Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | May 05, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Securities Act File Number | 001-37348 | |
Entity Registrant Name | Corbus Pharmaceuticals Holdings, Inc. | |
Entity Central Index Key | 0001595097 | |
Entity Tax Identification Number | 46-4348039 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 500 River Ridge Drive | |
Entity Address, City or Town | Norwood | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02062 | |
City Area Code | (617) | |
Local Phone Number | 963-0100 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | CRBP | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 4,215,133 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 7,324,437 | $ 17,002,715 |
Investments | 36,902,563 | 42,194,296 |
Restricted cash | 192,475 | 192,475 |
Prepaid expenses and other current assets | 1,445,524 | 791,616 |
Total current assets | 45,864,999 | 60,181,102 |
Restricted cash | 477,425 | 477,425 |
Property and equipment, net | 1,431,945 | 1,613,815 |
Operating lease right of use assets | 3,688,468 | 3,884,252 |
Other assets | 182,436 | 155,346 |
Total assets | 51,645,273 | 66,311,940 |
Current liabilities: | ||
Notes payable | 203,258 | 353,323 |
Accounts payable | 1,322,990 | 2,173,963 |
Accrued expenses | 6,468,302 | 5,999,252 |
Derivative liability | 36,868 | 36,868 |
Operating lease liabilities, current | 1,318,671 | 1,280,863 |
Current portion of long-term debt | 5,008,858 | 2,795,669 |
Total current liabilities | 14,358,947 | 12,639,938 |
Long-term debt, net of debt discount | 13,972,360 | 15,984,426 |
Other long-term liabilities | 2,522,205 | 22,205 |
Operating lease liabilities, noncurrent | 4,332,809 | 4,675,354 |
Total liabilities | 35,186,321 | 33,321,923 |
Stockholders' equity | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2023 and December 31, 2022. See Note 11 | 0 | 0 |
Common stock, $0.0001 par value; 300,000,000 shares authorized, 4,215,133 and 4,171,297 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 422 | 417 |
Additional paid-in capital | 426,352,478 | 425,196,359 |
Accumulated deficit | (409,825,479) | (392,080,667) |
Accumulated other comprehensive loss | (68,469) | (126,092) |
Total stockholders’ equity | 16,458,952 | 32,990,017 |
Total liabilities and stockholders’ equity | $ 51,645,273 | $ 66,311,940 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 |
Common Stock, Shares Authorized | 300,000,000 | 300,000,000 |
Common Stock, Shares, Issued | 4,215,133 | 4,171,297 |
Common Stock, Shares, Outstanding | 4,215,133 | 4,171,297 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating expenses: | ||
Research and development | $ 13,388,343 | $ 3,286,236 |
General and administrative | 3,908,682 | 5,230,923 |
Total operating expenses | 17,297,025 | 8,517,159 |
Operating loss | (17,297,025) | (8,517,159) |
Other income (expense), net: | ||
Other income (expense), net | 229,507 | (193,351) |
Interest income (expense), net | (678,022) | (458,909) |
Change in fair value of derivative liability | 0 | |
Foreign currency exchange gain (loss), net | 728 | (267,823) |
Other income (expense), net | (447,787) | (920,083) |
Net loss | $ (17,744,812) | $ (9,437,242) |
Net loss per share ,basic | $ (4.24) | $ (2.26) |
Net loss per share, diluted | $ (4.24) | $ (2.26) |
Weighted average number of common shares outstanding-basic | 4,181,556 | 4,170,043 |
Weighted average number of common shares outstanding, diluted | 4,181,556 | 4,170,043 |
Comprehensive loss: | ||
Net loss | $ (17,744,812) | $ (9,437,242) |
Other comprehensive income (loss): | ||
Change in unrealized gain (loss) on marketable debt securities | 57,623 | (107,248) |
Total other comprehensive income (loss) | 57,623 | (107,248) |
Total comprehensive loss | $ (17,687,189) | $ (9,544,490) |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - USD ($) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | AOCI Attributable to Parent [Member] |
Beginning balance, value at Dec. 31, 2021 | $ 69,108,027 | $ 416 | $ 418,903,820 | $ (349,733,764) | $ (62,445) |
Beginning balance, shares at Dec. 31, 2021 | 4,169,631 | ||||
Issuance of common stock, net of issuance costs | 1 | $ 1 | |||
Issuance of common stock, net of issuance costs, shares | 833 | ||||
Stock-based compensation expense | 1,591,746 | 1,591,746 | |||
Unrealized loss on marketable debt securities | (107,248) | (107,248) | |||
Net loss | (9,437,242) | (9,437,242) | |||
Ending balance, value at Mar. 31, 2022 | 61,155,284 | $ 417 | 420,495,566 | (359,171,006) | (169,693) |
Ending balance, shares at Mar. 31, 2022 | 4,170,464 | ||||
Beginning balance, value at Dec. 31, 2022 | 32,990,017 | $ 417 | 425,196,359 | (392,080,667) | (126,092) |
Beginning balance, shares at Dec. 31, 2022 | 4,171,297 | ||||
Stock-based compensation expense | 1,026,379 | 1,026,379 | |||
Issuance of common stock upon exercise of stock options | $ 129,745 | $ 5 | 129,740 | ||
Issuance of common stock upon exercise of stock options, shares | 43,836 | 43,836 | |||
Unrealized loss on marketable debt securities | $ 57,623 | 57,623 | |||
Net loss | (17,744,812) | (17,744,812) | |||
Ending balance, value at Mar. 31, 2023 | $ 16,458,952 | $ 422 | $ 426,352,478 | $ (409,825,479) | $ (68,469) |
Ending balance, shares at Mar. 31, 2023 | 4,215,133 |
Condensed Consolidated Statem_3
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) (Parenthetical) | 3 Months Ended |
Mar. 31, 2022 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Stock issuance cost | $ 0 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (17,744,812) | $ (9,437,242) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 1,026,379 | 1,591,746 |
Depreciation and amortization | 181,870 | 195,719 |
Net amortization on premium of investments | (201,908) | 454,978 |
(Gain) Loss on foreign exchange | (2,917) | 349,226 |
Amortization of debt discount | 201,123 | 176,901 |
Realized loss on investments | 1,561 | 7,752 |
Changes in operating assets and liabilities: | ||
(Increase) Decrease in prepaid expenses and other current assets | (561,219) | 203,150 |
Increase in other assets | (27,090) | (28,890) |
Decrease in operating lease right of use asset | (195,784) | (172,734) |
Increase in other long-term liabilities | 2,500,000 | 0 |
(Decrease) Increase in accounts payable | (848,056) | 565,308 |
Increase (Decrease) in accrued expenses | 469,050 | (4,596,906) |
Decrease in operating lease liabilities | (304,737) | (269,826) |
Net cash used in operating activities | (15,114,972) | (10,615,350) |
Cash flows from investing activities: | ||
Purchases of investments | (13,308,006) | (6,471,309) |
Proceeds from sales and maturities of investments | 18,857,710 | 49,446,935 |
Purchases of property and equipment | 0 | (13,449) |
Net cash provided by investing activities | 5,549,704 | 42,962,177 |
Cash flows from financing activities: | ||
Repayment of short-term borrowings | (150,066) | (327,125) |
Proceeds from issuance of common stock | 37,056 | 0 |
Net cash used in provided by financing activities | (113,010) | (327,125) |
Net increase (decrease) in cash, cash equivalents, and restricted cash | (9,678,278) | 32,019,702 |
Cash, cash equivalents, and restricted cash at beginning of the period | 17,672,615 | 25,676,532 |
Cash, cash equivalents, and restricted cash at end of the period | 7,994,337 | 57,696,234 |
Supplemental disclosure of cash flow information and non-cash transactions: | ||
Cash paid during the period for interest | 641,458 | 430,998 |
Proceeds from issuance of common stock not yet received | $ 92,689 | $ 0 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | 1. NATURE OF OPERATIONS Business Corbus Pharmaceuticals Holdings, Inc. (the “Company” or “Corbus”) is a precision oncology company committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus' internally developing pipeline includes CRB-701, a next generation antibody drug conjugate (ADC) that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, and CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. The Company has also developed CRB-913, an endocannabinoid small molecule drug, for the treatment of obesity and is seeking partners to fund further development. Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets and raising capital. The Company’s business is subject to significant risks and uncertainties and the Company will be dependent on raising substantial additional capital before it becomes profitable, and it may never achieve profitability. The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions and accounts have been eliminated in consolidation. In the opinion of management of the Company, the accompanying unaudited condensed consolidated interim financial statements reflect all adjustments (which include only normal recurring adjustments) necessary to present fairly, in all material respects, the condensed consolidated financial position of the Company as of March 31, 2023 and the results of its operations and changes in stockholders’ equity for the three months ended March 31, 2023 and 2022 and its cash flows for the three months ended March 31, 2023 and 2022. The December 31, 2022 condensed consolidated balance sheet was derived from audited financial statements. The Company prepared the condensed consolidated financial statements following the requirements of the U.S. Securities and Exchange Commission (the “SEC”) for interim reporting. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) have been condensed or omitted. It is suggested that these condensed consolidated financial statements be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 , filed on March 7, 2023 (the “2022 Annual Report”). The results of operations for such interim periods are not necessarily indicative of the operating results for the full fiscal year. |
LIQUIDITY
LIQUIDITY | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LIQUIDITY | 2. LIQUIDITY The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses since inception and as of March 31, 2023, had an accumulated deficit of approximately $ 409,825,000 . The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research funding, development of its product candidates and its pre-clinical and clinical programs, strategic alliances and the development of its administrative organization. The Company expects the cash, cash equivalents, and investments of $ 44,227,000 at March 31, 2023 will be sufficient to meet its operating and capital requirements at least twelve months from the issuance of this Quarterly Report on Form 10-Q. The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of the Company’s clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to the Company. Lack of necessary funds may require the Company to, among other things, delay, scale back or eliminate some or all of the Company’s planned clinical or pre-clinical trials. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | 3. SIGNIFICANT ACCOUNTING POLICIES A summary of the significant accounting policies followed by the Company in the preparation of the condensed consolidated financial statements is as follows: Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. Reverse Stock Split On February 14, 2023, the Company completed a 1-for-30 reverse stock split of its outstanding common stock (the “Reverse Stock Split”). The Reverse Stock Split did not change the number of authorized shares of common stock or par value. All references in these condensed consolidated financial statements to shares, share prices, exercise prices, and other per share information in all periods have been adjusted, on a retroactive basis, to reflect the Reverse Stock Split (see Note 12). Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions and accounts have been eliminated in consolidation. Use of Estimates The process of preparing financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and changes in estimates may occur. The most significant estimates are related to stock-based compensation expense, the accrual of research, product development and clinical obligations, and the valuation of warrants (see Note 9 and Note 14) and the derivative liability associated with the K2 Loan and Security Agreement (see Note 15) . Cash, Cash Equivalents, and Restricted Cash The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within 90 days from date of purchase to be cash equivalents. At March 31, 2023 and December 31, 2022, cash equivalents were comprised of money market funds, commercial paper, and other debt securities with maturities less than three months from the date of purchase. Restricted cash as of March 31, 2023 included security for a stand-by letter of credit issued in favor of a landlord for $ 669,900 of which $ 192,475 was classified in current assets and $ 477,425 was classified in noncurrent assets as of March 31, 2023. Cash, cash equivalents, and restricted cash consist of the following: March 31, 2023 December 31, 2022 Cash $ 2,897,157 $ 3,805,156 Cash equivalents 4,427,280 13,197,559 Cash and cash equivalents $ 7,324,437 $ 17,002,715 Restricted cash, current 192,475 192,475 Restricted cash, noncurrent 477,425 477,425 Restricted cash $ 669,900 $ 669,900 Total cash, cash equivalents, and restricted cash shown in the statement of cash $ 7,994,337 $ 17,672,615 As of March 31, 2023, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $ 1,986,000 of cash which was held in its subsidiaries in the United Kingdom and Australia. As of December 31, 2022 , all of the Company’s cash was held in the United States, except for approximately $ 2,805,000 of cash which was held in its subsidiaries in the United Kingdom and Australia. Investments Investments consist of debt securities and term deposits with maturities greater than 90 days at their acquisition date. The Company has classified its investments with maturities beyond one year as current, based on their highly liquid nature and because such investments represent the investment of cash that is available for current operations. The Company classifies all of its marketable debt securities as available-for-sale securities. The Company’s marketable debt securities are measured and reported at fair value using quoted prices in active markets for similar securities. Unrealized gains and losses on available-for-sale debt securities that are not related to credit losses are reported as accumulated other comprehensive gain or loss, which is a separate component of stockholders’ equity. The cost of debt securities sold is determined on a specific identification basis, and realized gains and losses are included in other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. The Company evaluates its marketable debt securities with unrealized losses for impairment. When assessing marketable debt securities for potential impairment, the Company considers available evidence, including the extent to which fair value is less than cost, whether an allowance for credit loss is required, and adverse factors that could affect the value of the securities. An impairment has occurred if the Company does not expect to recover the entire amortized cost basis of the marketable debt security. If the Company does not intend to sell the impaired debt security and it is not more likely than not required to sell the debt security before the recovery of its amortized cost basis, the amount of the impairment related to credit losses is recognized in an allowance for credit losses with an offsetting entry to Other income (expense), net. The remaining portion of the impairment related to other factors is recognized in Other comprehensive loss. Realized gains and losses for debt securities are included in Other income (expense), net. No such adjustments were necessary during the periods presented. Concentrations of Credit Risk The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company may, from time to time, have cash in its U.S. banks in excess of Federal Deposit Insurance Corporation insurance limits and in its foreign banks in excess of their local insurance limits. However, the Company believes the risk of loss is minimal as these banks are large financial institutions. Financial Instruments The carrying values of the notes payable and debt approximate their fair value due to the fact that they are at market terms. Fair Value Measurements The valuation of the Company’s debt and embedded derivatives are determined primarily by an income approach that considers the present value of net cash flows of the debt with and without prepayment and default features. These embedded debt features, which are determined to be classified as derivative liabilities are marked-to-market each reporting period, with a corresponding non-cash gain or loss charged to the current period. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, there exists a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access as of the measurement date. Level 2 – Inputs other than quoted prices included within Level 1 that are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Level 3 – Unobservable inputs for the asset or liability only used when there is little, if any, market activity for the asset or liability at the measurement date. The Company’s investments, debt, and its derivative liabilities are carried at fair value determined according to the fair value hierarchy described above. The carrying values of the Company’s prepaid expenses and other current assets and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. To determine the fair value of our embedded derivatives, management evaluates assumptions regarding the probability of certain future events. Other factors used to determine fair value include the discount rate, risk free interest rate and derivative term. The fair value recorded for the derivative liability varies from period to period. This variability may result in the actual derivative liability for a period either above or below the estimates recorded on our condensed consolidated financial statements, resulting in fluctuations in other income (expense) because of the corresponding non-cash gain or loss recorded. Property and Equipment The estimated life for the Company’s property and equipment is as follows: three years for computer hardware and software and three to five years for office furniture and equipment. The Company’s leasehold improvements and assets under capital lease are amortized over the shorter of their useful lives or the respective leases. See Note 7 for details of property and equipment and Note 8 for operating and capital lease commitments. Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities, and operating lease liabilities in the Company’s condensed consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has subleased a portion of its leased facility under an agreement considered to be an operating lease according to U.S. GAAP. The Company has not been legally released from its primary obligations under the original lease and therefore it continues to account for the original lease as it did before commencement of the sublease. The Company will record both fixed and variable payments received from the sublessee in its statement of operations on a straight-line basis as an offset to rent expense. Accruals for Research and Development Expenses and Clinical Trials As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the timing of various aspects of the expenses. The Company determines accrual estimates by taking into account discussions with applicable internal personnel and outside service providers as to the progress of clinical trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations (“CROs”) and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the three months ended March 31, 2023 and 2022 , there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. Revenue Recognition We recognize revenue in accordance with Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (“ASC 606”), which applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements, and financial instruments. Under ASC 606, we recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Research and Development Expenses Costs incurred for research and development are expensed as incurred. Nonrefundable advance payments for goods or services that have the characteristics that will be used or rendered for future research and development activities pursuant to executory contractual arrangements with third party research organizations are deferred and recognized as an expense as the related goods are delivered or the related services are performed. Asset Acquisitions We account for asset acquisitions under the accounting standards for business combinations and research and development, as applicable. In-process research and development acquired in an asset acquisition is expensed immediately unless there is an alternative future use. Subsequent payments made for the achievement of milestones are evaluated to determine whether they have an alternative future use or should be expensed. Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one operating segment, which is developing and commercializing therapeutics for cancer. As of March 31, 2023, all of the Company’s assets were located in the United States, except for approximately $ 1,986,000 of cash and cash equivalents and $ 836,000 of prepaid expenses and other assets which were held outside of the United States, principally in its subsidiary in the United Kingdom. As of December 31, 2022, all of the Company’s assets were located in the United States, except for approximately $ 2,805,000 of cash and cash equivalents and $ 136,000 of prepaid expenses and other assets which were held outside of the United States, principally in its subsidiary in the United Kingdom. Income Taxes For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded to reduce a net deferred tax benefit when it is not more likely than not that the tax benefit from the deferred tax assets will be realized. Accordingly, given the cumulative losses since inception, the Company has provided a valuation allowance equal to 100 % of the deferred tax assets in order to eliminate the deferred tax assets amounts. Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold, as well as accrued interest and penalties, if any, would be recorded as a tax expense in the current year. There were no uncertain tax positions that require accrual or disclosure to the financial statements as of March 31, 2023 or December 31, 2022 . Impairment of Long-lived Assets The Company continually monitors events and changes in circumstances that could indicate that carrying amounts of long-lived assets may not be recoverable. An impairment loss is recognized when expected undiscounted cash flows of an asset are less than an asset’s carrying value. Accordingly, when indicators of impairment are present, the Company evaluates the carrying value of such assets in relation to the operating performance and future undiscounted cash flows of the underlying assets. An impairment loss equal to the excess of the fair value of the asset over its carrying amount is recorded when it is determined that the carrying value of the asset may not be recoverable. The Company notes no impairment charges were taken in the three months ended March 31, 2023 and 2022 . Stock-based Payments The Company recognizes compensation costs resulting from the issuance of stock-based awards, including stock options and restricted stock units (“RSUs”), to employees, non-employees and directors as an expense in the statements of operations and comprehensive loss over the service period based on a measurement of fair value for each stock-based award. The fair value of each stock option grant is estimated as of the date of grant using the Black-Scholes option-pricing model. The fair value of restricted stock units is the quoted closing market price per share on the grant date. Forfeitures are estimated on the grant date based on historical experience and management’s expectations of future forfeitures. To the extent actual forfeitures differ from the estimates, the difference is recorded as a cumulative adjustment in the period in which the estimates are revised. The fair value of each grant is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period . Foreign Currency Transaction gains and losses arising from currency exchange rate fluctuations on transactions denominated in a currency other than the U.S. Dollar functional currency are recorded in Other income (expense), net in the Company’s statements of operations and comprehensive loss. Such transaction gains and losses may be realized or unrealized depending upon whether the transaction settled during the period or remains outstanding at the balance sheet date. The functional currency of the Company's foreign subsidiaries is the U.S. Dollar. Net Loss Per Common Share Basic and diluted net loss per share of the Company’s common stock has been computed by dividing net loss by the weighted average number of shares outstanding during the period. For periods in which there is a net loss, options and warrants are anti-dilutive and therefore excluded from diluted loss per share calculations. The following table sets forth the computation of basic and diluted earnings per share for the three months ended March 31, 2023 and 2022: Three Months Ended 2023 2022 Net loss $ ( 17,744,812 ) $ ( 9,437,242 ) Weighted average number of common shares-basic 4,181,556 4,170,043 Net loss per share of common stock-basic $ ( 4.24 ) $ ( 2.26 ) Warrants and stock options that have not been exercised and unvested restricted stock units (see Notes 13 and 14) have been excluded from the diluted calculation as all periods presented have a net loss and the impact of these securities would be anti-dilutive. Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) , which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes may result in earlier recognition of credit losses. In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses , which narrowed the scope and changed the effective date for non-public entities for ASU 2016-13. The FASB subsequently issued supplemental guidance within ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief (“ASU 2019-05”) . ASU 2019-05 provides an option to irrevocably elect the fair value option for certain financial assets previously measured at amortized cost basis. The Company's adoption of ASU 2016-13 as of January 1, 2023 had no impact on the Company's financial statements as there are no assets held at amortized cost on the balance sheet, and there are no credit losses associated with our available-for-sale debt securities. In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity which is intended to simplify various aspects of U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. The Company's early adoption of ASU 2020-06 as of January 1, 2023 had no impact on the Company's financial statements and disclosures. Recently Issued Accounting Pronouncements The Company considers the applicability and impact of all ASUs. Management determined that recently issued ASUs are not expected to have a material impact on its condensed consolidated financial statements. |
INVESTMENTS
INVESTMENTS | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
INVESTMENTS | 4. INVESTMENTS The following table summarizes the Company’s investments as of March 31, 2023: Amortized Cost Gross Gross Fair Value Debt Securities: Commercial paper $ 11,367,511 $ — $ — $ 11,367,511 Corporate debt securities 25,603,521 — ( 68,469 ) 25,535,052 Total $ 36,971,032 $ — $ ( 68,469 ) $ 36,902,563 The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable securities by contractual maturity as of March 31, 2023: Amortized Cost Fair Value Maturing in one year or less $ 36,971,032 $ 36,902,563 Maturing after one year but less than three years — — $ 36,971,032 $ 36,902,563 The following table summarizes the Company’s investments as of December 31, 2022: Amortized Cost Gross Gross Fair Value Debt Securities: Commercial paper $ 12,173,980 $ — $ — $ 12,173,980 Corporate debt securities 30,146,060 — ( 125,744 ) 30,020,316 Total $ 42,320,040 $ — $ ( 125,744 ) $ 42,194,296 The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable securities by contractual maturity as of December 31, 2022: Amortized Cost Fair Value Maturing in one year or less $ 42,320,040 $ 42,194,296 Maturing after one year but less than three years — — $ 42,320,040 $ 42,194,296 |
FAIR VALUE OF FINANCIAL ASSETS
FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES | 5. FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of March 31, 2023: Level 1 Level 2 Level 3 Total Assets: Cash Equivalents: Money market funds $ 4,427,280 $ — $ — $ 4,427,280 Investments: Commercial paper — 11,367,511 — 11,367,511 Corporate debt securities — 25,535,052 — 25,535,052 $ 4,427,280 $ 36,902,563 $ — $ 41,329,843 Liabilities: Derivative liabilities $ — $ — $ 36,868 $ 36,868 The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of December 31, 2022: Level 1 Level 2 Level 3 Total Assets: Cash Equivalents: Money Market funds $ 8,470,790 $ — $ — $ 8,470,790 Commercial paper — 1,494,538 — 1,494,538 Corporate debt securities — 3,232,231 — 3,232,231 Investments: Commercial paper — 12,173,980 — 12,173,980 Corporate debt securities — 30,020,316 — 30,020,316 $ 8,470,790 $ 46,921,065 $ — $ 55,391,855 Liabilities: Derivative liabilities $ — $ — $ 36,868 $ 36,868 |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 3 Months Ended |
Mar. 31, 2023 | |
License Agreements | |
LICENSE AGREEMENTS | 6. LICENSE AGREEMENTS The Company entered into a license agreement (the “Jenrin License Agreement”) with Jenrin Discovery, LLC (“Jenrin”), a privately-held Delaware limited liability company, effective September 20, 2018. Pursuant to the Jenrin License Agreement, Jenrin granted the Company exclusive worldwide rights to develop and commercialize the Licensed Products (as defined in the Jenrin Agreement) which includes the Jenrin library of over 600 compounds and multiple issued and pending patent filings. The compounds are designed to treat inflammatory and fibrotic diseases by targeting the endocannabinoid system. In consideration of the license and other rights granted by Jenrin, the Company paid Jenrin a $ 250,000 upfront cash payment and is obligated to pay potential milestone payments to Jenrin totaling up to $ 18,400,000 for each compound it elects to develop based upon the achievement of specified development and regulatory milestones. In addition, Corbus is obligated to pay Jenrin royalties in the mid, single digits based on net sales of any Licensed Products, subject to specified reductions. The Company entered into a license agreement (the “Milky Way License Agreement”) with Milky Way BioPharma, LLC (“Milky Way”), a subsidiary of Panorama Research Inc., effective May 25, 2021. Pursuant to the Milky Way License Agreement, the Company received an exclusive license, under certain patent rights and know-how owned or controlled by Milky Way, to develop, commercialize, and otherwise exploit products containing antibodies against integrin αvβ6 and/or integrin αvβ8 (“Licensed Products”), one of which the Company is referring to as CRB-602. Under the terms of the Milky Way License Agreement, the Company will have sole responsibility for research, development, and commercialization of any Licensed Products, and Company has agreed to use commercially reasonable efforts to perform these activities. The Milky Way Agreement may be terminated earlier in specified situations, including termination for material breach or termination by Corbus with advance notice. In consideration for the license and other rights granted to the Company under the Milky Way License Agreement, the Company paid Milky Way an upfront payment of $ 500,000 and issued to Milky Way 147,875 shares of its common stock. The Company is obligated to pay up to $ 53,000,000 in potential milestone payments for the achievement of certain development, regulatory, and sales milestones. At the Company’s election, the Company may satisfy a portion of certain milestone payments by issuing shares of its common stock. In addition, the Company is obligated to pay royalties in the low, single digits on sales of Licensed Products during the life of the applicable licensed patents on a country-by-county and product-by-product basis, which is subject to a minimum annual royalty obligation, as well as a percentage share of certain payments received by Company from sublicensees. The Company entered into a license agreement (the “UCSF License Agreement”) with the Regents of the University of California (“The Regents”) effective May 26, 2021. Pursuant to the UCSF License Agreement, the Company received an exclusive license to certain patents relating to humanized antibodies against integrin αvβ8, one of which the Company is referring to as CRB-601, along with non-exclusive licenses to certain related know-how and materials. The Company amended the UCSF License Agreement with The Regents effective November 17, 2022 adding additional antibody patents to the agreement. In consideration for the license and other rights granted to the Company under the UCSF License Agreement, the Company paid The Regents a license issue fee of $ 1,500,000 and in consideration for the additional antibody patents granted to the Company, the Company will pay The Regents a license issue fee of $ 750,000 , payable in two equal installments of $ 375,000 (first payment paid within 7 days of the Amendment Effective Date and the second payment due on the first anniversary of the Amendment Effective Date) . In addition to the license issuance fees, the Company is obligated to pay an annual license maintenance fee, as well as up to $ 153,150,000 in potential milestone payments, excluding indication milestones for antibodies used for diagnostic products and services that will be an additional $ 50,000 for each new indication, for the achievement of certain development, regulatory, and sales milestones. In addition, the Company is also obligated to pay royalties in the lower, single digits on sales of products falling within the scope of the licensed patents, which is subject to a minimum annual royalty obligation, and a percentage share of certain payments received by Company from sublicensees or in connection with the sale of the licensed program . The Company entered into a license agreement (the “CSPC License Agreement”) with CSPC Megalith Biopharmaceutical Co., Ltd ("CSPC"), a subsidiary of CSPC Pharmaceutical Group Limited, effective February 12, 2023. Pursuant to the CSPC License Agreement, the Company received an exclusive license to develop and commercialize a novel clinical stage antibody drug conjugate targeting Nectin-4, which the Company is referring to as CRB-701, in the United States ("U.S."), Canada, the European Union (including the European Free Trade Area), the United Kingdom, and Australia. In consideration for the license granted to the Company under the CSPC License Agreement, the Company will pay CSPC an upfront payment of $ 7,500,000 ($ 5,000,000 paid at signing during Q1 2023 followed by a $ 2,500,000 payment due after eighteen months). The Company is obligated to pay potential milestone payments to CSPC totaling up to $ 130,000,000 based upon the achievement of specified development and regulatory milestones and $ 555,000,000 in potential commercial milestone payments. In addition, we are obligated to pay royalties in the low, double digits based on net sales of any Licensed Products, as defined in the CSPC License Agreement. The Company determined that substantially all of the fair value of the Jenrin License Agreement and CSPC License Agreement was attributable to a single in-process research and development asset which did not constitute a business. The Company determined that substantially all of the fair value of the Milky Way License Agreement and the UCSF License Agreement was attributable to separate groups of in-process research and development assets which did not constitute a business. The Company concluded that it did not have any alternative future use for the acquired in-process research and development assets. Thus, the Company recorded the various upfront payment to research and development expenses in the quarter the license deals became effective. The Company will account for the development, regulatory, and sales milestone payments in the period that the relevant milestones are achieved as either research and development expense or as an intangible asset as applicable. In the first quarter of 2023, the Company recorded the $ 7,500,000 upfront license payment to CSPC as research and development expense, which includes $ 2,500,000 in other long-term liabilities. In addition, the Company recorded a $ 1,200,000 development milestone as accrued pre-clinical and clinical costs under the UCSF License Agreement for the filing of patent rights as research and development expense. To date, no other milestone payments have been made under any of the other above agreements. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | 7. PROPERTY AND EQUIPMENT Property and equipment consisted of the following: March 31, December 31, Computer hardware and software $ 262,203 $ 262,203 Office furniture and equipment 1,113,980 1,113,980 Leasehold improvements 3,330,855 3,330,855 Property and equipment, gross 4,707,038 4,707,038 Less: accumulated depreciation ( 3,275,093 ) ( 3,093,223 ) Property and equipment, net $ 1,431,945 $ 1,613,815 Depreciation expense was $ 181,870 and $ 195,719 for the three months ended March 31, 2023 and 2022 , respectively. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 8. COMMITMENTS AND CONTINGENCIES Operating Lease Commitment Pursuant to the terms of the Company’s non-cancelable lease agreements in effect at March 31, 2023, the following table summarizes the Company’s maturities of operating lease liabilities as of March 31, 2023: 2023 $ 1,280,934 2024 1,747,447 2025 1,794,889 2026 1,688,145 Total lease payments $ 6,511,415 Less: imputed interest ( 859,935 ) Total $ 5,651,480 Sublease Commitment Effective August 26, 2021, the Company entered into a sublease agreement with a third party to sublease 12,112 square feet of the 30,023 square feet currently being leased under one of its two existing lease agreements. The sublease commenced on October 1, 2021 and ends October 31, 2026. The Company notes sublease income of $ 55,133 and $ 55,133 was recognized and offset against rent expense for the three months ended March 31, 2023 and 2022 , respectively. Undiscounted sublease cash inflows have been summarized in the following table: 2023 $ 159,475 2024 278,576 2025 290,688 2026 252,333 Total sublease payments $ 981,072 |
NOTES PAYABLE
NOTES PAYABLE | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
NOTES PAYABLE | 9. NOTES PAYABLE D&O Financing In November 2021, the Company entered into a loan agreement with a financing company for $ 984,375 to finance one of the Company’s insurance policies. The terms of the loan stipulate equal monthly payments of principal and interest payments of $ 111,041 over a nine-month period . Interest accrues on this loan at an annual rate of 3.64 %. This loan was fully repaid in July 2022. In November 2022, the Company entered into a loan agreement with a financing company for $ 452,250 to finance one of the Company’s insurance policies. The terms of the loan stipulate equal monthly payments of principal and interest payments of $ 51,387 over a nine-month period . Interest accrues on this loan at an annual rate of 5.4 %. Prepaid expenses as of March 31, 2023 and December 31, 2022, included approximately $ 293,125 and $ 418,750 , respectively, related to the underlying insurance policy being financed. Loan and Security Agreement with K2 HealthVentures LLC On July 28, 2020, the Company, with its subsidiary, Corbus Pharmaceuticals, Inc., as borrower, entered into a $ 50,000,000 secured Loan and Security Agreement with K2 HealthVentures LLC (“K2HV”), an unrelated third party (the “Loan and Security Agreement”) and received the first $ 20,000,000 tranche upon signing. The second tranche of $ 20,000,000 and the third tranche of $ 10,000,000 are subject to the achievement of certain clinical and regulatory milestones related to Lenabasum, however, as the Company is no longer developing Lenabasum, these milestones will not be met and the Company will not become eligible to receive the additional funding. The loan matures on August 1, 2024 and the Company is obligated to make interest only payments for the first 24 months and then interest and equal principal payments for the next 24 months commencing on September 1, 2022. The Company entered into an Amendment to the Loan and Security Agreement (the "Amended Loan and Security Agreement") on October 25, 2022. The Amended Loan and Security Agreement defers the commencement of principal repayments by a one-year period from September 1, 2022 to September 1, 2023 and if the Company raises at least $30 million in net proceeds through capital raising transactions, the commencement of principal repayments will be deferred by an additional six months to March 1, 2024. Interest accrues at a variable annual rate equal to the greater of (i) 8.5% and (ii) the rate of interest noted in The Wall Street Journal, Money Rates section, as the “Prime Rate” plus 5.25%, in each case, subject to a step-down of 25 basis points upon the funding of the second tranche. The interest rate used at March 31, 2023 was 13.25 % . In accordance with ASC Topic No. 470-50, “Debt – Modifications and Extinguishments” (Topic No. 470), the amendment noted above was determined to be a modification, thus no gain or loss was recorded. Pursuant to the Loan and Security Agreement, K2HV may elect to convert up $ 5,000,000 of the outstanding loan balance into shares of the Company’s common stock at a conversion price of $ 282.00 per share. The Amended Loan and Security Agreement adjusts the conversion price of $ 2,000,000 of the maximum $ 5,000,000 convertible amount by adjusting the conversion price of $ 875,000 of the loan from $ 282.00 per share to $ 4.50 per share, and $ 1,125,000 of the loan from $ 282.00 per share to $ 7.875 per share. The remaining $ 3,000,000 will continue to have a conversion price of $ 282.00 per share. The decrease in the conversion price resulted in an increase in the fair value of the conversion option of $ 573,000 , which was recorded as an increase to the debt discount and additional paid in capital as of December 31, 2022. In connection with the Loan and Security Agreement, on July 28, 2020, the Company issued K2HV a warrant to purchase up to 2,874 common shares (the “K2 Warrant”) at an exercise price of $ 208.80 (the “Warrant Price”). The K2 Warrant may be exercised either for cash or on a cashless “net exercise” basis and expires on July 28, 2030. The total proceeds attributed to the K2 Warrant was approximately $ 472,000 based on the relative fair value of the K2 Warrant as compared to the sum of the fair values of the K2 Warrant, prepayment feature, default feature, and debt. Total proceeds attributed to the prepayment and default features was approximately $ 546,000 . The Company also incurred approximately $ 1,244,000 of debt issuance costs from the Loan and Security Agreement. In connection with entering into the Amended Loan and Security Agreement, the Company incurred an additional $ 119,000 of debt issuance costs. The proceeds attributed to the K2 Warrant, the prepayment and default features, and the debt issuance costs are all included in the debt discount. The Company is required to make a final payment in excess of the stated principal equal to $ 1,590,000 . See Note 14 for more detail on assumptions used in the valuation of the K2 warrant and see Note 15 for more information on the assumptions used in valuation of the default and prepayment features . The total principal amount of the loan under the Loan and Security Agreement outstanding at March 31, 2023 , including the $ 1,590,000 final payment discussed above, is $ 21,590,000 . Upon the occurrence of an Event of Default (as defined in the Loan and Security Agreement ), and during the continuance of an Event of Default, the applicable rate of interest, described above, will be increased by 5.00 % per annum. The secured term loan maturity date is August 1, 2024 , and the Loan and Security Agreement includes both financial and non-financial covenants. The Company was in compliance with these covenants as of March 31, 2023. The obligations under the Loan and Security Agreement are secured on a senior basis by a lien on substantially all of the assets of the Company and its subsidiaries. The subsidiaries of the Company are guarantors of the obligations of the Company under the Loan and Security Agreement. The total debt discount related to the Amended Loan and Security Agreement of approximately $ 2,954,000 is being charged to interest expense using the effective interest method over the term of the debt. At March 31, 2023 and December 31, 2022, the fair value of our outstanding debt, which is considered level 3 in the fair value hierarchy, approximates carrying value. Interest expense for the three months ended March 31, 2023 was approximately $ 937,000 . Interest expense for the three months ended March 31, 2022 was $ 684,000 . The net carrying amounts of the liability components consists of the following: March 31, 2023 December 31, 2022 Principal $ 20,000,000 $ 20,000,000 Less: debt discount ( 2,954,390 ) ( 2,954,390 ) Accretion of debt discount 1,935,608 1,734,485 Net carrying amount $ 18,981,218 $ 18,780,095 Less: current portion of long-term debt ( 5,008,858 ) ( 2,795,669 ) Total long-term debt, net of discount $ 13,972,360 $ 15,984,426 The following table summarizes the future principal payments due under long-term debt : Fiscal Years Ending December 31st, Principal Payments and final payment on Loan Agreement 2023 $ 2,963,785 2024 18,626,215 Total $ 21,590,000 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | 10. ACCRUED EXPENSES Accrued expenses consisted of the following: March 31, December 31, Accrued pre-clinical and clinical costs $ 4,074,713 $ 2,137,317 Accrued product development costs 409,691 247,500 Accrued compensation 826,703 2,224,951 Accrued administrative costs 143,175 473,376 Accrued interest 1,014,020 916,108 Total $ 6,468,302 $ 5,999,252 |
PREFERRED STOCK
PREFERRED STOCK | 3 Months Ended |
Mar. 31, 2023 | |
Preferred Stock, Number of Shares, Par Value and Other Disclosure [Abstract] | |
PREFERRED STOCK | 11. PREFERRED STOCK The Company has authorized 10,000,000 shares of preferred stock, $ 0.0001 par value per share, of which 0 shares were issued and outstanding as of March 31, 2023 and December 31, 2022, respectively. On October 12, 2022, the Board of Directors (the “Board”), declared a dividend of 0.008 of a share of Series A Preferred Stock (“Series A Preferred Stock”), for each outstanding share of Common Stock to stockholders of record at 5:00pm Eastern Time on October 22, 2022. The Certificate of Designation of Series A Preferred Stock was filed with the Delaware Secretary of State and became effective on October 12, 2022. The dividend was based on the number of outstanding shares of common stock prior to the Reverse Stock Split. This resulted in 1,002,247.048 shares of preferred stock being issued. The outstanding shares of Series A Preferred Stock were entitled to vote together with the outstanding shares of common stock as a single class exclusively with respect to any proposal to adopt an amendment to the Company’s Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to reclassify the outstanding shares of Common Stock into a smaller number of shares of Common Stock at a ratio specified in or determined in accordance with the terms of such amendment, as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Reverse Stock Split Proposal (the “Adjournment Proposal”). The Company held a special meeting of stockholders on December 20, 2022 (the “Special Meeting”) for the purpose of voting on the Reverse Stock Split and the Adjournment Proposal. All shares of Series A Preferred Stock that were not present in person or by proxy at the Special Meeting, which totaled 500,894.04 shares, were automatically redeemed by the Company immediately prior to the opening of the polls at Special Meeting (the “Initial Redemption”). All shares that were not redeemed pursuant to the Initial Redemption would be redeemed if ordered by the Board or automatically upon the effectiveness of the amendment to the Certificate of Incorporation implementing the Reverse Stock Split (the "Subsequent Redemption" and together with the Initial Redemption, the "Redemption"). Each share of Series A Preferred Stock is entitled to receive $0.001 in cash for each 10 whole shares of Series A Preferred Stock immediately prior to the Redemption. At the Special Meeting, both the Reverse Stock Split and Adjournment Proposal were approved. Upon issuance of the Series A Preferred Stock, the Company was not solely in control of the Redemption of the shares of Series A Preferred Stock since the holders had the option of deciding whether to attend or return a proxy card for the Special Meeting, which determined whether a given holder’s shares of Series A Preferred Stock were redeemed in the Initial Redemption. Since the Redemption of the Series A Preferred Stock was not solely in the control of the Company, the shares of Series A Preferred Stock are classified within mezzanine equity. The shares of Series A Preferred Stock were initially recorded at redemption value, which approximated fair value. After the Special Meeting upon approval of the Reverse Stock Split, the remaining 501,353.008 shares outstanding of Series A Preferred Stock would be considered mandatorily redeemable and reclassified to a current liability. As of December 31, 2022, the fair value of the Series A Preferred Stock were included in accrued expenses. As of March 31, 2023 and December 31, 2022, there were 0 shares of Series A Preferred Stock issued and outstanding within the condensed consolidated balance sheet, as such shares were considered a redemption payable. The Series A Preferred Stock were redeemed on February 14, 202 3, upon the effectiveness of the amendment to the Certificate of Incorporation implementing the Reverse Stock Split pursuant to the terms of the Certificate of Designation of the Series A Preferred Stock. |
COMMON STOCK
COMMON STOCK | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
COMMON STOCK | 12. COMMON STOCK On February 14, 2023, the Company completed a 1-for-30 reverse stock split of its outstanding common stock. The Reverse Stock Split did not change the number of authorized shares of common stock or par value. All references in these condensed consolidated financial statements to shares, share prices, exercise prices, and other per share information in all periods have been adjusted, on a retroactive basis, to reflect the Reverse Stock Split. The Company has authorized 300,000,000 shares of common stock, $ 0.0001 par value per share, of which 4,215,133 and 4,171,297 shares were issued and outstanding as of March 31, 2023 and December 31, 2022, respectively. On August 7, 2020, the Company entered into the August 2020 Sale Agreement with Jefferies pursuant to which Jefferies is serving as the Company’s sales agent to sell shares of the Company’s common stock through an “at the market offering.” As of August 7, 2020, the Company was authorized to sell up to $ 150,000,000 of shares of the Company’s common stock pursuant to the August 2020 Sale Agreement. During the three months ended March 31, 2023 and 2022, the Company did not sell any shares of its common stock under the August 2020 Sale Agreement. During the three months ended March 31, 2023 and 2022, the Company issued 43,836 and 0 shares of common stock upon the exercise of stock options to purchase common stock and the Company received proceeds of approximately $ 129,740 and $ 0 from these exercises, respectively. During the three months ended March 31, 2022, the Company issued 833 common shares from the vesting of shares from restricted stock under the 2014 Plan. No warrants were exercised during the three months ended March 31, 2023 and 2022 . |
STOCK OPTIONS
STOCK OPTIONS | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK OPTIONS | 13. STOCK BASED AWARDS In April 2014, the Company adopted the Corbus Pharmaceuticals Holdings, Inc. 2014 Equity Incentive Plan (the “2014 Plan”). Pursuant to the 2014 Plan, the Company’s Board may grant incentive and nonqualified stock options and restricted stock to employees, officers, directors, consultants and advisors. Pursuant to the terms of an annual evergreen provision in the 2014 Plan, the number of shares of common stock available for issuance under the 2014 Plan shall automatically increase on January 1 of each year by at least seven percent ( 7 %) of the total number of shares of common stock outstanding on December 31st of the preceding calendar year, or, pursuant to the terms of the 2014 Plan, in any year, the Board may determine that such increase will provide for a lesser number of shares. In accordance with the terms of the 2014 Plan, and pursuant to the annual evergreen provision contained in the 2014 Plan, effective as of January 1, 2022, the number of shares of common stock available for issuance under the 2014 Plan increased by 292,205 shares, which was seven percent ( 7 %) of the outstanding shares of common stock on December 31, 2021. As of January 1, 2022 there was a total reserve of 1,144,567 shares and 558,671 shares available for future grants. As of March 31, 2022 there were 426,486 shares available for future grants. In accordance with the terms of the 2014 Plan, and pursuant to the annual evergreen provision contained in the 2014 Plan, effective as of January 1, 2023, the number of shares of common stock available for issuance under the 2014 Plan increased by 291,991 shares, which was seven percent ( 7 %) of the outstanding shares of common stock on December 31, 2022. As of January 1, 2023, there was a total reserve of 1,436,558 shares and 741,870 shares available for future grants. As of March 31, 2023 there were 510,671 shares available for future grants. Share-based Compensation Expense In connection with all stock-based payment awards, total stock-based compensation expense, net of estimated forfeitures, recognized in the condensed consolidated statements of operations and comprehensive loss was as follows : Three Months Ended March 31, 2023 2022 Research and development expenses $ 93,922 $ 176,218 General and administrative expenses 932,457 1,415,528 Total stock-based compensation $ 1,026,379 $ 1,591,746 The total stock-based compensation expense recognized by award type was as follows: Three Months Ended March 31, 2023 2022 Stock Options $ 1,023,741 $ 1,591,746 Restricted Stock Units 2,638 — Total stock-based compensation $ 1,026,379 $ 1,591,746 Stock Options The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model that uses the assumptions noted in the following table. The Company uses historical data, as well as subsequent events occurring prior to the issuance of the financial statements, to estimate option exercises and employee terminations in order to estimate its forfeiture rate. The expected term of options granted under the 2014 Plan, all of which qualify as “plain vanilla” per SEC Staff Accounting Bulletin 107, is determined based on the simplified method due to the Company’s limited operating history, and is 6.25 years based on the average between the vesting period and the contractual life of the option. For non-employee options, the expected term is the contractual term. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the option. The weighted average assumptions used principally in determining the fair value of options granted to employees were as follows: Three Months Ended March 31, 2023 2022 Risk free interest rate 3.85 % 1.70 % Expected dividend yield 0 % 0 % Expected term in years 6.25 6.25 Expected volatility 100.13 % 97.49 % Estimated forfeiture rate 17.64 % 13.00 % A summary of option activity for the three months ended March 31, 2023 and is presented below: Options Shares Weighted Weighted Average Aggregate Outstanding at December 31, 2022 617,996 $ 88.99 Granted 246,967 4.22 Exercised ( 43,836 ) 0.85 Forfeited or Canceled ( 15,768 ) 55.23 Outstanding at March 31, 2023 805,359 $ 68.23 7.35 $ 21,943,617 Vested at March 31, 2023 406,396 $ 113.92 5.56 $ 5,049,321 Vested and expected to vest at March 31, 2023 715,248 $ 75.45 7.08 $ 17,485,170 The weighted average grant-date fair value of options granted during the three months ended March 31, 2023 and 2022 was $ 3.44 and $ 11.10 per share, respectively. The aggregate intrinsic value of options exercised during the three months ended March 31, 2023 and 2022 was approximately $ 92,689 and $ 0 , respectively. As of March 31, 2023, there was approximately $ 5,733,215 of total unrecognized compensation expense, related to non-vested share-based option compensation arrangements. The unrecognized compensation expense is estimated to be recognized over a period of 2.02 years as of March 31, 2023. Restricted Stock Units A RSU represents the right to receive one share of our common stock upon vesting of the RSU. The fair value of each RSU is based on the closing price of our common stock on the date of grant. We grant RSUs with service conditions that vest in four equal annual installments provided that the employee remains employed with us on the vesting date. A summary of RSU activity for the three months ended March 31, 2023 and is presented below: RSU's Number of Shares Underlying RSUs Weighted Unvested at December 31, 2022 — $ — Granted 23,990 4.26 Forfeited — — Vested — — Unvested at March 31, 2023 23,990 $ 4.26 As of March 31, 2023, there was $ 81,163 of unrecognized compensation costs related to unvested RSUs, which are expected to be recognized over a weighted-average period of 3.87 years. |
WARRANTS
WARRANTS | 3 Months Ended |
Mar. 31, 2023 | |
Warrants | |
WARRANTS | 14. WARRANTS No warrants were exercised during the three months ended March 31, 2023 and 2022. At March 31, 2023, there were warrants outstanding to purchase 50,207 shares of common stock with a weighted average exercise price of $ 283.81 and a weighted average remaining life of 2.36 years. On January 26, 2018, the Company entered into an Investment Agreement with the Cystic Fibrosis Foundation ("CFF") that included issuance of a warrant to purchase an aggregate of 33,334 shares of the Company’s common stock (the “CFF Warrant”) at an exercise price of $ 396 per share. The CFF Warrant is currently exercisable for 33,334 shares of the Company’s common stock and expires on January 26, 2025 . Any shares of the Company’s common stock issued upon exercise of the CFF Warrant will be unregistered and subject to a one-year lock-up. The CFF Warrant is classified as equity as it meets all the conditions under U.S. GAAP for equity classification. In accordance with U.S. GAAP, the Company has calculated the fair value of the warrant for initial measurement and will reassess whether equity classification for the warrant is appropriate upon any changes to the warrants or capital structure, at each balance sheet date. The weighted average assumptions used in determining the $ 6,215,225 fair value of the CFF Warrant were as follows: Risk free interest rate 2.60 % Expected dividend yield — % Expected term in years 7.00 Expected volatility 83.5 % On July 28, 2020, the Company entered into the Loan and Security Agreement with K2HV pursuant to which K2HV may provide the Company with term loans in an aggregate principal amount of up to $ 50,000,000 . On July 28, 2020, in connection with the funding of the first $ 20,000,000 tranche, the Company issued a warrant exercisable for 2,874 shares of the Company’s common stock (the “K2 Warrant”) at an exercise price of $ 208.80 per share. The K2 Warrant is immediately exercisable for 2,874 shares and expires on July 28, 2030 . Any shares of the Company’s common stock issued upon exercise of the K2 Warrant are permitted to be settled in unregistered shares. The K2 Warrant is classified as equity as it meets all the conditions under U.S. GAAP for equity classification. In accordance with U.S. GAAP, the Company has calculated the fair value of the warrant for initial measurement and will reassess whether equity classification for the warrant is appropriate upon any changes to the warrants or capital structure, at each balance sheet date. The weighted average assumptions used in determining the $ 472,409 fair value of the K2 Warrant were as follows: Risk free interest rate 0.60 % Expected dividend yield — % Expected term in years 10.00 Expected volatility 80.0 % On October 16, 2020, the Company entered into a professional services agreement with an investor relations service provider. Pursuant to the agreement, the Company issued warrants exercisable for a total of 14,000 shares of the Company’s common stock (the “Warrants”) at an exercise price of $ 32.10 per share. The Warrants will be fully vested on October 19, 2021. Any shares of the Company’s common stock issued upon exercise of the Warrants are permitted to be settled in unregistered shares. The Warrants are classified as equity as they meet all the conditions under U.S. GAAP for equity classification. In accordance with U.S. GAAP, the Company has calculated the fair value of the warrants for initial measurement and will reassess whether classification for the warrant is appropriate upon any changes to the warrants or capital structure, at each balance sheet date. The weighted average assumptions used in determining the $ 334,740 fair value of the Warrants were as follows: Risk free interest rate 0.90 % Expected dividend yield — % Expected term in years 5.00 Expected volatility 100.6 % |
DERIVATIVE LIABILITY
DERIVATIVE LIABILITY | 3 Months Ended |
Mar. 31, 2023 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
DERIVATIVE LIABILITY | 15. DERIVATIVE LIABILITY On July 28, 2020, the Company, with its subsidiary, Corbus Pharmaceuticals, Inc., as borrower, entered into a $ 50,000,000 secured Loan and Security Agreement with K2HV, an unrelated third party (the “Loan and Security Agreement”) and received the first $ 20,000,000 tranche upon signing. The Company has determined that a prepayment feature and default feature needed to be separately valued and marked to market each reporting period after assessing the agreement under ASC 815. The value of these features is determined each reporting period by taking the present value of net cash flows with and without the prepayment features. The significant assumption used to determine the fair value of the debt without any features is the discount rate which has been estimated by using published market rates of triple CCC rated public companies. All other inputs are taken from the Loan and Security Agreement. The additional significant assumptions used when valuing the prepayment feature is the probability of a change of control event. The Company has determined the probability from December 31, 2022 to March 31, 2023 has stayed consistent. The additional significant assumption used when valuing the default feature is the probability of defaulting on the repayment of loan. The Company has determined the probability from December 31, 2022 to March 31, 2023 has remained consistent . The value of these features was determined to be approximately $ 36,868 at December 31, 2022 and March 31, 2023 which resulted in no expense recognized in the first three months of 2023. The Company considers the fair value of the derivative liability to be Level 3 under the three-tier fair value hierarchy. A roll forward of the fair value of the derivative liabilities for the three months ended March 31, 2023 is presented below. March 31, 2023 Beginning balance, December 31, 2022 $ 36,868 Change in fair value of derivative liabilities — Ending balance, March 31, 2023 $ 36,868 |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. |
Reverse Stock Split | Reverse Stock Split On February 14, 2023, the Company completed a 1-for-30 reverse stock split of its outstanding common stock (the “Reverse Stock Split”). The Reverse Stock Split did not change the number of authorized shares of common stock or par value. All references in these condensed consolidated financial statements to shares, share prices, exercise prices, and other per share information in all periods have been adjusted, on a retroactive basis, to reflect the Reverse Stock Split (see Note 12). |
Consolidation | Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions and accounts have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The process of preparing financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and changes in estimates may occur. The most significant estimates are related to stock-based compensation expense, the accrual of research, product development and clinical obligations, and the valuation of warrants (see Note 9 and Note 14) and the derivative liability associated with the K2 Loan and Security Agreement (see Note 15) . |
Cash, Cash Equivalents, and Restricted Cash | Cash, Cash Equivalents, and Restricted Cash The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within 90 days from date of purchase to be cash equivalents. At March 31, 2023 and December 31, 2022, cash equivalents were comprised of money market funds, commercial paper, and other debt securities with maturities less than three months from the date of purchase. Restricted cash as of March 31, 2023 included security for a stand-by letter of credit issued in favor of a landlord for $ 669,900 of which $ 192,475 was classified in current assets and $ 477,425 was classified in noncurrent assets as of March 31, 2023. Cash, cash equivalents, and restricted cash consist of the following: March 31, 2023 December 31, 2022 Cash $ 2,897,157 $ 3,805,156 Cash equivalents 4,427,280 13,197,559 Cash and cash equivalents $ 7,324,437 $ 17,002,715 Restricted cash, current 192,475 192,475 Restricted cash, noncurrent 477,425 477,425 Restricted cash $ 669,900 $ 669,900 Total cash, cash equivalents, and restricted cash shown in the statement of cash $ 7,994,337 $ 17,672,615 As of March 31, 2023, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $ 1,986,000 of cash which was held in its subsidiaries in the United Kingdom and Australia. As of December 31, 2022 , all of the Company’s cash was held in the United States, except for approximately $ 2,805,000 of cash which was held in its subsidiaries in the United Kingdom and Australia. |
Investments | Investments Investments consist of debt securities and term deposits with maturities greater than 90 days at their acquisition date. The Company has classified its investments with maturities beyond one year as current, based on their highly liquid nature and because such investments represent the investment of cash that is available for current operations. The Company classifies all of its marketable debt securities as available-for-sale securities. The Company’s marketable debt securities are measured and reported at fair value using quoted prices in active markets for similar securities. Unrealized gains and losses on available-for-sale debt securities that are not related to credit losses are reported as accumulated other comprehensive gain or loss, which is a separate component of stockholders’ equity. The cost of debt securities sold is determined on a specific identification basis, and realized gains and losses are included in other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. The Company evaluates its marketable debt securities with unrealized losses for impairment. When assessing marketable debt securities for potential impairment, the Company considers available evidence, including the extent to which fair value is less than cost, whether an allowance for credit loss is required, and adverse factors that could affect the value of the securities. An impairment has occurred if the Company does not expect to recover the entire amortized cost basis of the marketable debt security. If the Company does not intend to sell the impaired debt security and it is not more likely than not required to sell the debt security before the recovery of its amortized cost basis, the amount of the impairment related to credit losses is recognized in an allowance for credit losses with an offsetting entry to Other income (expense), net. The remaining portion of the impairment related to other factors is recognized in Other comprehensive loss. Realized gains and losses for debt securities are included in Other income (expense), net. No such adjustments were necessary during the periods presented. |
Concentrations of Credit Risk | Concentrations of Credit Risk The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company may, from time to time, have cash in its U.S. banks in excess of Federal Deposit Insurance Corporation insurance limits and in its foreign banks in excess of their local insurance limits. However, the Company believes the risk of loss is minimal as these banks are large financial institutions. |
Financial Instruments | Financial Instruments The carrying values of the notes payable and debt approximate their fair value due to the fact that they are at market terms. |
Fair Value Measurements | Fair Value Measurements The valuation of the Company’s debt and embedded derivatives are determined primarily by an income approach that considers the present value of net cash flows of the debt with and without prepayment and default features. These embedded debt features, which are determined to be classified as derivative liabilities are marked-to-market each reporting period, with a corresponding non-cash gain or loss charged to the current period. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, there exists a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access as of the measurement date. Level 2 – Inputs other than quoted prices included within Level 1 that are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Level 3 – Unobservable inputs for the asset or liability only used when there is little, if any, market activity for the asset or liability at the measurement date. The Company’s investments, debt, and its derivative liabilities are carried at fair value determined according to the fair value hierarchy described above. The carrying values of the Company’s prepaid expenses and other current assets and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. To determine the fair value of our embedded derivatives, management evaluates assumptions regarding the probability of certain future events. Other factors used to determine fair value include the discount rate, risk free interest rate and derivative term. The fair value recorded for the derivative liability varies from period to period. This variability may result in the actual derivative liability for a period either above or below the estimates recorded on our condensed consolidated financial statements, resulting in fluctuations in other income (expense) because of the corresponding non-cash gain or loss recorded. |
Property and Equipment | Property and Equipment The estimated life for the Company’s property and equipment is as follows: three years for computer hardware and software and three to five years for office furniture and equipment. The Company’s leasehold improvements and assets under capital lease are amortized over the shorter of their useful lives or the respective leases. See Note 7 for details of property and equipment and Note 8 for operating and capital lease commitments. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities, and operating lease liabilities in the Company’s condensed consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has subleased a portion of its leased facility under an agreement considered to be an operating lease according to U.S. GAAP. The Company has not been legally released from its primary obligations under the original lease and therefore it continues to account for the original lease as it did before commencement of the sublease. The Company will record both fixed and variable payments received from the sublessee in its statement of operations on a straight-line basis as an offset to rent expense. |
Accruals for Research and Development Expenses and Clinical Trials | Accruals for Research and Development Expenses and Clinical Trials As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the timing of various aspects of the expenses. The Company determines accrual estimates by taking into account discussions with applicable internal personnel and outside service providers as to the progress of clinical trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations (“CROs”) and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the three months ended March 31, 2023 and 2022 , there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
Revenue Recognition | Revenue Recognition We recognize revenue in accordance with Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (“ASC 606”), which applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements, and financial instruments. Under ASC 606, we recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. |
Research and Development Expenses | Research and Development Expenses Costs incurred for research and development are expensed as incurred. Nonrefundable advance payments for goods or services that have the characteristics that will be used or rendered for future research and development activities pursuant to executory contractual arrangements with third party research organizations are deferred and recognized as an expense as the related goods are delivered or the related services are performed. |
Asset Acquisitions | Asset Acquisitions We account for asset acquisitions under the accounting standards for business combinations and research and development, as applicable. In-process research and development acquired in an asset acquisition is expensed immediately unless there is an alternative future use. Subsequent payments made for the achievement of milestones are evaluated to determine whether they have an alternative future use or should be expensed. |
Segment Information | Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one operating segment, which is developing and commercializing therapeutics for cancer. As of March 31, 2023, all of the Company’s assets were located in the United States, except for approximately $ 1,986,000 of cash and cash equivalents and $ 836,000 of prepaid expenses and other assets which were held outside of the United States, principally in its subsidiary in the United Kingdom. As of December 31, 2022, all of the Company’s assets were located in the United States, except for approximately $ 2,805,000 of cash and cash equivalents and $ 136,000 of prepaid expenses and other assets which were held outside of the United States, principally in its subsidiary in the United Kingdom. |
Income Taxes | Income Taxes For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded to reduce a net deferred tax benefit when it is not more likely than not that the tax benefit from the deferred tax assets will be realized. Accordingly, given the cumulative losses since inception, the Company has provided a valuation allowance equal to 100 % of the deferred tax assets in order to eliminate the deferred tax assets amounts. Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold, as well as accrued interest and penalties, if any, would be recorded as a tax expense in the current year. There were no uncertain tax positions that require accrual or disclosure to the financial statements as of March 31, 2023 or December 31, 2022 . |
Impairment of Long-lived Assets | Impairment of Long-lived Assets The Company continually monitors events and changes in circumstances that could indicate that carrying amounts of long-lived assets may not be recoverable. An impairment loss is recognized when expected undiscounted cash flows of an asset are less than an asset’s carrying value. Accordingly, when indicators of impairment are present, the Company evaluates the carrying value of such assets in relation to the operating performance and future undiscounted cash flows of the underlying assets. An impairment loss equal to the excess of the fair value of the asset over its carrying amount is recorded when it is determined that the carrying value of the asset may not be recoverable. The Company notes no impairment charges were taken in the three months ended March 31, 2023 and 2022 . |
Stock-based Payments | Stock-based Payments The Company recognizes compensation costs resulting from the issuance of stock-based awards, including stock options and restricted stock units (“RSUs”), to employees, non-employees and directors as an expense in the statements of operations and comprehensive loss over the service period based on a measurement of fair value for each stock-based award. The fair value of each stock option grant is estimated as of the date of grant using the Black-Scholes option-pricing model. The fair value of restricted stock units is the quoted closing market price per share on the grant date. Forfeitures are estimated on the grant date based on historical experience and management’s expectations of future forfeitures. To the extent actual forfeitures differ from the estimates, the difference is recorded as a cumulative adjustment in the period in which the estimates are revised. The fair value of each grant is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period . |
Foreign Currency | Foreign Currency Transaction gains and losses arising from currency exchange rate fluctuations on transactions denominated in a currency other than the U.S. Dollar functional currency are recorded in Other income (expense), net in the Company’s statements of operations and comprehensive loss. Such transaction gains and losses may be realized or unrealized depending upon whether the transaction settled during the period or remains outstanding at the balance sheet date. The functional currency of the Company's foreign subsidiaries is the U.S. Dollar. |
Net Loss Per Common Share | Net Loss Per Common Share Basic and diluted net loss per share of the Company’s common stock has been computed by dividing net loss by the weighted average number of shares outstanding during the period. For periods in which there is a net loss, options and warrants are anti-dilutive and therefore excluded from diluted loss per share calculations. The following table sets forth the computation of basic and diluted earnings per share for the three months ended March 31, 2023 and 2022: Three Months Ended 2023 2022 Net loss $ ( 17,744,812 ) $ ( 9,437,242 ) Weighted average number of common shares-basic 4,181,556 4,170,043 Net loss per share of common stock-basic $ ( 4.24 ) $ ( 2.26 ) Warrants and stock options that have not been exercised and unvested restricted stock units (see Notes 13 and 14) have been excluded from the diluted calculation as all periods presented have a net loss and the impact of these securities would be anti-dilutive. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) , which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes may result in earlier recognition of credit losses. In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses , which narrowed the scope and changed the effective date for non-public entities for ASU 2016-13. The FASB subsequently issued supplemental guidance within ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief (“ASU 2019-05”) . ASU 2019-05 provides an option to irrevocably elect the fair value option for certain financial assets previously measured at amortized cost basis. The Company's adoption of ASU 2016-13 as of January 1, 2023 had no impact on the Company's financial statements as there are no assets held at amortized cost on the balance sheet, and there are no credit losses associated with our available-for-sale debt securities. In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity which is intended to simplify various aspects of U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. The Company's early adoption of ASU 2020-06 as of January 1, 2023 had no impact on the Company's financial statements and disclosures. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements The Company considers the applicability and impact of all ASUs. Management determined that recently issued ASUs are not expected to have a material impact on its condensed consolidated financial statements. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | Cash, cash equivalents, and restricted cash consist of the following: March 31, 2023 December 31, 2022 Cash $ 2,897,157 $ 3,805,156 Cash equivalents 4,427,280 13,197,559 Cash and cash equivalents $ 7,324,437 $ 17,002,715 Restricted cash, current 192,475 192,475 Restricted cash, noncurrent 477,425 477,425 Restricted cash $ 669,900 $ 669,900 Total cash, cash equivalents, and restricted cash shown in the statement of cash $ 7,994,337 $ 17,672,615 |
SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE | The following table sets forth the computation of basic and diluted earnings per share for the three months ended March 31, 2023 and 2022: Three Months Ended 2023 2022 Net loss $ ( 17,744,812 ) $ ( 9,437,242 ) Weighted average number of common shares-basic 4,181,556 4,170,043 Net loss per share of common stock-basic $ ( 4.24 ) $ ( 2.26 ) |
INVESTMENTS (Tables)
INVESTMENTS (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
SUMMARY OF MARKETABLE SECURITIES | The following table summarizes the Company’s investments as of March 31, 2023: Amortized Cost Gross Gross Fair Value Debt Securities: Commercial paper $ 11,367,511 $ — $ — $ 11,367,511 Corporate debt securities 25,603,521 — ( 68,469 ) 25,535,052 Total $ 36,971,032 $ — $ ( 68,469 ) $ 36,902,563 The following table summarizes the Company’s investments as of December 31, 2022: Amortized Cost Gross Gross Fair Value Debt Securities: Commercial paper $ 12,173,980 $ — $ — $ 12,173,980 Corporate debt securities 30,146,060 — ( 125,744 ) 30,020,316 Total $ 42,320,040 $ — $ ( 125,744 ) $ 42,194,296 |
SCHEDULE OF AVAILABLE FOR SALE DEBT SECURITIES BY CONTRACTUAL MATURITY | The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable securities by contractual maturity as of March 31, 2023: Amortized Cost Fair Value Maturing in one year or less $ 36,971,032 $ 36,902,563 Maturing after one year but less than three years — — $ 36,971,032 $ 36,902,563 The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable securities by contractual maturity as of December 31, 2022: Amortized Cost Fair Value Maturing in one year or less $ 42,320,040 $ 42,194,296 Maturing after one year but less than three years — — $ 42,320,040 $ 42,194,296 |
FAIR VALUE OF FINANCIAL ASSET_2
FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE ON RECURRING BASIS | The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of March 31, 2023: Level 1 Level 2 Level 3 Total Assets: Cash Equivalents: Money market funds $ 4,427,280 $ — $ — $ 4,427,280 Investments: Commercial paper — 11,367,511 — 11,367,511 Corporate debt securities — 25,535,052 — 25,535,052 $ 4,427,280 $ 36,902,563 $ — $ 41,329,843 Liabilities: Derivative liabilities $ — $ — $ 36,868 $ 36,868 The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of December 31, 2022: Level 1 Level 2 Level 3 Total Assets: Cash Equivalents: Money Market funds $ 8,470,790 $ — $ — $ 8,470,790 Commercial paper — 1,494,538 — 1,494,538 Corporate debt securities — 3,232,231 — 3,232,231 Investments: Commercial paper — 12,173,980 — 12,173,980 Corporate debt securities — 30,020,316 — 30,020,316 $ 8,470,790 $ 46,921,065 $ — $ 55,391,855 Liabilities: Derivative liabilities $ — $ — $ 36,868 $ 36,868 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
SUMMARY OF PROPERTY AND EQUIPMENT | Property and equipment consisted of the following: March 31, December 31, Computer hardware and software $ 262,203 $ 262,203 Office furniture and equipment 1,113,980 1,113,980 Leasehold improvements 3,330,855 3,330,855 Property and equipment, gross 4,707,038 4,707,038 Less: accumulated depreciation ( 3,275,093 ) ( 3,093,223 ) Property and equipment, net $ 1,431,945 $ 1,613,815 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES | Pursuant to the terms of the Company’s non-cancelable lease agreements in effect at March 31, 2023, the following table summarizes the Company’s maturities of operating lease liabilities as of March 31, 2023: 2023 $ 1,280,934 2024 1,747,447 2025 1,794,889 2026 1,688,145 Total lease payments $ 6,511,415 Less: imputed interest ( 859,935 ) Total $ 5,651,480 |
SUMMARY OF UNDISCOUNTED SUBLEASE CASH INFLOWS | Undiscounted sublease cash inflows have been summarized in the following table: 2023 $ 159,475 2024 278,576 2025 290,688 2026 252,333 Total sublease payments $ 981,072 |
NOTES PAYABLE (Tables)
NOTES PAYABLE (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF NOTES PAYABLE | The net carrying amounts of the liability components consists of the following: March 31, 2023 December 31, 2022 Principal $ 20,000,000 $ 20,000,000 Less: debt discount ( 2,954,390 ) ( 2,954,390 ) Accretion of debt discount 1,935,608 1,734,485 Net carrying amount $ 18,981,218 $ 18,780,095 Less: current portion of long-term debt ( 5,008,858 ) ( 2,795,669 ) Total long-term debt, net of discount $ 13,972,360 $ 15,984,426 |
SCHEDULE OF PRINCIPAL MATURITIES ON LONG TERM DEBT | The following table summarizes the future principal payments due under long-term debt : Fiscal Years Ending December 31st, Principal Payments and final payment on Loan Agreement 2023 $ 2,963,785 2024 18,626,215 Total $ 21,590,000 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCRUED EXPENSES | Accrued expenses consisted of the following: March 31, December 31, Accrued pre-clinical and clinical costs $ 4,074,713 $ 2,137,317 Accrued product development costs 409,691 247,500 Accrued compensation 826,703 2,224,951 Accrued administrative costs 143,175 473,376 Accrued interest 1,014,020 916,108 Total $ 6,468,302 $ 5,999,252 |
STOCK OPTIONS (Tables)
STOCK OPTIONS (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE | In connection with all stock-based payment awards, total stock-based compensation expense, net of estimated forfeitures, recognized in the condensed consolidated statements of operations and comprehensive loss was as follows : Three Months Ended March 31, 2023 2022 Research and development expenses $ 93,922 $ 176,218 General and administrative expenses 932,457 1,415,528 Total stock-based compensation $ 1,026,379 $ 1,591,746 The total stock-based compensation expense recognized by award type was as follows: Three Months Ended March 31, 2023 2022 Stock Options $ 1,023,741 $ 1,591,746 Restricted Stock Units 2,638 — Total stock-based compensation $ 1,026,379 $ 1,591,746 |
SUMMARY OF FAIR VALUE OF OPTIONS GRANTED | The weighted average assumptions used principally in determining the fair value of options granted to employees were as follows: Three Months Ended March 31, 2023 2022 Risk free interest rate 3.85 % 1.70 % Expected dividend yield 0 % 0 % Expected term in years 6.25 6.25 Expected volatility 100.13 % 97.49 % Estimated forfeiture rate 17.64 % 13.00 % |
SUMMARY OF OPTION ACTIVITY | A summary of option activity for the three months ended March 31, 2023 and is presented below: Options Shares Weighted Weighted Average Aggregate Outstanding at December 31, 2022 617,996 $ 88.99 Granted 246,967 4.22 Exercised ( 43,836 ) 0.85 Forfeited or Canceled ( 15,768 ) 55.23 Outstanding at March 31, 2023 805,359 $ 68.23 7.35 $ 21,943,617 Vested at March 31, 2023 406,396 $ 113.92 5.56 $ 5,049,321 Vested and expected to vest at March 31, 2023 715,248 $ 75.45 7.08 $ 17,485,170 |
SUMMARY OF NON-VESTED STOCK OPTIONS | A summary of RSU activity for the three months ended March 31, 2023 and is presented below: RSU's Number of Shares Underlying RSUs Weighted Unvested at December 31, 2022 — $ — Granted 23,990 4.26 Forfeited — — Vested — — Unvested at March 31, 2023 23,990 $ 4.26 |
WARRANTS (Tables)
WARRANTS (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
CFF Warrant [Member] | |
Class of Warrant or Right [Line Items] | |
SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS | Risk free interest rate 2.60 % Expected dividend yield — % Expected term in years 7.00 Expected volatility 83.5 % |
K2 Warrant [Member] | |
Class of Warrant or Right [Line Items] | |
SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS | Risk free interest rate 0.60 % Expected dividend yield — % Expected term in years 10.00 Expected volatility 80.0 % |
Warrants [Member] | |
Class of Warrant or Right [Line Items] | |
SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS | Risk free interest rate 0.90 % Expected dividend yield — % Expected term in years 5.00 Expected volatility 100.6 % |
DERIVATIVE LIABILITY (Tables)
DERIVATIVE LIABILITY (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
SCHEDULE OF FAIR VALUE OF DERIVATIVE LIABILITY | A roll forward of the fair value of the derivative liabilities for the three months ended March 31, 2023 is presented below. March 31, 2023 Beginning balance, December 31, 2022 $ 36,868 Change in fair value of derivative liabilities — Ending balance, March 31, 2023 $ 36,868 |
LIQUIDITY (Details Narrative)
LIQUIDITY (Details Narrative) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Retained earnings (accumulated deficit) | $ 409,825,479 | $ 392,080,667 |
Accumulated deficit | 409,825,000 | |
Cash, cash equivalents and marketable debt securities | $ 44,227,000 |
SCHEDULE OF CASH AND CASH EQUIV
SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Accounting Policies [Abstract] | ||
Cash | $ 2,897,157 | $ 3,805,156 |
Cash Equivalents | 4,427,280 | 13,197,559 |
Cash and cash equivalents | 7,324,437 | 17,002,715 |
Restricted cash, current | 192,475 | 192,475 |
Restricted Cash, Noncurrent | 477,425 | 477,425 |
Restricted cash | 669,900 | 669,900 |
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | $ 7,994,337 | $ 17,672,615 |
SCHEDULE OF COMPUTATION OF NET
SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Accounting Policies [Abstract] | ||
Net loss | $ (17,744,812) | $ (9,437,242) |
Weighted average number of common shares outstanding-basic | 4,181,556 | 4,170,043 |
Net loss per share ,basic | $ (4.24) | $ (2.26) |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 3 Months Ended | |||
Feb. 14, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | ||||
Stockholders equity, reverse stock split | 1-for-30 | |||
Restricted cash | $ 669,900 | $ 669,900 | ||
Restricted cash, current | 192,475 | 192,475 | ||
Restricted Cash, noncurrent | 477,425 | 477,425 | ||
Cash and Cash Equivalents, at Carrying Value | 7,324,437 | 17,002,715 | ||
Prepaid Expense and Other Assets, Current | 1,445,524 | 791,616 | ||
Property, Plant and Equipment, Net | 1,431,945 | 1,613,815 | ||
Unrecognized Tax Benefits | 0 | 0 | ||
Cash, cash equivalents and marketable debt securities | 44,227,000 | |||
Other income (expense), net | 229,507 | $ (193,351) | ||
Impairment charges | $ 0 | $ 0 | ||
Deferred Tax Assets [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Valuation allowance | 100% | |||
Computer Hardware and Software [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Property and equipment, estimated useful life | 3 years | |||
Office Furniture and Equipment [Member] | Minimum [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Property and equipment, estimated useful life | 3 years | |||
Office Furniture and Equipment [Member] | Maximum [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Property and equipment, estimated useful life | 5 years | |||
Leaseholds and Leasehold Improvements [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, Plant and Equipment, Estimated Useful Lives | The Company’s leasehold improvements and assets under capital lease are amortized over the shorter of their useful lives or the respective leases. See Note 7 for details of property and equipment and Note 8 for operating and capital lease commitments. | |||
UNITED KINGDOM | ||||
Property, Plant and Equipment [Line Items] | ||||
Cash held in subsidiary | $ 1,986,000 | 2,805,000 | ||
Prepaid Expense and Other Assets, Current | 836,000 | 136,000 | ||
Cash, cash equivalents and investments | 1,986,000 | $ 2,805,000 | ||
Letter of Credit [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Restricted cash | 669,900 | |||
Restricted cash, current | 192,475 | |||
Restricted Cash, noncurrent | $ 477,425 |
SUMMARY OF INVESTMENTS (Details
SUMMARY OF INVESTMENTS (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Net Investment Income [Line Items] | ||
Debt Securities, Available-for-sale, Amortized Cost | $ 36,971,032 | $ 42,320,040 |
Available for Sale Other Investments And Debt Securities Amortized Cost Basis | 36,971,032 | 42,320,040 |
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax | 0 | 0 |
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax | (68,469) | (125,744) |
Debt Securities, Available-for-sale | 36,902,563 | 42,194,296 |
Debt Securities, Available-for-sale | 36,902,563 | 42,194,296 |
Corporate Debt Securities [Member] | ||
Net Investment Income [Line Items] | ||
Debt Securities, Available-for-sale, Amortized Cost | 25,603,521 | 30,146,060 |
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax | 0 | 0 |
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax | (68,469) | (125,744) |
Debt Securities, Available-for-sale | 25,535,052 | 30,020,316 |
Commercial Paper [Member] | ||
Net Investment Income [Line Items] | ||
Debt Securities, Available-for-sale, Amortized Cost | 11,367,511 | 12,173,980 |
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax | 0 | 0 |
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax | 0 | 0 |
Debt Securities, Available-for-sale | $ 11,367,511 | $ 12,173,980 |
Summarizes the Amortized Cost a
Summarizes the Amortized Cost and Fair Value (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Investments, Debt and Equity Securities [Abstract] | ||
Amortized Cost, Maturing in one year or less | $ 36,971,032 | $ 42,320,040 |
Amortized Cost, Maturing after one year but less than three years | 0 | 0 |
Debt Securities, Available-for-sale, Amortized Cost | 36,971,032 | 42,320,040 |
Fair Value, Maturing in one year or less | 36,902,563 | 42,194,296 |
Fair Value, Maturing after one year but less than three years | 0 | 0 |
Fair Value | $ 36,902,563 | $ 42,194,296 |
MARKETABLE SECURITIES (Details
MARKETABLE SECURITIES (Details Narrative) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Investments, Debt and Equity Securities [Abstract] | ||
Debt Securities, Available-for-sale | $ 36,902,563 | $ 42,194,296 |
SCHEDULE OF ASSETS AND LIABILIT
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE ON RECURRING BASIS (Details) - Fair Value, Recurring [Member] - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, Fair Value | $ 41,329,843 | $ 55,391,855 |
Liabilities, Fair Value | 36,868 | 36,868 |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 4,427,280 | 8,470,790 |
Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 1,494,538 | |
Marketable Securities, Fair Value | 11,367,511 | 12,173,980 |
Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 3,232,231 | |
Marketable Securities, Fair Value | 25,535,052 | 30,020,316 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, Fair Value | 4,427,280 | 8,470,790 |
Liabilities, Fair Value | 0 | 0 |
Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 4,427,280 | 8,470,790 |
Fair Value, Inputs, Level 1 [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 0 | |
Marketable Securities, Fair Value | 0 | 0 |
Fair Value, Inputs, Level 1 [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 0 | |
Marketable Securities, Fair Value | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, Fair Value | 36,902,563 | 46,921,065 |
Liabilities, Fair Value | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 1,494,538 | |
Marketable Securities, Fair Value | 11,367,511 | 12,173,980 |
Fair Value, Inputs, Level 2 [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 3,232,231 | |
Marketable Securities, Fair Value | 25,535,052 | 30,020,316 |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, Fair Value | 0 | 0 |
Liabilities, Fair Value | 36,868 | 36,868 |
Fair Value, Inputs, Level 3 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 0 | |
Marketable Securities, Fair Value | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 0 | |
Marketable Securities, Fair Value | $ 0 | $ 0 |
LICENSE AGREEMENTS (Details Nar
LICENSE AGREEMENTS (Details Narrative) - USD ($) | 3 Months Ended | |||||
Feb. 12, 2023 | May 26, 2021 | May 25, 2021 | Sep. 20, 2018 | Mar. 31, 2023 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
License issuance fee | $ 750,000 | |||||
Other long-term liabilities | $ 2,522,205 | $ 22,205 | ||||
Jenrin Agreement [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Upfront cash payment | $ 250,000 | |||||
Jenrin Agreement [Member] | Maximum [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Potential milestone payments | $ 18,400,000 | |||||
Milky Way Licence Agreement [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Upfront cash payment | $ 500,000 | |||||
Stock Issued During Period, Shares, Acquisitions | 147,875 | |||||
Milky Way Licence Agreement [Member] | Maximum [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Potential milestone payments | $ 53,000,000 | |||||
UCSF Lincense Agreement [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Sales Milestone Payment | 50,000 | |||||
License issuance fee | 1,500,000 | |||||
Installment of license issuance fee | 375,000 | |||||
UCSF Lincense Agreement [Member] | Maximum [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Potential milestone payments | $ 153,150,000 | |||||
Cspc License Agreement [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Upfront cash payment | $ 7,500,000 | |||||
Potential milestone payments | 1,200,000 | |||||
Installment of license issuance fee | 7,500,000 | |||||
Other long-term liabilities | 2,500,000 | |||||
Cspc License Agreement [Member] | Maximum [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Potential milestone payments | 555,000,000 | |||||
Installment of license issuance fee | $ 5,000,000 | |||||
Cspc License Agreement [Member] | Minimum [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Potential milestone payments | 130,000,000 | |||||
Installment of license issuance fee | $ 2,500,000 |
SUMMARY OF PROPERTY AND EQUIPME
SUMMARY OF PROPERTY AND EQUIPMENT (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,707,038 | $ 4,707,038 |
Less: accumulated depreciation | (3,275,093) | (3,093,223) |
Property an equipment, net | 1,431,945 | 1,613,815 |
Computer Hardware and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 262,203 | 262,203 |
Office Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,113,980 | 1,113,980 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 3,330,855 | $ 3,330,855 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation | $ 181,870 | $ 195,719 |
SCHEDULE OF MATURITIES OF OPERA
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES (Details) | Mar. 31, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2023 | $ 1,280,934 |
2024 | 1,747,447 |
2025 | 1,794,889 |
2026 | 1,688,145 |
Total lease payments | 6,511,415 |
Less: imputed interest | (859,935) |
Total | $ 5,651,480 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) | 3 Months Ended | ||
Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Aug. 26, 2021 ft² | |
Commitments and Contingencies Disclosure [Abstract] | |||
Sublease Area | 12,112 | ||
Sublease Area Total | 30,023 | ||
Sublease Agreement Description | Effective August 26, 2021, the Company entered into a sublease agreement with a third party to sublease 12,112 square feet of the 30,023 square feet currently being leased under one of its two existing lease agreements. The sublease commenced on October 1, 2021 and ends October 31, 2026. The Company notes sublease income of $55,133 and $55,133 was recognized and offset against rent expense for the three months ended March 31, 2023 and 2022, respectively. | ||
Subleases Income | $ | $ 55,133 | $ 55,133 |
SUMMARY OF UNDISCOUNTED SUBLEAS
SUMMARY OF UNDISCOUNTED SUBLEASE CASH INFLOWS (Details) | Mar. 31, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2024 | $ 278,576 |
2025 | 290,688 |
2026 | 252,333 |
Total sublease payments | $ 981,072 |
SCHEDULE OF NOTES PAYABLE (Deta
SCHEDULE OF NOTES PAYABLE (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Principal | $ 20,000,000 | $ 20,000,000 |
Less: debt discount | (2,954,390) | (2,954,390) |
Accretion of Debt Discount | 1,935,608 | 1,734,485 |
Net Carrying amount | 18,981,218 | 18,780,095 |
Less: current portion of long term debt | (5,008,858) | (2,795,669) |
Total long-term debt, net of discount | $ 13,972,360 | $ 15,984,426 |
SCHEDULE OF PRINCIPAL MATURITIE
SCHEDULE OF PRINCIPAL MATURITIES ON LONG TERM DEBT (Details) | Mar. 31, 2023 USD ($) |
Debt Disclosure [Abstract] | |
2023 | $ 2,963,785 |
2024 | 18,626,215 |
Total | $ 21,590,000 |
NOTES PAYABLE (Details Narrativ
NOTES PAYABLE (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Jul. 28, 2020 | Nov. 30, 2022 | Nov. 30, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Interest Expense, Debt | $ 937,000 | $ 684,000 | ||||
Debt Instrument, Unamortized Discount | 2,954,390 | $ 2,954,390 | ||||
Lenders [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Debt Instrument, Unamortized Discount | 2,954,000 | |||||
Insurance Policy [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Prepaid expenses | 293,125 | 418,750 | ||||
Loan and Security Agreement [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Monthly principal and interest payments | $ 51,387 | $ 111,041 | ||||
Monthly loan payments term | nine-month period | nine-month period | ||||
Notes payable | $ 452,250 | $ 984,375 | ||||
Annual interest rate | 5.40% | 3.64% | ||||
Loan and Security Agreement [Member] | K2 HealthVentures LLC [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Debt description | The loan matures on August 1, 2024 and the Company is obligated to make interest only payments for the first 24 months and then interest and equal principal payments for the next 24 months commencing on September 1, 2022. | |||||
Increase in fair value of conversion option | 573,000 | |||||
Debt issuance cost | $ 1,244,000 | |||||
Proceeds from prepayment and default features | 546,000 | |||||
Secured debt | 50,000,000 | $ 21,590,000 | ||||
Annual interest rate | 13.25% | |||||
Proceeds from Warrant Exercises | $ 472,000 | |||||
Debt conversion amount | $ 5,000,000 | |||||
Debt conversion per share | $ 282 | |||||
Debt maturity date | Aug. 01, 2024 | |||||
Warrant exercisable price per share | $ 208.80 | |||||
Warrants to purchase shares of common stock, exercised | 2,874 | |||||
Final payment | $ 1,590,000 | $ 1,590,000 | ||||
Loan and Security Agreement [Member] | K2 HealthVentures LLC [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Secured debt | 20,000,000 | |||||
Loan and Security Agreement [Member] | K2 HealthVentures LLC [Member] | Share-based Payment Arrangement, Tranche Two [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Secured debt | 20,000,000 | |||||
Loan and Security Agreement [Member] | K2 HealthVentures LLC [Member] | Share-based Payment Arrangement, Tranche Three [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Secured debt | $ 10,000,000 | |||||
Loan and Security Agreement [Member] | Debt 1 [Member] | K2 HealthVentures LLC [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Debt conversion amount | $ 2,000,000 | |||||
Loan and Security Agreement [Member] | Debt 1 A [Member] | K2 HealthVentures LLC [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Debt conversion amount | $ 875,000 | |||||
Loan and Security Agreement [Member] | Debt 1 A [Member] | Minimum [Member] | K2 HealthVentures LLC [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Debt conversion per share | $ 282 | |||||
Loan and Security Agreement [Member] | Debt 1 A [Member] | Maximum [Member] | K2 HealthVentures LLC [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Debt conversion per share | $ 4.50 | |||||
Loan and Security Agreement [Member] | Debt 2 [Member] | K2 HealthVentures LLC [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Debt conversion amount | $ 3,000,000 | |||||
Debt conversion per share | $ 282 | |||||
Loan and Security Agreement [Member] | Debt 1 B [Member] | K2 HealthVentures LLC [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Debt conversion amount | $ 1,125,000 | |||||
Loan and Security Agreement [Member] | Debt 1 B [Member] | Minimum [Member] | K2 HealthVentures LLC [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Debt conversion per share | $ 282 | |||||
Loan and Security Agreement [Member] | Debt 1 B [Member] | Maximum [Member] | K2 HealthVentures LLC [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Debt conversion per share | $ 7.875 | |||||
Event of Default - Loan Agreement [Member] | K2 HealthVentures LLC [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Annual interest rate | 5% | |||||
Debt maturity date | Aug. 01, 2024 | |||||
Amended Loan Agreement [Member] | K2 HealthVentures LLC [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Debt description | The Company entered into an Amendment to the Loan and Security Agreement (the "Amended Loan and Security Agreement") on October 25, 2022. The Amended Loan and Security Agreement defers the commencement of principal repayments by a one-year period from September 1, 2022 to September 1, 2023 and if the Company raises at least $30 million in net proceeds through capital raising transactions, the commencement of principal repayments will be deferred by an additional six months to March 1, 2024. Interest accrues at a variable annual rate equal to the greater of (i) 8.5% and (ii) the rate of interest noted in The Wall Street Journal, Money Rates section, as the “Prime Rate” plus 5.25%, in each case, subject to a step-down of 25 basis points upon the funding of the second tranche. | |||||
Debt issuance cost | $ 119,000 |
SCHEDULE OF ACCRUED EXPENSES (D
SCHEDULE OF ACCRUED EXPENSES (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued pre-clinical and clinical costs | $ 4,074,713 | $ 2,137,317 |
Accrued product development costs | 409,691 | 247,500 |
Accrued compensation | 826,703 | 2,224,951 |
Accrued administrative costs | 143,175 | 473,376 |
Accrued interest | 1,014,020 | 916,108 |
Total | $ 6,468,302 | $ 5,999,252 |
PREFERRED STOCK (Additional Inf
PREFERRED STOCK (Additional Information) (Details) - $ / shares | 3 Months Ended | |||
Mar. 31, 2023 | Dec. 31, 2022 | Dec. 20, 2022 | Oct. 12, 2022 | |
Preferred stock authorised | 10,000,000 | 10,000,000 | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | ||
Preferred stock outstanding | 0 | 0 | ||
Preferred Stock, Shares Issued | 0 | 0 | ||
Series A Preferred Stock [Member] | ||||
Dividend declared, per share | $ 0.008 | |||
Preferred Stock, Shares Issued | 500,894.04 | 1,002,247.048 | ||
Preferred Stock, Description | Each share of Series A Preferred Stock is entitled to receive $0.001 in cash for each 10 whole shares of Series A Preferred Stock immediately prior to the Redemption. | |||
Stock issued during period, shares, reverse stock splits | 501,353.008 |
COMMON STOCK (Details Narrative
COMMON STOCK (Details Narrative) - USD ($) | 3 Months Ended | |||
Apr. 07, 2020 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Common stock, shares authorized | 300,000,000 | 300,000,000 | ||
Common stock, par value | $ 0.0001 | $ 0.0001 | ||
Common stock, shares issued | 4,215,133 | 4,171,297 | ||
Common stock, shares outstanding | 4,215,133 | 4,171,297 | ||
Gross proceeds from sale of stock | $ 37,056 | $ 0 | ||
Stock issuance cost | $ 0 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 43,836 | |||
2014 Plan | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Common stock issued | 833 | |||
Warrant [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Exercised | 0 | 0 | ||
Equity Option [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 43,836 | 0 | ||
Proceeds from Stock Options Exercised | $ 129,740 | $ 0 | ||
August 2020 Sale Agreement [Member] | Jefferies LLC [Member] | Maximum [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Aggregate common stock sold, shares | 150,000,000 |
SCHEDULE OF STOCK-BASED COMPENS
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | $ 1,026,379 | $ 1,591,746 |
Research and Development Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | 93,922 | 176,218 |
General and Administrative Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | 932,457 | 1,415,528 |
Stock Options [member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | 1,023,741 | 1,591,746 |
Restricted Stock Units (RSUs) [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | $ 2,638 |
SUMMARY OF FAIR VALUE OF OPTION
SUMMARY OF FAIR VALUE OF OPTIONS GRANTED (Details) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Option Indexed to Issuer's Equity [Line Items] | ||
Expected term in years | 6 years 3 months | |
Employee Stock Option [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Risk free interest rate | 3.85% | 1.70% |
Expected dividend yield | 0% | 0% |
Expected term in years | 6 years 3 months | 6 years 3 months |
Expected volatility | 100.13% | 97.49% |
Estimated Forfeiture Rate | 17.64% | 13% |
SUMMARY OF OPTION ACTIVITY (Det
SUMMARY OF OPTION ACTIVITY (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Shares, Outstanding, Beginning balance | 617,996 | |
Weighted Average Exercise Price, Outstanding, Beginning balance | $ 88.99 | |
Shares, Granted | 246,967 | |
Weighted Average Exercise Price, Granted | $ 4.22 | |
Shares, Exercised | (43,836) | |
Shares, Forfeited | (15,768) | |
Weighted Average Exercise Price, Forfeited | $ 55.23 | |
Weighted Average Exercise Price , Expired | $ 0.85 | |
Shares, Outstanding, Ending balance | 805,359 | |
Weighted Average Exercise Price, Outstanding, Ending balance | $ 68.23 | |
Weighted Average Remaining Contractual Term in Years, Outstanding | 7 years 4 months 6 days | |
Average Intrinsic Value, Outstanding | $ 21,943,617 | |
Shares, Vested | 406,396 | |
Weighted Average Exercise Price, Vested | $ 113.92 | |
Weighted Average Remaining Contractual Term in Years, Vested | 5 years 6 months 21 days | |
Average Intrinsic Value, Vested | $ 5,049,321 | |
Shares, Vested and expected to vest | 715,248 | |
Weighted Average Exercise Price, Vested and expected to vest | $ 75.45 | |
Weighted Average Remaining Contractual Term in Years, Vested and expected to vest | 7 years 29 days | |
Aggregate Intrinsic Value, Vested and expected to vest | $ 17,485,170 |
summary of RSU activity (Detail
summary of RSU activity (Details) | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number, Ending Balance | shares | 23,990 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period | shares | 23,990 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ / shares | $ 4.26 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value, Ending Balance | $ / shares | $ 4.26 |
STOCK OPTIONS (Details Narrativ
STOCK OPTIONS (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Apr. 30, 2014 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Jan. 01, 2023 | Jan. 01, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||
Stock-based compensation expense | $ 1,026,379 | $ 1,591,746 | |||||
Option granted expected term | 6 years 3 months | ||||||
Weighted average grant-date fair value, options granted | $ 3.44 | $ 11.10 | |||||
Total fair value of options vested | $ 21,943,617 | ||||||
Total unrecognized compensation expense | $ 81,163 | ||||||
Share-based compensation expense, not yet recognized period of recognition | 3 years 10 months 13 days | ||||||
Shares, Granted | 246,967 | ||||||
Equity Option [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||
Average intrinsic value of options exercised | $ 92,689 | $ 0 | |||||
Total unrecognized compensation expense | $ 5,733,215 | ||||||
Share-based compensation expense, not yet recognized period of recognition | 2 years 7 days | ||||||
2014 Equity Incentive Plan [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||
Percentage of outstanding common shares | 7% | ||||||
Shares available for future issuance | 1,436,558 | 1,144,567 | |||||
Shares available for grant | 510,671 | 426,486 | 741,870 | 558,671 | |||
Common Stock, Capital Shares Reserved for Future Issuance | 1,436,558 | 1,144,567 | |||||
2014 Equity Incentive Plan [Member] | January 1, 2023 [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||
Percentage of outstanding common shares | 7% | 7% | |||||
Increase in number of shares of common stock available for issuance | 291,991 | 292,205 |
WARRANTS (Details Narrative)
WARRANTS (Details Narrative) - USD ($) | 3 Months Ended | |||||
Oct. 16, 2020 | Jul. 28, 2020 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Jan. 26, 2018 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Debt face amount | $ 20,000,000 | $ 20,000,000 | ||||
Share-Based Payment Arrangement, Tranche One [Member] | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Debt face amount | $ 20,000,000 | |||||
CFF Warrant [Member] | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 33,334 | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 33,334 | |||||
Exercise price of warrants | $ 396 | |||||
Investment Agreement [Member] | CFF Warrant [Member] | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 50,207 | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 50,207 | |||||
Exercise price of warrants | $ 283.81 | |||||
Weighted average remaining life of warrants | 2 years 4 months 9 days | |||||
Warrant expire date | Jan. 26, 2025 | |||||
Fair value of warrants issued | $ 6,215,225 | |||||
Loan and Security Agreement [Member] | K2 Warrant [Member] | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Warrants to purchase shares of common stock, exercised | 2,874 | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,874 | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,874 | |||||
Exercise price of warrants | $ 208.80 | |||||
Warrant expire date | Jul. 28, 2030 | |||||
Fair value of warrants issued | $ 472,409 | |||||
Loan and Security Agreement [Member] | K2 Warrant [Member] | Maximum [Member] | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Debt face amount | $ 50,000,000 | |||||
Professional Services Agreement [Member] | Warrants [Member] | Investor Relations Service Provider [Member] | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 14,000 | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 14,000 | |||||
Exercise price of warrants | $ 32.10 | |||||
Fair value of warrants issued | $ 334,740 | |||||
Warrant [Member] | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Warrants to purchase shares of common stock, exercised | 0 | 0 |
SCHEDULE OF WEIGHTED AVERAGE AS
SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS (Details) | Mar. 31, 2023 |
CFF Warrant [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 2.60 |
CFF Warrant [Member] | Measurement Input, Expected Dividend Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0 |
CFF Warrant [Member] | Measurement Input, Expected Term [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, term | 7 years |
CFF Warrant [Member] | Measurement Input, Price Volatility [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 83.5 |
K2 Warrant [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0.60 |
K2 Warrant [Member] | Measurement Input, Expected Dividend Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0 |
K2 Warrant [Member] | Measurement Input, Expected Term [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, term | 10 years |
K2 Warrant [Member] | Measurement Input, Price Volatility [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 80 |
Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0.90 |
Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0 |
Warrants [Member] | Measurement Input, Expected Term [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, term | 5 years |
Warrants [Member] | Measurement Input, Price Volatility [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 100.6 |
SCHEDULE OF FAIR VALUE OF DERIV
SCHEDULE OF FAIR VALUE OF DERIVATIVE LIABILITY (Details) | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Beginning balance, December 31, 2020 | $ 36,868 |
Change in fair value of derivative liability | 0 |
Ending balance, September 30, 2021 | $ 36,868 |
DERIVATIVE LIABILITY (Details N
DERIVATIVE LIABILITY (Details Narrative) - USD ($) | 3 Months Ended | |||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Jul. 28, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Fair value of derivative liabilities | $ 36,868 | $ 36,868 | ||
Gain (Loss) on Sale of Derivatives | 0 | |||
Loan and Security Agreement [Member] | K2 HealthVentures LLC [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Secured debt | $ 21,590,000 | $ 50,000,000 | ||
Gain (Loss) on Sale of Derivatives | $ 0 | |||
Loan and Security Agreement [Member] | K2 HealthVentures LLC [Member] | Share-based Payment Arrangement, Tranche One [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Secured debt | $ 20,000,000 |