Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Mar. 01, 2018 | Jun. 30, 2017 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | TG THERAPEUTICS, INC. | ||
Entity Central Index Key | 1,001,316 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 75,579,785 | ||
Entity Public Float | $ 490,249,542 | ||
Trading Symbol | TGTX |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 56,717,847 | $ 25,031,280 |
Short-term investment securities | 27,998,810 | 19,853,860 |
Interest receivable | 108,468 | 83,852 |
Prepaid research and development | 8,055,486 | 5,678,755 |
Other current assets | 436,789 | 216,397 |
Total current assets | 93,317,400 | 50,864,144 |
Restricted cash | 587,291 | 583,208 |
Leasehold interest, net | 2,429,434 | 2,042,281 |
Equipment, net | 248,020 | 328,148 |
Goodwill | 799,391 | 799,391 |
Other assets | 0 | 164,375 |
Total assets | 97,381,536 | 54,781,547 |
Current liabilities: | ||
Accounts payable and accrued expenses | 25,877,218 | 15,267,668 |
Accrued compensation | 1,800,000 | 1,389,516 |
Current portion of deferred revenue | 152,381 | 152,381 |
Notes payable | 127,614 | 68,875 |
Total current liabilities | 27,957,213 | 16,878,440 |
Deferred rent | 1,364,601 | 816,257 |
Deferred revenue, net of current portion | 1,066,667 | 1,219,048 |
Total liabilities | 30,388,481 | 18,913,745 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value per share (10,000,000 shares authorized, none issued and outstanding as of December 31, 2017 and 2016) | 0 | 0 |
Common stock, $0.001 par value per share (150,000,000 shares authorized, 73,181,750 and 56,820,422 shares issued, 73,140,441 and 56,779,113 shares outstanding at December 31, 2017 and 2016, respectively) | 73,182 | 56,820 |
Additional paid-in capital | 422,017,042 | 272,432,139 |
Treasury stock, at cost, 41,309 shares at December 31, 2016 and 2015 | (234,337) | (234,337) |
Accumulated deficit | (354,862,832) | (236,386,820) |
Total stockholders' equity | 66,993,055 | 35,867,802 |
Total liabilities and stockholders' equity | $ 97,381,536 | $ 54,781,547 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 73,181,750 | 56,820,423 |
Common stock, shares outstanding | 73,140,441 | 56,779,114 |
Treasury stock, shares | 41,309 | 41,309 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Statement [Abstract] | |||
License revenue | $ 152,381 | $ 152,381 | $ 152,381 |
Research and development: | |||
Noncash compensation | 5,646,716 | 2,742,354 | 4,261,406 |
Other research and development | 96,886,134 | 66,489,820 | 43,445,817 |
Total research and development | 102,532,850 | 69,232,174 | 47,707,223 |
General and administrative: | |||
Noncash compensation | 10,298,568 | 4,767,645 | 11,435,686 |
Other general and administrative | 6,032,714 | 5,121,690 | 4,189,488 |
Total general and administrative | 16,331,282 | 9,889,335 | 15,625,174 |
Total costs and expenses | 118,864,132 | 79,121,509 | 63,332,397 |
Operating loss | (118,711,751) | (78,969,128) | (63,180,016) |
Other (income) expense: | |||
Interest income | (294,478) | (323,032) | (174,653) |
Other (income) expense | 58,739 | (393,202) | (56,717) |
Total other income, net | (235,739) | (716,234) | (231,370) |
Net loss | $ (118,476,012) | $ (78,252,894) | $ (62,948,646) |
Basic and diluted net loss per common share (in dollars per share) | $ (1.91) | $ (1.60) | $ (1.38) |
Weighted average shares used in computing basic and diluted net loss per common share (in shares) | 62,069,570 | 49,041,354 | 45,646,414 |
Consolidated Statements of Equi
Consolidated Statements of Equity - USD ($) | Common Stock [Member] | Contingently Issuable Share [Member] | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2014 | $ 44,974 | $ 175,476,521 | $ (234,337) | $ (95,185,280) | $ 80,101,884 | |
Balance (in shares) at Dec. 31, 2014 | 44,974,248 | 6 | 41,309 | |||
Issuance of common stock in connection with exercise of warrants | $ 2,946 | 1,064,393 | 1,067,339 | |||
Issuance of common stock in connection with exercise of warrants (in shares) | 2,946,703 | |||||
Issuance of common stock in connection with cashless exercise of warrants | $ 3 | (3) | 0 | |||
Issuance of common stock in connection with cashless exercise of warrants (in shares) | 2,915 | |||||
Issuance of common stock in connection with conversion of notes payable | $ 1 | 6,924 | 6,925 | |||
Issuance of common stock in connection with conversion of notes payable (in shares) | 522 | |||||
Issuance of restricted stock | $ 1,993 | (1,993) | 0 | |||
Issuance of restricted stock (in shares) | 1,992,535 | |||||
Forfeiture of restricted stock | $ (31) | 31 | 0 | |||
Forfeiture of restricted stock (in shares) | (31,166) | |||||
Issuance of common stock to related party for cash (See Note 9) | $ 115 | 749,890 | 750,005 | |||
Issuance of common stock to related party for cash (See Note 9) (in shares) | 114,855 | |||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 15,697,092 | 15,697,092 | ||||
Issuance of common stock in At the Market offering | $ 4,094 | 66,894,609 | 66,898,703 | |||
Issuance of common stock in At the Market offering (in shares) | 4,094,498 | |||||
Net loss | (62,948,646) | (62,948,646) | ||||
Balance at Dec. 31, 2015 | $ 54,095 | 259,887,464 | $ (234,337) | (158,133,926) | 101,573,302 | |
Balance (in shares) at Dec. 31, 2015 | 54,095,110 | 6 | 41,309 | |||
Issuance of common stock in connection with exercise of warrants | $ 273 | 617,969 | 618,242 | |||
Issuance of common stock in connection with exercise of warrants (in shares) | 273,370 | |||||
Issuance of common stock in connection with conversion of notes payable | $ 4 | 33,013 | 33,017 | |||
Issuance of common stock in connection with conversion of notes payable (in shares) | 3,710 | |||||
Issuance of restricted stock | $ 1,925 | (1,925) | 0 | |||
Issuance of restricted stock (in shares) | 1,924,639 | |||||
Forfeiture of restricted stock | $ (47) | 47 | 0 | |||
Forfeiture of restricted stock (in shares) | (46,773) | |||||
Issuance of common stock in At-the-Market offering (net of offering costs) | $ 570 | 4,385,566 | 4,386,136 | |||
Issuance of common stock in At-the-Market offering (net of offering costs) (in shares) | 570,366 | |||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 7,509,999 | 7,509,999 | ||||
Adjustment to contingently issuable shares | $ (6) | 6 | 0 | |||
Net loss | (78,252,894) | (78,252,894) | ||||
Balance at Dec. 31, 2016 | $ 56,820 | 0 | 272,432,139 | $ (234,337) | (236,386,820) | 35,867,802 |
Balance (in shares) at Dec. 31, 2016 | 56,820,422 | 41,309 | ||||
Issuance of common stock in connection with exercise of warrants | $ 888 | 2,142,197 | 2,143,085 | |||
Issuance of common stock in connection with exercise of warrants (in shares) | 887,585 | |||||
Issuance of restricted stock | $ 1,837 | (1,837) | ||||
Issuance of restricted stock (in shares) | 1,836,511 | |||||
Forfeiture of restricted stock | $ (54) | 54 | ||||
Forfeiture of restricted stock (in shares) | (53,875) | |||||
Issuance of common stock in At-the-Market offering (net of offering costs) | $ 5,897 | 53,634,115 | 53,640,012 | |||
Issuance of common stock in At-the-Market offering (net of offering costs) (in shares) | 5,897,436 | |||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 15,945,284 | 15,945,284 | ||||
Issuance of common stock in At the Market offering | $ 7,794 | 77,865,090 | 77,872,884 | |||
Issuance of common stock in At the Market offering (in shares) | 7,793,671 | |||||
Net loss | (118,476,012) | (118,476,012) | ||||
Balance at Dec. 31, 2017 | $ 73,182 | $ 0 | $ 422,017,042 | $ (234,337) | $ (354,862,832) | $ 66,993,055 |
Balance (in shares) at Dec. 31, 2017 | 73,181,750 | 41,309 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |||
Consolidated net loss | $ (118,476,012) | $ (78,252,894) | $ (62,948,646) |
Adjustments to reconcile consolidated net loss to net cash used in operating activities: | |||
Gain on sale of long-term securities | 0 | (33,042) | 0 |
Noncash stock compensation expense | 15,945,284 | 7,509,999 | 15,697,092 |
Depreciation | 82,355 | 62,960 | 15,452 |
Amortization of premium on investment securities | 61,320 | 459,429 | 536,142 |
Change in fair value of notes payable and accrued interest | 58,739 | (109,657) | (56,717) |
Changes in assets and liabilities: | |||
Increase in restricted cash | (4,083) | (4,065) | (4,131) |
Decrease (increase) in other current assets | (2,665,222) | 3,564,316 | (3,105,771) |
Decrease (increase) in leasehold interest | 124,947 | (2,042,281) | 0 |
(Increase) decrease in accrued interest receivable | (24,616) | 102,169 | (100,505) |
Decrease (increase) in other assets | 161,730 | (4,784) | (41,722) |
Increase (decrease) in accounts payable and accrued expenses | 11,020,034 | 6,492,644 | 5,470,915 |
Increase in deferred rent | 104,343 | 816,257 | 0 |
Decrease in deferred revenue | (152,381) | (152,381) | (152,381) |
Net cash used in operating activities | (93,763,562) | (61,591,330) | (44,690,272) |
CASH FLOWS FROM INVESTING ACTIVITIES | |||
Purchases of equipment | (2,227) | (343,985) | (42,217) |
Investment in held-to-maturity securities | (28,006,270) | (15,199,922) | (48,993,652) |
Proceeds from maturity of short-term securities | 19,800,000 | 29,500,000 | 24,350,000 |
Proceeds from the sale of long-term securities | 0 | 12,589,219 | 0 |
Net cash provided by (used in) investing activities | (8,208,497) | 26,545,312 | (24,685,869) |
CASH FLOWS FROM FINANCING ACTIVITIES | |||
Proceeds from the exercise of warrants | 2,143,085 | 618,242 | 1,067,339 |
Proceeds from sale of common stock, net | 131,515,541 | 4,411,233 | 67,760,517 |
Deferred financing costs paid | 0 | (13,506) | (104,170) |
Net cash provided by financing activities | 133,658,626 | 5,015,969 | 68,723,686 |
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | 31,686,567 | (30,030,049) | (652,455) |
Cash and cash equivalents at beginning of year | 25,031,280 | 55,061,329 | 55,713,784 |
CASH AND CASH EQUIVALENTS AT END OF YEAR | 56,717,847 | 25,031,280 | 55,061,329 |
NONCASH TRANSACTIONS | |||
Reclassification of deferred financing costs to additional paid-in capital | (2,645) | (25,097) | (111,810) |
Conversion of convertible notes payable to common stock | $ 0 | $ 33,017 | $ 6,924 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | DESCRIPTION OF BUSINESS We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, we are developing two therapies targeting hematologic malignancies. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a unique epitope on the CD20 antigen found on mature B-lymphocytes. We are also developing TGR-1202 (umbralisib), an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-lymphocytes. Both TG-1101 and TGR-1202, or the combination of which is referred to as "U2," are in Phase 3 clinical development for patients with hematologic malignancies, with TG-1101 also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought its anti-PD-L1 monoclonal antibody into Phase 1 development and aims to bring additional pipeline assets into the clinic in the future. We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities. To date, we have not received approval for the sale of any of our drug candidates in any market and, therefore, have not generated any product sales from our drug candidates. LIQUIDITY AND CAPITAL RESOURCES We have incurred operating losses since our inception, and expect to continue to incur operating losses for the foreseeable future and may never become profitable. As of December 31, 2017, we have an accumulated deficit of $354.9 million. Our major sources of cash have been proceeds from the private placement and public offering of equity securities. We have not yet commercialized any of our drug candidates and cannot be sure if we will ever be able to do so. Even if we commercialize one or more of our drug candidates, we may not become profitable. Our ability to achieve profitability depends on many factors, including our ability to obtain regulatory approval for our drug candidates; successfully complete any post-approval regulatory obligations; and successfully commercialize our drug candidates alone or in partnership. We may continue to incur substantial operating losses even if we begin to generate revenues from our drug candidates. As of December 31, 2017, we had $84.8 million in cash and cash equivalents, investment securities, and interest receivable. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of December 31, 2017 combined with the additional capital raised in the first quarter of 2018 (see Note 13) will be sufficient to fund the Company’s planned operations into the second quarter of 2019. The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for our drug candidates. We are dependent upon significant future financing to provide the cash necessary to execute our current operations, including the commercialization of any of our drug candidates. Our common stock is quoted on the Nasdaq Capital Market and trades under the symbol “TGTX.” RECENTLY ISSUED ACCOUNTING STANDARDS In May 2017, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update (“ASU”) No. 2017-09, “Scope of Modification Accounting” (“ASU 2017-09”). ASU 2017-09 provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. An entity should account for the effects of a modification unless all the following are met: ● The fair value (or calculated value or intrinsic value, if such an alternative measurement method is used) of the modified award is the same as the fair value (or calculated value or intrinsic value, if such an alternative measurement method is used) of the original award immediately before the original award is modified. If the modification does not affect any of the inputs to the valuation technique that the entity uses to value the award, the entity is not required to estimate the value immediately before and after the modification. ● The vesting conditions of the modified award are the same as the vesting conditions of the original award immediately before the original award is modified. ● The classification of the modified award as an equity instrument or a liability instrument is the same as the classification of the original award immediately before the original award is modified. ASU 2017-09 is effective for annual and interim periods beginning on or after December 15, 2017. Early adoption is permitted for public business entities for reporting periods for which financial statements have not yet been issued, and all other entities for reporting periods for which financial statements have not yet been made available for issuance. The amendments should be applied prospectively to an award modified on or after the adoption date. The Company adopted ASU 2017-09 on January 1, 2018. The adoption of ASU 2017-09 did not have a material effect on our consolidated financial statements as of December 31, 2017. In January 2017, the FASB issued ASU No. 2017-04, “Simplifying the Test for Goodwill Impairment” (“ASU 2017-04”). ASU 2017-04 removes the requirement to compare the implied fair value of goodwill with its carrying amount as part of step 2 of the goodwill impairment test. As a result, under ASU 2017-04, an entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount and should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. In addition, ASU 2017-04: ● Clarifies the requirements for excluding and allocating foreign currency translation adjustments to reporting units in connection with an entity’s testing of reporting units for goodwill impairment. ● Clarifies that an entity should consider income tax effects from any tax deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss, if applicable. ● Makes minor changes to the overview and background sections of certain Accounting Standards Codification (“ASC” or “Codification”) subtopics and topics as part of the Board’s initiative to unify and improve those sections throughout the Codification. ASU 2017-04 is effective prospectively for annual and interim periods beginning on or after December 15, 2019, and early adoption is permitted on testing dates after January 1, 2017. The Company does not expect the adoption of ASU 2017-04 to have a material impact on the Company’s condensed consolidated financial statements. In January 2017, the FASB issued ASU No. 2017-01, “FASB Clarifies the Definition of a Business” (“ASU 2017-01”). ASU 2017-01 clarifies the definition of a business in ASC 805. The amendments in ASU 2017-01 are intended to make application of the guidance more consistent and cost-efficient. The amendments in ASU 2017-01: ● Provide a screen to determine when a set of assets and activities is not a business. The screen requires that when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. This screen reduces the number of transactions that need to be further evaluated. ● Provide that if the screen is not met, (1) to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output and (2) remove the evaluation of whether a market participant could replace missing elements. The amendments provide a framework to assist entities in evaluating whether both an input and a substantive process are present. The framework includes two sets of criteria to consider that depend on whether a set has outputs. Although outputs are not required for a set to be a business, outputs generally are a key element of a business; therefore, the Board has developed more stringent criteria for sets without outputs. ● Narrow the definition of the term output so that the term is consistent with how outputs are described in Topic 606. ASU 2017-01 is effective for annual and interim periods beginning after December 15, 2017, with early adoption permitted for transactions that occurred before the issuance date or effective date of the standard if the transactions were not reported in financial statements that have been issued or made available for issuance. The Company adopted ASU 2017-01 on January 1, 2018. The adoption of ASU 2017-01 did not have a material effect on our consolidated financial statements as of December 31, 2017. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which supersedes all existing revenue recognition requirements, including most industry-specific guidance. ASU 2014-09 provides a single set of criteria for revenue recognition among all industries. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the Company expects to receive for those goods or services. ASU 2014-09 includes guidance for determining whether a license transfers to a customer at a point in time or over time based on the nature of the entity’s promise to the customer. To determine whether the entity’s promise is to provide a right to access its intellectual property or a right to use its intellectual property, the entity should consider the nature of the intellectual property to which the customer will have rights. ASU 2014-09 is effective for interim and annual periods beginning after December 15, 2017. The standard allows for two transition methods - full retrospective, in which the standard is applied to each prior reporting period presented, or modified retrospective, in which the cumulative effect of initially applying the standard is recognized at the date of initial adoption. The Company adopted ASU 2014-09 on January 1, 2018, using the modified retrospective approach. The adoption of ASU 2014-09 did not have a material effect on our consolidated financial statements as of December 31, 2017. Other pronouncements issued by the FASB or other authoritative accounting standards with future effective dates are either not applicable or not significant to our condensed consolidated financial statements. USE OF ESTIMATES The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the applicable reporting period. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation. Actual results could differ from those estimates. Such differences could be material to the financial statements. CASH AND CASH EQUIVALENTS We treat liquid investments with original maturities of less than three months when purchased as cash and cash equivalents. RESTRICTED CASH We record cash pledged or held in trust as restricted cash. As of December 31, 2017, we have approximately $0.6 million of restricted cash pledged to secure a line of credit as a security deposit for an Office Agreement (see Note 9). INVESTMENT SECURITIES Investment securities at both December 31, 2017 and 2016 consist of short-term government securities. We classify these securities as held-to-maturity. Held-to-maturity securities are those securities in which we have the ability and intent to hold the security until maturity. Held-to-maturity securities are recorded at amortized cost, adjusted for the amortization or accretion of premiums or discounts. Premiums and discounts are amortized or accreted over the life of the related held-to-maturity security as an adjustment to yield using the effective interest method. A decline in the market value of any investment security below cost, that is deemed to be other than temporary, results in a reduction in the carrying amount to fair value. The impairment is charged to operations and a new cost basis for the security is established. Other-than-temporary impairment charges are included in interest and other income (expense), net. Unrealized gains, if determined to be temporary, are included in accumulated other comprehensive income in equity. Dividend and interest income are recognized when earned. CREDIT RISK Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents with high-credit quality financial institutions. At times, such amounts may exceed federally-insured limits. REVENUE RECOGNITION We recognize license revenue in accordance with the revenue recognition guidance of the FASB Accounting Standards Codification, or Codification. We analyze each element of our licensing agreement to determine the appropriate revenue recognition. The terms of the license agreement may include payments to us of non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. We recognize revenue from upfront payments over the period of significant involvement under the related agreements unless the fee is in exchange for products delivered or services rendered that represent the culmination of a separate earnings process and no further performance obligation exists under the contract. We recognize milestone payments as revenue upon the achievement of specified milestones only if (1) the milestone payment is non-refundable, (2) substantive effort is involved in achieving the milestone, (3) the amount of the milestone is reasonable in relation to the effort expended or the risk associated with achievement of the milestone, and (4) the milestone is at risk for both parties. If any of these conditions are not met, we defer the milestone payment and recognize it as revenue over the estimated period of performance under the contract. RESEARCH AND DEVELOPMENT COSTS Generally, research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered or the related services are performed, subject to an assessment of recoverability. We make estimates of costs incurred in relation to external clinical research organizations, or CROs, and clinical site costs. We analyze the progress of clinical trials, including levels of patient enrollment, invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. Significant judgments and estimates must be made and used in determining the accrued balance and expense in any accounting period. We review and accrue CRO expenses and clinical trial study expenses based on work performed and rely upon estimates of those costs applicable to the stage of completion of a study. Accrued CRO costs are subject to revisions as such trials progress to completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. With respect to clinical site costs, the financial terms of these agreements are subject to negotiation and vary from contract to contract. Payments under these contracts may be uneven, and depend on factors such as the achievement of certain events, the successful recruitment of patients, the completion of portions of the clinical trial or similar conditions. The objective of our policy is to match the recording of expenses in our financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical site costs are recognized based on our estimate of the degree of completion of the event or events specified in the specific clinical study or trial contract. Prepaid research and development in our consolidated balance sheets includes, among other things, certain fees related to development and manufacturing services. These development and manufacturing agreements often require payments in advance of services performed or goods received. Accordingly, as of December 31, 2017 and 2016, we recorded approximately $8.1 million and $5.7 million, respectively, in prepaid research and development related to such advance agreements. INCOME TAXES Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. If the likelihood of realizing the deferred tax assets or liability is less than “more likely than not,” a valuation allowance is then created. We, and our subsidiaries, file income tax returns in the U.S. Federal jurisdiction and in various states. We have tax net operating loss carryforwards that are subject to examination for a number of years beyond the year in which they were generated for tax purposes. Since a portion of these net operating loss carryforwards may be utilized in the future, many of these net operating loss carryforwards will remain subject to examination. We recognize interest and penalties related to uncertain income tax positions in income tax expense. Refer to Note 7 for further information for impact of tax reform. STOCK-BASED COMPENSATION We recognize all share-based payments to employees and non-employee directors (as compensation for service) as noncash compensation expense in the consolidated financial statements based on the fair values of such payments. Stock-based compensation expense recognized each period is based on the value of the portion of share-based payment awards that is ultimately expected to vest during the period. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. For share-based payments to consultants and other third-parties (including related parties), noncash compensation expense is determined at the “measurement date.” The expense is recognized over the vesting period of the award. Until the measurement date is reached, the total amount of compensation expense remains uncertain. We record compensation expense based on the fair value of the award at the reporting date. The awards to consultants and other third-parties (including related parties) are then revalued, or the total compensation is recalculated based on the then current fair value, at each subsequent reporting date. In addition, because some of the options, restricted stock and warrants issued to employees, consultants and other third-parties vest upon achievement of certain milestones, the total expense is uncertain. Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such milestone becomes probable. BASIC AND DILUTED NET LOSS PER COMMON SHARE Basic net loss per common share is calculated by dividing net loss applicable to common shares by the weighted-average number of common shares outstanding for the period. Diluted net loss per common share is the same as basic net loss per common share, since potentially dilutive securities from stock options, stock warrants and convertible notes would have an antidilutive effect either because the Company incurred a net loss during the period presented or because such potentially dilutive securities were out of the money and the Company realized net income during the period presented. The amounts of potentially dilutive securities excluded from the calculation were 4,835,706, 8,033,779 and 7,064,396 at December 31, 2017, 2016 and 2015, respectively. During the years ended December 31, 2017, 2016 and 2015 the Company incurred a net loss, therefore, all of the securities are antidilutive and excluded from the computation of diluted loss per share. December 31, 2017 2016 2015 Unvested restricted stock 4,820,143 7,142,055 5,859,914 Shares issuable upon note conversion 15,563 14,812 17,733 Warrants -- 876,912 1,186,749 Total 4,835,706 8,033,779 7,064,396 LONG-LIVED ASSETS AND GOODWILL Long-lived assets are reviewed for an impairment loss when circumstances indicate that the carrying value of long-lived tangible and intangible assets with finite lives may not be recoverable. Management’s policy in determining whether an impairment indicator, a triggering event, exists comprises measurable operating performance criteria as well as qualitative measures. If an analysis is necessitated by the occurrence of a triggering event, we make certain assumptions in determining the impairment amount. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized. Goodwill is reviewed for impairment annually, or when events arise that could indicate that an impairment exists. We test for goodwill impairment using a two-step process. The first step compares the fair value of the reporting unit with the unit's carrying value, including goodwill. When the carrying value of the reporting unit is greater than fair value, the unit’s goodwill may be impaired, and the second step must be completed to measure the amount of the goodwill impairment charge, if any. In the second step, the implied fair value of the reporting unit’s goodwill is compared with the carrying amount of the unit’s goodwill. If the carrying amount is greater than the implied fair value, the carrying value of the goodwill must be written down to its implied fair value. We will continue to perform impairment tests annually, at December 31, and whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. |
CASH AND CASH EQUIVALENTS
CASH AND CASH EQUIVALENTS | 12 Months Ended |
Dec. 31, 2017 | |
Cash and Cash Equivalents [Abstract] | |
CASH AND CASH EQUIVALENTS | The following tables summarize our cash and cash equivalents at December 31, 2017 and 2016: December 31, 2017 December 31, 2016 Checking and bank deposits $ 55,681,820 $ 4,052,333 Money market funds 1,036,027 20,978,947 Total $ 56,717,847 $ 25,031,280 |
INVESTMENT SECURITIES
INVESTMENT SECURITIES | 12 Months Ended |
Dec. 31, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
INVESTMENT SECURITIES | Our investments as of December 31, 2017 and 2016 are classified as held-to-maturity. Held-to-maturity investments are recorded at amortized cost. During the year ended December 31, 2016, we liquidated our long-term investment securities with a net carrying amount of approximately $12.6 million, realizing a gain of approximately $33,000 on the sale. The decision to sell our long-term securities was made due to market rate conditions on long-term securities coupled with the recognized gain we were able to yield on the sale of the securities. The following tables summarize our investment securities at December 31, 2017 and 2016: December 31, 2017 Amortized cost, as adjusted Gross unrealized holding gains Gross unrealized holding losses Estimated fair value Short-term investments: Obligations of domestic governmental agencies (maturing between January 2018 and November 2018) (held-to-maturity) $ 27,998,810 $ -- $ 35,235 $ 27,963,575 Total short-term investment securities $ 27,998,810 $ -- $ 35,235 $ 27,963,575 December 31, 2016 Amortized cost, as adjusted Gross unrealized holding gains Gross unrealized holding losses Estimated fair value Short-term investments: Obligations of domestic governmental agencies (maturing between February 2017 and September 2017) (held-to-maturity) $ 19,853,860 $ 3,270 $ 2,492 $ 19,854,638 Total short-term investment securities $ 19,853,860 $ 3,270 $ 2,492 $ 19,854,638 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | We measure certain financial assets and liabilities at fair value on a recurring basis in the financial statements. The fair value hierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires financial assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories: ● Level 1 – quoted prices in active markets for identical assets and liabilities; ● Level 2 – inputs other than Level 1 quoted prices that are directly or indirectly observable; and ● Level 3 – unobservable inputs that are not corroborated by market data. As of December 31, 2017 and 2016, the fair values of cash and cash equivalents, restricted cash, and notes and interest payable approximate their carrying value. At the time of our merger (we were then known as Manhattan Pharmaceuticals, Inc. (“Manhattan”)) with Ariston Pharmaceuticals, Inc. (“Ariston”) in March 2010, Ariston issued $15.5 million of five-year 5% notes payable (the “5% Notes”) in satisfaction of several note payable issuances. The 5% Notes and accrued and unpaid interest thereon are convertible at the option of the holder into common stock at the conversion price of $1,125 per share. Ariston agreed to make quarterly payments on the 5% Notes equal to 50% of the net product cash flow received from the exploitation or commercialization of Ariston’s product candidates, AST-726 and AST-915. We have no obligations under the 5% Notes aside from a) 50% of the net product cash flows from Ariston’s product candidates, if any, payable to noteholders; and b) the conversion feature, discussed above. The cumulative liability including accrued and unpaid interest of the 5% Notes was approximately $17.5 million at December 31, 2017 and $16.7 million at December 31, 2016. No payments have been made on the 5% Notes as of December 31, 2017. In December 2011, we elected the fair value option for valuing the 5% Notes. The fair value option was elected in order to reflect in our financial statements the assumptions that market participants use in evaluating these financial instruments. As of December 31, 2013, as a result of expiring intellectual property rights and other factors, it was determined that net product cash flows from AST-726 were unlikely. As we have no other obligations under the 5% Notes aside from the net product cash flows and the conversion feature, the conversion feature was used to estimate the 5% Notes’ fair value as of December 31, 2017 and 2016. The assumptions, assessments and projections of future revenues are subject to uncertainties, difficult to predict, and require significant judgment. The use of different assumptions, applying different judgment to inherently subjective matters and changes in future market conditions could result in significantly different estimates of fair value and the differences could be material to our consolidated financial statements. The following tables provide the fair value measurements of applicable financial liabilities as of December 31, 2017 and 2016: Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 127,614 $ 127,614 Totals $ -- $ -- $ 127,614 $ 127,614 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 68,875 $ 68,875 Totals $ -- $ -- $ 68,875 $ 68,875 The Level 3 amounts above represent the fair value of the 5% Notes and related accrued interest. The following table summarizes the changes in Level 3 instruments for the years ended December 31, 2016 and 2017: Balance at January 1, 2016 $ 211,549 Interest accrued on face value of 5% Notes 886,084 Conversion of 5% Notes (33,017 ) Change in fair value of Level 3 liabilities (995,741 ) Balance at December 31, 2016 68,875 Interest accrued on face value of 5% Notes 844,797 Conversion of 5% Notes -- Change in fair value of Level 3 liabilities (786,058 ) Balance at December 31, 2017 $ 127,614 The change in the fair value of the Level 3 liabilities is reported in other (income) expense in the accompanying consolidated statements of operations. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2017 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS' EQUITY | Preferred Stock Our amended and restated certificate of incorporation authorizes the issuance of up to 10,000,000 shares of preferred stock, $0.001 par value, with rights senior to those of our common stock, issuable in one or more series. Upon issuance, the Company can determine the rights, preferences, privileges and restrictions thereof. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation of such series, any or all of which may be greater than the rights of common stock. Stockholder Rights Plan On July 18, 2014, we adopted a stockholder rights plan. The stockholder rights plan is embodied in the Stockholder Protection Rights Agreement dated as of July 18, 2014 (the "Rights Agreement"), between us and American Stock Transfer & Trust Company, LLC, as rights agent (the "Rights Agent"). Accordingly, the Board of Directors declared a distribution of one right (a “Right”) for each outstanding share of common stock, to stockholders of record at the close of business on July 28, 2014, for each share of common stock issued (including shares distributed from treasury) by us thereafter and prior to the Separation Time (as defined in the Rights Agreement), and for certain shares of common stock issued after the Separation Time. Following the Separation Time, each Right entitles the registered holder to purchase from us one one-thousandth (1/1,000) of a share of Series A Junior Participating Preferred Stock, par value $0.001 per share (the "Preferred Stock"), at a purchase price of $100.00 (the "Exercise Price"), subject to adjustment. The description and terms of the Rights are set forth in the Rights Agreement. Each one one-thousandth of a share of Preferred Stock has substantially the same rights as one share of common stock. Subject to the terms and conditions of the Rights Agreement, Rights become exercisable ten days after the public announcement that a “Person” has become an “Acquiring Person” (as each such term is defined in the Rights Agreement). Any Rights held by an Acquiring Person are void and may not be exercised. If a Person becomes an Acquiring Person, all holders of Rights, except the Acquiring Person, may purchase at the Right’s then-current exercise price, common stock having a market value equal to twice the exercise price. Moreover, at any time after a Person becomes an Acquiring Person (unless such Person acquires 50 percent or more of our common stock then outstanding, as more fully described in the Rights Agreement), the Board of Directors may exchange all (but not less than all) of the then outstanding Rights (other than rights owned by such Person, which would have become void) for shares of common stock at an exchange ratio of one share of common stock per Right, appropriately adjusted in order to protect the interests of holders of Rights. The Rights Agreement was approved by our Board of Directors on July 18, 2014. The Rights will expire at the close of business on its ten year anniversary, unless earlier exchanged or terminated by us. Common Stock Our amended and restated certificate of incorporation authorizes the issuance of up to 150,000,000 shares of $0.001 par value common stock. On June 21, 2013, we entered into an At-the-Market Issuance Sales Agreement (the "2013 ATM") with MLV & Co. LLC ("MLV") under which we could issue and sell shares of our common stock, having an aggregate offering price of up to $50.0 million, from time to time through MLV, acting as the sales agent. Under the agreement we would pay MLV a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock sold through MLV. During the year ended December 31, 2014, we sold a total of 4,850,055 shares of common stock under the 2013 ATM for aggregate total gross proceeds of approximately $50.0 million at an average selling price of $10.31 per share. Net proceeds were approximately $48.9 million after deducting commissions and other transactions costs. In December 2014, we filed a shelf registration statement on Form S-3 (the "2015 S-3"), which was declared effective in January 2015. Under the 2015 S-3, the Company may sell up to a total of $250 million of its securities. In connection with the 2015 S-3, we amended our 2013 At-the-Market Issuance Sales Agreement with MLV (the "2015 ATM") such that we may issue and sell additional shares of our common stock, having an aggregate offering price of up to $175.0 million, from time to time through MLV and FBR Capital Markets & Co. ("FBR", each of MLV and FBR individually an "Agent" and collectively the "Agents"), acting as the sales agents. Under the 2015 ATM we pay the Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock sold through the Agents. During the year ended December 31, 2017, we sold a total of 3,104,253 shares of common stock under the 2015 ATM for aggregate total gross proceeds of approximately $31.6 million at an average selling price of $10.18 per share, resulting in net proceeds of approximately $31.0 million after deducting commissions and other transaction costs. During the year ended December 31, 2016, we sold a total of 570,366 shares of common stock under the 2015 ATM for aggregate total gross proceeds of approximately $4.5 million at an average selling price of $7.88 per share, resulting in net proceeds of approximately $4.4 million after deducting commissions and other transaction costs. In March 2017, we completed an underwritten public offering of 5,128,206 shares of our common stock (plus a 30-day underwriter overallotment option to purchase up to an additional 769,230 shares of common stock, which was exercised) at a price of $9.75 per share. Net proceeds from this offering, including the overallotment option, were approximately $54 million, net of underwriting discounts and offering expenses of approximately $3.6 million. In May 2017, we filed a shelf registration statement on Form S-3 (the "2017 S-3"), which was declared effective in June 2017, replacing the 2015 S-3. Under the 2017 S-3, the Company may sell up to a total of $300 million of its securities. In connection with the 2017 S-3, we entered into an At-the-Market Issuance Sales Agreement (the "2017 ATM") with Jefferies LLC, Cantor Fitzgerald & Co., FBR Capital Markets & Co., SunTrust Robinson Humphrey, Inc., Raymond James & Associates, Inc., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC (each a "2017 Agent" and collectively, the "2017 Agents"), relating to the sale of shares of our common stock. Under the 2017 ATM we pay the 2017 Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock. During the year ended December 31, 2017, we sold a total of 4,689,418 shares of common stock under the 2017 ATM for aggregate total gross proceeds of approximately $47.7 million at an average selling price of $10.18 per share, resulting in net proceeds of approximately $46.9 million after deducting commissions and other transactions costs. Subsequent to December 31, 2017, we sold an aggregate of 2,889,344 shares of common stock pursuant to the 2017 ATM for total gross proceeds of approximately $35.9 million at an average selling price of $12.42 per share, resulting in net proceeds of approximately $35.3 million after deducting commissions and other transactions costs. The 2017 S-3 is currently our only active shelf registration statement. After deducting shares already sold, there is approximately $252.3 million and $216.4 million of common stock that remains available for sale under the 2017 S-3 at December 31, 2017 and post year-end December 31, 2017, respectively. We may offer the securities under the 2017 S-3 from time to time in response to market conditions or other circumstances if we believe such a plan of financing is in the best interests of our stockholders. We believe that the 2017 S-3 provides us with the flexibility to raise additional capital to finance our operations as needed. Treasury Stock As of December 31, 2017 and 2016, 41,309 shares of common stock are being held in Treasury, at a cost of approximately $234,000, representing the fair market value on the date the shares were surrendered to the Company to satisfy employee tax obligations. Equity Incentive Plans The TG Therapeutics, Inc. Amended and Restated 2012 Incentive Plan (“2012 Incentive Plan”) was approved by stockholders in June 2015. As of December 31, 2017 and 2016, no options were outstanding and up to an additional 504,128 shares may be issued under the 2012 Incentive Plan. Effective as of January 1, 2017, we entered into an amendment (the “Amendment”) to the employment agreement entered into as of December 15, 2011 (together with the Amendment, the “Employment Agreement”) with Michael S. Weiss, our Executive Chairman and Chief Executive Officer and President. Under the Amendment, Mr. Weiss will remain as Chief Executive Officer and President, removing the interim status. Simultaneously, we entered into a Strategic Advisory Agreement (the “Advisory Agreement”) with Caribe BioAdvisors, LLC (the “Advisor”) owned by Mr. Weiss to provide the services of Mr. Weiss as Chairman of the Board and as Executive Chairman. As part of the Amendment, Mr. Weiss also agreed to forfeit 3,381,866 restricted shares previously granted under the Employment Agreement that were predominantly subject to time-based vesting over the next three years. Simultaneously, (i) Mr. Weiss was issued 418,371 restricted shares under the Employment Agreement that vest in 2018 and 2019 and (ii) the Advisor was issued 2,960,000 restricted shares under the Advisory Agreement that vested on market capitalization thresholds ranging from $375 million to $750 million. In accordance with GAAP, there was no incremental stock compensation expense recognition as a result of the modification. Stock Options The following table summarizes stock option activity for the years ended December 31, 2017, 2016 and 2015: Number of shares Weighted- average exercise price Weighted- average contractual term Aggregate intrinsic value (in years) Outstanding at January 1, 2015 194 971.70 3.50 $ -- Granted -- -- Exercised -- -- Forfeited (152 ) 463.32 Expired (42 ) 2,811.53 Outstanding at December 31, 2015 -- -- -- $ -- Granted -- -- Exercised -- -- Forfeited -- -- -- Expired -- -- Outstanding at December 31, 2016 -- -- -- $ -- Granted -- -- Exercised -- -- Forfeited -- -- Expired -- -- Outstanding at December 31, 2017 -- $ -- -- $ -- Exercisable at December 31, 2017 -- $ -- -- $ -- As of December 31, 2017, there are no unvested option awards and no unrecognized compensation cost related to option awards. Restricted Stock Certain employees, directors and consultants have been awarded restricted stock. The restricted stock vesting consists of milestone and time-based vesting. The following table summarizes restricted share activity for the years ended December 31, 2017, 2016 and 2015: Number of Shares Weighted Average Grant Date Fair Value Outstanding at January 1, 2015 6,400,001 5.86 Granted 1,992,535 12.89 Vested (1,001,455 ) 5.04 Forfeited (31,166 ) 16.76 Outstanding at December 31, 2015 7,359,915 7.83 Granted 1,924,639 4.99 Vested (595,726 ) 7.38 Forfeited (46,773 ) 10.34 Outstanding at December 31, 2016 8,642,055 $ 7.20 Granted 1,836,511 6.40 Vested (4,103,048 ) 5.24 Forfeited (53,875 ) 8.47 Outstanding at December 31, 2017 6,321,643 $ 7.17 Total compensation expense associated with restricted stock grants was $15,945,284, $7,509,999 and $15,697,092 during the years ended December 31, 2017, 2016 and 2015, respectively. As of December 31, 2017, there was approximately $14.8 million of total unrecognized compensation expense related to unvested time-based restricted stock, which is expected to be recognized over a weghted-average period of 1.0 year. This amount does not include, as of December 31, 2017, 242,000 shares of restricted stock outstanding which are milestone-based and vest upon certain corporate milestones; and 2,413,917 shares of restricted stock outstanding issued to non-employees. Milestone-based non-cash compensation expense will be measured and recorded if and when a milestone becomes probable. The expense for non-employee shares is determined at the “measurement date.” The expense is recognized over the vesting period of the award. Until the measurement date is reached, the total amount of compensation expense remains uncertain. We record compensation expense based on the fair value of the award at the reporting date. Warrants The following table summarizes warrant activity for the years ended December 31, 2017, 2016 and 2015: Warrants Weighted- average exercise price Aggregate intrinsic value Outstanding at January 1, 2015 4,148,228 0.94 $ 61,792,184 Issued -- -- Exercised (2,950,115 ) 0.36 Expired (11,364 ) 2.25 Outstanding at December 31, 2015 1,186,749 2.37 $ 11,341,452 Issued -- -- Exercised (273,370 ) 2.26 Expired -- 2.25 Outstanding at December 31, 2016 913,379 $ 2.41 $ 1,961,403 Issued -- -- Exercised (887,585 ) 2.41 Expired (25,794 ) -- Outstanding at December 31, 2017 -- $ -- $ -- |
NOTES PAYABLE
NOTES PAYABLE | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
NOTES PAYABLE | The following is a summary of notes payable: December 31, 2017 December 31, 2016 Current portion, net Non-current portion, net Total Current portion, net Non-current portion, net Total Convertible 5% Notes Payable $ 127,614 $ -- $ 127,614 $ 68,875 $ -- $ 68,875 Totals $ 127,614 $ -- $ 127,614 $ 68,875 $ -- $ 68,875 Convertible 5% Notes Payable The 5% Notes and accrued and unpaid interest thereon are convertible at the option of the holder into common stock at the conversion price of $1,125 per share. We have no obligation under the 5% Notes aside from (a) 50% of the net product cash flows from Ariston’s product candidates, if any, payable to noteholders; and (b) the conversion feature, discussed above. The cumulative liability including accrued and unpaid interest of these notes was approximately $17.5 million at December 31, 2017 and $16.7 million at December 31, 2016. No payments have been made on the 5% Notes as of December 31 In December 2011, we elected the fair value option for valuing the 5% Notes. The fair value option was elected in order to reflect in our financial statements the assumptions that market participants use in evaluating these financial instruments (see Note 4 for further details). |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. In determining the need for a valuation allowance, management reviews both positive and negative evidence, including current and historical results of operations, future income projections and the overall prospects of our business. Based upon management's assessment of all available evidence, we believe that it is more-likely-than-not that the deferred tax assets will not be realizable, and therefore, a valuation allowance has been established. The valuation allowance for deferred tax assets was approximately $99,713,000 and $116,172,000 as of December 31, 2017 and 2016, respectively. On December 22, 2017, H.R.1, commonly known as the Tax Cuts and Jobs Act (the “Act”) was signed into law. Among other things, the Act reduces our corporate federal tax rate from 34% to 21% effective January 1, 2018. As a result, we are required to re-measure, through income tax expense, our deferred tax assets and liabilities using the enacted rate at which we expect them to be recovered or settled. The re-measurement of our net deferred tax asset would have resulted in additional income tax expense of $51,767,584; however, with full valuation allowance in place, the expense is reversed through a corresponding adjustment to the valuation allowance, resulting in no impact on income tax expense. As of December 31, 2017, we have U.S. net operating loss carryforwards (“NOLs”) of approximately $375,475,000 and research and development credit carryforwards (“R&D credits”) of approximately $10,491,000. For income tax purposes, these NOLs and R&D credits will expire in various amounts through 2037. The Tax Reform Act of 1986 contains provisions which limit the ability to utilize net operating loss carryforwards and R&D credit carryforwards in the case of certain events including significant changes in ownership interests. The Exchange Transaction with TG Bio may have resulted in a “change in ownership” as defined by IRC Section 382 of the Internal Revenue Code of 1986, as amended. Additionally, stock issuance activities may have resulted in a “change in ownership” as defined by IRC Section 382 of the Internal Revenue Code of 1986, as amended. Accordingly, a substantial portion of the Company’s NOLs above may be subject to annual limitations in reducing any future year’s taxable income, and a substantial portion of the R&D Credit carryforwards may be subject to annual limitations in reducing any future year’s tax. The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2017 and 2016 are presented below. 2017 2016 Deferred tax assets (liabilities): Net operating loss carryforwards $ 83,655,879 $ 95,329,928 Research and development credit 10,490,793 7,326,715 Noncash compensation 4,933,807 12,915,672 Other 632,274 599,514 Deferred tax asset, excluding valuation allowance 99,712,753 116,171,829 Less valuation allowance (99,712,753 ) (116,171,829 ) Net deferred tax assets $ -- $ -- There was no current or deferred income tax expense for the year ended December 31, 2017. Income tax expense differed from amounts computed by applying the US Federal income tax rate of 34% to pretax loss as follows: 2017 2016 2015 Loss before income taxes, as reported in the consolidated statements of operations $ (118,476,012 ) $ (78,252,894 ) $ (62,948,646 ) Computed “expected” tax benefit $ (40,281,844 ) $ (26,605,984 ) $ (21,402,540 ) Increase (decrease) in income taxes resulting from: Expected benefit from state and local taxes (1,105,708 ) (835,072 ) (672,306 ) Research and development credits (3,697,258 ) (2,364,417 ) (1,603,364 ) Other 1,563,114 (7,506 ) 566,310 Impact of change in state tax rates on deferred taxes -- -- 5,836,819 Stock awards 8,213,188 Effects of federal tax reform rate changes 51,767,584 Change in the balance of the valuation allowance for deferred tax assets (16,459,076) 29,812,979 17,275,081 $ -- $ -- $ -- We file income tax returns in the U.S Federal and various state and local jurisdictions. With certain exceptions, the Company is no longer subject to U.S. Federal and state income tax examinations by tax authorities for years prior to 2014. However, NOLs and tax credits generated from those prior years could still be adjusted upon audit. The Company would recognize interest and penalties, if any, to uncertain tax position in income tax expense in the statement of operations. There was no accrual for interest and penalties related to uncertain tax positions for 2017. We do not believe that there will be a material change in our unrecognized tax positions over the next twelve months. All of the unrecognized tax benefits, if recognized, would be offset by the valuation allowance. |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 12 Months Ended |
Dec. 31, 2017 | |
License Agreement [Abstract] | |
LICENSE AGREEMENTS | BET In May 2016, as part of a broader agreement with Jubilant Biosys (“Jubilant”), an India-based biotechnology company, we entered into a sub-license agreement (“JBET Agreement”) with Checkpoint Therapeutics, Inc. (“Checkpoint”) (see Note 9), for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies. Under the terms of the agreement, we paid Checkpoint an up-front licensing fee of $1.0 million and will make additional payments contingent on certain preclinical, clinical, and regulatory milestones, including commercial milestones totaling up to approximately $177 million and a single-digit royalty on net sales. TG will also provide funding to support certain targeted research efforts at Jubilant. Anti-PD-L1 and anti-GITR On March 3, 2015, we entered into a Global Collaboration Agreement (the “Collaboration”) with Checkpoint, a subsidiary of Fortress Biotech, Inc. (“FBIO”), a related party, for the development and commercialization of Checkpoint’s anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies. Checkpoint retains the rights to develop and commercialize these antibodies in solid tumors. Under the terms of the Collaboration, we made an up-front payment of $0.5 million, will make development and sales-based milestone payments up to an aggregate of $164 million, and will pay a tiered single digit royalty on net sales. The royalty term will terminate on a country by country basis upon the later of (i) ten years after the first commercial sale of any applicable licensed product in such country, or (ii) the expiration of the last-to-expire patent held by the Dana Farber Cancer Institute containing a valid claim to any licensed product in such country. Michael Weiss, our Executive Chairman, CEO and President is also the Executive Vice Chairman of FBIO and the Executive Chairman of Checkpoint (see Note 9). TGR-1202 On September 22, 2014, we exercised our option to license the global rights to TGR-1202, thereby entering into an exclusive licensing agreement (the “TGR-1202 License”) with Rhizen Pharmaceuticals, SA (“Rhizen”) for the development and commercialization of TGR-1202. Prior to this, we had been jointly developing TGR-1202 in a 50:50 joint venture with Rhizen. Under the terms of the TGR-1202 License, Rhizen received a $4.0 million cash payment and 371,530 shares of our common stock as an upfront license fee. With respect to TGR-1202, Rhizen will be eligible to receive regulatory filing, approval and sales-based milestone payments in the aggregate of approximately $175 million, a small portion of which will be payable on the first New Drug Application (NDA) filing and the remainder on approval in multiple jurisdictions for up to two oncology indications and one non-oncology indication and attaining certain sales milestones. In addition, if TGR-1202 is co-formulated with another drug to create a new product (a "New Product"), Rhizen will be eligible to receive similar regulatory approval and sales-based milestone payments for such New Product. Additionally, Rhizen will be entitled to tiered royalties on our future net sales of TGR-1202 and any New Product. In lieu of sales milestones and royalties on net sales, Rhizen shall also be eligible to participate in sublicensing revenue, if any, based on a percentage that decreases as a function of the number of patients treated in clinical trials following the exercise of the license option. Rhizen will retain global manufacturing rights to TGR-1202, provided that they are price competitive with alternative manufacturers. IRAK4 On June 23, 2014, we entered into an exclusive licensing agreement with Ligand Pharmaceuticals Incorporated ("Ligand") for the development and commercialization of Ligand's interleukin-1 receptor associated kinase-4 ("IRAK4") inhibitor technology, which currently is in preclinical development for potential use against certain cancers and autoimmune diseases. IRAK4 is a serine/threonine protein kinase that is a key downstream signaling component of the interleukin-1 receptor and multiple toll-like receptors. Under the terms of the license agreement, Ligand received 125,000 shares of our common stock as an upfront license fee. Ligand will also be eligible to receive maximum potential milestone payments of approximately $207 million upon the achievement of specific clinical, regulatory and commercial milestone events. Additionally, Ligand will be entitled to royalties on our future net sales of licensed products containing IRAK4 inhibitors. The basic royalty rate for licensed products covered by Ligand's issued patents will be 6% for annual sales of up to $1 billion and 9.5% for annual sales in excess of that threshold. Additionally, Opus Point Partners, LLC, who identified the opportunity and advised us on the transaction, will also be entitled to receive a 1% royalty for annual sales of up to $1 billion. Michael S. Weiss, our Executive Chairman and Chief Executive Officer, is a Managing Member of Opus Point Partners, LLC. TG-1101 In November 2012, we entered into an exclusive (within the territory) sublicense agreement with Ildong relating to the development and commercialization of TG-1101 in South Korea and Southeast Asia. Under the terms of the sublicense agreement, Ildong has been granted a royalty bearing, exclusive right, including the right to grant sublicenses, to develop and commercialize TG-1101 in South Korea, Taiwan, Singapore, Indonesia, Malaysia, Thailand, Philippines, Vietnam, and Myanmar. An upfront payment of $2.0 million, which was received in December 2012, net of $0.3 million of income tax withholdings December 31 December 31 We may receive up to an additional $5.0 million in payments upon the achievement of pre-specified milestones. In addition, upon commercialization, Ildong will make royalty payments to us on net sales of TG-1101 in the sublicense territory. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | LFB Biotechnologies On January 30, 2012, we entered into an exclusive license agreement with LFB Biotechnologies, GTC Biotherapeutics and LFB/GTC LLC, all wholly-owned subsidiaries of LFB Group, relating to the development of ublituximab (the “LFB License Agreement”). In connection with the LFB License Agreement, LFB Group was issued 5,000,000 shares of common stock, and a warrant to purchase 2,500,000 shares of common stock at a purchase price of $0.001 per share. In addition, on November 9, 2012, we nominated Dr. Yann Echelard to our Board of Directors as LFB Group’s nominee. LFB Group maintains the right to nominate a board member until such time as LFB Group owns less than 10% of the outstanding common stock. In connection with the LFB License Agreement, LFB Group maintained the right to purchase at least $750,000 in additional shares of common stock at a purchase price per share as defined in a November 2012 securities exchange agreement. Accordingly, in February 2015, LFB Group purchased 114,855 shares of our common stock at a price of $6.53 per share for net proceeds of $750,000. In May 2015, LFB Group exercised its warrant to purchase 2,500,000 shares of common stock at a purchase price of $0.001 per share. Under the terms of the LFB License Agreement, we utilize LFB Group for certain development and manufacturing services. We incurred approximately $2.3 million, $8.1 million and $9.3 million in expenses for such services during the years ended December 31 December 31 Other Parties In March 2014, we entered into a shared services agreement (the “Opus Shared Services Agreement”) with Opus Point Partners Management, LLC (“Opus”) in which the parties agreed to share a rented facility and costs for certain other services. Michael S. Weiss, our Executive Chairman and CEO, is a Managing Member of Opus. During the years ended December 31 December 31 In October 2014, we entered into an agreement (the “Office Agreement”) with FBIO to occupy approximately 45% of the 24,000 square feet of New York City office space leased by FBIO, which is now our corporate headquarters. The Office Agreement requires us to pay our respective share of the average annual rent and other costs of the 15-year lease. We approximate an average annual rental obligation of $1.1 million under the Office Agreement. We began to occupy this new space in April 2016, with rental payments beginning in the third quarter of 2016. During the years ended December 31, 2017 and 2016, we recorded rent expense of approximately $1.2 million and $1.4 million, and at December 31, 2017, have deferred rent of approximately $1.4 million . Mr. Weiss, our Executive Chairman and CEO, is also Executive Vice Chairman of FBIO. During the year ended December 31, 2017, we agreed to pay FBIO $2.8 million for our portion of the build-out costs, Also in connection with this lease, in October 2014 we pledged $0.6 million to secure a line of credit as a security deposit for the Office Agreement, which has been recorded as restricted cash in the accompanying consolidated balance sheets. In July 2015, we entered into a Shared Services Agreement (the “Shared Services Agreement”) with FBIO to share the cost of certain services such as facilities use, personnel costs and other overhead and administrative costs. This Shared Services Agreement requires us to pay our respective share of services utilized. In connection with the Shared Services Agreement, we incurred expenses of approximately $1.2 million and $0.8 million for shared services for the years ended December 31, 2017 and 2016, primarily related to shared personnel. In May 2016, as part of a broader agreement with Jubilant, an India-based biotechnology company, we entered into the JBET Agreement with Checkpoint, a subsidiary of FBIO, for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies. We paid Checkpoint an up-front licensing fee of $1.0 million in July 2016 and incurred expenses of $0.2 million in March 2017 for the first milestone achievement as part of the JBET Agreement recorded in other research and development in the accompanying consolidated statement of operations. As of December 31, 2017 and 2016, we had approximately $0.3 million and $0.8 million, respectively, recorded in accounts payable, related mostly to the JBET Agreement. Mr. Weiss is also the Executive Chairman of Checkpoint. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | As of December 31, 2017, we have known contractual obligations, commitments and contingencies of approximately $15.6 million related to our operating lease obligations. Total Less than 1 year 1-3 years 3-5 years More than 5 years Contractual obligations Operating leases $ 15,592,733 $ 1,081,927 $ 2,084,258 $ 2,154,566 $ 10,271,981 Total $ 15,592,733 $ 1,081,927 $ 2,084,258 $ 2,154,566 $ 10,271,981 Leases See Note 9 for a detailed description of our lease arrangement in New York. Total rental expense was approximately $1.4 million, $1.6 million and $0.3 million for the years ended December 31, 2017, 2016 and 2015, respectively. Future minimum lease commitments as of December 31, 2017, in the aggregate total approximately $15.6 million through December 31, 2031. The preceding table shows future minimum lease commitments, which include our office leases in New York, North Carolina and Tennessee, by year as of December 31, 2017. |
QUARTERLY FINANCIAL INFORMATION
QUARTERLY FINANCIAL INFORMATION | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure Text Block [Abstract] | |
QUARTERLY FINANCIAL INFORMATION | 3 Months Ended March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 License revenue $ 38,095 $ 38,095 $ 38,096 $ 38,095 Total costs and expenses 27,704,517 28,463,466 31,623,323 31,072,826 Net loss $ (27,727,509 ) $ (28,353,084 ) $ (31,535,652 ) $ (30,859,767 ) Basic and diluted net loss per common share $ (0.52 ) $ (0.45 ) $ (0.48 ) $ (0.46 ) 3 Months Ended March 31, 2016 June 30, 2016 September 30, 2016 December 31, 2016 License revenue $ 38,095 $ 38,095 $ 38,096 $ 38,095 Total costs and expenses 14,030,251 16,061,538 24,963,567 24,066,153 Net loss $ (13,848,662 ) $ (15,899,062 ) $ (24,831,027 ) $ (23,674,143 ) Basic and diluted net loss per common share $ (0.28 ) $ (0.33 ) $ (0.50 ) $ (0.48 ) |
LITIGATION
LITIGATION | 12 Months Ended |
Dec. 31, 2017 | |
Litigation | |
LITIGATION | On January 6, 2017, a purported securities class action complaint was filed in New York federal court against the Company and certain of its directors, officers or consultants on behalf of all shareholders who purchased or otherwise acquired TG Therapeutics common stock between September 15, 2014 and October 12, 2016 (the “Class Period”). The case was captioned John Lyon v. TG Therapeutics, Michael S. Weiss, Sean A. Power and Robert Niecestro Kenneth C. Wyzgoski v. TG Therapeutics, Michael S. Weiss, Sean A. Power and Robert Niecestro In re TG Therapeutics Securities Litigation |
ORGANIZATION AND SUMMARY OF S19
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Description of Business | We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, we are developing two therapies targeting hematologic malignancies. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a unique epitope on the CD20 antigen found on mature B-lymphocytes. We are also developing TGR-1202 (umbralisib), an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-lymphocytes. Both TG-1101 and TGR-1202, or the combination of which is referred to as "U2," are in Phase 3 clinical development for patients with hematologic malignancies, with TG-1101 also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought its anti-PD-L1 monoclonal antibody into Phase 1 development and aims to bring additional pipeline assets into the clinic in the future. We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities. To date, we have not received approval for the sale of any of our drug candidates in any market and, therefore, have not generated any product sales from our drug candidates. |
Liquidity and Capital Resources | We have incurred operating losses since our inception, and expect to continue to incur operating losses for the foreseeable future and may never become profitable. As of December 31, 2017, we have an accumulated deficit of $354.9 million. Our major sources of cash have been proceeds from the private placement and public offering of equity securities. We have not yet commercialized any of our drug candidates and cannot be sure if we will ever be able to do so. Even if we commercialize one or more of our drug candidates, we may not become profitable. Our ability to achieve profitability depends on many factors, including our ability to obtain regulatory approval for our drug candidates; successfully complete any post-approval regulatory obligations; and successfully commercialize our drug candidates alone or in partnership. We may continue to incur substantial operating losses even if we begin to generate revenues from our drug candidates. As of December 31, 2017, we had $84.8 million in cash and cash equivalents, investment securities, and interest receivable. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of December 31, 2017 combined with the additional capital raised in the first quarter of 2018 (see Note 13) will be sufficient to fund the Company’s planned operations into the second quarter of 2019. The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for our drug candidates. We are dependent upon significant future financing to provide the cash necessary to execute our current operations, including the commercialization of any of our drug candidates. Our common stock is quoted on the Nasdaq Capital Market and trades under the symbol “TGTX.” |
Recently Issued Accounting Standards | In May 2017, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update (“ASU”) No. 2017-09, “Scope of Modification Accounting” (“ASU 2017-09”). ASU 2017-09 provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. An entity should account for the effects of a modification unless all the following are met: ● The fair value (or calculated value or intrinsic value, if such an alternative measurement method is used) of the modified award is the same as the fair value (or calculated value or intrinsic value, if such an alternative measurement method is used) of the original award immediately before the original award is modified. If the modification does not affect any of the inputs to the valuation technique that the entity uses to value the award, the entity is not required to estimate the value immediately before and after the modification. ● The vesting conditions of the modified award are the same as the vesting conditions of the original award immediately before the original award is modified. ● The classification of the modified award as an equity instrument or a liability instrument is the same as the classification of the original award immediately before the original award is modified. ASU 2017-09 is effective for annual and interim periods beginning on or after December 15, 2017. Early adoption is permitted for public business entities for reporting periods for which financial statements have not yet been issued, and all other entities for reporting periods for which financial statements have not yet been made available for issuance. The amendments should be applied prospectively to an award modified on or after the adoption date. The Company adopted ASU 2017-09 on January 1, 2018. The adoption of ASU 2017-09 did not have a material effect on our consolidated financial statements as of December 31, 2017. In January 2017, the FASB issued ASU No. 2017-04, “Simplifying the Test for Goodwill Impairment” (“ASU 2017-04”). ASU 2017-04 removes the requirement to compare the implied fair value of goodwill with its carrying amount as part of step 2 of the goodwill impairment test. As a result, under ASU 2017-04, an entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount and should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. In addition, ASU 2017-04: ● Clarifies the requirements for excluding and allocating foreign currency translation adjustments to reporting units in connection with an entity’s testing of reporting units for goodwill impairment. ● Clarifies that an entity should consider income tax effects from any tax deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss, if applicable. ● Makes minor changes to the overview and background sections of certain Accounting Standards Codification (“ASC” or “Codification”) subtopics and topics as part of the Board’s initiative to unify and improve those sections throughout the Codification. ASU 2017-04 is effective prospectively for annual and interim periods beginning on or after December 15, 2019, and early adoption is permitted on testing dates after January 1, 2017. The Company does not expect the adoption of ASU 2017-04 to have a material impact on the Company’s condensed consolidated financial statements. In January 2017, the FASB issued ASU No. 2017-01, “FASB Clarifies the Definition of a Business” (“ASU 2017-01”). ASU 2017-01 clarifies the definition of a business in ASC 805. The amendments in ASU 2017-01 are intended to make application of the guidance more consistent and cost-efficient. The amendments in ASU 2017-01: ● Provide a screen to determine when a set of assets and activities is not a business. The screen requires that when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. This screen reduces the number of transactions that need to be further evaluated. ● Provide that if the screen is not met, (1) to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output and (2) remove the evaluation of whether a market participant could replace missing elements. The amendments provide a framework to assist entities in evaluating whether both an input and a substantive process are present. The framework includes two sets of criteria to consider that depend on whether a set has outputs. Although outputs are not required for a set to be a business, outputs generally are a key element of a business; therefore, the Board has developed more stringent criteria for sets without outputs. ● Narrow the definition of the term output so that the term is consistent with how outputs are described in Topic 606. ASU 2017-01 is effective for annual and interim periods beginning after December 15, 2017, with early adoption permitted for transactions that occurred before the issuance date or effective date of the standard if the transactions were not reported in financial statements that have been issued or made available for issuance. The Company adopted ASU 2017-01 on January 1, 2018. The adoption of ASU 2017-01 did not have a material effect on our consolidated financial statements as of December 31, 2017. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which supersedes all existing revenue recognition requirements, including most industry-specific guidance. ASU 2014-09 provides a single set of criteria for revenue recognition among all industries. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the Company expects to receive for those goods or services. ASU 2014-09 includes guidance for determining whether a license transfers to a customer at a point in time or over time based on the nature of the entity’s promise to the customer. To determine whether the entity’s promise is to provide a right to access its intellectual property or a right to use its intellectual property, the entity should consider the nature of the intellectual property to which the customer will have rights. ASU 2014-09 is effective for interim and annual periods beginning after December 15, 2017. The standard allows for two transition methods - full retrospective, in which the standard is applied to each prior reporting period presented, or modified retrospective, in which the cumulative effect of initially applying the standard is recognized at the date of initial adoption. The Company adopted ASU 2014-09 on January 1, 2018, using the modified retrospective approach. The adoption of ASU 2014-09 did not have a material effect on our consolidated financial statements as of December 31, 2017. Other pronouncements issued by the FASB or other authoritative accounting standards with future effective dates are either not applicable or not significant to our condensed consolidated financial statements. |
Use of Estimates | The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the applicable reporting period. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation. Actual results could differ from those estimates. Such differences could be material to the financial statements. |
Cash and Cash Equivalents | We treat liquid investments with original maturities of less than three months when purchased as cash and cash equivalents. |
Cash and Cash Equivalents, Restricted Cash and Cash Equivalents | We record cash pledged or held in trust as restricted cash. As of December 31, 2017, we have approximately $0.6 million of restricted cash pledged to secure a line of credit as a security deposit for an Office Agreement (see Note 9). |
Investment Securities | Investment securities at both December 31, 2017 and 2016 consist of short-term government securities. We classify these securities as held-to-maturity. Held-to-maturity securities are those securities in which we have the ability and intent to hold the security until maturity. Held-to-maturity securities are recorded at amortized cost, adjusted for the amortization or accretion of premiums or discounts. Premiums and discounts are amortized or accreted over the life of the related held-to-maturity security as an adjustment to yield using the effective interest method. A decline in the market value of any investment security below cost, that is deemed to be other than temporary, results in a reduction in the carrying amount to fair value. The impairment is charged to operations and a new cost basis for the security is established. Other-than-temporary impairment charges are included in interest and other income (expense), net. Unrealized gains, if determined to be temporary, are included in accumulated other comprehensive income in equity. Dividend and interest income are recognized when earned. |
Credit Risk | Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents with high-credit quality financial institutions. At times, such amounts may exceed federally-insured limits. |
Revenue Recognition | We recognize license revenue in accordance with the revenue recognition guidance of the FASB Accounting Standards Codification, or Codification. We analyze each element of our licensing agreement to determine the appropriate revenue recognition. The terms of the license agreement may include payments to us of non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. We recognize revenue from upfront payments over the period of significant involvement under the related agreements unless the fee is in exchange for products delivered or services rendered that represent the culmination of a separate earnings process and no further performance obligation exists under the contract. We recognize milestone payments as revenue upon the achievement of specified milestones only if (1) the milestone payment is non-refundable, (2) substantive effort is involved in achieving the milestone, (3) the amount of the milestone is reasonable in relation to the effort expended or the risk associated with achievement of the milestone, and (4) the milestone is at risk for both parties. If any of these conditions are not met, we defer the milestone payment and recognize it as revenue over the estimated period of performance under the contract. |
Research and Development Costs | Generally, research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered or the related services are performed, subject to an assessment of recoverability. We make estimates of costs incurred in relation to external clinical research organizations, or CROs, and clinical site costs. We analyze the progress of clinical trials, including levels of patient enrollment, invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. Significant judgments and estimates must be made and used in determining the accrued balance and expense in any accounting period. We review and accrue CRO expenses and clinical trial study expenses based on work performed and rely upon estimates of those costs applicable to the stage of completion of a study. Accrued CRO costs are subject to revisions as such trials progress to completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. With respect to clinical site costs, the financial terms of these agreements are subject to negotiation and vary from contract to contract. Payments under these contracts may be uneven, and depend on factors such as the achievement of certain events, the successful recruitment of patients, the completion of portions of the clinical trial or similar conditions. The objective of our policy is to match the recording of expenses in our financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical site costs are recognized based on our estimate of the degree of completion of the event or events specified in the specific clinical study or trial contract. Prepaid research and development in our consolidated balance sheets includes, among other things, certain fees related to development and manufacturing services. These development and manufacturing agreements often require payments in advance of services performed or goods received. Accordingly, as of December 31, 2017 and 2016, we recorded approximately $8.1 million and $5.7 million, respectively, in prepaid research and development related to such advance agreements. |
Income Taxes | Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. If the likelihood of realizing the deferred tax assets or liability is less than “more likely than not,” a valuation allowance is then created. We, and our subsidiaries, file income tax returns in the U.S. Federal jurisdiction and in various states. We have tax net operating loss carryforwards that are subject to examination for a number of years beyond the year in which they were generated for tax purposes. Since a portion of these net operating loss carryforwards may be utilized in the future, many of these net operating loss carryforwards will remain subject to examination. We recognize interest and penalties related to uncertain income tax positions in income tax expense. Refer to Note 7 for further information for impact of tax reform. |
Stock-Based Compensation | We recognize all share-based payments to employees and non-employee directors (as compensation for service) as noncash compensation expense in the consolidated financial statements based on the fair values of such payments. Stock-based compensation expense recognized each period is based on the value of the portion of share-based payment awards that is ultimately expected to vest during the period. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. For share-based payments to consultants and other third-parties (including related parties), noncash compensation expense is determined at the “measurement date.” The expense is recognized over the vesting period of the award. Until the measurement date is reached, the total amount of compensation expense remains uncertain. We record compensation expense based on the fair value of the award at the reporting date. The awards to consultants and other third-parties (including related parties) are then revalued, or the total compensation is recalculated based on the then current fair value, at each subsequent reporting date. In addition, because some of the options, restricted stock and warrants issued to employees, consultants and other third-parties vest upon achievement of certain milestones, the total expense is uncertain. Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such milestone becomes probable. |
Basic and Diluted Net Loss Per Share Common Share | Basic net loss per common share is calculated by dividing net loss applicable to common shares by the weighted-average number of common shares outstanding for the period. Diluted net loss per common share is the same as basic net loss per common share, since potentially dilutive securities from stock options, stock warrants and convertible notes would have an antidilutive effect either because the Company incurred a net loss during the period presented or because such potentially dilutive securities were out of the money and the Company realized net income during the period presented. The amounts of potentially dilutive securities excluded from the calculation were 4,835,706, 8,033,779 and 7,064,396 at December 31, 2017, 2016 and 2015, respectively. During the years ended December 31, 2017, 2016 and 2015 the Company incurred a net loss, therefore, all of the securities are antidilutive and excluded from the computation of diluted loss per share. December 31, 2017 2016 2015 Unvested restricted stock 4,820,143 7,142,055 5,859,914 Shares issuable upon note conversion 15,563 14,812 17,733 Warrants -- 876,912 1,186,749 Total 4,835,706 8,033,779 7,064,396 |
Long-Lived Assets and Goodwill | Long-lived assets are reviewed for an impairment loss when circumstances indicate that the carrying value of long-lived tangible and intangible assets with finite lives may not be recoverable. Management’s policy in determining whether an impairment indicator, a triggering event, exists comprises measurable operating performance criteria as well as qualitative measures. If an analysis is necessitated by the occurrence of a triggering event, we make certain assumptions in determining the impairment amount. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized. Goodwill is reviewed for impairment annually, or when events arise that could indicate that an impairment exists. We test for goodwill impairment using a two-step process. The first step compares the fair value of the reporting unit with the unit's carrying value, including goodwill. When the carrying value of the reporting unit is greater than fair value, the unit’s goodwill may be impaired, and the second step must be completed to measure the amount of the goodwill impairment charge, if any. In the second step, the implied fair value of the reporting unit’s goodwill is compared with the carrying amount of the unit’s goodwill. If the carrying amount is greater than the implied fair value, the carrying value of the goodwill must be written down to its implied fair value. We will continue to perform impairment tests annually, at December 31, and whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. |
ORGANIZATION AND SUMMARY OF S20
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Organization And Summary Of Significant Accounting Policies Tables | |
Dilutive securities excluded from computation | December 31, 2017 2016 2015 Unvested restricted stock 4,820,143 7,142,055 5,859,914 Shares issuable upon note conversion 15,563 14,812 17,733 Warrants -- 876,912 1,186,749 Total 4,835,706 8,033,779 7,064,396 |
CASH AND CASH EQUIVALENTS (Tabl
CASH AND CASH EQUIVALENTS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash and Cash Equivalents | December 31, 2017 December 31, 2016 Checking and bank deposits $ 55,681,820 $ 4,052,333 Money market funds 1,036,027 20,978,947 Total $ 56,717,847 $ 25,031,280 |
INVESTMENT SECURITIES (Tables)
INVESTMENT SECURITIES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
Held-to-maturity Securities | December 31, 2017 Amortized cost, as adjusted Gross unrealized holding gains Gross unrealized holding losses Estimated fair value Short-term investments: Obligations of domestic governmental agencies (maturing between January 2018 and November 2018) (held-to-maturity) $ 27,998,810 $ -- $ 35,235 $ 27,963,575 Total short-term investment securities $ 27,998,810 $ -- $ 35,235 $ 27,963,575 December 31, 2016 Amortized cost, as adjusted Gross unrealized holding gains Gross unrealized holding losses Estimated fair value Short-term investments: Obligations of domestic governmental agencies (maturing between February 2017 and September 2017) (held-to-maturity) $ 19,853,860 $ 3,270 $ 2,492 $ 19,854,638 Total short-term investment securities $ 19,853,860 $ 3,270 $ 2,492 $ 19,854,638 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value, Liabilities Measured on Recurring and Nonrecurring Basis | Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 127,614 $ 127,614 Totals $ -- $ -- $ 127,614 $ 127,614 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 68,875 $ 68,875 Totals $ -- $ -- $ 68,875 $ 68,875 |
Change In Level Three Fair Value During Period | Balance at January 1, 2016 $ 211,549 Interest accrued on face value of 5% Notes 886,084 Conversion of 5% Notes (33,017 ) Change in fair value of Level 3 liabilities (995,741 ) Balance at December 31, 2016 68,875 Interest accrued on face value of 5% Notes 844,797 Conversion of 5% Notes -- Change in fair value of Level 3 liabilities (786,058 ) Balance at December 31, 2017 $ 127,614 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Share-based Compensation, Stock Options, Activity | Number of shares Weighted- average exercise price Weighted- average contractual term Aggregate intrinsic value (in years) Outstanding at January 1, 2015 194 971.70 3.50 $ -- Granted -- -- Exercised -- -- Forfeited (152 ) 463.32 Expired (42 ) 2,811.53 Outstanding at December 31, 2015 -- -- -- $ -- Granted -- -- Exercised -- -- Forfeited -- -- -- Expired -- -- Outstanding at December 31, 2016 -- -- -- $ -- Granted -- -- Exercised -- -- Forfeited -- -- Expired -- -- Outstanding at December 31, 2017 -- $ -- -- $ -- Exercisable at December 31, 2017 -- $ -- -- $ -- |
Schedule of Nonvested Restricted Stock Units Activity | Number of Shares Weighted Average Grant Date Fair Value Outstanding at January 1, 2015 6,400,001 5.86 Granted 1,992,535 12.89 Vested (1,001,455 ) 5.04 Forfeited (31,166 ) 16.76 Outstanding at December 31, 2015 7,359,915 7.83 Granted 1,924,639 4.99 Vested (595,726 ) 7.38 Forfeited (46,773 ) 10.34 Outstanding at December 31, 2016 8,642,055 $ 7.20 Granted 1,836,511 6.40 Vested (4,103,048 ) 5.24 Forfeited (53,875 ) 8.47 Outstanding at December 31, 2017 6,321,643 $ 7.17 |
Schedule Of Warrants Activity | Warrants Weighted- average exercise price Aggregate intrinsic value Outstanding at January 1, 2015 4,148,228 0.94 $ 61,792,184 Issued -- -- Exercised (2,950,115 ) 0.36 Expired (11,364 ) 2.25 Outstanding at December 31, 2015 1,186,749 2.37 $ 11,341,452 Issued -- -- Exercised (273,370 ) 2.26 Expired -- 2.25 Outstanding at December 31, 2016 913,379 $ 2.41 $ 1,961,403 Issued -- -- Exercised (887,585 ) 2.41 Expired (25,794 ) -- Outstanding at December 31, 2017 -- $ -- $ -- |
NOTES PAYABLE (Tables)
NOTES PAYABLE (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | December 31, 2017 December 31, 2016 Current portion, net Non-current portion, net Total Current portion, net Non-current portion, net Total Convertible 5% Notes Payable $ 127,614 $ -- $ 127,614 $ 68,875 $ -- $ 68,875 Totals $ 127,614 $ -- $ 127,614 $ 68,875 $ -- $ 68,875 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities | 2017 2016 Deferred tax assets (liabilities): Net operating loss carryforwards $ 83,655,879 $ 95,329,928 Research and development credit 10,490,793 7,326,715 Noncash compensation 4,933,807 12,915,672 Other 632,274 599,514 Deferred tax asset, excluding valuation allowance 99,712,753 116,171,829 Less valuation allowance (99,712,753 ) (116,171,829 ) Net deferred tax assets $ -- $ -- |
Schedule of Effective Income Tax Rate Reconciliation | 2017 2016 2015 Loss before income taxes, as reported in the consolidated statements of operations $ (118,476,012 ) $ (78,252,894 ) $ (62,948,646 ) Computed “expected” tax benefit $ (40,281,844 ) $ (26,605,984 ) $ (21,402,540 ) Increase (decrease) in income taxes resulting from: Expected benefit from state and local taxes (1,105,708 ) (835,072 ) (672,306 ) Research and development credits (3,697,258 ) (2,364,417 ) (1,603,364 ) Other 1,563,114 (7,506 ) 566,310 Impact of change in state tax rates on deferred taxes -- -- 5,836,819 Stock awards 8,213,188 Effects of federal tax reform rate changes 51,767,584 Change in the balance of the valuation allowance for deferred tax assets (16,459,076) 29,812,979 17,275,081 $ -- $ -- $ -- |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Loss Contingencies by Contingency | Total Less than 1 year 1-3 years 3-5 years More than 5 years Contractual obligations Operating leases $ 15,592,733 $ 1,081,927 $ 2,084,258 $ 2,154,566 $ 10,271,981 Total $ 15,592,733 $ 1,081,927 $ 2,084,258 $ 2,154,566 $ 10,271,981 |
QUARTERLY FINANCIAL INFORMATI28
QUARTERLY FINANCIAL INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Table Text Block Supplement [Abstract] | |
Schedule of Quarterly Financial Information | 3 Months Ended March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 License revenue $ 38,095 $ 38,095 $ 38,096 $ 38,095 Total costs and expenses 27,704,517 28,463,466 31,623,323 31,072,826 Net loss $ (27,727,509 ) $ (28,353,084 ) $ (31,535,652 ) $ (30,859,767 ) Basic and diluted net loss per common share $ (0.52 ) $ (0.45 ) $ (0.48 ) $ (0.46 ) 3 Months Ended March 31, 2016 June 30, 2016 September 30, 2016 December 31, 2016 License revenue $ 38,095 $ 38,095 $ 38,096 $ 38,095 Total costs and expenses 14,030,251 16,061,538 24,963,567 24,066,153 Net loss $ (13,848,662 ) $ (15,899,062 ) $ (24,831,027 ) $ (23,674,143 ) Basic and diluted net loss per common share $ (0.28 ) $ (0.33 ) $ (0.50 ) $ (0.48 ) |
ORGANIZATION AND SUMMARY OF S29
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Antidilutive securities excluded from computation of diluted loss per share | 4,835,706 | 8,033,779 | 7,064,396 |
Restricted Stock [Member] | |||
Antidilutive securities excluded from computation of diluted loss per share | 4,820,143 | 7,142,055 | 5,859,914 |
Shares Upon Note Conversion [Member] | |||
Antidilutive securities excluded from computation of diluted loss per share | 15,563 | 14,812 | 17,733 |
Warrants [Member] | |||
Antidilutive securities excluded from computation of diluted loss per share | 0 | 876,912 | 1,186,749 |
ORGANIZATION AND SUMMARY OF S30
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Accounting Policies [Abstract] | |||
Accumulated deficit | $ (354,862,832) | $ (236,386,820) | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 4,835,706 | 8,033,779 | 7,064,396 |
Restricted Cash and Investments | $ 600,000 | $ 600,000 | |
Prepaid Manufacturing | $ 8,100,000 | $ 5,700,000 |
CASH AND CASH EQUIVALENTS (Deta
CASH AND CASH EQUIVALENTS (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Cash and Cash Equivalents [Abstract] | ||||
Money market funds | $ 1,036,027 | $ 20,978,947 | ||
Checking and bank deposits | 55,681,820 | 4,052,333 | ||
Total | $ 56,717,847 | $ 25,031,280 | $ 55,061,329 | $ 55,713,784 |
INVESTMENT SECURITIES (Details)
INVESTMENT SECURITIES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Amortized cost, as adjusted | $ 27,998,810 | $ 19,853,860 |
Gross unrealized holding gains | 0 | 3,270 |
Gross unrealized holding losses | 35,235 | 2,492 |
Estimated fair value | 27,963,575 | 19,854,638 |
Short-term Investments [Member] | US Government Agencies Debt Securities [Member] | ||
Amortized cost, as adjusted | 27,998,810 | 19,853,860 |
Gross unrealized holding gains | 0 | 3,270 |
Gross unrealized holding losses | 35,235 | 2,492 |
Estimated fair value | $ 27,963,575 | $ 19,854,638 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
5% Notes | $ 127,614 | $ 68,875 |
Totals | 127,614 | 68,875 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
5% Notes | 0 | 0 |
Totals | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
5% Notes | 0 | 0 |
Totals | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
5% Notes | 127,614 | 68,875 |
Totals | $ 127,614 | $ 68,875 |
FAIR VALUE MEASUREMENTS (Deta34
FAIR VALUE MEASUREMENTS (Details 1) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | ||
Balance at January | $ 68,875 | $ 211,549 |
Interest accrued on face value of 5% Notes | 844,797 | 886,084 |
Conversion of 5% Notes | 0 | (33,017) |
Change in fair value of Level 3 liabilities | (786,058) | (995,741) |
Balance at December | $ 127,614 | $ 68,875 |
FAIR VALUE MEASUREMENTS (Deta35
FAIR VALUE MEASUREMENTS (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |
Mar. 31, 2010 | Dec. 31, 2017 | Dec. 31, 2016 | |
Fair Value Measurement [Line Items] | |||
Cumulative Liability | $ 17,500,000 | $ 16,700,000 | |
Manhattan and Ariston Pharmaceuticals Merger [Member] | |||
Fair Value Measurement [Line Items] | |||
Notes Issued | $ 15,500,000 | ||
Debt Instrument, Convertible, Conversion Price | $ 1,125 | ||
Percentage Of Cash Proceeds From Operation To Repay Convertible Debt | 50.00% | ||
Debt Instrument, Term | 5 years | ||
Debt Instrument, Interest Rate During Period | 5.00% | ||
Convertible Notes Payable [Member] | |||
Fair Value Measurement [Line Items] | |||
Cumulative Liability | $ 17,500,000 | $ 16,700,000 | |
Debt Instrument, Convertible, Conversion Price | $ 1,125 | $ 1,125 | |
Debt Instrument, Interest Rate During Period | 5.00% |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - Employee Stock Option [Member] - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Equity Incentive Plans Stock Option Activity [Line Items] | |||
Number of shares, Outstanding Beginning Balance | 0 | 0 | 194 |
Number of shares, Granted | 0 | 0 | 0 |
Number of shares, Exercised | 0 | 0 | 0 |
Number of shares, Forfeited | 0 | 0 | (152) |
Number of shares, Expired | 0 | 0 | (42) |
Number of shares, Outstanding Ending Balance | 0 | 0 | 0 |
Weighted - average exercise price, Outstanding Beginning Balance | $ 0 | $ 0 | $ 971.7 |
Weighted - average exercise price, Granted | 0 | 0 | 0 |
Weighted - average exercise price, Exercised | 0 | 0 | 0 |
Weighted - average exercise price, Forfeited | 0 | 0 | 463.32 |
Weighted - average exercise price, Expired | 0 | 0 | 2,811.53 |
Weighted - average exercise price, Outstanding Ending Balance | $ 0 | $ 0 | $ 0 |
Weighted - average Contractual Term (in years) | 0 years | 3 years 6 months | |
Weighted - average Contractual Term, Exercisable at December 31, 2017 (in years) | 0 years | 0 years | |
Aggregate Intrinsic Value, Outstanding Ending Balance | $ 0 | $ 0 | $ 0 |
STOCKHOLDERS' EQUITY (Details 1
STOCKHOLDERS' EQUITY (Details 1) - Restricted Stock [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Equity Incentive Plans Restricted Stock Activity [Line Items] | |||
Number of Shares, Outstanding at Begining Balance | 8,642,055 | 7,359,915 | 6,400,001 |
Number of Shares, Granted | 1,836,511 | 1,924,639 | 1,992,535 |
Number of Shares, Vested | (4,103,048) | (595,726) | (1,001,455) |
Number of Shares, Forfeited | (53,875) | (46,773) | (31,166) |
Number of Shares, Outstanding at Ending Balance | 6,321,643 | 8,642,055 | 7,359,915 |
Weighted Average Grant Date Fair Value, Outstanding at Begining Balance | $ 7.20 | $ 7.83 | $ 5.86 |
Weighted Average Grant Date Fair Value, Granted | 6.40 | 4.99 | 12.89 |
Weighted Average Grant Date Fair Value, Vested | 5.24 | 7.38 | 5.04 |
Weighted Average Grant Date Fair Value, Forfeited | 8.47 | 10.34 | 16.76 |
Weighted Average Grant Date Fair Value, Outstanding at Ending Balance | $ 7.17 | $ 7.20 | $ 7.83 |
STOCKHOLDERS' EQUITY (Details 2
STOCKHOLDERS' EQUITY (Details 2) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Statement of Stockholders' Equity [Abstract] | |||
Warrants, Outstanding at Beginning Balance | 913,379 | 1,186,749 | 4,148,228 |
Warrants, Issued | 0 | 0 | 0 |
Warrants, Exercised | (887,585) | (273,370) | (2,950,115) |
Warrants, Expired | (25,794) | 0 | (11,364) |
Warrants, Outstanding at Ending Balance | 0 | 913,379 | 1,186,749 |
Weighted - average exercise price of Warrants, Outstanding at Beginning Balance | $ 2.41 | $ 2.37 | $ 0.94 |
Weighted - average exercise price of Warrants, Issued | 0 | 0 | 0 |
Weighted - average exercise price of Warrants, Exercised | 2.41 | 2.26 | 0.36 |
Weighted - average exercise price of Warrants, Expired | 0 | 2.25 | 2.25 |
Weighted - average exercise price of Warrants, Outstanding at Ending Balance | $ 0 | $ 2.41 | $ 2.37 |
Aggregate Intrinsic Value of Warrants, Outstanding at Beginning Balance | $ 1,961,403 | $ 11,341,452 | $ 61,792,184 |
Aggregate Intrinsic Value of Warrants, Outstanding at Ending Balance | $ 0 | $ 1,961,403 | $ 11,341,452 |
STOCKHOLDERS' EQUITY (Details N
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2013 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Employee Service Share-based Compensation, Nonvested Awards, Total Compensation Cost Not yet Recognized, Period for Recognition | 1 year | |||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Total | $ 14,800,000,000 | $ 18,800,000,000 | ||
Milestone-based restricted stock outstanding | 242,000 | 696,172 | ||
Net Proceeds From Shares New Issues Over-Allotments | $ 131,515,541 | $ 4,411,233 | $ 67,760,517 | |
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 | 150,000,000 | |
Share-based Compensation, Total | $ 15,945,284 | $ 7,509,999 | $ 15,697,092 | |
Treasury Stock, Shares | 41,309 | 41,309 | 41,309 | |
Treasury Stock, Value | $ 234,337 | $ 234,337 | $ 234,337 | |
Available-for-sale Securities, Equity Securities | $ 175,000,000 | |||
Atm [Member] | ||||
Stock Issued During Period, Shares, New Issues | 3,104,253 | 570,366 | 4,850,055 | |
Share Price | $ 10.18 | $ 7.88 | $ 10.31 | |
Stock Issued During Period, Value, New Issues | $ 31,600,000 | $ 4,400,000 | $ 67,000,000 | |
Proceeds From Issuance Of Common Stock | $ 31,000,000 | $ 4,500,000 | $ 68,200,000 | |
Common Stock Value Reserved for Future Issuance | $ 50,000,000 | |||
Commission Percentage | 3.00% | |||
Non Employee Restricted Stock | ||||
Milestone-based restricted stock outstanding | 2,413,917 |
NOTES PAYABLE (Details)
NOTES PAYABLE (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Notes Payable [Line Items] | ||
Notes payable, Current portion, net | $ 127,614 | $ 68,875 |
Notes payable, Non-current portion, net | 0 | 0 |
Total | 127,614 | 68,875 |
Convertible Notes [Member] | ||
Notes Payable [Line Items] | ||
Notes payable, Current portion, net | 127,614 | 68,875 |
Notes payable, Non-current portion, net | 0 | 0 |
Total | $ 127,614 | $ 68,875 |
NOTES PAYABLE (Details Narrativ
NOTES PAYABLE (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Notes Payable [Line Items] | ||
Cumulative Liability | $ 17,500,000 | $ 16,700,000 |
Convertible Notes Payable [Member] | ||
Notes Payable [Line Items] | ||
Debt Instrument, Convertible, Conversion Price | $ 1,125 | $ 1,125 |
Debt Instrument, Interest Rate During Period | 5.00% | |
Cumulative Liability | $ 17,500,000 | $ 16,700,000 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred tax assets (liabilities): | |||
Net operating loss carryforwards | $ 83,655,879 | $ 95,329,928 | |
Research and development credit | 10,490,793 | 7,326,715 | |
Noncash compensation | 4,933,807 | 12,915,672 | |
Other | 632,274 | 599,514 | |
Deferred tax asset, excluding valuation allowance | 99,712,753 | 116,171,829 | |
Less valuation allowance | (99,712,753) | (116,171,829) | $ (86,358,850) |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |||
Loss before income taxes, as reported in the consolidated statements of operations | $ (118,476,012) | $ (78,252,894) | $ (62,948,646) |
Computed "expected" tax benefit | (40,281,844) | (26,605,984) | (21,402,540) |
Increase (decrease) in income taxes resulting from: | |||
Expected benefit from state and local taxes | (1,105,708) | (835,072) | (672,306) |
Research and development credits | (3,697,258) | (2,364,417) | (1,603,364) |
Other | 1,563,114 | (7,506) | 566,310 |
Impact of change in state tax rates on deferred taxes | 0 | 0 | 5,836,819 |
Stock awards | 8,213,188 | 0 | 0 |
Effects of federal tax reform rate changes | 51,767,584 | 0 | 0 |
Change in the balance of the valuation allowance for deferred tax assets | (16,459,076) | 29,812,979 | 17,275,081 |
Income Tax Expense (Benefit) | $ 0 | $ 0 | $ 0 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Deferred Tax Assets And Liabilities [Line Items] | |||
Deferred Tax Assets, Valuation Allowance | $ 99,712,753 | $ 116,171,829 | $ 86,358,850 |
Operating Loss Carryforwards | 375,475,000 | ||
Research and Development Carryforward | $ 10,491,000 | ||
Us Federal Income Tax [Member] | |||
Deferred Tax Assets And Liabilities [Line Items] | |||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 34.00% |
LICENSE AGREEMENTS (Details Nar
LICENSE AGREEMENTS (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Jun. 23, 2014 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2012 | Dec. 31, 2014 | Dec. 31, 2013 | |
License Agreement [Line Items] | |||||||
License revenue | $ 152,381 | $ 152,381 | $ 152,381 | ||||
Deferred Revenue | 1,219,000 | 1,371,000 | 1,524,000 | $ 1,676,000 | $ 1,829,000 | ||
Income taxes | 0 | $ 0 | 0 | ||||
Royalty payment Effective Percentage | 6.00% | ||||||
Other Research and Development Expense | $ 96,886,134 | $ 66,489,820 | $ 43,445,817 | ||||
JBET Agreement [Member] | |||||||
License Agreement [Line Items] | |||||||
Additional Amount Receivable On Achievement Of Pre Specified Milestones | $ 177,000,000 | ||||||
Opus [Member] | |||||||
License Agreement [Line Items] | |||||||
Royalty payment Effective Percentage | 1.00% | ||||||
Licensing Agreements [Member] | |||||||
License Agreement [Line Items] | |||||||
Upfront Fee Received From Sub License | $ 2,000,000 | ||||||
Income taxes | $ 300,000 | ||||||
Licensing Agreements IRAK4[Member] | |||||||
License Agreement [Line Items] | |||||||
Stock Issued During Period, Shares, Issued for Services | 125,000 | ||||||
Maximum Potential Payments Payable | $ 207,000,000 | ||||||
Royalty payment Effective Percentage | 6.00% | ||||||
Maximum sales for royalty expense | $ 1,000,000,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Related Party Transaction [Line Items] | |||
Other research and development | $ 96,886,134 | $ 66,489,820 | $ 43,445,817 |
Prepaid Research And Development | 8,055,486 | 5,678,755 | |
Average Annual Rental Payments | 1,100,000 | ||
Lfb Group [Member] | |||
Related Party Transaction [Line Items] | |||
Other research and development | 2,300,000 | 8,100,000 | |
Accounts Payable | 0 | 400,000 | |
Costs and Expenses, Related Party | 8,100,000 | ||
Prepaid Research And Development | 0 | 1,300,000 | |
Shared Services Agreement [Member] | |||
Related Party Transaction [Line Items] | |||
Costs and Expenses, Related Party | 1,200,000 | 800,000 | |
Opus [Member] | |||
Related Party Transaction [Line Items] | |||
Costs and Expenses, Related Party | 300,000 | ||
JBET Agreement [Member] | |||
Related Party Transaction [Line Items] | |||
Accounts Payable | $ 300,000 | $ 800,000 |
COMMITMENTS AND CONTINGENCIES47
COMMITMENTS AND CONTINGENCIES (Details) | Dec. 31, 2017USD ($) |
Payment due by period, Contractual obligations, Operating leases, Less than 1 year | $ 1,081,927 |
Payment due by period, Contractual obligations, Operating leases, 1-3 years | 2,084,258 |
Payment due by period, Contractual obligations, Operating leases, 3-5 years | 2,154,566 |
Payment due by period, Contractual obligations, Operating leases, More than 5 years | 10,271,981 |
Payment due by period, Contractual obligations, Operating leases, Total | 15,592,733 |
Contractual obligations [Member] | |
Payment due by period, Contractual obligations, Operating leases, Less than 1 year | 1,081,927 |
Payment due by period, Contractual obligations, Operating leases, 1-3 years | 2,084,258 |
Payment due by period, Contractual obligations, Operating leases, 3-5 years | 2,154,566 |
Payment due by period, Contractual obligations, Operating leases, More than 5 years | 10,271,981 |
Payment due by period, Contractual obligations, Operating leases, Total | $ 15,592,733 |
COMMITMENTS AND CONTINGENCIES48
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Operating Leases, Rent Expense, Net, Total | $ 1,400,000 | $ 1,600,000 | $ 300,000 |
Operating Leases, Future Minimum Payments Due, Total | 15,592,733 | ||
Contractual obligations [Member] | |||
Operating Leases, Future Minimum Payments Due, Total | $ 15,592,733 |
QUARTERLY FINANCIAL INFORMATI49
QUARTERLY FINANCIAL INFORMATION (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Table Text Block Supplement [Abstract] | |||||||||||
License revenue | $ 38,095 | $ 38,096 | $ 38,095 | $ 38,095 | $ 38,095 | $ 38,096 | $ 38,095 | $ 38,095 | |||
Total costs and expenses | 31,072,826 | 31,623,323 | 28,463,466 | 27,704,517 | 24,066,153 | 24,963,567 | 16,061,538 | 14,030,251 | $ 118,864,132 | $ 79,121,509 | $ 63,332,397 |
Net loss | $ (30,859,767) | $ (31,535,652) | $ (28,353,084) | $ (27,727,509) | $ (23,674,143) | $ (24,831,027) | $ (15,899,062) | $ (13,848,662) | |||
Basic and diluted net loss per common share | $ (0.46) | $ (0.48) | $ (0.45) | $ (0.52) | $ (0.48) | $ (0.50) | $ (0.33) | $ (0.28) | $ (1.91) | $ (1.60) | $ (1.38) |