Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 02, 2020 | |
Cover [Abstract] | ||
Entity Registrant Name | CELCUITY INC. | |
Entity Central Index Key | 0001603454 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Emerging Growth Company | true | |
Entity Current Reporting Status | Yes | |
Document Period End Date | Sep. 30, 2020 | |
Entity Filer Category | Accelerated Filer | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2020 | |
Entity Ex Transition Period | false | |
Entity Common Stock Shares Outstanding | 10,296,998 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Interactive Data Current | Yes | |
Entity Incorporation State Country Code | DE | |
Entity Address State Or Province | MN | |
Entity File Number | 001-38207 | |
Entity Address Address Line 1 | 16305 36th Avenue North; | |
Entity Address Address Line 2 | Suite 100 | |
Entity Address City Or Town | Minneapolis | |
Entity Address Postal Zip Code | 55446 | |
City Area Code | 763 | |
Local Phone Number | 392-0767 | |
Security 12b Title | Common Stock, $0.001 par value per share | |
Trading Symbol | CELC | |
Security Exchange Name | NASDAQ | |
Entity Tax Identification Number | 82-2863566 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Current Assets: | ||
Cash and cash equivalents | $ 13,696,387 | $ 18,735,002 |
Deposits | 22,009 | 22,009 |
Deferred transaction costs | 0 | 28,743 |
Payroll tax receivable | 190,000 | 190,000 |
Prepaid assets | 103,610 | 274,600 |
Total current assets | 14,012,006 | 19,250,354 |
Property and equipment, net | 626,271 | 833,463 |
Operating lease right-of-use assets | 275,696 | 196,983 |
Total Assets | 14,913,973 | 20,280,800 |
Current Liabilities: | ||
Accounts payable | 83,130 | 142,773 |
Finance lease liabilities | 5,799 | 5,769 |
Operating lease liabilities | 189,400 | 178,466 |
Accrued expenses | 756,873 | 584,319 |
Total current liabilities | 1,035,202 | 911,327 |
Finance lease liabilities | 9,756 | 14,109 |
Operating lease liabilities | 107,040 | 57,793 |
Total Liabilities | 1,151,998 | 983,229 |
Stockholders' Equity: | ||
Preferred stock, $0.001 par value: 2,500,000 shares authorized; 0 shares issued and outstanding as of September 30, 2020 and December 31, 2019 | 0 | 0 |
Common stock, $0.001 par value: 25,000,000 shares authorized; 10,289,253 and 10,253,988 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively | 10,289 | 10,254 |
Additional paid-in capital | 37,522,374 | 36,134,723 |
Accumulated deficit | (23,770,688) | (16,847,406) |
Total Stockholders' Equity | 13,761,975 | 19,297,571 |
Total Liabilities and Stockholders' Equity | $ 14,913,973 | $ 20,280,800 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
Condensed Balance Sheets | ||
Preferred stock, par or stated value per share | $ 0.001 | $ 0.01 |
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 | 10,289,253 | 10,289,253 |
Common stock, shares outstanding | 10,253,988 | 10,253,988 |
Condensed Statements of Operati
Condensed Statements of Operations (unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Operating expenses: | ||||
Research and development | $ 1,962,610 | $ 1,711,597 | $ 5,576,250 | $ 4,772,286 |
General and administrative | 517,465 | 379,718 | 1,428,578 | 1,135,251 |
Total operating expenses | 2,480,075 | 2,091,315 | 7,004,828 | 5,907,537 |
Loss from operations | (2,480,075) | (2,091,315) | (7,004,828) | (5,907,537) |
Other income (expense) | ||||
Interest expense | (28) | (39) | (93) | (123) |
Interest income | 5,805 | 107,100 | 81,639 | 357,321 |
Other income, net | 5,777 | 107,061 | 81,546 | 357,198 |
Net loss before income taxes | (2,474,298) | (1,984,254) | (6,923,282) | (5,550,339) |
Income tax benefits | 0 | 0 | 0 | 0 |
Net loss | $ (2,474,298) | $ (1,984,254) | $ (6,923,282) | $ (5,550,339) |
Net loss per share, basic and diluted | $ (0.24) | $ (0.19) | $ (0.67) | $ (0.54) |
Weighted average common shares outstanding, basic and diluted | 10,273,567 | 10,239,957 | 10,262,636 | 10,217,443 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' Equity (unaudited) - USD ($) | Total | Common Stock | Additional Paid-In Capital | 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) |
Stock-based compensation | 184,645 | $ 0 | 184,645 | 0 |
Exercise of common stock options, shares | 22,733 | |||
Exercise of common stock options, amount | 174,957 | $ 23 | 174,934 | 0 |
Net loss | (1,845,908) | $ 0 | 0 | (1,845,908) |
Balance, shares at Mar. 31, 2019 | 10,209,115 | |||
Balance, amount at Mar. 31, 2019 | 23,863,305 | $ 10,209 | 35,187,046 | (11,333,950) |
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) |
Net loss | (5,550,339) | |||
Balance, shares at Sep. 30, 2019 | 10,248,590 | |||
Balance, amount at Sep. 30, 2019 | 20,712,429 | $ 10,249 | 35,740,561 | (15,038,381) |
Balance, shares at Mar. 31, 2019 | 10,209,115 | |||
Balance, amount at Mar. 31, 2019 | 23,863,305 | $ 10,209 | 35,187,046 | (11,333,950) |
Stock-based compensation | 192,246 | 0 | 192,246 | 0 |
Net loss | (1,720,177) | $ 0 | 0 | (1,720,177) |
Exercise of common stock options, net of shares withheld for exercise price, shares | 4,325 | |||
Exercise of common stock options, net of shares withheld for exercise price, amount | 0 | $ 4 | (4) | 0 |
Employee stock purchases, shares | 6,876 | |||
Employee stock purchases, amount | 58,065 | $ 7 | 58,058 | 0 |
Balance, shares at Jun. 30, 2019 | 10,220,316 | |||
Balance, amount at Jun. 30, 2019 | 22,393,439 | $ 10,220 | 35,437,346 | (13,054,127) |
Stock-based compensation | 303,244 | 0 | 303,244 | 0 |
Net loss | (1,984,254) | $ 0 | 0 | (1,984,254) |
Exercise of common stock options, net of shares withheld for exercise price, shares | 28,274 | |||
Exercise of common stock options, net of shares withheld for exercise price, amount | 0 | $ 29 | (29) | 0 |
Balance, shares at Sep. 30, 2019 | 10,248,590 | |||
Balance, amount at Sep. 30, 2019 | 20,712,429 | $ 10,249 | 35,740,561 | (15,038,381) |
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 | 464,649 | 0 | 464,649 | 0 |
Net loss | (2,246,995) | $ 0 | 0 | (2,246,995) |
Balance, shares at Mar. 31, 2020 | 10,253,988 | |||
Balance, amount at Mar. 31, 2020 | 17,515,225 | $ 10,254 | 36,599,372 | (19,094,401) |
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) |
Net loss | (6,923,282) | |||
Balance, shares at Sep. 30, 2020 | 10,289,253 | |||
Balance, amount at Sep. 30, 2020 | 13,761,975 | $ 10,289 | 37,522,374 | (23,770,688) |
Balance, shares at Mar. 31, 2020 | 10,253,988 | |||
Balance, amount at Mar. 31, 2020 | 17,515,225 | $ 10,254 | 36,599,372 | (19,094,401) |
Stock-based compensation | 423,193 | 16 | 423,177 | 0 |
Net loss | (2,201,989) | $ 0 | 0 | (2,201,989) |
Employee stock purchases, shares | 4,678 | |||
Employee stock purchases, amount | 23,897 | $ 4 | 23,893 | 0 |
Stock-based compensation, shares | 15,686 | |||
Issuance of common stock in an at-the-market ("ATM") offering, shares | 14,901 | |||
Issuance of common stock in an at-the-market ("ATM") offering, amount | 154,142 | $ 15 | 154,127 | 0 |
Issuance costs associated with ATM offering | (52,110) | $ 0 | (52,110) | 0 |
Balance, shares at Jun. 30, 2020 | 10,289,253 | |||
Balance, amount at Jun. 30, 2020 | 15,862,358 | $ 10,289 | 37,148,459 | (21,296,390) |
Stock-based compensation | 448,947 | 0 | 448,947 | 0 |
Net loss | (2,474,298) | 0 | 0 | (2,474,298) |
Issuance costs associated with ATM offering | (75,032) | $ 0 | (75,032) | 0 |
Balance, shares at Sep. 30, 2020 | 10,289,253 | |||
Balance, amount at Sep. 30, 2020 | $ 13,761,975 | $ 10,289 | $ 37,522,374 | $ (23,770,688) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (6,923,282) | $ (5,550,339) |
Adjustments to reconcile net loss to net cash used for operations: | ||
Depreciation | 287,701 | 245,689 |
Stock-based compensation | 1,336,789 | 680,134 |
Non-cash interest income, net of cash received | 0 | 29,082 |
Changes in operating assets and liabilities: | ||
Prepaid assets and deposits | 170,990 | 144,743 |
Accounts payable | (64,657) | 102,977 |
Accrued expenses | 172,554 | 70,571 |
Non-cash operating lease, net | (18,533) | (17,810) |
Net cash used for operating activities | (5,038,438) | (4,294,953) |
Cash flows from investing activities: | ||
Proceeds from sale of investments | 0 | 4,745,000 |
Purchases of property and equipment | (75,494) | (352,490) |
Net cash provided by (used for) investing activities | (75,494) | 4,392,510 |
Cash flows from financing activities: | ||
Proceeds from exercise of employee stock options | 0 | 174,957 |
Proceeds from employee stock purchases | 23,897 | 58,065 |
Gross proceeds from an ATM offering | 154,142 | 0 |
Payments for secondary registration statement costs | (98,399) | (1,300) |
Payments for finance leases | (4,323) | (4,293) |
Net cash provided by financing activities | 75,317 | 227,429 |
Net change in cash and cash equivalents | (5,038,615) | 324,986 |
Cash and cash equivalents: | ||
Beginning of period | 18,735,002 | 15,944,609 |
End of period | 13,696,387 | 16,269,595 |
Supplemental disclosures of non-cash investing and financing activities: | ||
Property and equipment included in accounts payable | $ 7,714 | $ 2,005 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2020 | |
Organization | |
Note 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 proprietary CELsignia diagnostic platform analyzes living tumor cells to untangle the complexity of the cellular activity driving a patient’s cancer. This allows Celcuity to discover new cancer sub-types molecular diagnostics cannot detect. Celcuity is driven to improve outcomes for patients and to transform how pharmaceutical companies define the patient populations for their targeted therapies. 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 | 9 Months Ended |
Sep. 30, 2020 | |
Summary of Significant Accounting Policies | |
Note 2. Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited financial statements include the accounts of the Company and have been prepared in accordance with Article 10 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”). Accordingly, as permitted by Article 10, the unaudited financial statements do not include all of the information required by accounting principles generally accepted in the United States (“U.S. GAAP”). The balance sheet at December 31, 2019 was derived from the audited financial statements at that date and does not include all the disclosures required by U.S. GAAP. In the opinion of management, all adjustments which are of a normal recurring nature and necessary for a fair presentation have been reflected in the financial statements. These unaudited condensed financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2019 and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019. Operating results for the three and nine months ended September 30, 2020 are not necessarily indicative of the results to be expected during the remainder of the current year or for any future period. Accounting Estimates Management uses estimates and assumptions in preparing these unaudited condensed 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 material. Significant items subject to such estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs. 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. 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 includes 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. Application of New or Revised Accounting Standards Pursuant to the Jumpstart Our Business Startups Act of 2012 (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), |
Net Loss Per Common Share
Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2020 | |
Net Loss Per Common Share | |
Note 3. Net Loss Per Common Share | 3. 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 three and nine months ended September 30, 2020 and 2019, potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding were options to purchase 810,725 and 577,469 shares of common stock, respectively, warrants to purchase 353,585 and 353,980 shares of common stock, respectively, and 15,686 and 0 shares of restricted common stock, respectively. |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2020 | |
Commitments | |
Note 4. Commitments | 4. 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 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. The original lease agreement was set to terminate on April 30, 2021, but in July 2020 the Company signed an amendment to extend the 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 amendment includes the option to extend the term for one additional year. The option to extend is at the Company’s discretion and because it has not been 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 option and when it is reasonably certain of exercise, the Company will include the renewal period in the 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 September 30, 2020: Operating Lease Right-of-use assets $ 275,696 Operating lease liability $ 296,440 Less: short term portion (189,400 ) Long term portion $ 107,040 Finance Lease Furniture and equipment $ 28,932 Less: Accumulated depreciation (13,502 ) Net book value of property and equipment under finance lease $ 15,430 Finance lease liability $ 15,555 Less: short term portion (5,799 ) Long term portion $ 9,756 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 $50,000, $200,000 and $350,000 in 2019, 2018 and 2017, respectively. 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 $2,720,000 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. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2020 | |
Stockholders' Equity | |
Note 5. Stockholders' Equity | 5. 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 three months ended September 30, 2020, the Company sold zero shares of common stock pursuant to the ATM Agreement. During the nine months ended September 30, 2020, the Company sold 14,901 shares of common stock pursuant to the ATM Agreement, at an average selling price of $10.34 per share. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2020 | |
Stock-Based Compensation | |
Note 6. Stock-Based Compensation | The Company recognized stock-based compensation expense for stock options of $410,544 and $288,087 for the three months ended September 30, 2020 and 2019, respectively, and $1,275,481 and $625,785 for the nine months ended September 30, 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 three and nine months ended September 30, 2020 was approximately $19,000 and $70,000, respectively. The effect on stock-based compensation over the remaining service period will be approximately $149,000. 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 nine months ended September 30: 2020 2019 Risk-free interest rate 0.35% - 1.66 % 1.42% - 2.47 % Expected volatility 73.3% - 77.1 % 78.1% - 80.0 % Expected life (years) 5.5 to 6.12 5.5 to 6.32 Expected dividend yield 0 % 0 % |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying unaudited financial statements include the accounts of the Company and have been prepared in accordance with Article 10 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”). Accordingly, as permitted by Article 10, the unaudited financial statements do not include all of the information required by accounting principles generally accepted in the United States (“U.S. GAAP”). The balance sheet at December 31, 2019 was derived from the audited financial statements at that date and does not include all the disclosures required by U.S. GAAP. In the opinion of management, all adjustments which are of a normal recurring nature and necessary for a fair presentation have been reflected in the financial statements. These unaudited condensed financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2019 and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019. Operating results for the three and nine months ended September 30, 2020 are not necessarily indicative of the results to be expected during the remainder of the current year or for any future period. |
Accounting Estimates | Accounting Estimates Management uses estimates and assumptions in preparing these unaudited condensed 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 material. Significant items subject to such estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs. |
Risks and Uncertainties | 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. |
Clinical Trial Costs | 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 includes 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. |
Application of New or Revised Accounting Standards | Application of New or Revised Accounting Standards Pursuant to the Jumpstart Our Business Startups Act of 2012 (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 | Recently Adopted Accounting Pronouncements Effective January 1, 2019, the Company adopted Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842), |
Commitments (Tables)
Commitments (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Commitments | |
Schedule of maturity analysis under lease agreements | Maturity analysis under lease agreements consisted of the following as of September 30, 2020: Operating Leases Finance Leases 2020 $ 48,705 $ 1,814 2021 194,821 7,255 2022 64,940 7,255 2023 - 3,022 Total minimum lease payments 308,466 19,346 Less: Present value discount (12,026 ) (149 ) Less amount representing services (3,642 ) Present value of net minimum lease payments $ 296,440 $ 15,555 |
Schedule of weighted average discount rate | Weighted Average Remaining Lease Term Discount Rate Operating lease 1.6 years 4.0 % Finance lease 2.7 years 1.0 % |
Schedule of lease costs for the period | Lease costs for the period ended September 30, 2020: Three-month Period Nine-month Period Operating lease cost $ 43,974 $ 126,100 Finance lease cost: Amortization 1,447 4,340 Interest 28 93 Variable lease cost 20,300 64,965 $ 65,749 $ 195,498 |
Schedule of supplemental cash flow information related to leases | Supplemental cash flow information related to leases for the period ended September 30, 2020: Three-month Period Nine-month Period Cash paid for amounts included in operating and finance leases: Operating cash outflow from operating leases $ 46,003 $ 209,598 Operating cash outflow from finance leases 28 93 Financing cash outflow from finance leases 1,444 4,323 $ 47,475 $ 214,014 |
Schedule of supplemental balance sheet information related to leases | Operating Lease Right-of-use assets $ 275,696 Operating lease liability $ 296,440 Less: short term portion (189,400 ) Long term portion $ 107,040 Finance Lease Furniture and equipment $ 28,932 Less: Accumulated depreciation (13,502 ) Net book value of property and equipment under finance lease $ 15,430 Finance lease liability $ 15,555 Less: short term portion (5,799 ) Long term portion $ 9,756 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Stock-Based Compensation | |
Schedule of stock-based compensation expense | Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Stock-based compensation expense in operating expenses: Research and development $ 254,537 $ 163,343 $ 813,099 $ 364,902 General and administrative 194,410 139,901 523,690 315,232 Total $ 448,947 $ 303,244 $ 1,336,789 $ 680,134 |
Schedule of unrecognized compensation cost | 2020 $ 412,433 2021 1,299,933 2022 997,358 2023 644,448 2024 145,405 Total estimated compensation cost to be recognized $ 3,499,577 |
Schedule of fair value of equity-based awards | 2020 2019 Risk-free interest rate 0.35% - 1.66 % 1.42% - 2.47 % Expected volatility 73.3% - 77.1 % 78.1% - 80.0 % Expected life (years) 5.5 to 6.12 5.5 to 6.32 Expected dividend yield 0 % 0 % |
Schedule of stock options outstanding | 6. Stock-Based Compensation The following table summarizes the activity for all stock options outstanding for the nine months ended September 30: 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 238,762 6.67 236,701 20.07 Exercised - - (62,388 ) 5.21 Forfeited (13,252 ) 11.54 (75,347 ) 10.53 Balance at September 30 810,725 $ 9.29 577,469 $ 14.35 Options exercisable at September 30: 371,550 $ 10.28 250,202 $ 8.82 Weighted Average Grant Date Fair Value for options granted during the period: $ 4.29 $ 13.75 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 810,725 8.07 $ 9.29 $ 401,866 371,550 $ 10.28 $ 231,702 |
Schedule of activity for all stock options outstanding | 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 238,762 6.67 236,701 20.07 Exercised - - (62,388 ) 5.21 Forfeited (13,252 ) 11.54 (75,347 ) 10.53 Balance at September 30 810,725 $ 9.29 577,469 $ 14.35 Options exercisable at September 30: 371,550 $ 10.28 250,202 $ 8.82 Weighted Average Grant Date Fair Value for options granted during the period: $ 4.29 $ 13.75 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details Narrative) | Jan. 01, 2019USD ($) |
Summary of Significant Accounting Policies | |
Operating lease liabilities | $ 404,931 |
Operating lease, right-of-use asset | 356,539 |
Eliminated deferred rent | 63,875 |
Prepaid rent | $ 15,483 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details Narrative) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Employee Stock Option | ||||
Antidilutive securities excluded from computation of earnings per share | 810,725 | 577,469 | 810,725 | 577,469 |
Warrants to Purchase | ||||
Antidilutive securities excluded from computation of earnings per share | 353,585 | 353,980 | 353,585 | 353,980 |
Restricted Stock | ||||
Antidilutive securities excluded from computation of earnings per share | 15,686 | 0 | 15,686 | 0 |
Commitments (Details)
Commitments (Details) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Right-of-use asset | $ 275,696 | $ 196,983 |
Operating lease liability | 189,400 | 178,466 |
Operating lease liabilities, Long term portion | 107,040 | 57,793 |
Finance lease liability | 5,799 | 5,769 |
Finance lease liability, Long term portion | 9,756 | $ 14,109 |
Supplemental balance sheet information [Member] | ||
Right-of-use asset | 275,696 | |
Operating lease liability | 296,440 | |
Less: short term portion | (189,400) | |
Operating lease liabilities, Long term portion | 107,040 | |
Furniture and equipment | 28,932 | |
Less: accumulated depreciation | 13,502 | |
Net book value of property and equipment under finance lease | 15,430 | |
Finance lease liability | 15,555 | |
Less: short term portion | (5,799) | |
Finance lease liability, Long term portion | $ 9,756 |
Commitments (Details 1)
Commitments (Details 1) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Present value of net minimum lease payments | $ 189,400 | $ 178,466 |
Operating Leases [Member] | ||
2020 | 48,705 | |
2021 | 194,821 | |
2022 | 64,940 | |
2023 | 0 | |
Total minimum lease payments | 308,466 | |
Less: present value discount | (12,026) | |
Present value of net minimum lease payments | 296,440 | |
Finance Leases [Member] | ||
2020 | 1,814 | |
2021 | 7,255 | |
2022 | 7,255 | |
2023 | 3,022 | |
Total minimum capital lease payments | 19,346 | |
Less: present value discount | 149 | |
Less amount representing services | (3,642) | |
Present value of net minimum lease payments | $ 15,555 |
Commitments (Details 2)
Commitments (Details 2) | 9 Months Ended |
Sep. 30, 2020 | |
Commitments | |
Operating lease, weighted average remaining lease term | 1 year 7 months 6 days |
Operating lease, weighted average discount rate, percent | 40.00% |
Finance lease, weighted average remaining lease term | 2 years 8 months 12 days |
Finance lease, weighted average discount rate, percent | 10.00% |
Commitments (Details 3)
Commitments (Details 3) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2020 | Sep. 30, 2020 | |
Commitments | ||
Operating lease cost | $ 43,974 | $ 126,100 |
Finance lease cost: | ||
Amortization | 1,447 | 4,340 |
Interest | 28 | 93 |
Variable lease cost | 20,300 | 64,965 |
Total lease cost | $ 65,749 | $ 195,498 |
Commitments (Details 4)
Commitments (Details 4) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2020 | Sep. 30, 2020 | |
Cash paid for amounts included in operating and finance leases: | ||
Operating cash outflow from operating leases | $ 46,003 | $ 209,598 |
Operating cash outflow from finance leases | 28 | 93 |
Financing cash outflow from finance leases | 1,444 | 4,323 |
Total cash paid for amounts included in operating and finance leases | $ 47,475 | $ 214,014 |
Commitments (Details Narrative)
Commitments (Details Narrative) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Payments to acquire in process research and development | $ 50,000 | $ 200,000 | $ 350,000 | |
Increase in operating ROU asset and lease liability | $ 197,211 | |||
May 2017 [Member] | ||||
Maximum estimated future payment | 2,720,000 | |||
October 2018 [Member] | ||||
Payments to acquire in process research and development | $ 70,000 | |||
Maximum estimated future payment | $ 112,000 |
Stockholders Equity (Details Na
Stockholders Equity (Details Narrative) - USD ($) | 9 Months Ended | ||
Sep. 30, 2020 | Jun. 05, 2020 | Dec. 31, 2019 | |
Common stock par value | $ 0.001 | $ 0.001 | |
Placement Shares [Member] | ATM Agreement [Member] | |||
Aggregate offering price, common stock shares | $ 10,000,000 | ||
Common stock par value | $ 0.001 | ||
Sale of stock number of shares issued in transaction | 14,901 | ||
Average selling price per share | $ 10.34 |
StockBased Compensation (Detail
StockBased Compensation (Details) - Employee Stock Option - $ / shares | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Shares options outstanding, beginning | 585,215 | 478,503 |
Shares, granted | 238,762 | 236,701 |
Shares, exercised | (62,388) | |
shares, forfeited | (13,252) | (75,347) |
Shares options outstanding, ending | 810,725 | 577,469 |
Shares, options exercisable | 371,550 | 250,202 |
Weighted average exercise price, beginning | $ 14.37 | $ 9.73 |
Weighted average exercise price, granted | 6.67 | 20.07 |
Weighted average exercise price, exercised | 0 | 5.21 |
Weighted average exercise price, forfeited | 11.54 | 10.53 |
Weighted average exercise price, ending | 9.29 | 14.35 |
Weighted average exercise price, options exercisable | 10.28 | 8.82 |
Weighted average grant date fair value for options granted during the period: | $ 4.29 | $ 13.75 |
StockBased Compensation (Deta_2
StockBased Compensation (Details 1) - Employee Stock Option | 9 Months Ended |
Sep. 30, 2020USD ($)$ / sharesshares | |
Shares, options outstanding, beginning | shares | 810,725 |
Options outstanding, weighted average remaining contractual life | 8 years 25 days |
Weighted average exercise price, options outstanding, beginning | $ / shares | $ 9.29 |
Options outstanding, aggregate intrinsic value | $ | $ 401,866 |
Options exercisable | shares | 371,550 |
Options exercisable, weighted average exercise price | $ / shares | $ 10.28 |
Options exercisable, aggregate intrinsic value | $ | $ 231,702 |
StockBased Compensation (Deta_3
StockBased Compensation (Details 2) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Minimum | ||
Expected volatility | 733.00% | 781.00% |
Risk-free interest rate | 0.35% | 1.42% |
Expected life (years) | 5 years 6 months | 5 years 6 months |
Maximum | ||
Expected volatility | 771.00% | 800.00% |
Risk-free interest rate | 1.66% | 2.47% |
Expected life (years) | 6 years 1 month 13 days | 6 years 3 months 25 days |
Employee Stock Option | ||
Expected dividend yield | 0.00% | 0.00% |
StockBased Compensation (Deta_4
StockBased Compensation (Details 3) | Sep. 30, 2020USD ($) |
Stock-Based Compensation | |
2020 | $ 412,433 |
2021 | 1,299,933 |
2022 | 997,358 |
2023 | 644,448 |
2024 | 145,405 |
Total estimated compensation cost to be recognized | $ 3,499,577 |
StockBased Compensation (Deta_5
StockBased Compensation (Details 4) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Stock-based compensation | $ 448,947 | $ 303,244 | $ 1,336,789 | $ 680,134 |
Research And Development Expense | ||||
Stock-based compensation | 254,537 | 163,343 | 813,099 | 364,902 |
General And Administrative Expense | ||||
Stock-based compensation | $ 194,410 | $ 139,901 | $ 523,690 | $ 315,232 |
StockBased Compensation (Deta_6
StockBased Compensation (Details Narrative) - USD ($) | May 14, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 |
Shares available for grant under the 2017 Plan | 238,146 | 238,146 | |||
Stock-based compensation | $ 448,947 | $ 303,244 | $ 1,336,789 | $ 680,134 | |
2017 Stock Incentive Plan | |||||
Stock-based compensation | $ 410,544 | 288,087 | $ 1,275,481 | 625,785 | |
Common stock shares reserved for future issuance | 750,000 | 750,000 | |||
Common stock shares reserved description | 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. | ||||
Stock option awards shares modified | 203,750 | ||||
Exercise price | $ 5.10 | ||||
Restricted Stock Units (RSUs) [Member] | |||||
Stock-based compensation | $ 20,904 | $ 0 | $ 31,815 | $ 17,047 | |
Restricted stock vested | 0 | 2,571 | |||
Restricted stock outstanding | 15,686 | 0 | 15,686 | 0 | |
Employee Stock Option | |||||
Stock-based compensation | $ 17,499 | $ 15,157 | $ 29,493 | $ 37,302 | |
Expense Stock Options [Member] | |||||
Stock-based compensation | $ 19,000 | 70,000 | |||
Future expenses | $ 149,000 | ||||
Employee Stock Purchase Plan [Member] | |||||
Common stock shares reserved for future issuance | 100,000 | 100,000 | |||
Common stock shares reserved description | 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. | ||||
Remaining shares available for issuance | 119,956 | 119,956 |