Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 05, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Entity Registrant Name | Celcuity Inc. | ||
Entity Central Index Key | 0001603454 | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
Entity Voluntary Filers | No | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well Known Seasoned Issuer | No | ||
Entity Small Business | true | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | true | ||
Entity Current Reporting Status | Yes | ||
Document Period End Date | Dec. 31, 2020 | ||
Entity Filer Category | Non-accelerated Filer | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2020 | ||
Entity Ex Transition Period | true | ||
Entity Common Stock Shares Outstanding | 10,304,089 | ||
Entity Public Float | $ 40,900,174 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 001-38207 | ||
Entity Incorporation State Country Code | DE | ||
Entity Tax Identification Number | 82-2863566 | ||
Entity Address Address Line 1 | 16305 36th Avenue North, | ||
Entity Address Address Line 2 | Suite 100 | ||
Entity Address City Or Town | Minneapolis | ||
Entity Address State Or Province | MN | ||
Entity Address Postal Zip Code | 55446 | ||
City Area Code | 763 | ||
Local Phone Number | 392-0767 | ||
Security 12b Title | Common Stock, $0.001 par value per share | ||
Trading Symbol | CELC | ||
Security Exchange Name | NASDAQ | ||
Entity Interactive Data Current | Yes |
Balance Sheets
Balance Sheets - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current Assets: | ||
Cash and cash equivalents | $ 11,637,911 | $ 18,735,002 |
Deposits | 22,009 | 22,009 |
Deferred transaction costs | 0 | 28,743 |
Payroll tax receivable | 190,000 | 190,000 |
Prepaid assets | 317,040 | 274,600 |
Total current assets | 12,166,960 | 19,250,354 |
Property and equipment, net | 558,876 | 833,463 |
Operating lease right-of-use assets | 230,911 | 196,983 |
Total Assets | 12,956,747 | 20,280,800 |
Current Liabilities: | ||
Accounts payable | 217,377 | 142,773 |
Finance lease liabilities | 5,810 | 5,769 |
Operating lease liabilities | 187,518 | 178,466 |
Accrued expenses | 774,612 | 584,319 |
Total current liabilities | 1,185,317 | 911,327 |
Finance lease liabilities | 8,299 | 14,109 |
Operating lease liabilities | 60,861 | 57,793 |
Total Liabilities | 1,254,477 | 983,229 |
Stockholders' Equity: | ||
Preferred stock, $0.001 par value: 2,500,000 shares authorized; 0 shares issued and outstanding as of December 31, 2020 and December 31, 2019 | 0 | 0 |
Common stock, $0.001 par value: 25,000,000 shares authorized; 10,299,822 and 10,253,988 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively | 10,300 | 10,254 |
Additional paid-in capital | 38,013,551 | 36,134,723 |
Accumulated deficit | (26,321,581) | (16,847,406) |
Total Stockholders' Equity | 11,702,270 | 19,297,571 |
Total Liabilities and Stockholders' Equity | $ 12,956,747 | $ 20,280,800 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Balance Sheets | ||
Preferred stock, par or stated value per share | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 2,500,000 | 2,500,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par or stated value per share | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 25,000,000 | 25,000,000 |
Common stock, shares issued | 10,299,822 | 10,253,988 |
Common stock, shares outstanding | 10,299,822 | 10,253,988 |
Statements of Operations
Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating expenses: | ||
Research and development | $ 7,683,522 | $ 6,269,308 |
General and administrative | 1,872,642 | 1,535,993 |
Total operating expenses | 9,556,164 | 7,805,301 |
Loss from operations | (9,556,164) | (7,805,301) |
Other income (expense) | ||
Interest expense | (120) | (159) |
Interest income | 82,109 | 446,096 |
Other income, net | 81,989 | 445,937 |
Net loss before income taxes | (9,474,175) | (7,359,364) |
Income tax benefits | 0 | 0 |
Net loss | $ (9,474,175) | $ (7,359,364) |
Net loss per share, basic and diluted | $ (0.92) | $ (0.72) |
Weighted average common shares outstanding, basic and diluted | 10,266,884 | 10,226,041 |
Statements of Changes in Stockh
Statements of Changes in Stockholders' Equity - USD ($) | Total | Common Stock | Additional Paid-In Capital | Retained Earnings (Accumulated Deficit) |
Balance, shares at Dec. 31, 2018 | 10,186,382 | |||
Balance, amount at Dec. 31, 2018 | $ 25,349,611 | $ 10,186 | $ 34,827,467 | $ (9,488,042) |
Exercise of common stock warrants, shares | 395 | |||
Exercise of common stock warrants, amount | 3,752 | $ 0 | 3,752 | |
Stock-based compensation | 1,040,989 | $ 0 | 1,040,989 | 0 |
Exercise of common stock options, net of shares withheld for exercise price, shares | 58,127 | |||
Exercise of common stock options, net of shares withheld for exercise price, amount | 174,958 | $ 59 | 174,899 | 0 |
Employee stock purchases, shares | 9,084 | |||
Employee stock purchases, amount | 87,625 | $ 9 | 87,616 | 0 |
Net loss | (7,359,364) | $ 0 | 0 | (7,359,364) |
Balance, shares at Dec. 31, 2019 | 10,253,988 | |||
Balance, amount at Dec. 31, 2019 | 19,297,571 | $ 10,254 | 36,134,723 | (16,847,406) |
Stock-based compensation | 1,763,879 | $ 16 | 1,763,863 | 0 |
Employee stock purchases, shares | 12,423 | |||
Employee stock purchases, amount | 60,303 | $ 12 | 60,291 | 0 |
Net loss | (9,474,175) | $ 0 | 0 | (9,474,175) |
Stock-based compensation, shares | 15,686 | |||
Issuance of common stock in an at-the-market ("ATM") offering, shares | 17,725 | |||
Issuance of common stock in an at-the-market ("ATM") offering, amount | 182,694 | $ 18 | 182,676 | 0 |
Issuance costs associated with ATM offering | (128,002) | $ 0 | (128,002) | 0 |
Balance, shares at Dec. 31, 2020 | 10,299,822 | |||
Balance, amount at Dec. 31, 2020 | $ 11,702,270 | $ 10,300 | $ 38,013,551 | $ (26,321,581) |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (9,474,175) | $ (7,359,364) |
Adjustments to reconcile net loss to net cash used for operations: | ||
Depreciation | 385,591 | 338,996 |
Stock-based compensation | 1,763,879 | 1,040,989 |
Non-cash interest income, net of cash received | 0 | 42,907 |
Changes in operating assets and liabilities: | ||
Payroll tax receivable | 0 | (190,000) |
Prepaid assets and deposits | (42,440) | (20,143) |
Accounts payable | 52,971 | 45,617 |
Accrued expenses | 190,293 | 111,403 |
Non-cash operating lease, net | (21,808) | (9,116) |
Net cash used for operating activities | (7,145,689) | (5,998,711) |
Cash flows from investing activities: | ||
Proceeds from sale of investments | 0 | 8,910,000 |
Purchases of property and equipment | (89,371) | (380,201) |
Net cash provided by (used for) investing activities | (89,371) | 8,529,799 |
Cash flows from financing activities: | ||
Proceeds from exercise of common stock warrants | 0 | 3,752 |
Proceeds from exercise of employee stock options | 0 | 174,958 |
Proceeds from employee stock purchases | 60,303 | 87,625 |
Gross proceeds from an ATM offering | 182,694 | 0 |
Payments for secondary registration statement costs | (99,259) | (1,300) |
Payments for finance leases | (5,769) | (5,730) |
Net cash provided by financing activities | 137,969 | 259,305 |
Net change in cash and cash equivalents | (7,097,091) | 2,790,393 |
Cash and cash equivalents: | ||
Beginning of period | 18,735,002 | 15,944,609 |
End of period | 11,637,911 | 18,735,002 |
Supplemental disclosures of non-cash investing and financing activities: | ||
Property and equipment included in accounts payable | $ 24,333 | $ 2,700 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2020 | |
Organization | |
1. Organization | 1. Organization Nature of Business Celcuity Inc., a Delaware corporation (the “Company”), is a clinical stage biotechnology company translating discoveries of new cancer sub-types into pioneering companion diagnostics and expanded therapeutic options for cancer patients. The Company’s 3rd generation diagnostic platform, CELsignia, analyzes living tumor cells to untangle the complexity of the cellular activity driving a patient’s cancer. This allows the Company to discover new cancer sub-types molecular diagnostics cannot detect. The Company is driven to improve outcomes for patients and to transform how pharmaceutical companies define the patient populations for their targeted therapies. The Company’s proprietary CELsignia diagnostic platform is currently the only commercially ready technology the Company is aware of that uses a patient’s living tumor cells to evaluate the functional status of the cell signaling pathways associated with cancer. The Company was co-founded in 2012 by Brian F. Sullivan and Dr. Lance G. Laing and is based in Minnesota. The Company has not generated any revenues to date. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Summary of Significant Accounting Policies | |
2. Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Operating results for the year ended December 31, 2020 are not necessarily indicative of results to be expected for any future year. Accounting Estimates Management uses estimates and assumptions in preparing these financial statements in accordance with U.S. GAAP. Those estimates and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenues and expenses. Actual results could differ from those estimates and the difference could be significant. Significant items subject to such estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs. Cash and Cash Equivalents The Company maintains its accounts primarily at one financial institution. At times throughout the year, the Company’s cash balances may exceed amounts insured by the Federal Deposit Insurance Corporation. At December 31, 2020 and December 31, 2019, the Company had $11,378,685 and $18,369,229, respectively, in money market funds that are considered cash equivalents and not insured by the Federal Deposit Insurance Corporation. Property and Equipment Property and equipment are stated at cost. Depreciation is provided over estimated useful lives using the straight-line method. Maintenance and repairs are expensed as incurred; major improvements and betterments are capitalized. Estimated useful lives of property and equipment are as follows for the major classes of assets: Asset Description Estimated Lives Furniture and Equipment 4-5 Leasehold Improvements 2-3 Long-Lived Assets Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values, and third-party independent appraisals, as considered necessary. Deferred Transaction Costs Deferred transaction costs primarily consist of legal fees, SEC filing fees and other fees relating to the Company’s Registration Statement on Form S-3 filed on September 21, 2018. The deferred transaction costs were capitalized as incurred and were offset against proceeds from the sale of shares of common stock pursuant to the ATM Agreement. Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. For all periods presented, there was no difference between net loss and comprehensive loss. Risks and Uncertainties The Company is subject to risks common to companies in the development stage including, but not limited to, dependency on the clinical and commercial success of its diagnostic tests, ability to obtain regulatory approval of its diagnostic tests, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians and consumers, and significant competition. Fair Value of Financial Instruments The Company’s accounting for fair value measurements of assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring or nonrecurring basis adheres to the Financial Accounting Standards Board (“FASB”) fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are as follows: · Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the Company at the measurement date. · Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. · Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement date. The level in the fair value hierarchy within which a fair value measurement in its entirety falls, is based on the lowest level input that is significant to the fair value measurement in its entirety. The carrying values of cash equivalents, accounts payable, accrued expenses and other financial working capital items approximate fair value at December 31, 2020 and December 31, 2019, due to the short maturity nature of these items. Income Taxes The Company accounts for income taxes using the asset and liability method, as required by the accounting standard for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as net operating loss and tax credit carryforwards. Deferred taxes are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred taxes of a change in tax rates is recognized in results of operations in the period that includes the enactment date. The effects of any future changes in tax laws or rates have not been considered. The Company regularly reviews deferred tax assets to assess their potential realization and establish a valuation allowance for portions of such assets to reduce the carrying value if the Company does not consider it to be more likely than not that the deferred tax assets will be realized. The Company recognizes the impact of an uncertain tax position in its financial statements if, in management's judgment, the position is more-likely-than-not sustainable upon audit based on the position's technical merits. This involves the identification of potential uncertain tax positions, the evaluation of applicable tax laws and an assessment of whether a liability for an uncertain tax position is necessary. Stock-Based Compensation The Company’s stock-based compensation consists of stock options and restricted stock issued to certain employees and nonemployees of the Company and the Company’s 2017 Employee Stock Purchase Plan. The Company recognizes compensation expense based on an estimated grant date fair value using the Black-Scholes option-pricing method. If the factors change and different assumptions used, the Company’s stock-based compensation expense could be materially different in the future. The Company recognizes stock-based compensation expense for these options on a straight-line basis over the requisite service period. The Company has elected to account for forfeitures as they occur. Research and Development Research and development costs are expensed as incurred. Research and development costs amounted to $7,683,522 for the year ended December 31, 2020 and $6,269,308 for the year ended December 31, 2019. Clinical Trial Costs The Company records prepaid assets or accrued expenses for prepaid or estimated clinical trial costs conducted by third-party service providers, which include the conduct of preclinical studies and clinical trials. These costs can be a significant component of the Company’s research and development expenses. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with service agreements with its third-party service providers. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its prepaid assets or accrued expenses. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled, and the rate of patient enrollments may vary from the Company’s estimates, resulting in an adjustment to expense in future periods. Changes in these estimates that result in material changes to the Company’s prepaid assets or accrued expenses could materially affect the Company’s results of operations. Segment Data The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. Application of New or Revised Accounting Standards Pursuant to the JOBS Act, a company constituting an “emerging growth company” is, among other things, entitled to rely upon certain reduced reporting requirements. The Company is an emerging growth company but has irrevocably elected not to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. As a result, the Company will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for public companies that are not emerging growth companies. Recently Adopted Accounting Pronouncements Effective January 1, 2019, the Company adopted Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842), |
Liquidity
Liquidity | 12 Months Ended |
Dec. 31, 2020 | |
Liquidity | |
3. Liquidity | 3. Liquidity Based on the Company’s cash and cash equivalents on hand at December 31, 2020 of $11,637,911, the Company believes that its cash will be sufficient to fund the Company’s current operating plan through at least the next 12 months from the issuance date of this Annual Report. |
Net Loss Per Common Share
Net Loss Per Common Share | 12 Months Ended |
Dec. 31, 2020 | |
Net Loss Per Common Share | |
4. Net Loss Per Common Share | 4. Net Loss Per Common Share Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding during the period. For all periods presented, the common shares underlying the options and warrants have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted-average shares outstanding used to calculate both basic and diluted loss per common share are the same. For the years ended December 31, 2020 and 2019, potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding were options to purchase 849,949 and 585,215 shares of common stock, respectively, warrants to purchase 353,585 shares of common stock, and 15,686 and 0 shares of restricted common stock, respectively. |
Payroll Tax Receivable
Payroll Tax Receivable | 12 Months Ended |
Dec. 31, 2020 | |
Payroll Tax Receivable | |
5. Payroll Tax Receivable | 5. Payroll Tax Receivable The payroll tax receivable initially recorded in 2019, is the result of the Company’s utilization of research and development tax credits as authorized by the Path Act. The balance at December 31, 2020 and December 31, 2019 was $190,000. |
Prepaid Assets
Prepaid Assets | 12 Months Ended |
Dec. 31, 2020 | |
Prepaid Assets | |
6. Prepaid Assets | 6. Prepaid Assets Prepaid assets consisted of the following at December 31: 2020 2019 Current: Directors & officers' insurance $ 288,750 $ 229,167 Other 28,290 45,433 Total $ 317,040 $ 274,600 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
Property and Equipment | |
7. Property and Equipment | 7. Property and Equipment Property and equipment consisted of the following at December 31: 2020 2019 Leasehold improvements $ 302,848 $ 302,848 Furniture and equipment 1,461,512 1,350,508 1,764,360 1,653,356 Less: Accumulated depreciation (1,205,484 ) (819,893 ) Total $ 558,876 $ 833,463 Depreciation expense was $385,591 and $338,996 for the years ended December 31, 2020 and 2019, respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2020 | |
Liquidity | |
8. Accrued Expenses | 8. Accrued Expenses Accrued expenses consisted of the following at December 31: 2020 2019 Accrued compensation $ 628,121 $ 461,452 Employee Stock Purchase Plan 9,471 10,121 Other 137,020 112,746 Total $ 774,612 $ 584,319 |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2020 | |
Commitments | |
9. Commitments | 9. Commitments Operating and Finance Leases The Company leases its corporate space in Minneapolis, Minnesota. In September 2017, the Company entered into a non-cancelable operating lease agreement for building space. The new lease commenced, and the Company moved to the facility in May 2018, in conjunction with the termination of its then existing lease. Rent expense is recorded on a straight-line basis over the lease term. In July 2020 the Company signed an amendment to extend this lease through April 30, 2022. The lease amendment provides for monthly rent, real estate taxes and operating expenses. As a result of the lease amendment, the Company recorded an incremental $197,211 in the operating ROU asset and lease liability. The lease agreement, as amended, includes the option to extend the term for one additional year. The option to extend is at the Company’s discretion and because the Company has not determined if the option to extend will be exercised, the extended lease term is not included in the ROU assets and lease liabilities. The Company regularly evaluates the renewal options and when it is reasonably certain of exercise, the Company will include the renewal period in its lease term. In May 2018, the Company entered into a non-cancelable finance lease agreement for office equipment with a five-year term. The underlying assets are included in furniture and equipment. The lease contains a bargain purchase option at the end of the lease. When an implicit rate is not provided, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease payments. Supplemental balance sheet information consisted of the following at December 31, 2020: Operating Lease Right-of-use assets $ 230,911 Operating lease liability $ 248,379 Less: short term portion (187,518 ) Long term portion $ 60,861 Finance Lease Furniture and equipment $ 28,932 Less: Accumulated depreciation (14,948 ) Net book value of property and equipment under finance lease $ 13,984 Finance lease liability $ 14,109 Less: short term portion (5,810 ) Long term portion $ 8,299 Maturity analysis under lease agreements consisted of the following as of December 31, 2020: Operating Leases Finance Leases 2021 $ 194,821 $ 7,255 2022 64,940 7,255 2023 - 3,022 Total minimum lease payments 259,761 17,532 Less: Present value discount (11,382 ) (122 ) Less amount representing services - (3,301 ) Present value of net minimum lease payments $ 248,379 $ 14,109 Weighted Average Remaining Lease Term Discount Rate Operating lease 1.3 years 4.0 % Finance lease 2.4 years 1.0 % Lease costs for the year ended December 31: 2020 2019 Operating lease cost $ 171,530 $ 164,252 Finance lease cost: Amortization 5,786 5,786 Interest 119 159 Variable lease cost 85,265 82,885 $ 262,700 $ 253,082 Supplemental cash flow information related to leases for the year ended December 31: 2020 2019 Cash paid for amounts included in operating and finance leases: Operating cash outflow from operating leases $ 278,603 $ 248,450 Operating cash outflow from finance leases 119 159 Financing cash outflow from finance leases 5,769 5,730 $ 284,491 $ 254,339 Clinical Research Studies In May 2017, the Company entered into an agreement with a clinical research organization to conduct a clinical research study. The Company made payments of $100,000 and $50,000 in 2020 and 2019, respectively, and $550,000 prior to 2019. Additional payments will be due as certain milestones are met and clinical sites are added. The maximum amount of these additional payments is estimated to be approximately $2,620,000 over the course of the agreement. In October 2018, the Company entered into an agreement with a biopharmaceutical company and a cancer research center to conduct a clinical research study. The Company made payments of approximately $70,000 in 2019. Additional payments of approximately $112,000 will be due as certain milestones are met. In December 2020, the Company entered into an agreement with a biopharmaceutical company and a cancer research center to conduct a clinical research study. The Company made zero payments in 2020. Future payments of approximately $740,000 will be due as certain milestones are met. In January 2021, the Company entered into an agreement with a biopharmaceutical company and a cancer research center to conduct a clinical research study. Future payments of approximately $1,210,600 will be due as certain milestones are met. |
Stockholders Equity
Stockholders Equity | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders Equity | |
10. Stockholders' Equity | 10. Stockholders’ Equity On June 5, 2020, the Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with B. Riley FBR, Inc. (the “Agent”). Pursuant to the ATM Agreement, the Company may offer and sell from time to time, at its option, shares of common stock having an aggregate offering price of up to $10,000,000, par value $0.001 per share (the “Placement Shares”), through the Agent. The Placement Shares have been registered under the Securities Act of 1933, as amended, pursuant to the Registration Statement on Form S-3 (File No. 333-227466), which was originally filed with the SEC on September 21, 2018 and declared effective by the SEC on October 4, 2018, the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed on June 5, 2020. Sales of the Company’s common stock, if any, under this prospectus supplement may be made by any method deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. During the year ended December 31, 2020, the Company sold 17,725 shares of common stock pursuant to the ATM Agreement, at an average selling price of $10.31 per share. On September 15, 2017, in connection with its IPO, Celcuity LLC filed a certificate of conversion, whereby Celcuity LLC effected a corporate conversion from a Minnesota limited liability company to a Delaware corporation and changed its name to Celcuity Inc. Pursuant to the conversion, units of membership interest in the limited liability company were converted into shares of common stock of the corporation at a conversion ratio of 40 units for one share of common stock. The Company had 257,604,208 units issued and outstanding as of September 15, 2017. After giving effect to the corporate conversion, the number of common shares outstanding as of such date was 6,440,139. As a result of the corporate conversion, accumulated deficit was reduced to zero on the date of the corporate conversion, and the corresponding amount was credited to additional paid-in capital. The corporate conversion was approved by members holding a majority of the outstanding units of Celcuity LLC, and in connection with such conversion, the Company filed a certificate of incorporation and adopted bylaws. The Company determined that the corporate conversion is equivalent to a change in the Company’s capital structure. On September 22, 2017, the Company completed its IPO whereby it sold 2,760,000 shares of common stock at a public offering price of $9.50 per share. The aggregate net proceeds received by the Company from the IPO were approximately $23.3 million, net of underwriting commissions of approximately $1.8 million and offering expenses of approximately $1.1 million. Upon the closing of the IPO, 10,082,050 shares of common stock were outstanding, which included 881,911 shares of common stock issued as a result of the conversion of the Company’s convertible notes. Shares of the Company’s common stock began trading on September 20, 2017 on The Nasdaq Capital Market under the symbol “CELC”. On May 11, 2018, the Company filed an amendment to its certificate of incorporation with the Secretary of State of the State of Delaware to decrease the number of authorized shares of its common stock and preferred stock. Pursuant to the Company’s amended certificate of incorporation, the Company is authorized to issue up to 25,000,000 shares of common stock, $0.001 par value per share and 2,500,000 shares of preferred stock, $0.001 par value per share. At December 31, 2020 and 2019, the Company had 10,299,822 and 10,253,988 shares of common stock outstanding, respectively. Warrants In connection with the 2016 private placement offering of units, the Company issued ten-year warrants to the placement agent of the private placement. The warrants allow the placement agent to purchase up to 55,249 shares of common stock at $7.56 per share. The warrants were immediately exercisable and expire on January 14, 2026 and May 2, 2026. These warrants are equity classified and the $330,607 fair value of the warrants is reflected as additional paid-in capital. In connection with the private placement offering of convertible notes, the Company issued ten-year warrants to the placement agent to purchase 48,615 shares of common stock at a price of $8.42 per share. The warrants were immediately exercisable and expire on April 28, 2027 and May 17, 2027. These warrants are equity classified and the $286,999 fair value of the warrants is reflected as additional paid-in-capital. In addition, the Company granted the purchasers of the convertible notes the right to receive a seven-year warrant to purchase 131,675 shares of common stock at an exercise price equal to the conversion price of the convertible notes. With the completion of the IPO on September 22, 2017, these warrants were issued. These warrants were immediately exercisable and expire on September 22, 2024. These warrants are equity classified and the $776,717 fair value of the warrants is reflected as additional paid-in-capital. In connection with the IPO, the Company issued a five-year warrant to the underwriter. The warrant allows the underwriter to purchase up to 138,000 shares of common stock at $10.45 per share. This warrant was immediately exercisable and expires on September 19, 2022. This warrant is equity classified and the $784,111 fair value of the warrant is reflected as additional paid-in-capital. At December 31, 2020 and 2019, the Company had warrants to purchase 353,585 shares of common stock outstanding, at a weighted average exercise price of $9.42. A total of 0 and 395 warrants were exercised in the years ended December 31, 2020 and 2019, respectively. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Stock-Based Compensation | |
11. Stock-Based Compensation | 11. Stock-Based Compensation 2012 Equity Incentive Plan The 2012 Equity Incentive Plan, as amended, was adopted by the Company’s board and approved by the members of Celcuity LLC on August 10, 2012. The Company reserved a maximum of 625,000 shares of common stock for issuance under the 2012 Equity Incentive Plan. The 2012 Equity Incentive Plan provides for options, restricted stock awards, performance stock awards or stock bonuses. The exercise price of each option granted under the 2012 Equity Incentive Plan is not less than 100% of the fair market value of one share on the date of grant. The maximum permitted term of options granted under the 2012 Equity Incentive Plan is ten years. The Company’s board administers the 2012 Equity Incentive Plan and determines the provisions of incentive awards, including eligible recipients, number of shares subject to an incentive award, exercise price, vesting schedule, duration of an incentive award and other restrictions an incentive award may be subject to. The 2012 Equity Incentive Plan was frozen on September 6, 2017 and any new awards will be issued under the terms of the 2017 Amended and Restated Stock Incentive Plan. 2017 Stock Incentive Plan The 2017 Amended and Restated Stock Incentive Plan (the “2017 Plan”) was adopted by the Company’s board on September 6, 2017, became effective following the corporate conversion on September 15, 2017, and was approved by stockholders at the Company’s annual stockholder meeting on May 10, 2018. The 2017 Plan was amended and approved by stockholders at the Company’s annual stockholder meeting on May 14, 2020. The Company initially reserved a maximum of 750,000 shares of common stock for issuance under the 2017 Plan. The number of shares reserved for issuance was automatically increased by 102,540 shares on January 1, 2020 and will increase automatically on January 1 of each of 2021 through 2027 by the number of shares equal to 1.0% of the aggregate number of outstanding shares of Company common stock as of the immediately preceding December 31. However, the Company’s board may reduce the amount of the increase in any particular year. The 2017 Plan provides for options, restricted stock awards, stock appreciation rights, restricted stock units, performance awards and stock bonuses. The exercise price of each option granted under the 2017 Plan is not less than 100% of the fair market value of one share on the date of grant. The maximum permitted term of options granted under the 2017 Plan is ten years. The 2017 Plan is generally administered by the compensation committee of the Company’s board, which has the authority to interpret the 2017 Plan, grant awards and make all other determinations necessary for the administration of the 2017 Plan. The following table summarizes the activity for all stock options outstanding for the years ended December 31: 2020 2019 Shares Weighted Average Exercise Price Shares Weighted Average Exercise Price Options outstanding at beginning of year 585,215 $ 14.37 478,503 $ 9.73 Granted 277,986 7.17 248,756 19.69 Exercised - - (66,489 ) 5.13 Forfeited/Expired (13,252 ) 11.54 (75,555 ) 10.55 Balance at December 31 849,949 $ 9.33 585,215 $ 14.37 Options exercisable at December 31: 397,425 $ 10.35 264,280 $ 9.52 Weighted Average Grant Date Fair Value for Options Granted During the year: $ 4.63 $ 13.46 The following table summarizes additional information about stock options outstanding and exercisable at December 31, 2020: Options Outstanding Options Exercisable Options Outstanding Weighted Average Remaining Contractual Life Weighted Average Exercise Price Aggregate Intrinsic Value Options Exercisable Weighted Average Exercise Price Aggregate Intrinsic Value 849,949 7.92 $ 9.33 $ 2,010,091 397,425 $ 10.35 $ 762,234 The Company recognized stock-based compensation expense for stock options of $1,668,859 and $990,839 for the years ended December 31, 2020 and 2019, respectively. In May 2020, the Company modified the exercise price on 203,750 stock option awards to $5.10, the closing market price on the Nasdaq Capital Market on May 14, 2020. No director or officer awards were modified. The effect on stock-based compensation for the year ended December 31, 2020 was approximately $83,000. The effect on stock-based compensation over the remaining service period will be approximately $136,000. The Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards with the following weighted-average assumptions for the years ended December 31: 2020 2019 Risk-free interest rate .35% - 1.66% 1.42% -2.47% Expected volatility 73.3% - 77.1% 76.2%-80.0% Expected life (years) 5.5 to 6.1 5.2 to 6.3 Expected dividend yield 0% 0% The inputs for the Black-Scholes valuation model require management’s significant assumptions. Prior to the Company’s IPO, the price per share of common stock was determined by the Company’s board based on recent prices of common stock sold in private offerings. Subsequent to the IPO, the price per share of common stock is determined by using the closing market price on the Nasdaq Capital Market on the grant date. The risk-free interest rates are based on the rate for U.S. Treasury securities at the date of grant with maturity dates approximately equal to the expected life at the grant date. The expected life was based on the simplified method in accordance with SEC Staff Accounting Bulletin Nos. 107 and 110. The expected volatility was estimated based on historical volatility information of peer companies that are publicly available in combination with the Company’s calculated volatility since being publicly traded. All assumptions used to calculate the grant date fair value of nonemployee options are generally consistent with the assumptions used for options granted to employees. In the event the Company terminates any of its consulting agreements, the unvested options issued in connection with such agreements would also be cancelled. Restricted stock awards were granted to two members of the Company’s board during the year ended December 31, 2020. The Company had 15,686 and 0 shares of restricted stock outstanding as of December 31, 2020 and 2019, respectively, and 0 and 2,571 shares of restricted stock vested during the years ended December 31, 2020 and 2019. The Company recognized stock-based compensation expense for restricted stock of $52,727 and $17,047 for the years ended December 31, 2020 and 2019, respectively. The total remaining shares available for grant under the 2017 Plan is 198,922. Total unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized as follows: 2021 $ 1,387,174 2022 1,057,679 2023 704,222 2024 200,244 Total estimated compensation cost to be recognized $ 3,349,319 2017 Employee Stock Purchase Plan The Company’s 2017 Employee Stock Purchase Plan (the “ESPP”) was adopted by the Company’s board on September 6, 2017 and approved by stockholders at the Company’s annual stockholder meeting on May 10, 2018. The Company initially reserved a total of 100,000 shares for issuance under the ESPP. The number of shares reserved for issuance was automatically increased by 51,270 shares on January 1, 2020 and will increase automatically on each subsequent January 1 by the number of shares equal to 0.5% of the total outstanding number of shares of Company common stock as of the immediately preceding December 31. However, the Company’s board may reduce the amount of the increase in any particular year. The total remaining shares available for issuance under the employee stock purchase plan as of December 31, 2020 is 112,211. The ESPP provides participating employees with an opportunity to purchase shares of the Company’s common stock at a discount through payroll deductions. The ESPP is available to all employees unless they are employed for less than 20 hours per week or own 5% or more of the total combined voting power or value of the Company’s common stock. The ESPP is administered using overlapping 24 month offering periods, referred to as an Offering Period. Each Offering Period has four six-month purchase periods. A new Offering Period and purchase period begin every six months on May 1 and November 1 of each year. Participating employees may purchase common stock, on a voluntary after tax-basis, at a price equal to 85% of the fair market value of a share of common stock on either the offering date or the purchase date, whichever is lower. If the purchase date has a lower price, the employee will automatically be placed in the Offering Period beginning immediately after the purchase date. The Company recognized stock-based compensation expense related to the ESPP of $42,293 and $33,103 for the years ended December 31, 2020 and 2019, respectively. The Company recognized total stock-based compensation expense, as follows for the years ended December 31: 2020 2019 Stock-based compensation expense in operating expenses: Research and development $ 1,055,094 $ 567,305 General and administrative 708,785 473,684 Total $ 1,763,879 $ 1,040,989 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
12. Income Taxes | 12. Income Taxes Following the conversion of Celcuity LLC to Celcuity Inc. on September 15, 2017, Celcuity Inc. began filing federal and state returns where required. No income tax benefit was recorded for the years 2020 and 2019, due to net losses and recognition of a valuation allowance. The following table presents a reconciliation of the tax expense computed at the statutory federal rate and the Company’s tax expense for the years ending December 31: 2020 2019 Tax benefit at statutory federal rate $ (1,990,000 ) $ (1,545,000 ) State income tax benefit, net of federal tax effect (16,000 ) (24,000 ) Change in valuation allowance on deferred tax assets 2,159,000 1,781,000 Research and Development Credits (450,000 ) (138,000 ) Other permanent items 297,000 (74,000 ) Income tax benefits $ - $ - On December 22, 2017 H.R. 1, commonly referred to as the Tax Cuts and Jobs Act, (the “Tax Act”) was enacted. Among the significant changes to the U.S. Internal Revenue Code, the Tax Act lowered the U.S. federal corporate income tax rate (“Federal Tax Rate”) from 35% to 21% effective January 1, 2018. The Act also made changes related to the use and limitation of net operating loss carryforwards generated in tax years beginning after December 31, 2017. For years beginning after December 31, 2017 net operating losses have an indefinite carryforward and the utilization of losses is limited to 80% of taxable income each year. In response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic Security Act ("CARES Act") was signed into law on March 27, 2020. The CARES Act lifts certain deduction limitations originally imposed by the Tax Act. Corporate taxpayers may carryback net operating losses originating during 2018 through 2020 for up to five years, which was not previously allowed under the Tax Act. The CARES Act also eliminates the 80% of taxable income limitation allowing corporate entities to fully utilize net operating loss carryforwards to offset taxable income in 2018, 2019 and 2020. The enactment of the CARES Act did not result in any material impact to the Company’s income tax provision. On December 27, 2020 the Consolidated Appropriations Act, 2021 (“CAA”) was signed into law. The CAA includes the COVID-related Tax Relief Act of 2020 (“COVID TRA”). The Company is continuing to assess the effect of the CAA and does not believe it will result in a material impact to the Company’s income tax benefit. Deferred income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company’s deferred tax assets relate primarily to its net operating loss carryforwards and other balance sheet basis differences. In accordance with ASC 740, “ Income Taxes 2020 2019 Deferred tax assets (liabilities): Accrued expenses $ 79,000 $ 8,000 Share-based compensation 528,000 435,000 Property and equipment 255,000 175,000 Right-of-use assets (49,000 ) (41,000 ) Lease liability 53,000 50,000 Start-up expenditures 2,610,000 2,038,000 Net operating losses and tax credits 3,242,000 1,894,000 Valuation allowance (6,718,000 ) (4,559,000 ) Net deferred tax assets (liabilities) $ - $ - At December 31, 2020, the Company had federal and state research and development tax credit carryforwards resulting in deferred tax assets of approximately $0.6 million and $0.6 million, respectively. The federal and state credit carryforwards will begin to expire in the years ending December 31, 2037 and December 31, 2032, respectively. These deferred tax assets were subject to a full valuation allowance as of December 31, 2020 and 2019. Under the provisions of Section 382 of the Internal Revenue Code of 1986, certain substantial changes in the Company's ownership, including a sale of the Company, or significant changes in ownership due to sales of equity, may limit in the future the amount of net operating loss carryforwards available to offset future taxable income. The Company recognizes uncertain tax positions in accordance with ASC 740 on the basis of evaluating whether it is more-likely-than not that the tax positions will be sustained upon examination by tax authorities. For those tax positions that meet the more-likely-than not recognition threshold, we recognize the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement. As of December 31, 2020, and 2019, the Company has no significant uncertain tax positions. There are no unrecognized tax benefits included on the balance sheet that would, if recognized, impact the effective tax rate. The Company does not anticipate there will be a significant change in unrecognized tax benefits within the next 12 months. Prior to the conversion, Celcuity was a limited liability company and therefore was taxed as a partnership for income tax purposes. Accordingly, no benefit for income taxes was recorded prior to the conversion. For years prior to 2016, the Company is no longer subject to U.S. federal or state income tax examinations. The Company's policy is to recognize interest and penalties related to uncertain tax positions as a component of general and administrative expenses. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Operating results for the year ended December 31, 2020 are not necessarily indicative of results to be expected for any future year. |
Accounting Estimates | Management uses estimates and assumptions in preparing these financial statements in accordance with U.S. GAAP. Those estimates and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenues and expenses. Actual results could differ from those estimates and the difference could be significant. Significant items subject to such estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs. |
Cash and Cash Equivalents | The Company maintains its accounts primarily at one financial institution. At times throughout the year, the Company’s cash balances may exceed amounts insured by the Federal Deposit Insurance Corporation. At December 31, 2020 and December 31, 2019, the Company had $11,378,685 and $18,369,229, respectively, in money market funds that are considered cash equivalents and not insured by the Federal Deposit Insurance Corporation. |
Property and Equipment | Property and equipment are stated at cost. Depreciation is provided over estimated useful lives using the straight-line method. Maintenance and repairs are expensed as incurred; major improvements and betterments are capitalized. Estimated useful lives of property and equipment are as follows for the major classes of assets: Asset Description Estimated Lives Furniture and Equipment 4-5 Leasehold Improvements 2-3 |
Long-Lived Assets | Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values, and third-party independent appraisals, as considered necessary. |
Deferred Transaction Costs | Deferred transaction costs primarily consist of legal fees, SEC filing fees and other fees relating to the Company’s Registration Statement on Form S-3 filed on September 21, 2018. The deferred transaction costs were capitalized as incurred and were offset against proceeds from the sale of shares of common stock pursuant to the ATM Agreement. |
Comprehensive Loss | Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. For all periods presented, there was no difference between net loss and comprehensive loss. |
Risks and Uncertainties | The Company is subject to risks common to companies in the development stage including, but not limited to, dependency on the clinical and commercial success of its diagnostic tests, ability to obtain regulatory approval of its diagnostic tests, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians and consumers, and significant competition. |
Fair Value of Financial Instruments | The Company’s accounting for fair value measurements of assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring or nonrecurring basis adheres to the Financial Accounting Standards Board (“FASB”) fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are as follows: · Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the Company at the measurement date. · Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. · Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement date. The level in the fair value hierarchy within which a fair value measurement in its entirety falls, is based on the lowest level input that is significant to the fair value measurement in its entirety. The carrying values of cash equivalents, accounts payable, accrued expenses and other financial working capital items approximate fair value at December 31, 2020 and December 31, 2019, due to the short maturity nature of these items. |
Income Taxes | The Company accounts for income taxes using the asset and liability method, as required by the accounting standard for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as net operating loss and tax credit carryforwards. Deferred taxes are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred taxes of a change in tax rates is recognized in results of operations in the period that includes the enactment date. The effects of any future changes in tax laws or rates have not been considered. The Company regularly reviews deferred tax assets to assess their potential realization and establish a valuation allowance for portions of such assets to reduce the carrying value if the Company does not consider it to be more likely than not that the deferred tax assets will be realized. The Company recognizes the impact of an uncertain tax position in its financial statements if, in management's judgment, the position is more-likely-than-not sustainable upon audit based on the position's technical merits. This involves the identification of potential uncertain tax positions, the evaluation of applicable tax laws and an assessment of whether a liability for an uncertain tax position is necessary. |
Stock-Based Compensation | The Company’s stock-based compensation consists of stock options and restricted stock issued to certain employees and nonemployees of the Company and the Company’s 2017 Employee Stock Purchase Plan. The Company recognizes compensation expense based on an estimated grant date fair value using the Black-Scholes option-pricing method. If the factors change and different assumptions used, the Company’s stock-based compensation expense could be materially different in the future. The Company recognizes stock-based compensation expense for these options on a straight-line basis over the requisite service period. The Company has elected to account for forfeitures as they occur. |
Research and Development | Research and development costs are expensed as incurred. Research and development costs amounted to $7,683,522 for the year ended December 31, 2020 and $6,269,308 for the year ended December 31, 2019. |
Clinical Trial Costs | The Company records prepaid assets or accrued expenses for prepaid or estimated clinical trial costs conducted by third-party service providers, which include the conduct of preclinical studies and clinical trials. These costs can be a significant component of the Company’s research and development expenses. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with service agreements with its third-party service providers. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its prepaid assets or accrued expenses. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled, and the rate of patient enrollments may vary from the Company’s estimates, resulting in an adjustment to expense in future periods. Changes in these estimates that result in material changes to the Company’s prepaid assets or accrued expenses could materially affect the Company’s results of operations. |
Segment Data | The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. |
Application of New or Revised Accounting Standards | Pursuant to the JOBS Act, a company constituting an “emerging growth company” is, among other things, entitled to rely upon certain reduced reporting requirements. The Company is an emerging growth company but has irrevocably elected not to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. As a result, the Company will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for public companies that are not emerging growth companies. |
Recently Adopted Accounting Pronouncements | Effective January 1, 2019, the Company adopted Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842), |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Summary of Significant Accounting Policies | |
Schedule Of Estimated Useful Lives Of Property Plant And Equipment | Asset Description Estimated Lives Furniture and Equipment 4-5 Leasehold Improvements 2-3 |
Prepaid Assets (Tables)
Prepaid Assets (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Prepaid Assets | |
Schedule of Prepaid assets | 2020 2019 Current: Directors & officers' insurance $ 288,750 $ 229,167 Other 28,290 45,433 Total $ 317,040 $ 274,600 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property and Equipment | |
Schedule of Property and equipment | 2020 2019 Leasehold improvements $ 302,848 $ 302,848 Furniture and equipment 1,461,512 1,350,508 1,764,360 1,653,356 Less: Accumulated depreciation (1,205,484 ) (819,893 ) Total $ 558,876 $ 833,463 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Liquidity | |
Schedule of Accrued expenses | 2020 2019 Accrued compensation $ 628,121 $ 461,452 Employee Stock Purchase Plan 9,471 10,121 Other 137,020 112,746 Total $ 774,612 $ 584,319 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments | |
Schedule of Supplemental balance sheet information | Operating Lease Right-of-use assets $ 230,911 Operating lease liability $ 248,379 Less: short term portion (187,518 ) Long term portion $ 60,861 Finance Lease Furniture and equipment $ 28,932 Less: Accumulated depreciation (14,948 ) Net book value of property and equipment under finance lease $ 13,984 Finance lease liability $ 14,109 Less: short term portion (5,810 ) Long term portion $ 8,299 |
Schedule of Future Minimum Lease Payments for Capital Leases [Table Text Block] | Maturity analysis under lease agreements consisted of the following as of December 31, 2020: Operating Leases Finance Leases 2021 $ 194,821 $ 7,255 2022 64,940 7,255 2023 - 3,022 Total minimum lease payments 259,761 17,532 Less: Present value discount (11,382 ) (122 ) Less amount representing services - (3,301 ) Present value of net minimum lease payments $ 248,379 $ 14,109 Weighted Average Remaining Lease Term Discount Rate Operating lease 1.3 years 4.0 % Finance lease 2.4 years 1.0 % Lease costs for the year ended December 31: 2020 2019 Operating lease cost $ 171,530 $ 164,252 Finance lease cost: Amortization 5,786 5,786 Interest 119 159 Variable lease cost 85,265 82,885 $ 262,700 $ 253,082 |
Schedule of Supplemental cash flow information | Supplemental cash flow information related to leases for the year ended December 31: 2020 2019 Cash paid for amounts included in operating and finance leases: Operating cash outflow from operating leases $ 278,603 $ 248,450 Operating cash outflow from finance leases 119 159 Financing cash outflow from finance leases 5,769 5,730 $ 284,491 $ 254,339 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Stock-Based Compensation | |
Schedule of Stock Options Activity | 2020 2019 Shares Weighted Average Exercise Price Shares Weighted Average Exercise Price Options outstanding at beginning of year 585,215 $ 14.37 478,503 $ 9.73 Granted 277,986 7.17 248,756 19.69 Exercised - - (66,489 ) 5.13 Forfeited/Expired (13,252 ) 11.54 (75,555 ) 10.55 Balance at December 31 849,949 $ 9.33 585,215 $ 14.37 Options exercisable at December 31: 397,425 $ 10.35 264,280 $ 9.52 Weighted Average Grant Date Fair Value for Options Granted During the year: $ 4.63 $ 13.46 |
Sechdule of stock options outstanding | Options Outstanding Options Exercisable Options Outstanding Weighted Average Remaining Contractual Life Weighted Average Exercise Price Aggregate Intrinsic Value Options Exercisable Weighted Average Exercise Price Aggregate Intrinsic Value 849,949 7.92 $ 9.33 $ 2,010,091 397,425 $ 10.35 $ 762,234 |
Schedule of fair value of equity-based awards assumptions | 2020 2019 Risk-free interest rate .35% - 1.66% 1.42% -2.47% Expected volatility 73.3% - 77.1% 76.2%-80.0% Expected life (years) 5.5 to 6.1 5.2 to 6.3 Expected dividend yield 0% 0% |
Schedule of Unrecognized Compensation Cost | 2021 $ 1,387,174 2022 1,057,679 2023 704,222 2024 200,244 Total estimated compensation cost to be recognized $ 3,349,319 |
Schedule of stock-based compensation expense | 2020 2019 Stock-based compensation expense in operating expenses: Research and development $ 1,055,094 $ 567,305 General and administrative 708,785 473,684 Total $ 1,763,879 $ 1,040,989 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Schedule of Effective Income Tax Rate Reconciliation | 2020 2019 Tax benefit at statutory federal rate $ (1,990,000 ) $ (1,545,000 ) State income tax benefit, net of federal tax effect (16,000 ) (24,000 ) Change in valuation allowance on deferred tax assets 2,159,000 1,781,000 Research and Development Credits (450,000 ) (138,000 ) Other permanent items 297,000 (74,000 ) Income tax benefits $ - $ - |
Schedule of Deferred Tax Assets and Liabilities | 2020 2019 Deferred tax assets (liabilities): Accrued expenses $ 79,000 $ 8,000 Share-based compensation 528,000 435,000 Property and equipment 255,000 175,000 Right-of-use assets (49,000 ) (41,000 ) Lease liability 53,000 50,000 Start-up expenditures 2,610,000 2,038,000 Net operating losses and tax credits 3,242,000 1,894,000 Valuation allowance (6,718,000 ) (4,559,000 ) Net deferred tax assets (liabilities) $ - $ - |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Furniture and Equipment | |
Estimated useful lives | 4-5 |
Leasehold Improvements | |
Estimated useful lives | 2-3 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash equivalents | $ 11,378,685 | $ 18,369,229 |
Short term investments | 8,952,907 | 0 |
Deferred costs | 0 | 28,743 |
Research and development expense | 7,683,522 | 6,269,308 |
Operating lease right-of-use assets | 230,911 | 196,983 |
Operating lease liabilities | 187,518 | $ 178,466 |
January 1, 2019 [Member] | Accounting Standards Update [Member] | ||
Operating lease right-of-use assets | 356,539 | |
Operating lease liabilities | 404,931 | |
Deferred rent | 63,875 | |
Prepaid rent | $ 15,483 |
Liquidity (Details Narrative)
Liquidity (Details Narrative) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Liquidity | |||
Cash and cash equivalents | $ 11,637,911 | $ 18,735,002 | $ 15,944,609 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details Narative) - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Restricted Stock | ||
Antidilutive securities excluded from computation of earnings per share | 15,686 | 0 |
Stock Option [Member] | ||
Antidilutive securities excluded from computation of earnings per share | 849,949 | 585,215 |
Warrant [Member] | ||
Antidilutive securities excluded from computation of earnings per share | 353,585 | 353,585 |
Payroll Tax Receivable (Details
Payroll Tax Receivable (Details Narrative) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Net Loss Per Common Share | ||
Payroll tax receivable | $ 190,000 | $ 190,000 |
Prepaid Assets (Details)
Prepaid Assets (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Prepaid Assets (Details) | ||
Directors & officers' insurance | $ 288,750 | $ 229,167 |
Other | 28,290 | 45,433 |
Total | $ 317,040 | $ 274,600 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Property, plant and equipment, gross | $ 1,764,360 | $ 1,653,356 |
Less: accumulated depreciation | (1,205,484) | (819,893) |
Property, plant and equipment, net | 558,876 | 833,463 |
Furniture and Equipment | ||
Property, plant and equipment, gross | 1,461,512 | 1,350,508 |
Leasehold Improvements | ||
Property, plant and equipment, gross | $ 302,848 | $ 302,848 |
Property and Equipment (Detai_2
Property and Equipment (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property and Equipment | ||
Depreciation | $ 385,591 | $ 338,996 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Liquidity | ||
Accrued compensation | $ 628,121 | $ 461,452 |
Employee stock purchase plan | 9,471 | 10,121 |
Other | 137,020 | 112,746 |
Total | $ 774,612 | $ 584,319 |
Commitments (Details)
Commitments (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Right-of-use asset | $ 230,911 | $ 196,983 |
Long term portion | 60,861 | 57,793 |
Finance lease liability | 53,000 | 50,000 |
Long term portion | 8,299 | $ 14,109 |
Supplemental balance sheet information [Member] | ||
Right-of-use asset | 230,911 | |
Operating lease liability | 248,379 | |
Less: short term portion | (187,518) | |
Long term portion | 60,861 | |
Furniture and equipment | 28,932 | |
Less: Accumulated depreciation | (14,948) | |
Net book value of property and equipment under finance lease | 13,984 | |
Finance lease liability | 14,109 | |
Less: short term portion | (5,810) | |
Long term portion | $ 8,299 |
Commitments (Details 1)
Commitments (Details 1) | Dec. 31, 2020USD ($) |
Operating Leases | |
2021 | $ 194,821 |
2022 | 64,940 |
2023 | 0 |
Total minimum lease payments | 259,761 |
Less: present value discount | (11,382) |
Less amount representing services | 0 |
Present value of net minimum lease payments | 248,379 |
Finance Leases | |
2021 | 7,255 |
2022 | 7,255 |
2023 | 3,022 |
Total minimum lease payments | 17,532 |
Less: present value discount | (122) |
Less amount representing services | (3,301) |
Present value of net minimum lease payments | $ 14,109 |
Commitments (Details 2)
Commitments (Details 2) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments | |
Operating lease, weighted average remaining lease term | 1 year 3 months 18 days |
Operating lease, weighted average discount rate, percent | 4.00% |
Finance lease, weighted average remaining lease term | 2 years 4 months 24 days |
Finance lease, weighted average discount rate, percent | 1.00% |
Commitments (Details 3)
Commitments (Details 3) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Commitments | ||
Operating lease cost | $ 171,530 | $ 164,252 |
Finance lease cost: | ||
Amortization | 5,786 | 5,786 |
Interest | 119 | 159 |
Variable lease cost | 85,265 | 82,885 |
Total lease cost | $ 262,700 | $ 253,082 |
Commitments (Details 4)
Commitments (Details 4) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash paid for amounts included in operating and finance leases: | ||
Operating cash outflow from operating leases | $ 278,603 | $ 248,450 |
Operating cash outflow from finance leases | 119 | 159 |
Financing cash outflow from finance leases | 5,769 | 5,730 |
Total cash paid for amounts included in operating and finance leases | $ 284,491 | $ 254,339 |
Commitments (Details Narrative)
Commitments (Details Narrative) - USD ($) | 12 Months Ended | 77 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Increase in operating ROU asset and lease liability | $ 197,211 | ||
Payments to acquire in process research and development | 100,000 | $ 50,000 | $ 550,000 |
Maximum amount of payments over the course of the agreement | 2,620,000 | ||
Agreement with biopharmaceutical company 3 [Member] | January 2021 [Member] | |||
Future payments required upon certain milestones being met | 1,210,600 | ||
Agreement with biopharmaceutical company 1 [Member] | |||
Future payments required upon certain milestones being met | 112,000 | ||
Contractual obligation | $ 70,000 | ||
Agreement with biopharmaceutical company 2 [Member] | |||
Future payments required upon certain milestones being met | $ 740,000 |
Stockholders Equity (Details Na
Stockholders Equity (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||
Sep. 22, 2017 | Dec. 31, 2020 | Dec. 31, 2019 | Jun. 05, 2020 | May 11, 2018 | Sep. 15, 2017 | May 17, 2017 | May 02, 2016 | |
Common stock, shares outstanding | 10,082,050 | 10,299,822 | 10,253,988 | |||||
Preferred stock, shares par value | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Preferred stock, shares authorized | 2,500,000 | 2,500,000 | 2,500,000 | |||||
Common stock, shares sold | 2,760,000 | |||||||
Public offering price | $ 9.50 | |||||||
Net proceeds | $ 23,300,000 | |||||||
Net of underwriting commissions | 1,800,000 | |||||||
Offering expenses | $ 1,100,000 | |||||||
Common stock, shares issued | 881,911 | 10,299,822 | 10,253,988 | |||||
Common stock, shares authorized | 25,000,000 | 25,000,000 | 25,000,000 | |||||
Common stock, par or stated value per share | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Shares issued upon corporate conversion | 257,604,208 | |||||||
Shares outstanding upon corporate conversion | 257,604,208 | |||||||
Warrants outstanding | 353,585 | 353,585 | ||||||
Common stock, shares outstanding | 6,440,139 | |||||||
Warrants exercised | 0 | 395 | ||||||
Sale of stock number of shares issued in transaction | 17,725 | |||||||
Average selling price per share | $ 10.31 | |||||||
Aggregate offering price, common stock shares | $ 10,000,000 | |||||||
Weighted average exercise price of warrants | 9.42 | $ 9.42 | ||||||
Warrant Three [Member] | ||||||||
Weighted average exercise price of warrants | $ 10.45 | |||||||
Warrants expire date | Sep. 19, 2022 | |||||||
Fair value of warrants | $ 784,111 | |||||||
Warrant One [Member] | ||||||||
Weighted average exercise price of warrants | $ 8.42 | |||||||
Warrants to purchase shares of common stock | 48,615 | |||||||
Warrants expire date | May 17, 2027 | |||||||
Fair value of warrants | $ 286,999 | |||||||
Warrants Two [Member] | ||||||||
Warrants to purchase shares of common stock | 131,675 | |||||||
Warrants expire date | Sep. 22, 2024 | |||||||
Fair value of warrants | $ 776,717 | |||||||
Warrant [Member] | 2016 Stock Incentive Plan | ||||||||
Weighted average exercise price of warrants | $ 8.42 | $ 7.56 | ||||||
Warrants to purchase shares of common stock | 55,249 | |||||||
Warrants expire date | May 2, 2026 | |||||||
Fair value of warrants | $ 330,607 | |||||||
Underwriter [Member] | ||||||||
Warrants to purchase shares of common stock | 138,000 |
STOCKBASED COMPENSATION (Detail
STOCKBASED COMPENSATION (Details) - Stock Option [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Options outstanding at end of year | 849,949 | |
Weighted average exercise price, options outstanding, end | $ 9.33 | |
2017 Plan [Member] | ||
Options outstanding at beginning of year | 585,215 | 478,503 |
Shares, Granted | 277,986 | 248,756 |
Shares, Exercised | (66,489) | |
Shares, Forfeited/Expired | (13,252) | (75,555) |
Options outstanding at end of year | 849,949 | 585,215 |
Options exercisable | 397,425 | 264,280 |
Weighted average exercise price, options outstanding, beginning | $ 14.37 | $ 9.73 |
Weighted Average Exercise Price, Granted | 7.17 | 19.69 |
Weighted Average Exercise Price, Exercised | 5.13 | |
Weighted Average Exercise, Forfeited/Expired | 11.54 | 10.55 |
Weighted average exercise price, options outstanding, end | 9.33 | 14.37 |
Weighted Average Exercise Price, Options exercisable | 10.35 | 9.52 |
Weighted Average Grant Date Fair Value for Options Granted During the year: | $ 4.63 | $ 13.46 |
STOCKBASED COMPENSATION (Deta_2
STOCKBASED COMPENSATION (Details 1) - Stock Option [Member] | 12 Months Ended |
Dec. 31, 2020USD ($)$ / sharesshares | |
Shares, options outstanding, beginning | shares | 849,949 |
Options outstanding, weighted average remaining contractual life | 7 years 11 months 1 day |
Weighted average exercise price, options outstanding, beginning | $ / shares | $ 9.33 |
Options outstanding, aggregate intrinsic value | $ | $ 2,010,091 |
Options exercisable | shares | 397,425 |
Options exercisable, weighted average exercise price | $ / shares | $ 10.35 |
Options exercisable, aggregate intrinsic value | $ | $ 762,234 |
STOCKBASED COMPENSATION (Deta_3
STOCKBASED COMPENSATION (Details 2) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Expected dividend yield | 0.00% | 0.00% |
Minimum | ||
Risk-free interest rate | 0.35% | 1.42% |
Expected volatility | 73.30% | 76.20% |
Expected life (years) | 5 years 6 months | 5 years 2 months 12 days |
Maximum | ||
Risk-free interest rate | 1.66% | 2.47% |
Expected volatility | 77.10% | 80.00% |
Expected life (years) | 6 years 1 month 6 days | 6 years 3 months 18 days |
STOCKBASED COMPENSATION (Deta_4
STOCKBASED COMPENSATION (Details 3) - Stock Options And Restricted Stock [Member] | Dec. 31, 2020USD ($) |
2021 | $ 1,387,174 |
2022 | 1,057,679 |
2023 | 704,222 |
2024 | 200,244 |
Total estimated compensation cost to be recognized | $ 3,349,319 |
STOCKBASED COMPENSATION (Deta_5
STOCKBASED COMPENSATION (Details 4) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Stock-based compensation expense | $ 1,763,879 | $ 1,040,989 |
Research and Development | ||
Stock-based compensation expense | 1,055,094 | 567,305 |
General and Administrative | ||
Stock-based compensation expense | $ 708,785 | $ 473,684 |
STOCKBASED COMPENSATION (Deta_6
STOCKBASED COMPENSATION (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2020 | |
Restricted stock awards granted | 15,686 | 0 | |
Restricted stock vested | 0 | 2,571 | |
Shares available for grant under the 2017 Plan | 198,922 | ||
Restricted Stock | |||
Stock-based compensation | $ 52,727 | $ 17,047 | |
Stock Option [Member] | |||
Stock-based compensation | $ 1,668,859 | $ 990,839 | |
May 2020 [Member] | |||
Modified share exercise price | $ 5.10 | ||
Effect of stock option modification | 203,750 | ||
Stock-based compensation | $ 83,000 | ||
2017 Employee Stock Purchase Plan [Member] | |||
Shares available for grant under the 2017 Plan | 112,211 | ||
Common stock, shares reserved for issuance | 100,000 | ||
Percentage of increse in number of shares | 0.50% | ||
Change in common stock, shares reserved for issuance | 51,270 | ||
2012 Equity Incentive Plan [Member] | |||
Common stock, shares reserved for issuance | 625,000 | ||
2017 Stock Incentive Plan | |||
Common stock, shares reserved for issuance | 750,000 | ||
Change in common stock, shares reserved for issuance | 102,540 | ||
Stock-based compensation | $ 42,293 | $ 33,103 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes | ||
Tax benefit at statutory federal rate | $ (1,990,000) | $ (1,545,000) |
State income tax benefit, net of federal tax effect | (16,000) | (24,000) |
Change in valuation allowance on deferred tax assets | 2,159,000 | 1,781,000 |
Research and Development Credits | (450,000) | (138,000) |
Other permanent items | 297,000 | (74,000) |
Income tax benefits | $ 0 | $ 0 |
Income Taxes (Details 1)
Income Taxes (Details 1) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Income Taxes | ||
Accrued expenses | $ 79,000 | $ 8,000 |
Share-based compensation | 528,000 | 435,000 |
Property and equipment | 255,000 | 175,000 |
Right-of-use assets | (49,000) | (41,000) |
Lease liability | 53,000 | 50,000 |
Start-up expenditures | 2,610,000 | 2,038,000 |
Net operating losses and tax credits | 3,242,000 | 1,894,000 |
Valuation allowance | (6,718,000) | (4,559,000) |
Net deferred tax assets (liabilities) | $ 0 | $ 0 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) $ in Millions | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Fedral net operating loss carryforwards | $ 10.2 |
Deferred Tax Assets | 0.5 |
Research And Development [Member] | |
Fedral net operating loss carryforwards | 0.6 |
Deferred Tax Assets | $ 0.6 |
Minimum [Member] | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% |