Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 01, 2021 | Jun. 30, 2020 | |
Cover | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 001-37939 | ||
Document Period End Date | Dec. 31, 2020 | ||
Entity Registrant Name | MARKER THERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 45-4497941 | ||
Entity Address, Address Line One | 3200 Southwest Freeway | ||
Entity Address, Address Line Two | Suite 2500 | ||
Entity Address, City or Town | Houston | ||
Entity Address, State or Province | TX | ||
Entity Address, Postal Zip Code | 77027 | ||
City Area Code | 713 | ||
Local Phone Number | 400-6400 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | MRKR | ||
Security Exchange Name | NASDAQ | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 50,731,072 | ||
Entity Central Index Key | 0001094038 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Document Fiscal Year Focus | 2020 | ||
Entity Public Float | $ 64,600,000 | ||
Entity Voluntary Filers | No | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 21,352,382 | $ 43,903,949 |
Prepaid expenses and deposits | 2,057,924 | 1,526,442 |
Interest receivable | 559 | 56,189 |
Other receivable | 1,000,000 | 0 |
Total current assets | 24,410,865 | 45,486,580 |
Non-current assets: | ||
Property, plant and equipment, net | 3,570,736 | 417,528 |
Construction in progress | 6,789,098 | 0 |
Right-of-use assets, net | 10,844,116 | 455,174 |
Total non-current assets | 21,203,950 | 872,702 |
Total assets | 45,614,815 | 46,359,282 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 6,013,010 | 1,757,680 |
Lease liability | 388,792 | 204,132 |
Warrant liability | 0 | 31,000 |
Total current liabilities | 6,401,802 | 1,992,812 |
Non-current liabilities: | ||
Lease liability, net of current portion | 11,868,440 | 280,247 |
Total non-current liabilities | 11,868,440 | 280,247 |
Total liabilities | 18,270,242 | 2,273,059 |
Commitments and contingencies (see Note 15) | ||
Stockholders' equity: | ||
Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at December 31, 2020 and 2019, respectively | ||
Common stock, $0.001 par value, 150 million shares authorized, 50.7 million and 45.7 million shares issued and outstanding as of December 31, 2020 and 2019, respectively | 50,731 | 45,728 |
Additional paid-in capital | 383,533,326 | 371,573,909 |
Accumulated deficit | (356,239,484) | (327,533,414) |
Total stockholders' equity | 27,344,573 | 44,086,223 |
Total liabilities and stockholders' equity | $ 45,614,815 | $ 46,359,282 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock par value | $ 0.001 | $ 0.001 |
Preferred stock shares authorized | 5,000,000 | 5,000,000 |
Preferred stock issued | 0 | 0 |
Preferred stock outstanding | 0 | 0 |
Common stock shares par value | $ 0.001 | $ 0.001 |
Common stock shares authorized | 150,000,000 | 150,000,000 |
Common stock shares issued | 50,700,000 | 45,700,000 |
Common stock shares outstanding | 50,700,000 | 45,700,000 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues: | ||
Total revenues | $ 466,785 | $ 213,194 |
Operating expenses: | ||
Research and development | 18,880,751 | 12,764,804 |
General and administrative | 10,471,846 | 9,977,196 |
Total operating expenses | 29,352,597 | 22,742,000 |
Loss from operations | (28,885,812) | (22,528,806) |
Other income (expense): | ||
Change in fair value of warrant liabilities | 31,000 | 18,000 |
Interest income | 148,742 | 1,082,842 |
Net loss | $ (28,706,070) | $ (21,427,964) |
Net loss per share, basic and diluted | $ (0.61) | $ (0.47) |
Weighted average number of common shares outstanding | 47,039,862 | 45,587,734 |
Grant income | ||
Revenues: | ||
Total revenues | $ 466,785 | $ 213,194 |
CONSOLIDATED STATEMENT OF STOCK
CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) | Common Stock | Additional Paid- in Capital | Accumulated Deficit | Total |
Beginning Balance at Dec. 31, 2018 | $ 45,440 | $ 365,400,748 | $ (306,105,450) | $ 59,340,738 |
Beginning Balance, Shares at Dec. 31, 2018 | 45,440,704 | |||
Stock options exercised for cash | $ 12 | 57,732 | 0 | 57,744 |
Stock options exercised for cash, Shares | 11,980 | |||
Warrants exercised for cash | $ 190 | 758,543 | 0 | 758,733 |
Warrants exercised for cash, shares | 190,258 | |||
Stock warrants cashless exercised | $ 9 | (9) | 0 | 0 |
Stock warrants cashless exercised, Shares | 9,449 | |||
Stock-based compensation | $ 77 | 5,356,895 | 0 | 5,356,972 |
Stock-based compensation (in shares) | 76,440 | |||
Net loss | $ 0 | 0 | (21,427,964) | (21,427,964) |
Ending Balance at Dec. 31, 2019 | $ 45,728 | 371,573,909 | (327,533,414) | 44,086,223 |
Ending Balance, Shares at Dec. 31, 2019 | 45,728,831 | |||
Issuance common stock for cash | $ 4,114 | 6,181,897 | 0 | 6,186,011 |
Issuance common stock for cash, Shares | 4,113,440 | |||
Warrants exercised for cash | $ 459 | 549,541 | 0 | 550,000 |
Warrants exercised for cash, shares | 458,334 | |||
Issuance of common stock as commitment fee for future financing | $ 345 | (345) | 0 | 0 |
Issuance of common stock as commitment fee for future financing (Shares) | 345,357 | |||
Stock-based compensation | $ 85 | 5,228,324 | 0 | 5,228,409 |
Stock-based compensation (in shares) | 85,110 | |||
Net loss | $ 0 | 0 | (28,706,070) | (28,706,070) |
Ending Balance at Dec. 31, 2020 | $ 50,731 | $ 383,533,326 | $ (356,239,484) | $ 27,344,573 |
Ending Balance, Shares at Dec. 31, 2020 | 50,731,072 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (28,706,070) | $ (21,427,964) |
Reconciliation of net loss to net cash used in operating activities: | ||
Depreciation and amortization | 485,641 | 105,123 |
Changes in fair value of warrant liabilities | (31,000) | (18,000) |
Stock-based compensation | 5,228,409 | 5,356,972 |
Amortization on right-of-use assets | 590,039 | 181,459 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and deposits | (531,482) | (1,384,725) |
Interest receivable | 55,630 | 51,988 |
Accounts payable and accrued expenses | 4,222,470 | (963,967) |
Lease liability | (173,268) | (185,179) |
Net cash used in operating activities | (18,859,631) | (18,284,293) |
Cash Flows from Investing Activities: | ||
Purchase of property and equipment | (3,638,849) | (374,983) |
Purchase of construction in progress | (6,789,098) | 0 |
Net cash used in investing activities | (10,427,947) | (374,983) |
Cash Flows from Financing Activities: | ||
Proceeds from issuance of common stock | 6,186,011 | 0 |
Proceeds from exercise of stock options | 0 | 57,744 |
Proceeds from exercise of warrants | 550,000 | 758,733 |
Net cash provided by financing activities | 6,736,011 | 816,477 |
Net decrease in cash | (22,551,567) | (17,842,799) |
Cash and cash equivalents at beginning of the period | 43,903,949 | 61,746,748 |
Cash and cash equivalents at end of the period | 21,352,382 | 43,903,949 |
Supplemental schedule of non-cash financing activities: | ||
Issuance of common stock as commitment fee for future financing | 345 | 0 |
Recognition of right-of-use assets and lease liability from new operating lease agreements | 11,114,300 | 0 |
Stock warrants cashless exercised | $ 0 | $ 9 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2020 | |
NATURE OF OPERATIONS | |
NATURE OF OPERATIONS | NOTE 1: NATURE OF OPERATIONS Marker Therapeutics, Inc., a Delaware corporation (the “Company” or “we”), is a clinical-stage immuno-oncology company specializing in the development and commercialization of novel T cell-based immunotherapies and innovative peptide-based vaccines for the treatment of hematological malignancies and solid tumor indications. The Company’s MultiTAA-specific T cell technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens, which are tumor targets, and kill tumor cells expressing those targets. These T cells are designed to recognize multiple tumor targets to produce broad spectrum anti-tumor activity. The Company was incorporated in Nevada in 1992 and reincorporated in Delaware in October 2018. |
FINANCIAL CONDITION, GOING CONC
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS | 12 Months Ended |
Dec. 31, 2020 | |
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS | |
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS | NOTE 2: FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS As of December 31, 2020, the Company had cash and cash equivalents of approximately $21.4 million. The Company’s activities since inception have consisted principally of acquiring product and technology rights, raising capital, and performing research and development. Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations are dependent on future events, including, among other things, its ability to access potential markets; secure financing; successfully progress its product candidates through preclinical and clinical development; obtain regulatory approval of one or more of its product candidates; maintain and enforce intellectual property rights; develop a customer base; attract, retain and motivate qualified personnel; and develop strategic alliances and collaborations. From inception, the Company has been funded by a combination of equity and debt financings. The Company expects to continue to incur substantial losses over the next several years during its development phase. To fully execute its business plan, the Company will need to complete certain research and development activities and clinical trials. Further, the Company’s product candidates will require regulatory approval prior to commercialization. These activities will span many years and require substantial expenditures to complete and may ultimately be unsuccessful. Any delays in completing these activities could adversely impact the Company. The Company plans to meet its capital requirements primarily through issuances of debt and equity securities and, in the longer term, revenue from sales of its product candidates, if approved. Based on the Company’s clinical and research and development plans and its timing expectations related to the progress of its programs, the Company expects that its cash and cash equivalents as of December 31, 2020 will enable the Company to fund its operating expenses and capital expenditure requirements into the third quarter of 2021, as such these factors raise substantial doubt regarding the Company's ability to continue as a going concern. The Company has based this estimate on assumptions that may prove to be wrong, and the Company could utilize its available capital resources sooner than it currently expects. Furthermore, the Company’s operating plan may change, and it may need additional funds sooner than planned in order to meet operational needs and capital requirements for product development and commercialization. Because of the numerous risks and uncertainties associated with the development and commercialization of the Company’s product candidates and the extent to which the Company may enter into additional collaborations with third parties to participate in their development and commercialization, the Company is unable to estimate the amounts of increased capital outlays and operating expenditures associated with its current and anticipated clinical trials. The Company’s future funding requirements will depend on many factors, as it: ● initiates or continues clinical trials of its product candidates; ● continues the research and development of its product candidates and seeks to discover additional product candidates; ● seeks regulatory approvals for any product candidates that successfully complete clinical trials; ● maintains and enforces intellectual property rights; ● establishes sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product candidates that may receive regulatory approval; ● evaluates strategic transactions the Company may undertake; and ● enhances operational, financial and information management systems and hires additional personnel, including personnel to support development of product candidates and, if a product candidate is approved, commercialization efforts. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. The accompanying consolidated financial statements have been prepared on a going concern basis, which implies that the Company will continue to realize its assets and discharge its liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. In addition to the foregoing, based on the Company’s current assessment, the Company does not expect any material impact on its long-term liquidity due to the COVID-19 pandemic. However, the Company will continue to assess the effect of the pandemic on its operations, including its clinical programs. The extent to which the COVID-19 pandemic will impact the Company’s business and operations will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, the duration and effect of business disruptions and the short-term effects and ultimate effectiveness of the travel restrictions, quarantines, social distancing requirements and business closures in the United States and other countries to contain and treat the disease. While the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, a widespread pandemic could result in significant disruption of global financial markets, reducing the Company’s ability to access capital, which could in the future negatively affect the Company’s liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect the Company’s business and the value of its common stock. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2020 | |
SIGNIFICANT ACCOUNTING POLICIES | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 3: SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America. Any reference in these footnotes to applicable guidance is meant to refer to the authoritative U.S. generally accepted accounting principles (“GAAP”) as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Principles of Consolidation These consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Marker Cell Therapy, Inc. and GeneMax Pharmaceuticals Inc. – a dormant subsidiary that wholly owns GeneMax Pharmaceuticals Canada, Inc. All significant intercompany balances and transactions are eliminated upon consolidation. Use of Estimates Preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts and disclosures. Accordingly, actual results could differ materially from those estimates. Significant areas requiring management’s estimates and assumptions include valuation allowance on deferred tax assets, determining the fair value of stock-based compensation and stock-based transactions, the fair value of the components of the warrant liabilities and accrued liabilities. Cash, Cash Equivalents and Credit Risk The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents at December 31, 2020 consisted of cash and certificates of deposit in institutions in the United States. Balances at certain institutions have exceeded Federal Deposit Insurance Corporation insured limits and U.S. government agency securities. The Company maintains cash in accounts which are in excess of the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $250,000. As of December 31, 2020, approximately $2.7 million in cash was uninsured based upon the FDIC insurance coverage limits. Property and Equipment Leasehold improvements, furniture, equipment and software are recorded at cost and are depreciated using the straight-line method over the estimated useful lives of the related assets, which range from three to five years. Leasehold improvements are amortized over the shorter of the estimated useful life or the remaining lease term. Property and equipment - Construction in Progress In June 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas. In connection with the manufacturing facility, the Company has incurred costs pursuant to an agreement with a vendor to design, engineer, build and install modular cleanrooms in a manufacturing facility. The facility's construction was completed during December 2020, and a certificate of occupancy was delivered to the Company in January 2021, and as such was placed into service in January 2021. All costs associated with the buildout will be recorded as either manufacturing equipment and/or leasehold improvements and amortized over the estimated useful life of the asset and/or leasehold lease. Fair Value Measurements The Company follows Accounting Standards Codification (“ASC”) 820, “Fair Value Measurements and Disclosures,” (“ASC 820”) for the Company’s financial assets and liabilities that are re-measured and reported at fair value at each reporting period and are re-measured and reported at fair value at least annually using a fair value hierarchy that is broken down into three levels. Level inputs are defined as follows: ● Level 1 - Quoted prices (unadjusted) in active markets for identical assets and liabilities. ● Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities, financial instruments and concentration of credit risk. Patents and Patent Application Costs Although the Company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are, therefore, expensed as incurred. Stock-Based Compensation The Company incurs stock-based compensation expense related to the issuance of common stock and stock options. The Company estimates the fair value of stock options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility and expected option life: Expected Term Expected Volatility Risk-Free Interest Rate Expected Dividend Research and Development Costs Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for research and development employees and consultants, facilities expenses, overhead expenses, cost of laboratory supplies, manufacturing expenses, fees paid to third parties and other outside expenses. Research and development costs are expensed as incurred. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the clinical trial or project and the invoices received from its external service providers. The Company estimates depend on the timeliness and accuracy of the data provided by the vendors regarding the status of each project and total project spending. The Company adjusts its accrual as actual costs become known. Where contingent milestone payments are due to third parties under research and development arrangements, the milestone payment obligations are expensed when the milestone events are achieved. Income Taxes The Company follows the asset and liability method of accounting 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 assets and liabilities and their respective tax balances. Potential deferred tax assets and liabilities are measured using enacted tax rates expected to apply to the taxable income in the years in which those differences are expected to be recovered or settled. The effect on potential deferred tax assets and liabilities of a change in tax rates is recognized in the statement of operations in the period that includes the date of allowances against deferred tax assets. Tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured as the largest amount of benefit that is greater than 50 percent likely to be realized upon settlement. A liability for “unrecognized tax benefits” is recorded for any tax benefits claimed in the Company’s tax returns that do not meet these recognition and measurement standards. As of December 31, 2020 and 2019, no liability for unrecognized tax benefits was required to be reported. The guidance also discusses the classification of related interest and penalties on income taxes. The Company’s policy is to record interest and penalties on uncertain tax positions as a component of income tax expense. No interest or penalties were recorded during the years ended December 31, 2020 and 2019. Warrant Liability The Company evaluates options, warrants or other contracts to determine if those contracts or embedded components of those contracts qualify as derivatives to be separately accounted for. This accounting treatment requires that the carrying amounts of embedded derivatives be marked-to-market at each balance sheet date and carried at fair value. If the fair value is recorded as a liability, the change in fair value during the period is recorded in the Statement of Operations as either income or expense. Upon conversion, exercise or modification to the terms of a derivative instrument, the instrument is marked to fair value at the conversion date and then the related fair value is reclassified to equity. In circumstances where the embedded conversion option in a convertible instrument is required to be bifurcated and there are also other embedded derivative instruments in the convertible instrument that are required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument. The classification of financial instruments, including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting period. Equity instruments that are initially classified as equity that become subject to reclassification are reclassified to liability at the fair value of the instrument on the reclassification date. Derivative instrument liabilities will be classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the derivative instrument is expected within 12 months of the balance sheet date. Management must determine whether an instrument (or an embedded feature) is indexed to the Company’s own stock. An entity should use a two-step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions. This exercise affects the accounting for (i) certain freestanding warrants that contain exercise price adjustment features and (ii) convertible notes containing full-ratchet and anti-dilution protections (iii) certain free-standing warrants that contain contingently putable cash settlement. Grant Income The Company recognizes grant income in accordance with the terms stipulated under the grant awarded to the Company’s collaborators at the Mayo Foundation from the U. S. Department of Defense. In various situations, the Company receives certain payments from the U.S. Department of Defense for reimbursement of clinical supplies. These payments are non-refundable and are not dependent on the Company’s ongoing future performance. The Company has adopted a policy of recognizing these payments when received and as revenue in accordance with Accounting Standards Update No. 2014-09, “Revenue from Contracts with Customers (Topic 606)” issued by the Financial Accounting Standards Board. Loss per Common Share Basic loss per share includes only the weighted average common shares outstanding, without consideration of potentially dilutive securities. Diluted loss per share includes the weighted average common shares outstanding and any potentially dilutive common stock equivalent shares in the calculation. New Accounting Standards From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that we adopt as of the specified effective date. Unless otherwise discussed, the Company does not believe that the impact of recently issued standards that are not yet effective will have a material impact on its financial position or results of operations upon adoption. Recent Accounting Standards Not Yet Adopted Income Taxes In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company has adopted the new standard effective January 1, 2021 and is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. |
NET LOSS PER SHARE APPLICABLE T
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS | 12 Months Ended |
Dec. 31, 2020 | |
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS | |
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS | NOTE 4: NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS Net Loss per Share Applicable to Common Stockholders Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period. Diluted loss per common share is computed similarly to basic loss per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock. The following table sets forth the computation of loss per share for the years ended December 31, 2020 and 2019, respectively: For the Years Ended December 31, 2020 2019 Numerator: Net loss $ (28,706,070) $ (21,427,964) Denominator: Weighted average common shares outstanding 47,039,862 45,587,734 Net loss per share data: Basic and diluted $ (0.61) $ (0.47) The following securities, rounded to the thousand, were not included in the diluted net loss per share calculation because their effect was anti-dilutive for the periods presented: For the Years Ended December 31, 2020 2019 Common stock options 6,002,000 4,983,000 Common stock purchase warrants 20,830,000 22,605,000 Common stock warrants - liability treatment — 59,000 Potentially dilutive securities 26,832,000 27,647,000 |
OTHER RECEIVABLE
OTHER RECEIVABLE | 12 Months Ended |
Dec. 31, 2020 | |
OTHER RECEIVABLE | |
OTHER RECEIVABLE | NOTE 5: OTHER RECEIVABLE Pursuant to the Company’s lease agreement for its manufacturing facility, the Company incurred and paid for the construction invoices directly for both the structural improvements of the facility and the building of the manufacturing modular cleanroom (i.e. leasehold improvements and manufacturing equipment). At the time the construction invoices are received by the Company, a fixed asset is recorded in construction-in-progress. In accordance with the agreement, upon completion of the facility’s construction, the Company is owed up to $1.0 million as reimbursement, and as such a landlord receivable is recorded, which provides for a legal right to receive construction reimbursements from the landlord for tenant improvement allowances. The construction of the facility was completed during December 2020, and a certificate was occupancy was delivered to the Company in January 2021. During the fiscal year ended 2020, the Company recorded a $1.0 million receivable in its consolidated financial statements. The Company expects to receive the $1.0 million in the first half of 2021. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2020 | |
PROPERTY AND EQUIPMENT | |
PROPERTY AND EQUIPMENT | NOTE 6: PROPERTY AND EQUIPMENT Property and equipment consist of the following as of December 31, 2020 and 2019, respectively: December 31, December 31, Estimated Useful Lives 2020 2019 Lab equipment 5 Years $ 2,360,000 $ 111,000 Computers, equipment and software 3-5 Years 835,000 211,000 Office furniture 5 Years 678,000 178,000 Leasehold improvements Lesser of lease term or estimated useful life 289,000 23,000 Total 4,162,000 523,000 Less: accumulated depreciation (591,000) (105,000) Construction in progress 6,789,000 — Total fixed assets, net $ 10,360,000 $ 418,000 Depreciation expense for the years ended December 31, 2020 and 2019 was approximately $0.5 million and $0.1 million, respectively. In June 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas. In connection with the manufacturing facility, the Company has incurred costs pursuant to an agreement with a vendor to design, engineer, build and eventually install modular cleanrooms in a manufacturing facility. $6.8 million is recorded in fixed assets – construction in progress on the balance sheet as of December 31, 2020. The completion of the facility’s construction occurred during December 2020 and the Company received its certificate of occupancy in January 2021, and as such was placed into service in January 2021. During January 2021, all costs associated with the buildout will be recorded as either manufacturing equipment and/or leasehold improvements and amortized over the estimated useful life of the asset and/or leasehold lease. In connection with the research facility that the Company opened during the second quarter of 2020, the Company incurred approximately $2.2 million of costs acquiring necessary lab equipment to carry out its experiments. The $2.2 million is included in Lab equipment within fixed assets and is being depreciated over five years. Additionally, the Company incurred $0.3 million in leasehold improvements relating to the research facility. |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2020 | |
LEASES | |
LEASES | NOTE 7: LEASES The Company entered into a new agreement for its corporate headquarters in Houston, Texas, which commenced in August of 2020. The initial lease term is ten years with two five-year renewal options. Fixed rent payments under the initial term are approximately $5.6 million. Additionally, the Company is also responsible for its share of operating expenses. As of December 31, 2020, the Company had remaining $4.1 million from the lease liability and $4.0 million of the related right-of-use asset resulting from the lease of its corporate headquarters. In April 2020, the Company entered into a lease for a research facility in Houston, Texas. The lease term is 71 months. Fixed rent payments under the initial term are approximately $1.1 million. As of December 31, 2020, the Company had remaining $0.8 million from the lease liability and $0.8 million of the related right-of-use asset resulting from the lease of its research facility. In June 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas. The initial lease term is ten years from the rent commencement date in the fourth quarter of 2020 with two five-year renewal options. Fixed rent payments under the initial term are approximately $9.8 million. Additionally, the Company is also responsible for its share of operating expenses. In accordance with the agreement, upon completion of the facility’s construction, the Company is owed up to $1.0 million as reimbursement, and as such a landlord receivable is recorded, which provides for a legal right to receive construction reimbursements from the landlord for tenant improvement allowances. As of December 31, 2020, the Company had remaining $7.2 million from the lease liability and $5.8 million of the related right-of-use asset resulting from the lease of its manufacturing facility. The Company also leases office space under agreements classified as operating leases that expire in 2022. As of December 31, 2020, the Company had remaining $0.2 million from the lease liability and $0.2 million of the related right-of-use asset resulting from the lease of its Jacksonville, Florida office space, which expires in 2022. Such leases do not require any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees. Certain of the Company’s leases include renewal options and escalation clauses; renewal options have not been included in the calculation of the lease liabilities and right-of-use assets as the Company is not reasonably certain to exercise the options. Variable expenses generally represent the Company’s share of the landlord’s operating expenses. The Company does not act as a lessor or have any leases classified as financing leases. At December 31, 2020, the Company had operating lease liabilities of approximately $12.3 million and right-of-use assets of approximately $10.8 million, which were included in the consolidated balance sheet. The following summarizes quantitative information about the Company’s operating leases: For the Years Ended December 31, 2020 2019 Operating lease expense summary: Operating lease expense $ 960,000 $ 220,000 Short-term lease expense 22,000 100,000 Variable lease expense 167,000 90,000 Total $ 1,149,000 $ 410,000 Other information: Operating cash flows - operating leases $ 544,000 $ 225,000 Weighted-average remaining lease term – operating leases 9.3 1.6 Weighted-average discount rate as of adoption date – operating leases 5.7 % 6.8 % Maturities of the Company’s operating leases, excluding short-term leases, are as follows: Year ended December 31, 2021 $ 1,077,000 Year ended December 31, 2022 1,278,000 Year ended December 31, 2023 1,542,000 Year ended December 31, 2024 1,826,000 Year ended December 31, 2025 1,874,000 Thereafter 8,772,000 Total 16,369,000 Less present value discount (4,112,000) Operating lease liabilities included in the Condensed Consolidated Balance Sheet at December 31, 2020 $ 12,257,000 |
ACCOUNTS PAYABLE AND ACCRUED LI
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES | 12 Months Ended |
Dec. 31, 2020 | |
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES | |
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES | NOTE 8: ACCOUNTS PAYABLE AND ACCRUED LIABILITIES Accounts payable and accrued liabilities consist of the following as of December 31, 2020 and 2019, respectively: December 31, December 31, 2020 2019 Accounts payable $ 2,935,000 $ 993,000 Compensation and benefits 1,694,000 323,000 Professional fees 875,000 94,000 Technology license fees 105,000 105,000 Other 404,000 243,000 Total accounts payable and accrued liabilities $ 6,013,000 $ 1,758,000 |
WARRANT LIABILITY
WARRANT LIABILITY | 12 Months Ended |
Dec. 31, 2020 | |
WARRANT LIABILITY | |
WARRANT LIABILITY | NOTE 9: WARRANT LIABILITY A weighted average summary of quantitative information with respect to valuation methodology and significant unobservable inputs used for the Company’s common stock purchase warrants that are categorized within Level 3 of the fair value hierarchy for the years ended 2020 and 2019, respectively: Weighted Average Inputs For the Years Ended December 31, 2020 2019 Exercise price $ — $ 6.92 Contractual term (years) — 0.05 Volatility (annual) — 83 % Risk-free rate — 2 % Dividend yield (per share) — 0 % The foregoing assumptions are recalculated every reporting period and are subject to change based primarily on management’s assessment of the probability of the events described occurring. Accordingly, changes to these assessments could materially affect the valuations. The following table presents changes in Level 3 warrant liabilities, reflected in accrued expenses measured at fair value for the years ended December 31, 2020 and 2019, respectively: Warrant Liability Balance - January 1, 2019 49,000 Change in fair value of warrant liability (18,000) Balance – December 31, 2019 31,000 Change in fair value of warrant liability (31,000) Balance – December 31, 2020 $ — |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2020 | |
FAIR VALUE MEASUREMENTS | |
FAIR VALUE MEASUREMENTS | NOTE 10: FAIR VALUE MEASUREMENTS Financial assets and liabilities measured at fair value on a recurring basis are summarized below and disclosed on the balance sheet under Warrant liability: Fair value measured at December 31, 2020 Quoted prices in active Significant other Significant markets observable inputs unobservable inputs Fair value at (Level 1) (Level 2) (Level 3) December 31, 2020 Warrant liability $ — $ — $ — $ — Fair value measured at December 31, 2019 Quoted prices in active Significant other Significant markets observable inputs unobservable inputs Fair value at (Level 1) (Level 2) (Level 3) December 31, 2019 Warrant liability $ — $ — $ 31,000 $ 31,000 There were no transfers between Level 1, 2 or 3 during the years ended December 31, 2020 and 2019, respectively. The valuation of warrants is subjective and is affected by changes in inputs to the valuation model including the price per share of common stock, the historical volatility of the stock price, risk-free rates based on U. S. Treasury security yields, the expected term of the warrants and dividend yield. Changes in these assumptions can materially affect the fair value estimate. The Company could ultimately incur amounts to settle the warrant at a cash settlement value that is significantly different than the carrying value of the liability on the financial statements. The Company will continue to classify the fair value of the warrants as a liability until the warrants are exercised, expire, or are amended in a way that would no longer require these warrants to be classified as a liability. Changes in the fair value of the common stock warrants liability are recognized as a component of other income (expense) in the Statements of Operations. The net cash settlement value at the time of any future transactions, where the Company consolidates or merges with another entity, will depend upon the value of the following inputs at that time: the consideration value per share of the Company’s common stock, the volatility of the Company’s common stock, the remaining term of the warrant from announcement date, the risk-free interest rate based on U. S. Treasury security yields, and the Company’s dividend yield. The warrant requires use of a volatility assumption equal to the greater of 100% and the 100-day volatility function determined as of the trading day immediately following announcement of a Fundamental Transaction. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2020 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | NOTE 11: STOCKHOLDERS’ EQUITY Preferred Stock The Company has authorized up to 5,000,000 shares of preferred stock, $0.001 par value per share, for issuance. The preferred stock will have such rights, privileges and restrictions, including voting rights, dividend conversion rights, redemption privileges and liquidation preferences, as shall be determined by the Company’s board of directors upon its issuance. To date, the Company has not issued any preferred shares. Common Stock The Company has authorized up to 150,000,000 shares of common stock, $0.001 par value per share, for issuance. Significant 2020 and 2019 common stock transactions were as follows: 2020 Common Stock Transactions Exercise of Stock Warrants During the year ended December 31, 2020, certain outstanding warrants were exercised for 0.5 million shares of common stock providing aggregate proceeds to the Company of approximately $0.6 million. Board Compensation During the year ended December 31, 2020, the Company issued an aggregate of 0.1 Aspire Capital On February 28, 2020, the Company entered into a common stock purchase agreement (the “Purchase Agreement”) with Aspire Capital Fund, LLC (“Aspire Capital”) which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $30.0 million of shares of the Company’s common stock over the 30-month term of the purchase agreement. In consideration for entering into the purchase agreement, the Company issued to Aspire Capital 0.3 million shares of the Company’s common stock as a commitment fee. The Company recorded the commitment fee to additional paid in capital. As of December 31, 2020, Aspire Capital had purchased 4.1 million shares under the Purchase Agreement, providing aggregate proceeds to the Company of approximately $6.2 million. 2019 Common Stock Transactions Consulting Arrangements During the year ended December 31, 2019, the Company issued 0.05 million shares of common stock in connection with consulting agreements. The fair value of the common stock of approximately $0.3 million was recognized as stock-based compensation expense in general and administrative expenses. Board Compensation During the year ended December 31, 2019, the Company issued an aggregate of 0.03 million shares of common stock to its non-employee directors. The fair value of the common stock of approximately $0.2 million was recognized as stock-based compensation expense in general and administrative expenses. |
WARRANTS
WARRANTS | 12 Months Ended |
Dec. 31, 2020 | |
WARRANTS | |
WARRANTS | NOTE 12: WARRANTS Share Purchase Warrants A summary of the Company’s share purchase warrants as of December 31, 2020 and 2019, respectively, and changes during the period is presented below: Weighted Average Number of Weighted Average Remaining Contractual Total Intrinsic Warrants Exercise Price Life (in years) Value Balance - January 1, 2019 23,016,000 4.78 4.29 $ 26,066,000 Warrants granted 45,000 4.26 — — Exercised for cash (190,000) 3.99 — — Cashless exercise (17,000) 2.38 — — Expired or cancelled (190,000) 13.63 — — Balance - December 31, 2019 22,664,000 4.71 3.33 954,000 Exercised for cash (458,000) 1.20 — — Expired or cancelled (1,376,000) 9.46 — — Balance - December 31, 2020 20,830,000 $ 4.47 2.60 $ — 2020 Warrant Transactions Exercise of Stock Warrants During the year ended December 31, 2020, certain outstanding warrants were exercised for 0.5 million shares of common stock providing aggregate proceeds to the Company of approximately $0.6 million. 2019 Warrant Transactions Exercise of Stock Warrants During the year ended December 31, 2019, certain outstanding warrants were exercised for 0.2 million shares of common stock providing aggregate proceeds to the Company of approximately $0.8 million. |
STOCK OPTION PLANS
STOCK OPTION PLANS | 12 Months Ended |
Dec. 31, 2020 | |
STOCK OPTION PLANS | |
STOCK OPTION PLANS | NOTE 13: STOCK OPTION PLANS Options to Purchase Shares of Common Stock 2020 Equity Incentive Plan On May 19, 2020, the Board adopted the 2020 Equity Incentive Plan ("2020 Plan") which replaced the 2014 Omnibus Stock Option Plan (“2014 Plan”). The 2020 Plan allows for grants of stock options, restricted shares, stock bonuses and other equity-based awards to employees and non-employee directors of the Company. Awards under the 2020 Plan may be at prices and for terms as determined by the Board of Directors and may have vesting requirements as determined by the Board, provided that the exercise price for any stock option must be at least equal to the fair market value (as defined in the 2020 Plan) of a share of the stock on the grant date. Once granted, the exercise price of an option may not be reduced without the approval of the Company’s stockholders, other than under certain limited circumstances such as a stock split or take any other action with respect to a stock option that would be treated as a repricing under the rules and regulations of the New York Stock Exchange. Options granted under the 2020 Plan have a maximum term of ten years from the date of grant. Options granted in 2020 and 2019 generally vest over four years. As of December 31, 2020, approximately 4.7 million options are available to be issued from the 2020 Plan. 2014 Omnibus Stock Ownership Plan The 2014 Plan, which the Board adopted on May 19, 2020 and subsequently amended from time to time, allowed for grants of stock options, restricted shares, stock bonuses and other equity-based awards to employees and non-employee directors of the Company. The terms of the 2014 plan are substantially identical to the terms of the 2020 Plan described above. Stock Options A summary of the Company’s stock option activity is as follows for stock options: Weighted Average Remaining Weighted Average Total Intrinsic Contractual Number of Shares Exercise Price Value Life (in years) Outstanding as of January 1, 2020 4,983,314 $ 7.79 $ 18,000 8.9 Granted 1,531,000 2.08 — 9.2 Canceled (512,500) — — — Outstanding as of December 31, 2020 6,001,814 $ 6.22 $ — 8.3 Options vested and exercisable 2,598,981 $ 7.29 $ — 8.0 The Black-Scholes option pricing model is used to estimate the fair value of stock options granted under the Company’s share-based compensation plans. The weighted average assumptions used in calculating the fair values of stock options that were granted during the years ended December 31, 2020 and 2019, respectively, were as follows: For the Years Ended December 31, 2020 2019 Exercise price $ 2.08 $ 4.70 Expected term (years) 6.0 6.0 Expected stock price volatility 108 % 126 % Risk-free rate of interest 1 % 2 % Expected dividend rate 0 % 0 % The following table sets forth stock-based compensation expenses recorded during the respective periods: For the Years Ended December 31, 2020 2019 Stock Compensation expenses: Research and development $ 2,588,000 $ 2,574,000 General and administrative 2,640,000 2,783,000 Total stock compensation expenses $ 5,228,000 $ 5,357,000 At December 31, 2020, the total stock-based compensation cost related to unvested awards not yet recognized was $10.6 million. The expected weighted average period compensation costs to be recognized was 2.2 years. Future option grants will impact the compensation expense recognized. |
GRANT INCOME
GRANT INCOME | 12 Months Ended |
Dec. 31, 2020 | |
GRANT INCOME | |
GRANT INCOME | NOTE 14: GRANT INCOME During the years ended December 31, 2020 and 2019, the Company received $0.5 million and $0.2 million, respectively, of a grant awarded to Mayo Foundation from the U.S. Department of Defense for the Phase II Clinical Trial of TPIV200. The grant compensated the Company for clinical supplies manufactured and provided by the Company for the clinical study. In accordance with Accounting Standards Update No. 2014-09, “Revenue from Contracts with Customers (Topic 606)” issued by the Financial Accounting Standards Board, the Company recorded the $0.5 million and $0.2 million, respectively, of grant income as revenue. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2020 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | NOTE 15: COMMITMENTS AND CONTINGENCIES An arbitration proceeding was brought against the Company before the Financial Industry Regulatory Authority, Inc. by a broker seeking to be paid approximately $1.0 million as compensation for two financing transactions that occurred in 2018, a warrant conversion and a private placement brokered by another broker. The broker’s claims are based on a placement agent agreement for a private placement it brokered in 2017, under which it alleges it is entitled to compensation for the 2018 transactions. The Company believes it has defenses to all of the allegations and intends to vigorously defend itself in this matter. |
LEGAL PROCEEDINGS
LEGAL PROCEEDINGS | 12 Months Ended |
Dec. 31, 2020 | |
LEGAL PROCEEDINGS | |
LEGAL PROCEEDINGS | NOTE 16: LEGAL PROCEEDINGS From time to time, the Company may be party to ordinary, routine litigation incidental to their business. The Company knows of no material, active or pending legal proceedings against the Company, nor is the Company involved as a plaintiff in any material proceeding or pending litigation. There are no proceedings in which any of the Company’s directors, officers or affiliates, or any registered or beneficial shareholder, is an adverse party or has a material interest adverse to the Company’s interest. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2020 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 17: RELATED PARTY TRANSACTIONS The following table sets forth related party transaction expenses recorded for the years ended December 31, 2020 and 2019, respectively. For the Years Ended December 31, 2020 2019 Baylor College of Medicine $ 1,818,000 $ 69,000 Bio-Techne Corporation 152,000 51,000 Dr Juan Vera $ — $ 233,000 Total Research and development $ 1,970,000 $ 353,000 Agreements with The Baylor College of Medicine (“BCM”) . In November 2018 and February 2020, the Company entered in Sponsored Research Agreements with BCM, which provided for the conduct of research for the Company by credentialed personnel at BCM’s Center for Cell and Gene Therapy. In September 2019, the Company entered in a Clinical Supply Agreement with BCM, which provided for BCM to provide to the Company multi tumor antigen specific products. In October 2019, the Company entered in a Workforce Grant Agreement with BCM, which provided for BCM to provide to the Company manpower costs of projects for manufacturing, quality control testing and validation run activities. In August 2020, the Company entered in a Clinical Trial Agreement with BCM, which provided for BCM to provide to the Company investigator-initiated research studies. Purchases from Bio-Techne Corporation . The Company is currently utilizing Bio-Techne Corporation and two of its brands for the purchases of reagents, primarily cytokines. Mr. David Eansor is a member of the Company's board of directors and is serving as the President of the Protein Sciences Segment of Bio-Techne Corporation. Consulting Agreement with Dr. Juan Vera . |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2020 | |
INCOME TAXES | |
INCOME TAXES | NOTE 18: INCOME TAXES The Company has no income tax expense due to operating losses incurred for the years ended December 31, 2020 and 2019. The effects of temporary differences that give rise to significant portions of the deferred tax assets as of December 31, 2020 and 2019 are as follows: For the Years Ended December 31, 2020 2019 Deferred Tax Assets Net Operating Loss Carryforward 21,783,000 17,166,000 Stock Compensation 6,775,000 6,538,000 License Agreements 144,000 177,000 Research and Development 733,000 733,000 Charitable Contributions 8,000 9,000 Operating Lease Liability 2,626,000 115,000 32,069,000 24,738,000 Less: Valuation Allowance (29,689,000) (24,632,000) Total Deferred Tax Assets 2,380,000 106,000 Deferred Tax Liabilities Fixed Assets — (106,000) Right-of-Use Assets (2,380,000) — Total Deferred Tax Liabilities (2,380,000) (106,000) Net Deferred Tax Assets/(Liabilities) — — The Company assesses the likelihood that deferred tax assets will be realized. To the extent that realization is not likely, a valuation allowance is established. Based upon the history of losses, management believes that it is more likely than not that future benefits of deferred tax assets will not be realized and has established a full valuation allowance for the years ended December 31, 2020 and 2019. The valuation allowance increased by $5.1 million as of December 31, 2020. The Company has research and development tax credit carryforwards of $0.7 million available to offset future federal income taxes. The research and development tax credit carryforwards begin to expire in 2030. The Company has approximately $97.2 million of federal and $39.0 million of state Net Operating Losses (“NOL”s) that may be available to offset future taxable income, if any. The federal net operating loss carryforwards of $41.6 million, if not utilized, will expire between 2029 and 2037. The federal net operating loss carryforwards of $55.6 million generated in 2018 and thereafter are subject to an 80% limitation on taxable income, do not expire and will carry forward indefinitely. The state net operating loss carryforwards of $21.9 million, if not utilized, will begin to expire in 2035. The state net operating loss carryforwards of $17.1 million generated in 2018 and thereafter are subject to an 80% limitation on taxable income, do not expire and will carry forward indefinitely. In accordance with Section 382 of the Internal Revenue code, the usage of the Company’s net operating loss carryforwards may be limited in the event of a change in ownership. A full Section 382 analysis has not been prepared and NOLs could be subject to limitation under Section 382. The Company’s income tax returns for 2016 to 2019 are still open and subject to audit. In addition, net operating losses arising from prior years are also subject to examination at the time they are utilized in future years. For the years ended December 31, 2020 and 2019, the expected tax expense (benefit) based on the U. S. federal statutory rate is reconciled with the actual tax provision (benefit) as follows: For the Years Ended December 31, 2020 2019 Percent of Percent of Amount Pre-Tax Loss Amount Pre-Tax Loss U.S. federal statutory rate (6,028,000) 21.00 % (4,500,000) 21.00 % State taxes, net of federal benefit (118,000) 0.41 % (600,000) 2.80 % Tax rate change 677,000 (2.36) % 665,000 (3.10) % Permanent Differences - Change in fair value of derivative liabilities (7,000) 0.02 % (4,000) 0.02 % - Other permanent differences 182,000 (0.63) % 32,000 (0.15) % Change in valuation allowance 5,057,000 (17.62) % 4,681,000 (21.85) % Deferred true-up 237,000 (0.83) % (274,000) 1.28 % Income tax provision/(benefit) — 0.00 % — 0.00 % ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. As of December 31, 2020, and 2019, there were no unrecognized tax benefits. The Company recognizes accrued interest and penalties as income tax expense. No amounts were accrued for the payment of interest and penalties at December 31, 2020 and 2019. The Company is currently not aware of any issues under review that could result in significant payments, accruals or material deviation from its position in the next year. On March 27, 2020, the CARES Act was enabled in response to COVID-19 pandemic. Under ASC 740, the effects of changes in tax rates and laws are recognized in the period which the new legislation is enacted. The CARES Act made various tax law changes including among other things (i) increasing the limitation under Section 163(j) of the Internal Revenue Code of 1986, as amended (the “IRC”) for 2019 and 2020 to permit additional expensing of interest, (ii) enacting a technical correction so that qualified improvement property can be immediately expensed under IRC Section 168(k),(iii) making modifications to the federal net operating loss rules including permitting federal net operating losses incurred in 2018, 2019 and 2020 to be carried back to the five preceding taxable years in order to generate a refund of previously paid income taxes and (iv) enhancing the recoverability of alternative minimum tax credits. Given the Company’s full valuation allowance position, the CARES Act did not have an impact on the financial statements. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
SIGNIFICANT ACCOUNTING POLICIES | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America. Any reference in these footnotes to applicable guidance is meant to refer to the authoritative U.S. generally accepted accounting principles (“GAAP”) as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Principles of Consolidation | Principles of Consolidation These consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Marker Cell Therapy, Inc. and GeneMax Pharmaceuticals Inc. – a dormant subsidiary that wholly owns GeneMax Pharmaceuticals Canada, Inc. All significant intercompany balances and transactions are eliminated upon consolidation. |
Use of Estimates | Use of Estimates Preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts and disclosures. Accordingly, actual results could differ materially from those estimates. Significant areas requiring management’s estimates and assumptions include valuation allowance on deferred tax assets, determining the fair value of stock-based compensation and stock-based transactions, the fair value of the components of the warrant liabilities and accrued liabilities. |
Cash, Cash Equivalents and Credit Risk | Cash, Cash Equivalents and Credit Risk The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents at December 31, 2020 consisted of cash and certificates of deposit in institutions in the United States. Balances at certain institutions have exceeded Federal Deposit Insurance Corporation insured limits and U.S. government agency securities. The Company maintains cash in accounts which are in excess of the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $250,000. As of December 31, 2020, approximately $2.7 million in cash was uninsured based upon the FDIC insurance coverage limits. |
Property and Equipment | Property and Equipment Leasehold improvements, furniture, equipment and software are recorded at cost and are depreciated using the straight-line method over the estimated useful lives of the related assets, which range from three to five years. Leasehold improvements are amortized over the shorter of the estimated useful life or the remaining lease term. |
Property and equipment - Construction in Progress | Property and equipment - Construction in Progress In June 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas. In connection with the manufacturing facility, the Company has incurred costs pursuant to an agreement with a vendor to design, engineer, build and install modular cleanrooms in a manufacturing facility. The facility's construction was completed during December 2020, and a certificate of occupancy was delivered to the Company in January 2021, and as such was placed into service in January 2021. All costs associated with the buildout will be recorded as either manufacturing equipment and/or leasehold improvements and amortized over the estimated useful life of the asset and/or leasehold lease. |
Fair Value Measurements | Fair Value Measurements The Company follows Accounting Standards Codification (“ASC”) 820, “Fair Value Measurements and Disclosures,” (“ASC 820”) for the Company’s financial assets and liabilities that are re-measured and reported at fair value at each reporting period and are re-measured and reported at fair value at least annually using a fair value hierarchy that is broken down into three levels. Level inputs are defined as follows: ● Level 1 - Quoted prices (unadjusted) in active markets for identical assets and liabilities. ● Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities, financial instruments and concentration of credit risk. |
Patents and Patent Application Costs | Patents and Patent Application Costs Although the Company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are, therefore, expensed as incurred. |
Stock-Based Compensation | Stock-Based Compensation The Company incurs stock-based compensation expense related to the issuance of common stock and stock options. The Company estimates the fair value of stock options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility and expected option life: Expected Term Expected Volatility Risk-Free Interest Rate Expected Dividend |
Research and Development Costs | Research and Development Costs Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for research and development employees and consultants, facilities expenses, overhead expenses, cost of laboratory supplies, manufacturing expenses, fees paid to third parties and other outside expenses. Research and development costs are expensed as incurred. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the clinical trial or project and the invoices received from its external service providers. The Company estimates depend on the timeliness and accuracy of the data provided by the vendors regarding the status of each project and total project spending. The Company adjusts its accrual as actual costs become known. Where contingent milestone payments are due to third parties under research and development arrangements, the milestone payment obligations are expensed when the milestone events are achieved. |
Income Taxes | Income Taxes The Company follows the asset and liability method of accounting 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 assets and liabilities and their respective tax balances. Potential deferred tax assets and liabilities are measured using enacted tax rates expected to apply to the taxable income in the years in which those differences are expected to be recovered or settled. The effect on potential deferred tax assets and liabilities of a change in tax rates is recognized in the statement of operations in the period that includes the date of allowances against deferred tax assets. Tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured as the largest amount of benefit that is greater than 50 percent likely to be realized upon settlement. A liability for “unrecognized tax benefits” is recorded for any tax benefits claimed in the Company’s tax returns that do not meet these recognition and measurement standards. As of December 31, 2020 and 2019, no liability for unrecognized tax benefits was required to be reported. The guidance also discusses the classification of related interest and penalties on income taxes. The Company’s policy is to record interest and penalties on uncertain tax positions as a component of income tax expense. No interest or penalties were recorded during the years ended December 31, 2020 and 2019. |
Warrant Liability | Warrant Liability The Company evaluates options, warrants or other contracts to determine if those contracts or embedded components of those contracts qualify as derivatives to be separately accounted for. This accounting treatment requires that the carrying amounts of embedded derivatives be marked-to-market at each balance sheet date and carried at fair value. If the fair value is recorded as a liability, the change in fair value during the period is recorded in the Statement of Operations as either income or expense. Upon conversion, exercise or modification to the terms of a derivative instrument, the instrument is marked to fair value at the conversion date and then the related fair value is reclassified to equity. In circumstances where the embedded conversion option in a convertible instrument is required to be bifurcated and there are also other embedded derivative instruments in the convertible instrument that are required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument. The classification of financial instruments, including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting period. Equity instruments that are initially classified as equity that become subject to reclassification are reclassified to liability at the fair value of the instrument on the reclassification date. Derivative instrument liabilities will be classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the derivative instrument is expected within 12 months of the balance sheet date. Management must determine whether an instrument (or an embedded feature) is indexed to the Company’s own stock. An entity should use a two-step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions. This exercise affects the accounting for (i) certain freestanding warrants that contain exercise price adjustment features and (ii) convertible notes containing full-ratchet and anti-dilution protections (iii) certain free-standing warrants that contain contingently putable cash settlement. |
Grant Income | Grant Income The Company recognizes grant income in accordance with the terms stipulated under the grant awarded to the Company’s collaborators at the Mayo Foundation from the U. S. Department of Defense. In various situations, the Company receives certain payments from the U.S. Department of Defense for reimbursement of clinical supplies. These payments are non-refundable and are not dependent on the Company’s ongoing future performance. The Company has adopted a policy of recognizing these payments when received and as revenue in accordance with Accounting Standards Update No. 2014-09, “Revenue from Contracts with Customers (Topic 606)” issued by the Financial Accounting Standards Board. |
Loss per Common Share | Loss per Common Share Basic loss per share includes only the weighted average common shares outstanding, without consideration of potentially dilutive securities. Diluted loss per share includes the weighted average common shares outstanding and any potentially dilutive common stock equivalent shares in the calculation. |
New Accounting Standards | New Accounting Standards From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that we adopt as of the specified effective date. Unless otherwise discussed, the Company does not believe that the impact of recently issued standards that are not yet effective will have a material impact on its financial position or results of operations upon adoption. Recent Accounting Standards Not Yet Adopted Income Taxes In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company has adopted the new standard effective January 1, 2021 and is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. |
NET LOSS PER SHARE APPLICABLE_2
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS | |
Schedule of computation of loss per share | For the Years Ended December 31, 2020 2019 Numerator: Net loss $ (28,706,070) $ (21,427,964) Denominator: Weighted average common shares outstanding 47,039,862 45,587,734 Net loss per share data: Basic and diluted $ (0.61) $ (0.47) |
Schedule of anti-dilutive securities | For the Years Ended December 31, 2020 2019 Common stock options 6,002,000 4,983,000 Common stock purchase warrants 20,830,000 22,605,000 Common stock warrants - liability treatment — 59,000 Potentially dilutive securities 26,832,000 27,647,000 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
PROPERTY AND EQUIPMENT | |
Schedule of property and equipment | December 31, December 31, Estimated Useful Lives 2020 2019 Lab equipment 5 Years $ 2,360,000 $ 111,000 Computers, equipment and software 3-5 Years 835,000 211,000 Office furniture 5 Years 678,000 178,000 Leasehold improvements Lesser of lease term or estimated useful life 289,000 23,000 Total 4,162,000 523,000 Less: accumulated depreciation (591,000) (105,000) Construction in progress 6,789,000 — Total fixed assets, net $ 10,360,000 $ 418,000 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
LEASES | |
Schedule of quantitative information about operating leases | For the Years Ended December 31, 2020 2019 Operating lease expense summary: Operating lease expense $ 960,000 $ 220,000 Short-term lease expense 22,000 100,000 Variable lease expense 167,000 90,000 Total $ 1,149,000 $ 410,000 Other information: Operating cash flows - operating leases $ 544,000 $ 225,000 Weighted-average remaining lease term – operating leases 9.3 1.6 Weighted-average discount rate as of adoption date – operating leases 5.7 % 6.8 % |
Schedule of maturities of operating leases | Year ended December 31, 2021 $ 1,077,000 Year ended December 31, 2022 1,278,000 Year ended December 31, 2023 1,542,000 Year ended December 31, 2024 1,826,000 Year ended December 31, 2025 1,874,000 Thereafter 8,772,000 Total 16,369,000 Less present value discount (4,112,000) Operating lease liabilities included in the Condensed Consolidated Balance Sheet at December 31, 2020 $ 12,257,000 |
ACCOUNTS PAYABLE AND ACCRUED _2
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES | |
Schedule of accounts payable and accrued liabilities | December 31, December 31, 2020 2019 Accounts payable $ 2,935,000 $ 993,000 Compensation and benefits 1,694,000 323,000 Professional fees 875,000 94,000 Technology license fees 105,000 105,000 Other 404,000 243,000 Total accounts payable and accrued liabilities $ 6,013,000 $ 1,758,000 |
WARRANT LIABILITY (Tables)
WARRANT LIABILITY (Tables) - Level 3 | 12 Months Ended |
Dec. 31, 2020 | |
Schedule of valuation methodology | Weighted Average Inputs For the Years Ended December 31, 2020 2019 Exercise price $ — $ 6.92 Contractual term (years) — 0.05 Volatility (annual) — 83 % Risk-free rate — 2 % Dividend yield (per share) — 0 % |
Schedule of Changes in Level 3 Liabilities Measured at Fair Value | Warrant Liability Balance - January 1, 2019 49,000 Change in fair value of warrant liability (18,000) Balance – December 31, 2019 31,000 Change in fair value of warrant liability (31,000) Balance – December 31, 2020 $ — |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
FAIR VALUE MEASUREMENTS | |
Schedule of financial liabilities measured at fair value on a recurring basis | Fair value measured at December 31, 2020 Quoted prices in active Significant other Significant markets observable inputs unobservable inputs Fair value at (Level 1) (Level 2) (Level 3) December 31, 2020 Warrant liability $ — $ — $ — $ — Fair value measured at December 31, 2019 Quoted prices in active Significant other Significant markets observable inputs unobservable inputs Fair value at (Level 1) (Level 2) (Level 3) December 31, 2019 Warrant liability $ — $ — $ 31,000 $ 31,000 |
WARRANTS (Tables)
WARRANTS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Common stock purchase warrants | |
Schedule of share purchase warrants | Weighted Average Number of Weighted Average Remaining Contractual Total Intrinsic Warrants Exercise Price Life (in years) Value Balance - January 1, 2019 23,016,000 4.78 4.29 $ 26,066,000 Warrants granted 45,000 4.26 — — Exercised for cash (190,000) 3.99 — — Cashless exercise (17,000) 2.38 — — Expired or cancelled (190,000) 13.63 — — Balance - December 31, 2019 22,664,000 4.71 3.33 954,000 Exercised for cash (458,000) 1.20 — — Expired or cancelled (1,376,000) 9.46 — — Balance - December 31, 2020 20,830,000 $ 4.47 2.60 $ — |
STOCK OPTION PLANS (Tables)
STOCK OPTION PLANS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Schedule or Description of Weighted Average Discount Rate | The Black-Scholes option pricing model is used to estimate the fair value of stock options granted under the Company’s share-based compensation plans. The weighted average assumptions used in calculating the fair values of stock options that were granted during the years ended December 31, 2020 and 2019, respectively, were as follows: For the Years Ended December 31, 2020 2019 Exercise price $ 2.08 $ 4.70 Expected term (years) 6.0 6.0 Expected stock price volatility 108 % 126 % Risk-free rate of interest 1 % 2 % Expected dividend rate 0 % 0 % |
Schedule of stock-based compensation expenses | The following table sets forth stock-based compensation expenses recorded during the respective periods: For the Years Ended December 31, 2020 2019 Stock Compensation expenses: Research and development $ 2,588,000 $ 2,574,000 General and administrative 2,640,000 2,783,000 Total stock compensation expenses $ 5,228,000 $ 5,357,000 |
Common stock options | |
Schedule of Share-based Compensation, Nonemployee Director Stock Award Plan, Activity | A summary of the Company’s stock option activity is as follows for stock options: Weighted Average Remaining Weighted Average Total Intrinsic Contractual Number of Shares Exercise Price Value Life (in years) Outstanding as of January 1, 2020 4,983,314 $ 7.79 $ 18,000 8.9 Granted 1,531,000 2.08 — 9.2 Canceled (512,500) — — — Outstanding as of December 31, 2020 6,001,814 $ 6.22 $ — 8.3 Options vested and exercisable 2,598,981 $ 7.29 $ — 8.0 |
RELATED PARTY TRANSACTIONS (Tab
RELATED PARTY TRANSACTIONS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
RELATED PARTY TRANSACTIONS | |
Schedule of related party transaction expenses recorded during the respective periods | The following table sets forth related party transaction expenses recorded for the years ended December 31, 2020 and 2019, respectively. For the Years Ended December 31, 2020 2019 Baylor College of Medicine $ 1,818,000 $ 69,000 Bio-Techne Corporation 152,000 51,000 Dr Juan Vera $ — $ 233,000 Total Research and development $ 1,970,000 $ 353,000 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
INCOME TAXES | |
Schedule of Deferred Tax Assets and Liabilities | For the Years Ended December 31, 2020 2019 Deferred Tax Assets Net Operating Loss Carryforward 21,783,000 17,166,000 Stock Compensation 6,775,000 6,538,000 License Agreements 144,000 177,000 Research and Development 733,000 733,000 Charitable Contributions 8,000 9,000 Operating Lease Liability 2,626,000 115,000 32,069,000 24,738,000 Less: Valuation Allowance (29,689,000) (24,632,000) Total Deferred Tax Assets 2,380,000 106,000 Deferred Tax Liabilities Fixed Assets — (106,000) Right-of-Use Assets (2,380,000) — Total Deferred Tax Liabilities (2,380,000) (106,000) Net Deferred Tax Assets/(Liabilities) — — |
Summary Of Expected Tax Expense Benefit Based On Federal Statutory Rates Reconciled With Actual Tax Provision Benefit | For the Years Ended December 31, 2020 2019 Percent of Percent of Amount Pre-Tax Loss Amount Pre-Tax Loss U.S. federal statutory rate (6,028,000) 21.00 % (4,500,000) 21.00 % State taxes, net of federal benefit (118,000) 0.41 % (600,000) 2.80 % Tax rate change 677,000 (2.36) % 665,000 (3.10) % Permanent Differences - Change in fair value of derivative liabilities (7,000) 0.02 % (4,000) 0.02 % - Other permanent differences 182,000 (0.63) % 32,000 (0.15) % Change in valuation allowance 5,057,000 (17.62) % 4,681,000 (21.85) % Deferred true-up 237,000 (0.83) % (274,000) 1.28 % Income tax provision/(benefit) — 0.00 % — 0.00 % |
FINANCIAL CONDITION, GOING CO_2
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS | ||
Cash and cash equivalents | $ 21,352,382 | $ 43,903,949 |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Details) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
SIGNIFICANT ACCOUNTING POLICIES | |
Cash, FDIC Insured Amount | $ 250,000 |
Cash, Uninsured Amount | $ 2,700,000 |
Property, Plant and Equipment, Estimated Useful Lives | the straight-line method over the estimated useful lives of the related assets, which range from three to five years |
NET LOSS PER SHARE APPLICABLE_3
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS - Computation of loss per Share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Numerator: | ||
Net loss | $ (28,706,070) | $ (21,427,964) |
Denominator: | ||
Weighted average common shares outstanding | 47,039,862 | 45,587,734 |
Net loss per share data: | ||
Basic and diluted | $ (0.61) | $ (0.47) |
NET LOSS PER SHARE APPLICABLE_4
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS - Dilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Potentially dilutive securities | 26,832,000 | 27,647,000 |
Common stock options | ||
Common stock purchase warrants | 6,002,000 | 4,983,000 |
Common stock purchase warrants | ||
Common stock purchase warrants | 20,830,000 | 22,605,000 |
Common stock warrants - liability treatment | ||
Common stock purchase warrants | 0 | 59,000 |
OTHER RECEIVABLE (Details)
OTHER RECEIVABLE (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 |
OTHER RECEIVABLE | ||||
Reimbursements | $ 1,000,000 | |||
Other receivable | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 | $ 0 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | ||
Total | $ 4,162,000 | $ 523,000 |
Less: accumulated depreciation | (591,000) | (105,000) |
Construction in progress | 6,789,098 | 0 |
Property and equipment, net | 10,360,000 | 418,000 |
Lab equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total | $ 2,360,000 | 111,000 |
Estimated Useful Lives | 5 years | |
Computers, equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total | $ 835,000 | 211,000 |
Computers, equipment and software | Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Lives | 3 years | |
Computers, equipment and software | Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Lives | 5 years | |
Office furniture | ||
Property, Plant and Equipment [Line Items] | ||
Total | $ 678,000 | 178,000 |
Estimated Useful Lives | 5 years | |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total | $ 289,000 | $ 23,000 |
PROPERTY AND EQUIPMENT - Additi
PROPERTY AND EQUIPMENT - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |
Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Depreciation | $ 0.5 | $ 0.1 | |
Lease hold improvements | $ 0.3 | ||
Lab equipment | |||
Cost to acquire necessary lab equipment | $ 2.2 | ||
Estimated Useful Lives | 5 years |
LEASES - Quantitative Informati
LEASES - Quantitative Information About Operating Leases (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating lease expense summary: | ||
Operating lease expense | $ 960,000 | $ 220,000 |
Short-term lease expense | 22,000 | 100,000 |
Variable lease expense | 167,000 | 90,000 |
Total | 1,149,000 | 410,000 |
Other information: | ||
Operating cash flows - operating leases | $ 544,000 | $ 225,000 |
Weighted-average remaining lease term - operating leases | 9 years 3 months 18 days | 1 year 7 months 6 days |
Weighted-average discount rate as of adoption date - operating leases | 5.70% | 6.80% |
LEASES - Maturities of Operatin
LEASES - Maturities of Operating Leases (Details) | Dec. 31, 2020USD ($) |
LEASES | |
Year ended December 31, 2021 | $ 1,077,000 |
Year ended December 31, 2022 | 1,278,000 |
Year ended December 31, 2023 | 1,542,000 |
Year ended December 31, 2024 | 1,826,000 |
Year ended December 31, 2025 | 1,874,000 |
Thereafter | 8,772,000 |
Total | 16,369,000 |
Less present value discount | (4,112,000) |
Operating lease liabilities included in the Condensed Consolidated Balance Sheet at December 31, 2020 | $ 12,257,000 |
LEASES - Additional Information
LEASES - Additional Information (Details) | 1 Months Ended | ||||||
Aug. 31, 2020USD ($)Options | Jun. 30, 2020USD ($)Options | Aug. 31, 2021 | Jun. 30, 2021USD ($) | Dec. 31, 2020USD ($) | Apr. 30, 2020USD ($) | Dec. 31, 2019USD ($) | |
Operating lease, liability | $ 12,257,000 | ||||||
Operating lease, right-of-use asset | 10,844,116 | $ 455,174 | |||||
Initial lease term | 10 years | 10 years | 71 months | ||||
Number of renewal options | Options | 2 | 2 | |||||
Fixed lease rent payment | $ 5,600,000 | $ 9,800,000 | $ 1,100,000 | ||||
Receivables of reimbursement for out of pocket buildout costs | $ 1,000,000 | $ 1,000,000 | 1,000,000 | $ 0 | |||
Renewal term | 5 years | 5 years | |||||
Research Facility in Houston, Texas [Member] | |||||||
Operating lease, liability | 800,000 | ||||||
Operating lease, right-of-use asset | 800,000 | ||||||
Manufacturing Facility in Houston, Texas [Member] | |||||||
Operating lease, liability | 7,200,000 | ||||||
Operating lease, right-of-use asset | 5,800,000 | ||||||
Corporate headquarters (Member) | |||||||
Operating lease, liability | 4,100,000 | ||||||
Operating lease, right-of-use asset | 4,000,000 | ||||||
Office space (Member) | |||||||
Operating lease, liability | 200,000 | ||||||
Operating lease, right-of-use asset | $ 200,000 |
ACCOUNTS PAYABLE AND ACCRUED _3
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES | ||
Accounts payable | $ 2,935,000 | $ 993,000 |
Compensation and benefits | 1,694,000 | 323,000 |
Professional fees | 875,000 | 94,000 |
Technology license fees | 105,000 | 105,000 |
Other | 404,000 | 243,000 |
Total accounts payable and accrued liabilities | $ 6,013,010 | $ 1,757,680 |
WARRANT LIABILITY - Valuation M
WARRANT LIABILITY - Valuation Methodology (Details) - Share Purchase Warrants - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Exercise price | $ 0 | $ 6.92 |
Contractual term (years) | 0 years | 18 days |
Volatility (annual) | 0.00% | 83.00% |
Risk-free rate | 0.00% | 2.00% |
Dividend yield (per share) | 0.00% | 0.00% |
WARRANT LIABILITY - Changes in
WARRANT LIABILITY - Changes in Level 3 Liabilities Measured at Fair Value (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
WARRANT LIABILITY | ||
Balance | $ 31,000 | $ 49,000 |
Change in fair value of warrant liability | (31,000) | (18,000) |
Balance | $ 0 | $ 31,000 |
FAIR VALUE MEASUREMENTS - Finan
FAIR VALUE MEASUREMENTS - Financial Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Transfers between levels 1, 2 or 3 of the fair value hierarchy | $ 0 | $ 0 |
Fair value hedging | ||
Warrant liability | 0 | 31,000 |
Level 1 | Fair value hedging | ||
Warrant liability | 0 | 0 |
Level 2 | Fair value hedging | ||
Warrant liability | 0 | 0 |
Level 3 | Fair value hedging | ||
Warrant liability | $ 0 | $ 31,000 |
STOCKHOLDERS' EQUITY - Addition
STOCKHOLDERS' EQUITY - Additional Information (Details) - USD ($) | Feb. 28, 2020 | Dec. 31, 2020 | Dec. 31, 2019 |
Common Stock Capital Shares Reserved For Future Issuance [Line Items] | |||
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 | |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | |
Common stock shares authorized | 150,000,000 | 150,000,000 | |
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | |
Proceeds from Issuance of Warrants | $ 600,000 | $ 800,000 | |
Proceeds from Issuance of Common Stock | $ 6,186,011 | $ 0 | |
Consulting Arrangement | |||
Common Stock Capital Shares Reserved For Future Issuance [Line Items] | |||
Issuance common stock for cash, Shares | 50,000 | ||
Allocated Share-based Compensation Expense | $ 300,000 | ||
Aspire Capital | |||
Common Stock Capital Shares Reserved For Future Issuance [Line Items] | |||
Aggregate shares of common stock | 30,000,000 | ||
Agreement Term | 30 months | ||
Common shares issued | 300,000 | ||
Issuance common stock for cash, Shares | 4,100,000 | ||
Proceeds from Issuance of Common Stock | $ 6,200,000 | ||
Board Compensation | |||
Common Stock Capital Shares Reserved For Future Issuance [Line Items] | |||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 100,000 | 30,000 | |
Fair value of common stock | $ 200,000 | $ 200,000 | |
Exercise of Stock Warrants | |||
Common Stock Capital Shares Reserved For Future Issuance [Line Items] | |||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 500,000 | ||
Common Stock | |||
Common Stock Capital Shares Reserved For Future Issuance [Line Items] | |||
Issuance common stock for cash, Shares | 4,113,440 |
WARRANTS - Summary of Share Pur
WARRANTS - Summary of Share Purchase Warrants (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
WARRANTS | |||
Number of Warrants, Beginning balance | 22,664,000 | 23,016,000 | |
Number Of Warrants, Warrants granted | 45,000 | ||
Number of Warrants, Exercised for cash | (458,000) | (190,000) | |
Number of Warrants, Cashless exercised | (17,000) | ||
Number of Warrants, Expired or cancelled | (1,376,000) | (190,000) | |
Number of Warrants, Ending balance | 20,830,000 | 22,664,000 | 23,016,000 |
Weighted Average Exercise Price, Beginning Balance | $ 4.71 | $ 4.78 | |
Weighted Average Exercise Price, Warrants granted | $ 4.26 | ||
Weighted Average Exercise Price, Exercised for cash | 1.20 | $ 3.99 | |
Weighted Average Exercise Price, Cashless exercised | 2.38 | ||
Weighted Average Exercise Price, Expired or cancelled | 9.46 | 13.63 | |
Weighted Average Exercise Price, Ending Balance | $ 4.47 | $ 4.71 | $ 4.78 |
Weighted Average Remaining Contractual Life (in years) | 2 years 7 months 6 days | 3 years 3 months 29 days | 4 years 3 months 14 days |
Total Intrinsic Value | $ 954,000 | $ 26,066,000 |
WARRANTS - Additional Informati
WARRANTS - Additional Information (Details) - USD ($) shares in Millions, $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
WARRANTS | ||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 0.5 | 0.2 |
Proceeds from Issuance of Warrants | $ 0.6 | $ 0.8 |
STOCK OPTION PLANS - Stock Opti
STOCK OPTION PLANS - Stock Option Activity (Details) - Common stock options - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Shares Outstanding, Beginning Balance | 4,983,314 | |
Number of Shares, Granted | 1,531,000 | |
Number of Shares, Cancelled | (512,500) | |
Number of Shares Outstanding, Ending Balance | 6,001,814 | 4,983,314 |
Number of Shares, Options vested and exercisable | 2,598,981 | |
Weighted Average Exercise Price per Share Outstanding, Beginning Balance | $ 7.79 | |
Weighted Average Exercise Price per Share, Granted | 2.08 | |
Weighted Average Exercise Price per Share Outstanding, Ending Balance | 6.22 | $ 7.79 |
Weighted Average Exercise Price, Options vested and exercisable | $ 7.29 | |
Total Intrinsic Value Outstanding | $ 18,000 | |
Weighted Average Remaining Contractual Life, Outstanding | 8 years 3 months 18 days | 8 years 10 months 24 days |
Weighted Average Remaining Contractual Life, Options granted | 9 years 2 months 12 days | |
Weighted Average Remaining Contractual Life, Options vested and exercisable | 8 years |
STOCK OPTION PLANS - Weighted A
STOCK OPTION PLANS - Weighted Average Assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
STOCK OPTION PLANS | ||
Exercise price | $ 2.08 | $ 4.70 |
Expected term (years) | 6 years | 6 years |
Expected stock price volatility | 108.00% | 126.00% |
Risk-free rate of interest | 1.00% | 2.00% |
Expected dividend rate | 0.00% | 0.00% |
STOCK OPTION PLANS- Stock-based
STOCK OPTION PLANS- Stock-based compensation expenses (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Total stock compensation expenses | $ 5,228,409 | $ 5,356,972 |
Research and development | ||
Total stock compensation expenses | 2,588,000 | 2,574,000 |
General and administrative | ||
Total stock compensation expenses | $ 2,640,000 | $ 2,783,000 |
STOCK OPTION PLANS - Additional
STOCK OPTION PLANS - Additional Information (Details) - USD ($) shares in Millions, $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
STOCK OPTION PLANS | ||
Expiration period | 10 years | |
Award vesting period | 4 years | 4 years |
Number of shares options available to be issued | 4.7 | |
Compensation cost not yet recognized | $ 10.6 | |
Compensation cost not yet recognized, period for recognition | 2 years 2 months 12 days |
GRANT INCOME - Additional Infor
GRANT INCOME - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Grant received recorded as revenue | $ 466,785 | $ 213,194 |
Accounting Standards Update 2014-09 [Member] | ||
Grant received recorded as revenue | $ 500,000 | $ 200,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2020USD ($) | |
COMMITMENTS AND CONTINGENCIES | |
Loss Contingency, Damages Sought, Value | $ 1 |
Loss Contingency, Damages Sought, Number of Transactions | 2 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
RELATED PARTY TRANSACTIONS | ||
Related party transaction expenses | $ 1,970 | $ 353 |
Baylor College of Medicine | ||
RELATED PARTY TRANSACTIONS | ||
Related party transaction expenses | 1,818 | 69 |
Bio-Techne Corporation | ||
RELATED PARTY TRANSACTIONS | ||
Related party transaction expenses | $ 152 | 51 |
Dr Juan Vera | ||
RELATED PARTY TRANSACTIONS | ||
Related party transaction expenses | $ 233 |
INCOME TAXES - Summary of Effec
INCOME TAXES - Summary of Effects of Temporary Differences that Give Rise to Significant Portions of the Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred Tax Assets | ||
Net Operating Loss Carryforward | $ 21,783,000 | $ 17,166,000 |
Stock Compensation | 6,775,000 | 6,538,000 |
License Agreements | 144,000 | 177,000 |
Research and Development | 733,000 | 733,000 |
Charitable Contributions | 8,000 | 9,000 |
Operating Lease Liability | 2,626,000 | 115,000 |
Deferred Tax Assets | 32,069,000 | 24,738,000 |
Less: Valuation Allowance | (29,689,000) | (24,632,000) |
Total Deferred Tax Assets | 2,380,000 | 106,000 |
Deferred Tax Liabilities | ||
Fixed Assets | (106,000) | |
Right-of-Use Assets | (2,380,000) | |
Total Deferred Tax Liabilities | $ (2,380,000) | $ (106,000) |
INCOME TAXES- Summary of Expect
INCOME TAXES- Summary of Expected Tax Expense (Benefit) Based on the U.S. Federal Statutory Rate is Reconciled with the Actual Tax Provision (Benefit) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
INCOME TAXES | ||
U. S. federal statutory rate | $ (6,028,000) | $ (4,500,000) |
State taxes, net of federal benefit | (118,000) | (600,000) |
Tax rate change | $ 677,000 | $ 665,000 |
U. S. federal statutory rate, Percent | 21.00% | 21.00% |
State taxes, net of federal benefit, Percent | 0.41% | 2.80% |
Tax rate change, Percent | (2.36%) | (3.10%) |
Permanent Differences | ||
Permanent differences- Change in fair value of derivative liabilities | $ (7,000) | $ (4,000) |
Permanent differences- Other permanent differences | 182,000 | 32,000 |
Change in valuation allowance | 5,057,000 | 4,681,000 |
Deferred true-up | $ 237,000 | $ (274,000) |
Permanent differences- Change in fair value of derivative liabilities, Percent | 0.02% | 0.02% |
Permanent differences- Other permanent differences, Percent | (0.63%) | (0.15%) |
Change in valuation allowance, Percent | (17.62%) | (21.85%) |
Deferred true-up, Percent | (0.83%) | 1.28% |
Income tax provision (benefit), Percent | 0.00% | 0.00% |
INCOME TAXES - Additional Infor
INCOME TAXES - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax [Line Items] | ||
Tax credit carryforwards expiration period | 2029 | |
Deferred Tax Assets, Tax Credit Carryforwards, Research | $ 733,000 | $ 733,000 |
Tax credit carryforwards expiration year end | 2037 | |
Deferred Tax Assets, Operating Loss Carryforwards, Foreign | $ 97,200,000 | 41,600,000 |
Deferred Tax Assets, Operating Loss Carryforwards, State and Local | $ 39,000,000 | 21,900,000 |
Operating Loss Carryforwards Limitation Percentage | 80.00% | |
Decreased Deferred Tax Assets | $ 5,100,000 | |
Foreign Tax Authority [Member] | ||
Income Tax [Line Items] | ||
Operating Loss Carryforwards | 55,600,000 | |
State and Local Jurisdiction [Member] | ||
Income Tax [Line Items] | ||
Operating Loss Carryforwards | $ 17,100,000 |