calculates the theoretical value of an option based on certain parameters, including: (i) the threshold of exercising the option, (ii) the price of the underlying security, (iii) the time to expiration, or expected term, (iv) the expected volatility of the underlying security, (v) the risk-free rate, (vi) the number of paths, and (vii) an estimated probability of subsequent financing as defined in the 2022 Convertible Note. The Company estimated a probability of subsequent financing of 90% and 60% as of July 15, 2022 and December 31, 2022, respectively. On January 12, 2023, the Company amended the 2022 Convertible Note to among other things remove the subsequent financing requirement further described in Note 12—Subsequent Events. |
Deferred Offering Costs | Deferred Offering CostsDeferred offering costs consist principally of legal, accounting and underwriters’ fees related to offerings or the Company’s Shelf Registration Statement. Offering costs incurred prior to an offering are initially capitalized and then subsequently reclassified to additional paid-in capital upon completion of the offering. If the equity offering is not completed, any costs deferred will be expensed immediately upon termination of the offering. |
Patent Costs | Patent Costs |
Net Loss Per Share | Net Loss Per Share |
Comprehensive Loss | Comprehensive LossComprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. The Company is required to record all components of comprehensive loss in the consolidated financial statements in the period in which they are recognized. Net loss and other comprehensive loss, including unrealized gains and losses on investments are reported, net of their related tax effect, to arrive at a comprehensive loss. |
Segments | Segments |
Recently Issued Accounting Standards | Recently Issued Accounting Standards Accounting Pronouncements Adopted In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: December 31, 2022 2021 Accrued compensation and benefits $ 427,196 $ 1,633,295 Accrued clinical expenses 3,833,282 4,228,048 Other accrued expenses 119,295 106,479 Total $ 4,379,773 $ 5,967,822 |
Fair Value Measurement Inputs and Valuation Techniques | The table below summarizes the valuation inputs into the MCS model for the derivative liabilities associated with the 2022 Convertible Note on the date of issuance July 15, 2022 and period end as of December 31, 2022. Derivative Liability 2022 Convertible Note July 15, December 31, 2022 2022 Discount rate 24 % 20.1 % Expected stock price volatility 102.5 % 100 % Risk-free interest rate 3.1 % 4.2 % Expected term 3.0 years 2.5 years Price of the underlying common stock $ 4.87 $ 1.26 |
Fair Value, Assets Measured on Recurring and Nonrecurring Basis | The following table summarize the fair value hierarchy of financial liabilities measured at fair value as of December 31, 2022. December 31, 2022 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Total Derivative liability $ — $ — $ (1,585,000) $ (1,585,000) Commercial paper — 6,965,646 — 6,965,646 Total liabilities at fair value $ — $ 6,965,646 $ (1,585,000) $ 5,380,646 |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation | The following table summarizes the changes in fair value of the derivative liability classified in Level 3. Gains and losses reported in this table include changes in fair value that are attributable to unobservable inputs. Year Ended December 31, 2022 Beginning balance $ — Issuance of derivative liability (the 2022 Convertible Note) 2,022,000 Change in fair value of derivative liabilities (437,000) Ending balance $ 1,585,000 The amount of total gains (losses) for the period included in earnings attributable to the change in unrealized gains (losses) relating to the fair value liabilities still held at the end of the period $ 437,000 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The potentially dilutive securities consisted of the following: Year Ended December 31, 2022 2021 Options outstanding under the 2015 Stock Incentive Plan 179,630 265,067 Options outstanding under the 2012 Omnibus Incentive Plan, as amended 1,192,233 730,377 Options outstanding under the 2022 Stock Incentive Plan 36,880 — Options outstanding under the Option Grant Agreements granted to RDD Employees 49,295 49,295 Warrants outstanding at an exercise price of $50.80 112 112 Warrants outstanding at an exercise price of $63.60 5,702 5,702 Warrants outstanding at an exercise price of $11.7880 1,146,397 1,146,397 Shares issuable upon conversion of convertible debt (Note 6) 10,972,500 — Total 13,582,749 2,196,950 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following as of December 31, 2022 and 2021: December 31, 2022 2021 Furniture and fixtures $ 11,552 $ 11,552 Computer equipment 46,420 43,578 Leasehold improvements 29,994 29,994 Property and equipment, gross $ 87,966 $ 85,124 Less: Accumulated depreciation (77,553) (69,030) Property and equipment, net $ 10,413 $ 16,094 |
DEBT (Tables)
DEBT (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | The Amended 2022 Note, which is classified as current as of December 31, 2022, consisted of: December 31, 2022 Convertible notes payable, net $ 22,050,000 Less: principal payments of debt (105,000) Less: unamortized debt discount and OID (2,328,687) Total convertible notes payable, net $ 19,616,313 |
STOCKHOLDERS_ EQUITY (DEFICIT)
STOCKHOLDERS’ EQUITY (DEFICIT) (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Stock by Class | The Company had reserved shares of common stock for future issuance as follows: December 31, 2022 2021 Outstanding stock options 1,458,038 1,044,739 Warrants to purchase common stock 1,152,211 1,152,211 Shares reserved for issuance upon conversion of convertible debt (Note 6) 27,717,921 — For possible future issuance under the Company's incentive plans 565,120 273,940 Total common shares reserved for future issuance 30,893,290 2,470,890 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Share-based Compensation, Activity | The following table summarizes stock option activity under the Private Innovate Plan: Number of Weighted-Average Aggregate Weighted-Average Outstanding at December 31, 2021 265,067 $ 33.80 $ 837,459 2.7 Options granted — — — Options forfeited (85,437) 41.76 — Options exercised — — — Outstanding at December 31, 2022 179,630 29.88 — 2.7 Exercisable at December 31, 2022 179,630 29.88 — 2.7 Vested and expected to vest at December 31, 2022 179,630 $ 29.88 $ — 2.7 The following table summarizes stock option activity under the Omnibus Plan: Number of Weighted-Average Aggregate Weighted-Average Outstanding at December 31, 2021 730,377 $ 23.70 $ 2,296,720 8.5 Options granted 470,631 14.71 Options forfeited (8,775) 14.80 Options exercised — — Outstanding at December 31, 2022 1,192,233 20.22 — 8.1 Exercisable at December 31, 2022 519,256 23.78 — 7.4 Vested and expected to vest at December 31, 2022 1,153,870 $ 20.32 $ — 8.1 The following table summarizes stock option activity under the 2022 Plan: Number of Weighted-Average Aggregate Weighted-Average Outstanding at December 31, 2021 — $ — $ — — Options granted 36,880 5.27 Options forfeited — — Options exercised — — Outstanding at December 31, 2022 36,880 $ 5.27 $ — 9.5 Exercisable at December 31, 2022 5,940 $ 5.29 $ — 9.5 Vested and expected to vest at December 31, 2022 34,927 $ 5.27 $ — 9.5 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | The range of assumptions used in estimating the fair value of the options granted under the Omnibus Plan using the Black-Scholes option pricing model for the periods presented were as follows: Year Ended December 31, 2022 2021 Expected dividend yield 0% 0% Expected stock-price volatility 79% 68% - 85% Risk-free interest rate 1.4% - 1.9% 0.1% - 1.1% Expected term of options (in years) 6.1 2.3 - 6.1 The range of assumptions used in estimating the fair value of the options granted under the 2022 Plan using the Black-Scholes option pricing model for the periods presented were as follows: Year Ended December 31, 2022 2021 Expected dividend yield —% — Expected stock-price volatility 79% - 81% — Risk-free interest rate 3.0% - 3.2% — Expected term of options (in years) 5.8 - 6.0 — |
Share-based Payment Arrangement, Option, Activity | The following table summarizes stock option activity for the RDD Options: Number of Weighted-Average Aggregate Weighted-Average Outstanding at December 31, 2021 49,295 $ 12.60 $ 343,486 3.3 Options granted — Options forfeited — Options exercised — Outstanding at December 31, 2022 49,295 $ 12.60 $ 8,269 2.3 Exercisable at December 31, 2022 49,295 $ 12.60 $ 8,269 2.3 |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | Total share-based compensation expense recognized in the accompanying consolidated statements of operations and comprehensive loss was as follows: Year Ended December 31, 2022 2021 Research and development $ 950,000 $ 773,000 General and administrative 2,988,000 1,640,000 Total share-based compensation $ 3,938,000 $ 2,413,000 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities | December 31, 2022 2021 Domestic tax loss and contribution carryforwards $ 21,419,800 $ 18,656,500 Foreign tax loss carryforwards 4,531,900 5,134,700 Tax credits 3,718,100 2,534,600 Share-based compensation 3,908,000 3,647,100 Intangible assets 2,957,100 3,096,800 Accrued expenses 114,300 371,200 Section 174 - capitalized research and development 5,940,400 — Research and development expenses — 20,500 Other 19,200 5,900 Valuation allowance (42,608,800) (33,467,300) Total deferred tax assets, noncurrent $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation | The reasons for the difference between actual income tax expense (benefit) for the years ended December 31, 2022 and 2021, and the amount computed by applying the statutory federal income tax rate to losses before income tax (benefit) are as follows: 2022 2021 Amount % of Pretax Amount % of Pretax Income tax benefit at statutory rate $ (9,190,900) 21.0 % $ (7,726,800) 21.0 % State income taxes, net of federal tax benefit (41,000) 0.1 % (27,900) 0.1 % Non-deductible expenses 314,900 (0.7) % 4,500 — % Credits (1,210,000) 2.7 % (1,176,500) 3.2 % Foreign rate differential 3,100 — % 2,400 — % Change in state tax rate (8,500) — % 1,764,100 (4.8) % Other 367,500 (0.8) % 894,600 (2.5) % Change in valuation allowance 9,764,900 (22.3) % 6,265,600 (17.0) % Income tax benefit $ — — % $ — — % |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Payments for Operating Leases | Future minimum payments under the Company’s lease liability were as follows: Year ending December 31, Operating Leases 2023 $ 72,000 2024 54,000 Total lease payment 126,000 Less: imputed interest (12,858) Total $ 113,142 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) | 12 Months Ended | |||||||||
Oct. 17, 2022 | Apr. 05, 2021 USD ($) $ / shares shares | Mar. 30, 2021 $ / shares shares | Dec. 31, 2022 USD ($) segment shares | Dec. 31, 2021 USD ($) shares | Nov. 07, 2022 | Oct. 03, 2022 USD ($) | Jul. 15, 2022 | Oct. 02, 2020 USD ($) | Jul. 22, 2020 USD ($) | |
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Reverse stock split ratio | 0.05 | |||||||||
Sale of stock, shelf registration maximum equity offering price | $ 200,000,000 | |||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 20 | |||||||||
Property, plant and equipment, useful life | 3 years | |||||||||
Estimated probability of financing (as a percent) | 60% | 90% | ||||||||
Change in fair value of derivative liabilities | $ 437,000 | |||||||||
General and administrative | $ 11,008,900 | $ 9,662,875 | ||||||||
Antidilutive securities excluded from computation of earnings per share, amount (in shares) | shares | 13,582,749 | 2,196,950 | ||||||||
Number of operating segments | segment | 1 | |||||||||
Fair Value, Recurring | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Fair value disclosure liability | $ 5,380,646 | |||||||||
2022 Convertible Note | Convertible Debt | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Percentage of total market capitalization | 7.50% | |||||||||
Percentage of total outstanding principal | 50% | |||||||||
CMO | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Accounts payable | $ 2,700,000 | |||||||||
Purchase Benchmark | Supplier Concentration Risk | CMO | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Concentration risk (as a percent) | 21% | |||||||||
Unsecured Convertible Promissory Note | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Restricted cash | $ 16,900,000 | |||||||||
Letter of Credit | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Restricted cash | $ 100,000 | |||||||||
Minimum | 2022 Convertible Note | Convertible Debt | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Debt instrument, covenant compliance, liquidity requirement (as a percent) | 80% | 110% | ||||||||
Minimum | Letter of Credit | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Restricted cash | $ 23,600 | |||||||||
Patent Costs | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
General and administrative | $ 499,000 | $ 470,000 | ||||||||
Public Stock Offering | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Number of shares issued on transaction (in shares) | shares | 1,500,000 | |||||||||
Shares issued, price per share (in dollars per share) | $ / shares | $ 20 | |||||||||
Consideration received on transaction | $ 31,500,000 | |||||||||
Over-Allotment Option | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Number of shares issued on transaction (in shares) | shares | 225,000 | |||||||||
Sale of stock, option period | 30 days | |||||||||
April 2021 Offering | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Number of shares issued on transaction (in shares) | shares | 1,725,000 | |||||||||
April 2021 Offering | Chief Executive Officer, Chief Financial Officer, and Chairman of Board of Directors | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Number of shares issued on transaction (in shares) | shares | 22,500 | |||||||||
Consideration received on transaction | $ 450,000 | |||||||||
SunTrust Robinson Humphrey | ||||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||||
Sale of stock, ATM maximum equity offering price | $ 40,000,000 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Accrued Expenses (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||
Accrued compensation and benefits | $ 427,196 | $ 1,633,295 |
Accrued clinical expenses | 3,833,282 | 4,228,048 |
Other accrued expenses | 119,295 | 106,479 |
Total | $ 4,379,773 | $ 5,967,822 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Summary of Valuation Input for Warrant and Derivative Liabilities (Details) | Dec. 31, 2022 $ / shares | Jul. 15, 2022 $ / shares |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Expected term | 2 years 6 months | 3 years |
Discount rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement inputs | 0.201 | 0.24 |
Expected stock price volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement inputs | 1 | 1.025 |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement inputs | 0.042 | 0.031 |
Price of the underlying common stock | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Price of the underlying common stock (in dollars per share) | $ 1.26 | $ 4.87 |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Summary of Fair Value Hierarchy of Financial Liabilities Measured at Fair Value (Details) | Dec. 31, 2022 USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Derivative Liability, Statement of Financial Position [Extensible Enumeration] | Derivative liability |
Fair Value, Recurring | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Derivative liability | $ (1,585,000) |
Total liabilities at fair value | 5,380,646 |
Fair Value, Recurring | Commercial Paper | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Commercial paper | 6,965,646 |
Fair Value, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Derivative liability | 0 |
Total liabilities at fair value | 0 |
Fair Value, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Commercial Paper | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Commercial paper | 0 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Derivative liability | 0 |
Total liabilities at fair value | 6,965,646 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | Commercial Paper | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Commercial paper | 6,965,646 |
Fair Value, Recurring | Significant Unobservable Inputs (Level 3) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Derivative liability | (1,585,000) |
Total liabilities at fair value | (1,585,000) |
Fair Value, Recurring | Significant Unobservable Inputs (Level 3) | Commercial Paper | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Commercial paper | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN_8
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Changes in Fair Value Derivative Liability (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | |
Change in fair value of derivative liabilities | $ (437,000) |
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Derivative liability |
Derivative Financial Instruments, Liabilities | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | |
Beginning balance | $ 0 |
Change in fair value of derivative liabilities | (437,000) |
Ending balance | 1,585,000 |
The amount of total gains (losses) for the period included in earnings attributable to the change in unrealized gains (losses) relating to the fair value liabilities still held at the end of the period | 437,000 |
Derivative Financial Instruments, Liabilities | 2022 Convertible Note | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | |
Issuance of derivative liability | $ 2,022,000 |
SUMMARY OF SIGNIFICANT ACCOUN_9
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Potentially Dilutive Securities (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount (in shares) | 13,582,749 | 2,196,950 |
Stock options | Options outstanding under the 2015 Stock Incentive Plan | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount (in shares) | 179,630 | 265,067 |
Stock options | Options outstanding under the 2012 Omnibus Incentive Plan, as amended | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount (in shares) | 1,192,233 | 730,377 |
Stock options | Options outstanding under the 2022 Stock Incentive Plan | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount (in shares) | 36,880 | 0 |
Stock options | Options outstanding under the Option Grant Agreements granted to RDD Employees | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount (in shares) | 49,295 | 49,295 |
Warrants | Warrants outstanding at an exercise price of $50.80 | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount (in shares) | 112 | 112 |
Exercise price of warrants (in dollars per share) | $ 50.80 | |
Warrants | Warrants outstanding at an exercise price of $63.60 | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount (in shares) | 5,702 | 5,702 |
Exercise price of warrants (in dollars per share) | $ 63.60 | |
Warrants | Warrants outstanding at an exercise price of $11.7880 | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount (in shares) | 1,146,397 | 1,146,397 |
Exercise price of warrants (in dollars per share) | $ 11.7880 | |
Shares issuable upon conversion of convertible debt | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount (in shares) | 10,972,500 | 0 |
LIQUIDITY AND GOING CONCERN (De
LIQUIDITY AND GOING CONCERN (Details) - USD ($) | 1 Months Ended | |||
Mar. 15, 2023 | Mar. 27, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Cash and cash equivalents | $ 12,646,282 | $ 46,993,285 | ||
Direct Offering | Subsequent Event | ||||
Class of Stock [Line Items] | ||||
Consideration received on transaction | $ 4,400,000 | $ 4,400,000 |
MERGER AND ACQUISITION (Details
MERGER AND ACQUISITION (Details) - Lobesity Acquisition - USD ($) $ in Millions | 12 Months Ended | |
Jul. 19, 2021 | Dec. 31, 2021 | |
Business Acquisition [Line Items] | ||
Cash consideration | $ 2.3 | $ 2.3 |
Common stock consideration (in shares) | 120,861 | |
Regulatory and clinical milestone payments | $ 45.5 | |
Number of shares subject to restrictions (in shares) | 30,216 | |
Restriction period | 18 months | |
Value of common stock acquired | 2.6 | |
Transaction cost | $ 0.2 | |
Maximum | ||
Business Acquisition [Line Items] | ||
Regulatory and clinical milestone payments | $ 58 | |
Sales related milestone payments | $ 50 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment, Net, by Type [Abstract] | ||
Property and equipment, gross | $ 87,966 | $ 85,124 |
Less: Accumulated depreciation | (77,553) | (69,030) |
Property and equipment, net | 10,413 | 16,094 |
Depreciation | 8,523 | 7,573 |
Furniture and fixtures | ||
Property, Plant and Equipment, Net, by Type [Abstract] | ||
Property and equipment, gross | 11,552 | 11,552 |
Computer equipment | ||
Property, Plant and Equipment, Net, by Type [Abstract] | ||
Property and equipment, gross | 46,420 | 43,578 |
Leasehold improvements | ||
Property, Plant and Equipment, Net, by Type [Abstract] | ||
Property and equipment, gross | $ 29,994 | $ 29,994 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) | 12 Months Ended | ||
Apr. 05, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | |||
Shares issued, price per share (in dollars per share) | $ 20 | ||
April 2021 Offering | |||
Related Party Transaction [Line Items] | |||
Number of shares issued on transaction (in shares) | 1,725,000 | ||
LifeSci Advisors, LLC | |||
Related Party Transaction [Line Items] | |||
Related party transaction, expense | $ 300,000 | $ 300,000 | |
Payable to related parties | 100,000 | ||
LifeSci Communications, LLC | |||
Related Party Transaction [Line Items] | |||
Related party transaction, expense | $ 200,000 | $ 300,000 | |
Chief Executive Officer, Chief Financial Officer, and Chairman of Board of Directors | April 2021 Offering | |||
Related Party Transaction [Line Items] | |||
Number of shares issued on transaction (in shares) | 22,500 | ||
Consideration received on transaction | $ 450,000 |
DEBT - Narrative (Details)
DEBT - Narrative (Details) | 7 Months Ended | 12 Months Ended | ||||||
Jul. 01, 2023 USD ($) | Nov. 07, 2022 USD ($) trading_day $ / shares | Jul. 15, 2022 USD ($) tradingDay $ / shares | Jan. 10, 2020 USD ($) $ / shares | Jun. 01, 2023 USD ($) | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) | Mar. 31, 2023 USD ($) | |
Debt Instrument [Line Items] | ||||||||
Amortization of debt discount | $ 1,831,607 | $ 43,983 | ||||||
Repayments of debt | 0 | 58,199 | ||||||
Payments of debt issuance costs | 1,088,294 | 0 | ||||||
Change in restricted cash | 17,334,353 | (9,141,897) | ||||||
Interest paid | 835,038 | 569 | ||||||
Convertible Debt | 2020 Convertible Note | ||||||||
Debt Instrument [Line Items] | ||||||||
Convertible notes payable, net | $ 2,750,000 | |||||||
Conversion price (in dollars per share) | $ / shares | $ 65 | |||||||
Proceeds from notes payable | $ 2,500,000 | |||||||
Less: unamortized debt discount and OID | $ 250,000 | |||||||
Debt discount and derivative liability at the issuance date | $ 400,000 | |||||||
Amortization of debt discount | 0 | 44,000 | ||||||
Interest rate | 10% | |||||||
Repayments of debt | $ 100,000 | |||||||
Convertible Debt | 2022 Convertible Note | ||||||||
Debt Instrument [Line Items] | ||||||||
Convertible notes payable, net | $ 21,000,000 | |||||||
Conversion price (in dollars per share) | $ / shares | $ 7.06 | |||||||
Less: unamortized debt discount and OID | $ 1,100,000 | |||||||
Debt discount and derivative liability at the issuance date | $ 2,000,000 | |||||||
Amortization of debt discount | $ 1,800,000 | |||||||
Percentage of OID | 5% | |||||||
Aggregate limit of additional principal amount available for issuance | $ 70,000,000 | $ 70,000,000 | ||||||
Payments of debt issuance costs | $ 1,100,000 | |||||||
Debt issuance cost, amortization period | 2 years 6 months | 1 year 3 months 18 days | ||||||
Change in restricted cash | $ 6,300,000 | |||||||
Debt instrument, term | 3 years | |||||||
Lowest daily VWAP (as a percent) | 0.92 | |||||||
Threshold trading days | trading_day | 3 | |||||||
Debt instrument, floor price (in dollars per share) | $ / shares | $ 2 | |||||||
Total market capitalization (less than) | $ 100,000,000 | |||||||
Total market capitalization, number of consecutive trading days | tradingDay | 5 | |||||||
Redemption price (as a percentage) | 125% | |||||||
Periodic payment, interest | $ 100,000 | |||||||
Interest paid | $ 800,000 | |||||||
Debt conversion, converted instrument, shares issued (in shares) | shares | 55,719 | |||||||
Debt instrument, interest rate, effective percentage | 24.70% | |||||||
Unamortized discount and OID | $ 2,300,000 | |||||||
Convertible Debt | 2022 Convertible Note | Debt Instrument, Redemption, Period One | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, convertible settlement cash | 24,000,000 | |||||||
Convertible Debt | 2022 Convertible Note | Debt Instrument, Redemption, Period Two | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, convertible settlement cash | 21,900,000 | |||||||
Convertible Debt | 2022 Convertible Note | Debt Instrument, Redemption, Period Three | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, convertible settlement cash | $ 26,100,000 | |||||||
Convertible Debt | 2022 Convertible Note | Forecast | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt periodic payment | $ 1,680,000 | |||||||
Principal payments | $ 882,000 | |||||||
Debt covenant, minimum financing requirement | $ 25,000,000 | |||||||
Convertible Debt | 2022 Convertible Note | Minimum | ||||||||
Debt Instrument [Line Items] | ||||||||
Interest rate floor upon default (as a percent) | 0.06 | |||||||
Debt instrument, covenant compliance, liquidity requirement (as a percent) | 80% | 110% | ||||||
Shares reserved requirement (as a percentage) | 200% | |||||||
Debt instrument, redemption premium, percentage | 5% | |||||||
Convertible Debt | 2022 Convertible Note | Maximum | ||||||||
Debt Instrument [Line Items] | ||||||||
Interest rate floor upon default (as a percent) | 0.18 | |||||||
Debt instrument, redemption premium, percentage | 15% | |||||||
Convertible Debt | 2022 Convertible Note | Weighted Average | ||||||||
Debt Instrument [Line Items] | ||||||||
Conversion price (in dollars per share) | $ / shares | $ 1.89 | |||||||
Convertible Debt | 2022 Convertible Note | London Interbank Offered Rate (LIBOR) | ||||||||
Debt Instrument [Line Items] | ||||||||
Variable spread on benchmark rate (as a percent) | 5% |
DEBT - Schedule of Convertible
DEBT - Schedule of Convertible Debt (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Convertible note payable, net | $ 19,616,313 | $ 0 |
Unsecured Convertible Promissory Note | ||
Debt Instrument [Line Items] | ||
Convertible notes payable, net | 22,050,000 | |
Less: principal payments of debt | (105,000) | |
Less: unamortized debt discount and OID | (2,328,687) | |
Convertible note payable, net | $ 19,616,313 |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) $ in Millions | 12 Months Ended | ||||||
Apr. 11, 2022 USD ($) shares | Aug. 06, 2021 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2016 USD ($) | Jul. 19, 2021 USD ($) | May 06, 2020 licenseAgreement | |
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
Milestone payment | $ 0.5 | ||||||
Number of amended and restated license agreements | licenseAgreement | 2 | ||||||
Accrued milestone fees | $ 0.5 | $ 0.6 | |||||
European Biomedical Research Institute Of Salerno, Italy | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
License fees | $ 1 | ||||||
Milestone payment | 0.5 | ||||||
European Biomedical Research Institute Of Salerno, Italy | Common Stock | License Agreement | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
Consideration received on transaction | $ 0.5 | ||||||
European Biomedical Research Institute Of Salerno, Italy | Common Stock, Unregistered | License Agreement | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
Number of shares issued on transaction (in shares) | shares | 43,708 | ||||||
Lobesity Acquisition | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
Regulatory and clinical milestone payments | $ 45.5 | ||||||
Maximum | Lobesity Acquisition | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
Regulatory and clinical milestone payments | 58 | ||||||
Sales related milestone payments | 50 | ||||||
Alba Agreement | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
License fees | $ 0.5 | ||||||
Milestone payment | 1.5 | ||||||
Sales range, minimum | 100 | ||||||
Sales range, maximum | 1,500 | ||||||
Milestone sales target value | 1,500 | ||||||
Alba Agreement | License and Service | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
License and service revenue | 150 | ||||||
Payment for sale of product | $ 2.5 | ||||||
Cedars License | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
Milestone payment | 9.4 | ||||||
Lobesity License | Lobesity Acquisition | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
Regulatory and clinical milestone payments | 45.5 | ||||||
Lobesity License | Maximum | Lobesity Acquisition | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
Regulatory and clinical milestone payments | 58 | ||||||
Sales related milestone payments | $ 50 | ||||||
U.S and EU | Amunix License, GLP-1 | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
Milestone payment | 70.4 | ||||||
U.S and EU | Amunix License, GLP-2 | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
Milestone payment | 60.1 | ||||||
China and Related Territories | Amunix License, GLP-1 | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
Milestone payment | 20.5 | ||||||
South Korea And Eastern Asia | Amunix License, GLP-1 | |||||||
Assets Sold under Agreements to Repurchase [Line Items] | |||||||
Milestone payment | $ 20.5 |
STOCKHOLDERS' EQUITY (DEFICIT)
STOCKHOLDERS' EQUITY (DEFICIT) - Narrative (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Subsidiary, Sale of Stock [Line Items] | ||
Capital stock authorized (in shares) | 560,000,000 | |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock authorized (in shares) | 550,000,000 | 550,000,000 |
Preferred stock authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock issued (in shares) | 0 | 0 |
Preferred stock outstanding (in shares) | 0 | 0 |
Common stock outstanding (in shares) | 13,036,356 | 12,911,776 |
Truist Securities, Inc | ||
Subsidiary, Sale of Stock [Line Items] | ||
Sale of stock, agent commissions fee (as a percentage) | 3% | |
Truist Securities, Inc | At-the-Market Offering | ||
Subsidiary, Sale of Stock [Line Items] | ||
Number of shares issued on transaction (in shares) | 0 | 0 |
STOCKHOLDERS' EQUITY (DEFICIT_2
STOCKHOLDERS' EQUITY (DEFICIT) - Reserve Shares of Common Stock (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Class of Stock [Line Items] | ||
Capital shares reserved for future issuance (in shares) | 30,893,290 | 2,470,890 |
Outstanding stock options | ||
Class of Stock [Line Items] | ||
Capital shares reserved for future issuance (in shares) | 1,458,038 | 1,044,739 |
Warrants to purchase common stock | ||
Class of Stock [Line Items] | ||
Capital shares reserved for future issuance (in shares) | 1,152,211 | 1,152,211 |
Shares reserved for issuance upon conversion of convertible debt (Note 6) | ||
Class of Stock [Line Items] | ||
Capital shares reserved for future issuance (in shares) | 27,717,921 | 0 |
For possible future issuance under the Company's incentive plans | ||
Class of Stock [Line Items] | ||
Capital shares reserved for future issuance (in shares) | 565,120 | 273,940 |
SHARE-BASED COMPENSATION - Narr
SHARE-BASED COMPENSATION - Narrative (Details) | 12 Months Ended | ||||||
Jan. 01, 2022 shares | Apr. 23, 2021 shares | Jan. 01, 2021 | Dec. 31, 2022 USD ($) equity-basedIncentivePlan $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Jun. 22, 2022 shares | Apr. 30, 2020 shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of stock option plans | equity-basedIncentivePlan | 3 | ||||||
Expected term | 10 years | ||||||
Sale of stock, extended option period | 12 months | ||||||
Share-based compensation | $ | $ 3,938,000 | $ 2,413,000 | |||||
Total share-based compensation | $ | $ 3,938,000 | $ 2,413,000 | |||||
Capital shares reserved for future issuance (in shares) | 30,893,290 | 2,470,890 | |||||
Options outstanding under the 2015 Stock Incentive Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of options outstanding (in shares) | 179,630 | 265,067 | |||||
Options granted (in shares) | 0 | 0 | |||||
Intrinsic value of options exercised | $ | $ 635,000 | ||||||
Exercise of stock options (in shares) | 0 | ||||||
Fair value of stock option awards vested | $ | 49,000 | ||||||
Options vested (in shares) | 0 | ||||||
Unrecognized compensation costs | $ | $ 0 | ||||||
Private Plan Option Modifications | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of options outstanding (in shares) | 85,414 | ||||||
Share-based compensation | $ | $ 300,000 | ||||||
Options outstanding under the 2012 Omnibus Incentive Plan, as amended | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of options outstanding (in shares) | 1,192,233 | 730,377 | |||||
Options granted (in shares) | 470,631 | ||||||
Intrinsic value of options exercised | $ | $ 39,000 | ||||||
Exercise of stock options (in shares) | 0 | ||||||
Fair value of stock option awards vested | $ | $ 3,700,000 | 800,000 | |||||
Unrecognized compensation costs | $ | 6,500,000 | ||||||
Share-based compensation | $ | $ 1,100,000 | $ 100,000 | |||||
Purchase price of common stock, percent | 5% | 5% | |||||
Number of additional shares authorized (in shares) | 645,589 | ||||||
Weighted-average grant date fair value of shares granted (in dollars per share) | $ / shares | $ 9.89 | $ 18 | |||||
Weighted-average period for recognizing cost | 2 years 7 months 6 days | ||||||
Capital shares reserved for future issuance (in shares) | 565,120 | 273,940 | |||||
Options outstanding under the 2022 Stock Incentive Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of options outstanding (in shares) | 36,880 | 0 | |||||
Options granted (in shares) | 36,880 | 0 | |||||
Exercise of stock options (in shares) | 0 | ||||||
Fair value of stock option awards vested | $ | $ 22,000 | ||||||
Unrecognized compensation costs | $ | $ 100,000 | ||||||
Weighted-average grant date fair value of shares granted (in dollars per share) | $ / shares | $ 3.64 | ||||||
Weighted-average period for recognizing cost | 2 years 6 months | ||||||
Capital shares reserved for future issuance (in shares) | 600,000 | ||||||
Options available for future grants (in shares) | 565,120 | ||||||
Minimum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period | 3 years | ||||||
Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period | 4 years | ||||||
RDD Options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Options granted (in shares) | 0 | 0 | |||||
Intrinsic value of options exercised | $ | $ 27,000 | ||||||
Exercise of stock options (in shares) | 0 | ||||||
Employee Stock Option | Options outstanding under the 2012 Omnibus Incentive Plan, as amended | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Expected term | 10 years | ||||||
RSUs | Options outstanding under the 2012 Omnibus Incentive Plan, as amended | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
RSUs granted (in shares) | 0 | 0 | |||||
Nonvested number (in shares) | 0 | ||||||
Total share-based compensation | $ | $ 0 | $ 200,000 | |||||
RDD Pharma Ltd. | RDD Options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of options outstanding (in shares) | 50,714 |
SHARE-BASED COMPENSATION - Stoc
SHARE-BASED COMPENSATION - Stock Option Activity (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Options outstanding under the 2015 Stock Incentive Plan | ||
Number of Options | ||
Options outstanding at beginning of period (in shares) | 265,067 | |
Options granted (in shares) | 0 | 0 |
Options forfeited (in shares) | (85,437) | |
Options exercised (in shares) | 0 | |
Options outstanding at end of period (in shares) | 179,630 | 265,067 |
Options exercisable (in shares) | 179,630 | |
Options vested and expected to vest (in shares) | 179,630 | |
Weighted-Average Exercise Price | ||
Weighted-average exercise price of options outstanding at beginning of period (in dollars per share) | $ 33.80 | |
Options granted (in dollars per share) | 0 | |
Options forfeited (in dollars per share) | 41.76 | |
Options exercised (in dollars per share) | 0 | |
Weighted-average exercise price of options outstanding at end of period (in dollars per share) | 29.88 | $ 33.80 |
Weighted-average exercise price of options exercisable (in dollars per share) | 29.88 | |
Weighted-average exercise price of options vested and expected to vest (in dollars per share) | $ 29.88 | |
Aggregate Intrinsic Value | ||
Outstanding | $ 0 | $ 837,459 |
Exercisable | 0 | |
Vested and expected to vest | $ 0 | |
Weighted-Average Remaining Contractual Life (in years) | ||
Outstanding | 2 years 8 months 12 days | 2 years 8 months 12 days |
Exercisable | 2 years 8 months 12 days | |
Vested and expected to vest | 2 years 8 months 12 days | |
2012 Omnibus Incentive Plan | ||
Number of Options | ||
Options outstanding at beginning of period (in shares) | 730,377 | |
Options granted (in shares) | 470,631 | |
Options forfeited (in shares) | (8,775) | |
Options exercised (in shares) | 0 | |
Options outstanding at end of period (in shares) | 1,192,233 | 730,377 |
Options exercisable (in shares) | 519,256 | |
Options vested and expected to vest (in shares) | 1,153,870 | |
Weighted-Average Exercise Price | ||
Weighted-average exercise price of options outstanding at beginning of period (in dollars per share) | $ 23.70 | |
Options granted (in dollars per share) | 14.71 | |
Options forfeited (in dollars per share) | 14.80 | |
Options exercised (in dollars per share) | 0 | |
Weighted-average exercise price of options outstanding at end of period (in dollars per share) | 20.22 | $ 23.70 |
Weighted-average exercise price of options exercisable (in dollars per share) | 23.78 | |
Weighted-average exercise price of options vested and expected to vest (in dollars per share) | $ 20.32 | |
Aggregate Intrinsic Value | ||
Outstanding | $ 0 | $ 2,296,720 |
Exercisable | 0 | |
Vested and expected to vest | $ 0 | |
Weighted-Average Remaining Contractual Life (in years) | ||
Outstanding | 8 years 1 month 6 days | 8 years 6 months |
Exercisable | 7 years 4 months 24 days | |
Vested and expected to vest | 8 years 1 month 6 days | |
2022 Stock Incentive Plan | ||
Number of Options | ||
Options outstanding at beginning of period (in shares) | 0 | |
Options granted (in shares) | 36,880 | 0 |
Options forfeited (in shares) | 0 | |
Options exercised (in shares) | 0 | |
Options outstanding at end of period (in shares) | 36,880 | 0 |
Options exercisable (in shares) | 5,940 | |
Options vested and expected to vest (in shares) | 34,927 | |
Expected term of options (in years) | 0 years | |
Weighted-Average Exercise Price | ||
Weighted-average exercise price of options outstanding at beginning of period (in dollars per share) | $ 0 | |
Options granted (in dollars per share) | 5.27 | |
Options forfeited (in dollars per share) | 0 | |
Options exercised (in dollars per share) | 0 | |
Weighted-average exercise price of options outstanding at end of period (in dollars per share) | 5.27 | $ 0 |
Weighted-average exercise price of options exercisable (in dollars per share) | 5,290,000 | |
Weighted-average exercise price of options vested and expected to vest (in dollars per share) | $ 5,270,000 | |
Aggregate Intrinsic Value | ||
Outstanding | $ 0 | $ 0 |
Exercisable | 0 | |
Vested and expected to vest | $ 0 | |
Weighted-Average Remaining Contractual Life (in years) | ||
Outstanding | 9 years 6 months | 0 years |
Exercisable | 9 years 6 months | |
Vested and expected to vest | 9 years 6 months | |
RDD Options | ||
Number of Options | ||
Options outstanding at beginning of period (in shares) | 49,295 | |
Options granted (in shares) | 0 | |
Options forfeited (in shares) | 0 | |
Options exercised (in shares) | 0 | |
Options outstanding at end of period (in shares) | 49,295 | 49,295 |
Options exercisable (in shares) | 49,295 | |
Weighted-Average Exercise Price | ||
Weighted-average exercise price of options outstanding at beginning of period (in dollars per share) | $ 12.60 | |
Options granted (in dollars per share) | ||
Options forfeited (in dollars per share) | ||
Options exercised (in dollars per share) | ||
Weighted-average exercise price of options outstanding at end of period (in dollars per share) | 12.60 | $ 12.60 |
Weighted-average exercise price of options exercisable (in dollars per share) | $ 12.60 | |
Aggregate Intrinsic Value | ||
Outstanding | $ 8,269 | $ 343,486 |
Exercisable | $ 8,269 | |
Weighted-Average Remaining Contractual Life (in years) | ||
Outstanding | 2 years 3 months 18 days | 3 years 3 months 18 days |
Exercisable | 2 years 3 months 18 days |
SHARE-BASED COMPENSATION - Opti
SHARE-BASED COMPENSATION - Options Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
2012 Omnibus Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Expected stock-price volatility, minimum | 79% | 68% |
Expected stock-price volatility, maximum | 85% | |
Risk-free interest rate, minimum | 1.40% | 0.10% |
Risk-free interest rate, maximum | 1.90% | 1.10% |
2012 Omnibus Incentive Plan | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term of options (in years) | 2 years 3 months 18 days | |
2012 Omnibus Incentive Plan | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term of options (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days |
2022 Stock Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Expected stock-price volatility, minimum | 79% | |
Expected stock-price volatility, maximum | 81% | |
Expected stock-price volatility | 0% | |
Risk-free interest rate, minimum | 3% | |
Risk-free interest rate, maximum | 3.20% | |
Risk-free interest rate | 0% | |
Expected term of options (in years) | 0 years | |
2022 Stock Incentive Plan | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term of options (in years) | 5 years 9 months 18 days | |
2022 Stock Incentive Plan | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term of options (in years) | 6 years |
SHARE-BASED COMPENSATION - Fina
SHARE-BASED COMPENSATION - Financial Statements (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share-based compensation | $ 3,938,000 | $ 2,413,000 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share-based compensation | 950,000 | 773,000 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share-based compensation | $ 2,988,000 | $ 1,640,000 |
INCOME TAXES - Deferred Tax Ass
INCOME TAXES - Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | ||
Domestic tax loss and contribution carryforwards | $ 21,419,800 | $ 18,656,500 |
Foreign tax loss carryforwards | 4,531,900 | 5,134,700 |
Tax credits | 3,718,100 | 2,534,600 |
Share-based compensation | 3,908,000 | 3,647,100 |
Intangible assets | 2,957,100 | 3,096,800 |
Accrued expenses | 114,300 | 371,200 |
Section 174 - capitalized research and development | 5,940,400 | 0 |
Research and development expenses | 0 | 20,500 |
Other | 19,200 | 5,900 |
Valuation allowance | (42,608,800) | (33,467,300) |
Total deferred tax assets, noncurrent | $ 0 | $ 0 |
INCOME TAXES - Narrative (Detai
INCOME TAXES - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes [Line Items] | ||
Increase (decrease) in valuation allowance | $ 9,764,900 | $ 6,265,600 |
Contribution carryforwards | 10,300 | |
Research and development credits | 3,700,000 | |
Unrecognized tax benefits | 0 | 0 |
Interest and penalties accrued on uncertain tax positions | 0 | $ 0 |
Domestic Tax Authority | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards | 101,800,000 | |
Operating loss carryforward, subject to expire | 3,600,000 | |
Operating loss carryforward, not subject to expire | 98,300,000 | |
Research and development credits | 33,100 | |
State and Local Jurisdiction | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards | 102,100,000 | |
Operating loss carryforward, subject to expire | 102,000,000 | |
Operating loss carryforward, not subject to expire | 100,000 | |
Foreign Tax Authority | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards | $ 19,700,000 |
INCOME TAXES - Income Tax Recon
INCOME TAXES - Income Tax Reconciliation (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Amount | ||
Income tax benefit at statutory rate | $ (9,190,900) | $ (7,726,800) |
State income taxes, net of federal tax benefit | (41,000) | (27,900) |
Non-deductible expenses | 314,900 | 4,500 |
Credits | (1,210,000) | (1,176,500) |
Foreign rate differential | 3,100 | 2,400 |
Change in state tax rate | (8,500) | 1,764,100 |
Other | 367,500 | 894,600 |
Change in valuation allowance | 9,764,900 | 6,265,600 |
Income tax benefit | $ 0 | $ 0 |
% of Pretax Earnings | ||
Income tax benefit at statutory rate (as a percentage) | 21% | 21% |
State income taxes, net of federal tax benefit (as a percentage) | 0.10% | 0.10% |
Non-deductible expenses (as a percentage) | (0.70%) | 0% |
Credits (as a percentage) | 2.70% | 3.20% |
Foreign rate differential (as a percentage) | 0% | 0% |
Change in state tax rate (as a percentage) | 0% | (4.80%) |
Other (as a percentage) | (0.80%) | (2.50%) |
Change in valuation allowance (as a percentage) | (22.30%) | (17.00%) |
Income tax benefit (as a percentage) | 0% | 0% |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Narrative (Details) | 1 Months Ended | 12 Months Ended | ||
Oct. 03, 2022 USD ($) $ / ft² | Jul. 31, 2020 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Loss Contingencies [Line Items] | ||||
Severance provisions, annual base salary period | 12 months | |||
Severance provisions, continuation of health insurance benefits | 12 months | |||
Severance provisions, termination or resignation, annual base salary period | 18 months | |||
Severance expense | $ 400,000 | |||
Period of equal installment payments | 12 months | |||
Accrued severance obligation | $ 0 | |||
Term of contract | 4 years | |||
Operating lease annual rental payments | $ 72,000 | |||
Operating lease monthly rental payment | $ 6,000 | |||
Renewal term | 3 years | |||
Right-of-use asset | $ 233,206 | 112,302 | 166,618 | |
Total | $ 233,206 | $ 113,142 | ||
Operating lease, weighted average discount rate, percent | 12% | |||
Operating lease, cost | $ 71,520 | $ 71,520 | ||
Cash paid for operating leases | $ 100,000 | |||
Letter of Credit | ||||
Loss Contingencies [Line Items] | ||||
Restricted cash | $ 100,000 | |||
Minimum | Letter of Credit | ||||
Loss Contingencies [Line Items] | ||||
Restricted cash | $ 23,600 | |||
Raleigh, North Carolina | ||||
Loss Contingencies [Line Items] | ||||
Term of contract | 126 months | |||
Renewal term | 5 years | |||
Base rent payment | $ 24,000 | |||
Base rent payment per square foot (in dollars per square foot) | $ / ft² | 38 | |||
Tenant improvement allowance | $ 700,000 | |||
Raleigh, North Carolina | Maximum | ||||
Loss Contingencies [Line Items] | ||||
Base rent payment | $ 31,000 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Future Minimum Payments Due (Details) - USD ($) | Dec. 31, 2022 | Jul. 31, 2020 |
Leases [Abstract] | ||
2023 | $ 72,000 | |
2024 | 54,000 | |
Total lease payment | 126,000 | |
Less: imputed interest | (12,858) | |
Total | $ 113,142 | $ 233,206 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | |||||||||
Dec. 31, 2023 | Apr. 15, 2023 | Mar. 15, 2023 | Mar. 13, 2023 | Mar. 31, 2023 | Mar. 27, 2023 | Apr. 01, 2023 | Jan. 12, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Subsequent Event [Line Items] | ||||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||||||
Capital shares reserved for future issuance (in shares) | 30,893,290 | 2,470,890 | ||||||||
Unsecured Convertible Promissory Note | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Restricted cash | $ 16,900 | |||||||||
Subsequent Event | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Reduction in workforce (as a percent) | 52% | |||||||||
Subsequent Event | Forecast | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Workforce reduction, expected cost | $ 1,100 | |||||||||
Restructuring reserve | $ 400 | |||||||||
Cash retention bonuses (as a percent) | 50% | 50% | ||||||||
Subsequent Event | Forecast | RSUs | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Award vesting percentage | 50% | 50% | ||||||||
Subsequent Event | Forecast | RSUs | Employee | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Number of shares to be vested | 207,232 | |||||||||
Subsequent Event | Forecast | RSUs | Board Members | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Number of shares to be vested | 39,425 | |||||||||
Subsequent Event | Common Warrants | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Exercise price of warrants (in dollars per share) | $ 1.35 | |||||||||
Warrants and rights outstanding, term | 3 years 6 months | |||||||||
Subsequent Event | Placement Agent Warrants | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Capital shares reserved for future issuance (in shares) | 187,500 | |||||||||
Exercise price of warrants (in dollars per share) | $ 2 | |||||||||
Subsequent Event | Direct Offering | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Number of shares issued on transaction (in shares) | 1,300,000 | |||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | |||||||||
Consideration received on transaction | $ 4,400 | $ 4,400 | ||||||||
Subsequent Event | Direct Offering | Warrants | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Offering price (in dollars per share) | $ 1.5999 | |||||||||
Subsequent Event | Direct Offering | Pre-Funded Warrants | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Capital shares reserved for future issuance (in shares) | 1,825,000 | |||||||||
Exercise price of warrants (in dollars per share) | $ 0.0001 | |||||||||
Subsequent Event | Direct Offering | Common Warrants | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Capital shares reserved for future issuance (in shares) | 6,250,000 | |||||||||
Offering price (in dollars per share) | $ 1.60 | |||||||||
Subsequent Event | Convertible Debt | 2022 Convertible Note | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Convertible notes payable | $ 4,950 | |||||||||
Minimum liquidity requirement | 500 | |||||||||
Minimum financing amount required | 25,000 | |||||||||
Subsequent Event | Unsecured Convertible Promissory Note | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Restricted cash | $ 16,800 |