Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Nov. 01, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | TG THERAPEUTICS, INC. | |
Entity Central Index Key | 1,001,316 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Trading Symbol | TGTX | |
Entity Common Stock, Shares Outstanding | 70,652,267 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 91,842,167 | $ 25,031,280 |
Short-term investment securities | 0 | 19,853,860 |
Interest receivable | 0 | 83,852 |
Prepaid research and development | 5,022,846 | 5,678,755 |
Other current assets | 796,283 | 216,397 |
Total current assets | 97,661,296 | 50,864,144 |
Restricted cash | 586,259 | 583,208 |
Leasehold interest, net | 2,466,202 | 2,042,281 |
Equipment, net | 268,366 | 328,148 |
Goodwill | 799,391 | 799,391 |
Other assets | 0 | 164,375 |
Total assets | 101,781,514 | 54,781,547 |
Current liabilities: | ||
Accounts payable and accrued expenses | 18,179,772 | 15,267,668 |
Accrued compensation | 1,275,305 | 1,389,516 |
Current portion of deferred revenue | 152,381 | 152,381 |
Notes payable | 182,156 | 68,875 |
Total current liabilities | 19,789,614 | 16,878,440 |
Deferred rent | 1,341,372 | 816,257 |
Deferred revenue, net of current portion | 1,104,762 | 1,219,048 |
Total liabilities | 22,235,748 | 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 September 30, 2017 and December 31, 2016) | 0 | 0 |
Common stock, $0.001 par value per share (150,000,000 shares authorized, 70,693,576 and 56,820,422 shares issued; 70,652,267 and 56,779,113 shares outstanding at September 30, 2017 and December 31, 2016, respectively) | 70,694 | 56,820 |
Additional paid-in capital | 403,712,474 | 272,432,139 |
Treasury stock, at cost, 41,309 shares at September 30, 2017 and December 31, 2016 | (234,337) | (234,337) |
Accumulated deficit | (324,003,065) | (236,386,820) |
Total stockholders’ equity | 79,545,766 | 35,867,802 |
Total liabilities and stockholders’ equity | $ 101,781,514 | $ 54,781,547 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 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 | 70,693,576 | 56,820,422 |
Common stock, shares outstanding | 70,652,267 | 56,779,113 |
Treasury stock, shares | 41,309 | 41,309 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income Statement [Abstract] | ||||
License revenue | $ 38,096 | $ 38,096 | $ 114,286 | $ 114,286 |
Research and development: | ||||
Noncash compensation | 1,814,288 | 919,648 | 5,386,709 | 1,873,730 |
Other research and development | 25,334,762 | 20,878,108 | 71,150,033 | 45,075,097 |
Total research and development | 27,149,050 | 21,797,756 | 76,536,742 | 46,948,827 |
General and administrative: | ||||
Noncash compensation | 3,075,835 | 1,914,390 | 6,988,597 | 4,307,670 |
Other general and administrative | 1,398,438 | 1,251,421 | 4,265,967 | 3,798,859 |
Total general and administrative | 4,474,273 | 3,165,811 | 11,254,564 | 8,106,529 |
Total costs and expenses | 31,623,323 | 24,963,567 | 87,791,306 | 55,055,356 |
Operating loss | (31,585,227) | (24,925,471) | (87,677,020) | (54,941,070) |
Other (income) expense: | ||||
Interest income | (79,163) | (87,965) | (174,056) | (265,456) |
Other | 29,588 | (6,479) | 113,281 | (96,863) |
Total other (income) expense, net | (49,575) | (94,444) | (60,775) | (362,319) |
Net loss | $ (31,535,652) | $ (24,831,027) | $ (87,616,245) | $ (54,578,751) |
Basic and diluted net loss per common share | $ (0.48) | $ (0.50) | $ (1.45) | $ (1.11) |
Weighted average shares used in computing basic and diluted net loss per common share | 65,079,128 | 49,203,277 | 60,552,084 | 48,961,582 |
Condensed Consolidated Stateme5
Condensed Consolidated Statement of Stockholders' Equity - 9 months ended Sep. 30, 2017 - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2016 | $ 56,820 | $ 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 | $ 1,112 | (1,112) | |||
Issuance of restricted stock (in shares) | 1,112,131 | ||||
Forfeiture of restricted stock | $ (27) | 27 | |||
Forfeiture of restricted stock (in shares) | (26,625) | ||||
Issuance of common stock in public offering (net of offering costs of $3.6 million) | $ 5,898 | 53,634,115 | 53,640,013 | ||
Issuance of common stock in public offering (net of offering costs of $3.6 million) (in shares) | 5,897,436 | ||||
Issuance of common stock in At-the-Market offerings (net of offering costs of $1.1 million) | $ 6,003 | 63,129,802 | 63,135,805 | ||
Issuance of common stock in At-the-Market offerings (net of offering costs of $1.1 million) (in shares) | 6,002,627 | ||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 12,375,306 | 12,375,306 | |||
Net loss | (87,616,245) | (87,616,245) | |||
Balance at Sep. 30, 2017 | $ 70,694 | $ 403,712,474 | $ (234,337) | $ (324,003,065) | $ 79,545,766 |
Balance (in shares) at Sep. 30, 2017 | 70,693,576 | 41,309 |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (87,616,245) | $ (54,578,751) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Gain on sale of long-term securities | 0 | (33,042) |
Noncash stock compensation expense | 12,375,306 | 6,181,400 |
Depreciation | 62,009 | 42,464 |
Amortization of premium on investment securities | 53,860 | 367,673 |
Change in fair value of notes payable | 113,281 | (63,822) |
Changes in assets and liabilities: | ||
Increase in restricted cash | (3,051) | (3,041) |
Decrease (increase) in other current assets | 147,826 | (1,162,310) |
Decrease (increase) in leasehold interest | 88,179 | (2,517,771) |
Decrease in accrued interest receivable | 83,852 | 77,563 |
Decrease (increase) in other assets | 161,730 | (3,523) |
Increase in accounts payable and accrued expenses | 2,666,164 | 6,447,215 |
Increase in deferred rent | 72,942 | 793,968 |
Decrease in deferred revenue | (114,286) | (114,286) |
Net cash used in operating activities | (71,908,433) | (44,566,263) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property, plant and equipment | (2,227) | (323,015) |
Investment in held-to-maturity securities | 0 | (15,199,922) |
Proceeds from the sale of long-term securities | 0 | 18,000,000 |
Proceeds from maturity of short-term securities | 19,800,000 | 12,589,219 |
Net cash provided by investing activities | 19,797,773 | 15,066,282 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the exercise of warrants | 2,143,085 | 100,896 |
Proceeds from sale of common stock, net | 116,778,462 | 3,504,261 |
Financing costs | 0 | (9,984) |
Net cash provided by financing activities | 118,921,547 | 3,595,173 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 66,810,887 | (25,904,808) |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 25,031,280 | 55,061,329 |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | 91,842,167 | 29,156,521 |
NONCASH TRANSACTIONS | ||
Reclassification of deferred financing costs to additional paid-in capital | (2,645) | (56,988) |
Conversion of convertible notes payable to common stock | $ 0 | $ 30,601 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 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 specific and 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. The accompanying unaudited condensed consolidated financial statements were prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X of the Exchange Act. Accordingly, they may not include all of the information and footnotes required by GAAP for complete financial statements. All adjustments that are, in the opinion of management, of a normal recurring nature and are necessary for a fair presentation of the condensed consolidated financial statements have been included. Nevertheless, these condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2016. The accompanying condensed December 31, 2016 balance sheet has been derived from these statements. The results of operations for the three and nine months ended September 30, 2017 are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. 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 September 30, 2017, we have an accumulated deficit of approximately $324.0 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 completing any post-approval regulatory obligations; and successfully commercializing 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 September 30, 2017, we had approximately $91.8 million in cash and cash equivalents. The Company believes its cash and cash equivalents on hand as of September 30, 2017 will be sufficient to fund the Company’s planned operations through 2018. 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 execute our current strategic plan, including the commercialization of any of our drug candidates (see Note 5 for further details). Our common stock is listed 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 does not expect the adoption of ASU 2017-09 to have a material impact on the Company’s condensed consolidated financial statements. 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 does not expect the adoption of ASU 2017-01 to have a material impact on the Company’s condensed consolidated financial statements. 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 expects to elect the modified retrospective approach and is continuing to assess the impact of the new guidance on its accounting policies and procedures and is evaluating the new requirements. The Company does not expect the adoption of ASU 2014-09 to have a material impact on the Company’s condensed consolidated financial statements. 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 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. Actual results could differ from those estimates. Such differences could be material to the condensed consolidated financial statements. Cash and Cash Equivalents We treat liquid investments with original maturities of three months or less when purchased as cash and cash equivalents. Restricted Cash We record cash pledged or held in trust as restricted cash. As of September 30, 2017 and December 31, 2016, we have approximately $0.6 million of restricted cash pledged to secure a line of credit as a security deposit for an Office Agreement Investment Securities Investment securities at December 31, 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 would be included in interest and other (income) expense, net. 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 and short-term investments 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 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. Non-refundable 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 liability 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, costs related to agreements with CROs, certain costs to third party service providers related to development and manufacturing services as well as clinical development. These agreements often require payments in advance of services performed or goods received. Accordingly, as of September 30, 2017 and December 31, 2016, we recorded approximately $5.0 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, if any, related to uncertain income tax positions in income tax expense. 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 condensed 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 restricted stock 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 milestones becomes probable. Basic and Diluted Net Loss Per Common Share Basic net loss per share of our common stock is calculated by dividing net loss applicable to the common stock by the weighted-average number of our common stock outstanding for the period. Diluted net loss per share of common stock is the same as basic net loss per share of common stock since potentially dilutive securities from stock options, stock warrants and convertible preferred stock would have an antidilutive effect either because we 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 4,157,052 and 6,664,591 for the three and nine months ended September 30, 2017 and 2016, respectively. The following outstanding shares of common stock equivalents were excluded from the computation of net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive: Three and Nine Months Ended September 30, 2017 2016 Unvested restricted shares 4,141,680 5,507,250 Shares issuable upon note conversion 15,372 1,142,208 Warrants -- 15,133 Total 4,157,052 6,664,591 Long-Lived Assets and Goodwill Long-lived assets are reviewed for potential impairment 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 exists, a triggering event, 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 earlier 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. Rent Expense and Deferred Rent Rent expense and lease incentives, including landlord construction allowances, are recognized on a straight-line basis over the lease term, commencing generally on the date the Company takes possession of the leased property. The Company records lease incentives as deferred rent and recognizes the lease incentives as reductions of rental expense. The unamortized portion of deferred rent is included in deferred rent in the condensed consolidated balance sheets. |
CASH AND CASH EQUIVALENTS
CASH AND CASH EQUIVALENTS | 9 Months Ended |
Sep. 30, 2017 | |
Cash and Cash Equivalents [Abstract] | |
CASH AND CASH EQUIVALENTS | The following tables summarize our cash and cash equivalents at September 30, 2017 and December 31, 2016: September 30, 2017 December 31, 2016 Money market funds $ 29,055,021 $ 20,978,947 Checking and bank deposits 62,787,146 4,052,333 Total $ 91,842,167 $ 25,031,280 |
INVESTMENT SECURITIES
INVESTMENT SECURITIES | 9 Months Ended |
Sep. 30, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
INVESTMENT SECURITIES | Our investments as of December 31, 2016 are classified as held-to-maturity. Held-to-maturity investments are recorded at amortized cost. The following table summarizes our investment securities at 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 | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | We measure certain financial assets and liabilities at fair value on a recurring basis in the condensed consolidated 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 September 30, 2017 and December 31, 2016, the fair values of cash and cash equivalents, restricted cash, accounts payable, and notes and interest payable, current portion 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 $17.3 million at September 30, 2017 and $16.7 million at December 31, 2016. 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 September 30, 2017 and December 31, 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 condensed consolidated financial statements. The following tables provide the fair value measurements of applicable financial liabilities as of September 30, 2017 and December 31, 2016: Financial liabilities at fair value as of September 30, 2017 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 182,156 $ 182,156 Total $ -- $ -- $ 182,156 $ 182,156 Financial liabilities at fair value as of December 31, 2016 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 68,875 $ 68,875 Total $ -- $ -- $ 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 during the nine months ended September 30, 2017: Fair value at December 31, 2016 $ 68,875 Interest accrued on face value of 5% Notes 630,003 Conversion of 5% notes -- Change in fair value of Level 3 liabilities (516,722 ) Fair value at September 30, 2017 $ 182,156 The change in the fair value of the Level 3 liabilities is reported in other (income) expense in the accompanying condensed consolidated statements of operations. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 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, we 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. 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. 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 & Co. LLC (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 & Co. LLC ("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 nine months ended September 30, 2017, we sold a total of 3,104,253 shares of common stock under the 2015 ATM for 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. 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 nine months ended September 30, 2017, we sold a total of 2,898,374 shares of common stock under the 2017 ATM for aggregate total gross proceeds of approximately $32.7 million at an average selling price of $11.30 per share, resulting in net proceeds of approximately $32.2 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 $267.3 million of common stock that remains available for sale under the 2017 S-3. 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. 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 September 30, 2017, no options were outstanding and up to an additional 1,201,258 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. 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 nine months ended September 30, 2017: Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2016 8,642,055 $ 7.20 Granted 1,112,131 6.10 Vested (4,085,881 ) 5.23 Forfeited (26,625 ) 6.72 Outstanding at September 30, 2017 5,641,680 $ 7.06 Total expense associated with restricted stock grants was approximately $4.9 million and $2.8 million during the three months ended September 30, 2017 and 2016, respectively, and $12.4 million, and $6.2 million during the nine months ended September 30, 2017 and 2016, respectively. As of September 30, 2017, there was approximately $14.9 million of total unrecognized compensation cost related to unvested time-based restricted stock, which is expected to be recognized over a weighted-average period of 0.9 years. The unrecognized compensation amount does not include, as of September 30, 2017, 180,000 shares of restricted stock outstanding which are milestone-based and vest upon certain corporate milestones; and 2,289,917 shares of restricted stock outstanding issued to non-employees, the expense for which is determined each reporting period at the measurement date. The expense for non-employee awards 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 nine months ended September 30, 2017: Warrants Weighted-average exercise price Aggregate Intrinsic Value Outstanding at December 31, 2016 913,381 $ 2.41 $ 1,961,403 Issued -- -- Exercised (887,585 ) 2.41 Expired (25,796 ) -- Outstanding at September 30, 2017 -- $ -- $ -- Stock-Based Compensation We did not grant any stock options during the nine months ended September 30, 2017 and 2016. The following table summarizes stock-based compensation expense information about restricted stock for the three and nine months ended September 30, 2017 and 2016: Three months ended September 30, Nine months ended September 30, 2017 2016 2017 2016 Stock-based compensation expense associated with restricted stock $ 4,890,123 $ 2,834,038 $ 12,375,306 $ 6,181,400 Total $ 4,890,123 $ 2,834,038 $ 12,375,306 $ 6,181,400 |
NOTES PAYABLE
NOTES PAYABLE | 9 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
NOTES PAYABLE | The following is a summary of notes payable: September 30, 2017 December 31 2016 Current portion, net Non-current portion, net Total Current portion, net Non-current portion, net Total Convertible 5% Notes Payable $ 182,156 $ - $ 182,156 $ 68,875 $ - $ 68,875 Total $ 182,156 $ - $ 182,156 $ 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. Interest accrues monthly, is added to principal on an annual basis, every March 8, and is payable at maturity, which was March 8, 2015 (see Note 4 for further details). The cumulative liability including accrued and unpaid interest of these notes was approximately $17.3 million at September 30, 2017 and $16.7 million at December 31, 2016. No payments have been made on the 5% Notes as of September 30, 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 (see Note 4 for further details). |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 9 Months Ended |
Sep. 30, 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 8) for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies. Under the terms of the JBET 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. 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 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 | 9 Months Ended |
Sep. 30, 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, 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. Under the terms of the LFB License Agreement, we utilize LFB Group for certain development and manufacturing services. We incurred expenses of $1.8 million and $1.9 million during the three months ended September 30, 2017 and 2016, respectively, and $2.3 million and $4.3 million during the nine months ended September 30, 2017 and 2016, respectively, which have been included in other research and development expenses in the accompanying condensed consolidated statements of operations. As of September 30, 2017 and December 31, 2016, we had approximately $0 and $0.4 million, respectively, recorded in accounts payable related to the LFB License Agreement. In conjunction with the development and manufacturing services discussed above, certain agreements between us and LFB Group require payments in advance of services performed or goods delivered. Accordingly, as of September 30, 2017 and December 31, 2016, we recorded approximately $0 and $1.3 million, respectively, in prepaid research and development for such advance payments. 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 the costs of a rented facility and certain other services. Our Executive Chairman and Chief Executive Officer is a Managing Member of Opus. During the three and nine months ended September 30, 2017, we incurred no expenses related to this agreement, as compared to expenses incurred of approximately $0.02 million and $0.1 million during the three and nine months ended September 30, 2016, respectively. The Opus Shared Services Agreement is no longer in effect as we began occupying new office space in April 2016. In October 2014, we entered into an agreement (the “Office Agreement”) with Fortress Biotech, Inc. (“Fortress”), to occupy approximately 45% of the 24,000 square feet of New York City office space leased by Fortress, 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 nine months ended September 30, 2017, we recorded rent expense of approximately $0.9 million and at September 30, 2017, have deferred rent of approximately $1.3 million. Mr. Weiss is also Executive Vice Chairman of Fortress. Under the Office Agreement, we agreed to pay Fortress our portion of the build out costs, which have been allocated to us at the 45% rate mentioned above. The allocated build-out costs have been recorded in Leasehold Interest and will be amortized over the 15-year term of the Office Agreement. After an initial commitment of the 45% rate for a period of three (3) years, we and Fortress will determine actual office space utilization annually and if our utilization differs from the amount we have been billed, we will either receive credits or be assessed incremental utilization charges. As of September 30, 2017, we had approximately $131,000 recorded in accounts payable related to Fortress of which approximately $30,000 related to rent and build-out costs. In July 2015, we entered into a Shared Services Agreement (the “Shared Services Agreement”) with Fortress 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 approximately $1.0 million and $0.5 million in shared services for the nine months ended September 30, 2017 and 2016, respectively, and expenses of approximately $0.3 million for each of the three months ended September 30, 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 Fortress, 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. As of September 30, 2017 and December 31, 2016, we had approximately $0.2 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. |
LITIGATION
LITIGATION | 9 Months Ended |
Sep. 30, 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 S16
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 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 specific and 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. The accompanying unaudited condensed consolidated financial statements were prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X of the Exchange Act. Accordingly, they may not include all of the information and footnotes required by GAAP for complete financial statements. All adjustments that are, in the opinion of management, of a normal recurring nature and are necessary for a fair presentation of the condensed consolidated financial statements have been included. Nevertheless, these condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2016. The accompanying condensed December 31, 2016 balance sheet has been derived from these statements. The results of operations for the three and nine months ended September 30, 2017 are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. |
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 September 30, 2017, we have an accumulated deficit of approximately $324.0 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 completing any post-approval regulatory obligations; and successfully commercializing 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 September 30, 2017, we had approximately $91.8 million in cash and cash equivalents. The Company believes its cash and cash equivalents on hand as of September 30, 2017 will be sufficient to fund the Company’s planned operations through 2018. 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 execute our current strategic plan, including the commercialization of any of our drug candidates (see Note 5 for further details). Our common stock is listed 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 does not expect the adoption of ASU 2017-09 to have a material impact on the Company’s condensed consolidated financial statements. 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 does not expect the adoption of ASU 2017-01 to have a material impact on the Company’s condensed consolidated financial statements. 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 expects to elect the modified retrospective approach and is continuing to assess the impact of the new guidance on its accounting policies and procedures and is evaluating the new requirements. The Company does not expect the adoption of ASU 2014-09 to have a material impact on the Company’s condensed consolidated financial statements. 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 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. Actual results could differ from those estimates. Such differences could be material to the condensed consolidated financial statements. |
Cash and Cash Equivalents | We treat liquid investments with original maturities of three months or less when purchased as cash and cash equivalents. |
Restricted Cash | We record cash pledged or held in trust as restricted cash. As of September 30, 2017 and December 31, 2016, we have approximately $0.6 million of restricted cash pledged to secure a line of credit as a security deposit for an Office Agreement |
Investment Securities | Investment securities at December 31, 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 would be included in interest and other (income) expense, net. 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 and short-term investments 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 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. Non-refundable 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 liability 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, costs related to agreements with CROs, certain costs to third party service providers related to development and manufacturing services as well as clinical development. These agreements often require payments in advance of services performed or goods received. Accordingly, as of September 30, 2017 and December 31, 2016, we recorded approximately $5.0 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, if any, related to uncertain income tax positions in income tax expense. |
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 condensed 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 restricted stock 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 milestones becomes probable. |
Basic and Diluted Net Loss Per Common Share | Basic net loss per share of our common stock is calculated by dividing net loss applicable to the common stock by the weighted-average number of our common stock outstanding for the period. Diluted net loss per share of common stock is the same as basic net loss per share of common stock since potentially dilutive securities from stock options, stock warrants and convertible preferred stock would have an antidilutive effect either because we 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 4,157,052 and 6,664,591 for the three and nine months ended September 30, 2017 and 2016, respectively. The following outstanding shares of common stock equivalents were excluded from the computation of net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive: Three and Nine Months Ended September 30, 2017 2016 Unvested restricted shares 4,141,680 5,507,250 Shares issuable upon note conversion 15,372 1,142,208 Warrants -- 15,133 Total 4,157,052 6,664,591 |
Long-Lived Assets and Goodwill | Long-lived assets are reviewed for potential impairment 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 exists, a triggering event, 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 earlier 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. |
Rent Expense and Deferred Rent | Rent expense and lease incentives, including landlord construction allowances, are recognized on a straight-line basis over the lease term, commencing generally on the date the Company takes possession of the leased property. The Company records lease incentives as deferred rent and recognizes the lease incentives as reductions of rental expense. The unamortized portion of deferred rent is included in deferred rent in the condensed consolidated balance sheets. |
ORGANIZATION AND SUMMARY OF S17
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Three and Nine Months Ended September 30, 2017 2016 Unvested restricted shares 4,141,680 5,507,250 Shares issuable upon note conversion 15,372 1,142,208 Warrants -- 15,133 Total 4,157,052 6,664,591 |
CASH AND CASH EQUIVALENTS (Tabl
CASH AND CASH EQUIVALENTS (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash and Cash Equivalents | September 30, 2017 December 31, 2016 Money market funds $ 29,055,021 $ 20,978,947 Checking and bank deposits 62,787,146 4,052,333 Total $ 91,842,167 $ 25,031,280 |
INVESTMENT SECURITIES (Tables)
INVESTMENT SECURITIES (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
Held-to-maturity Securities | 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) | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value, Liabilities Measured on Recurring and Nonrecurring Basis | Financial liabilities at fair value as of September 30, 2017 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 182,156 $ 182,156 Total $ -- $ -- $ 182,156 $ 182,156 Financial liabilities at fair value as of December 31, 2016 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 68,875 $ 68,875 Total $ -- $ -- $ 68,875 $ 68,875 |
Change In Level Three Fair Value During Period | Fair value at December 31, 2016 $ 68,875 Interest accrued on face value of 5% Notes 630,003 Conversion of 5% notes -- Change in fair value of Level 3 liabilities (516,722 ) Fair value at September 30, 2017 $ 182,156 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Nonvested Restricted Stock Units Activity | Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2016 8,642,055 $ 7.20 Granted 1,112,131 6.10 Vested (4,085,881 ) 5.23 Forfeited (26,625 ) 6.72 Outstanding at September 30, 2017 5,641,680 $ 7.06 |
Schedule Of Warrants Activity | Warrants Weighted-average exercise price Aggregate Intrinsic Value Outstanding at December 31, 2016 913,381 $ 2.41 $ 1,961,403 Issued -- -- Exercised (887,585 ) 2.41 Expired (25,796 ) -- Outstanding at September 30, 2017 -- $ -- $ -- |
Schedule Of Share Based Compensation Expense | Three months ended September 30, Nine months ended September 30, 2017 2016 2017 2016 Stock-based compensation expense associated with restricted stock $ 4,890,123 $ 2,834,038 $ 12,375,306 $ 6,181,400 Total $ 4,890,123 $ 2,834,038 $ 12,375,306 $ 6,181,400 |
NOTES PAYABLE (Tables)
NOTES PAYABLE (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | September 30, 2017 December 31 2016 Current portion, net Non-current portion, net Total Current portion, net Non-current portion, net Total Convertible 5% Notes Payable $ 182,156 $ - $ 182,156 $ 68,875 $ - $ 68,875 Total $ 182,156 $ - $ 182,156 $ 68,875 $ - $ 68,875 |
ORGANIZATION AND SUMMARY OF S23
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Significant Accounting Policies [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 4,157,052 | 6,664,591 | 4,157,052 | 6,664,591 |
Unvested Restricted Shares [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 4,141,680 | 5,507,250 | 4,141,680 | 5,507,250 |
Share Issuable Upon Note Conversion [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 15,372 | 1,142,208 | 15,372 | 1,142,208 |
Warrant [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 0 | 15,133 | 0 | 15,133 |
ORGANIZATION AND SUMMARY OF S24
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Accounting Policies [Abstract] | |||||
Accumulated deficit | $ (324,003,065) | $ (324,003,065) | $ (236,386,820) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 4,157,052 | 6,664,591 | 4,157,052 | 6,664,591 | |
Cash, Cash Equivalents, and Short-term Investments, Total | $ 91,800,000 | $ 91,800,000 | |||
Restricted Cash and Investments | 600,000 | 600,000 | 600,000 | ||
Prepaid Manufacturing | $ 5,000,000 | $ 5,000,000 | $ 5,700,000 |
CASH AND CASH EQUIVALENTS (Deta
CASH AND CASH EQUIVALENTS (Details) - USD ($) | Sep. 30, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Dec. 31, 2015 |
Cash and Cash Equivalents [Abstract] | ||||
Money market funds | $ 29,055,021 | $ 20,978,947 | ||
Checking and bank deposits | 62,787,146 | 4,052,333 | ||
Total | $ 91,842,167 | $ 25,031,280 | $ 29,156,521 | $ 55,061,329 |
INVESTMENT SECURITIES (Details)
INVESTMENT SECURITIES (Details) | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Schedule of Held-to-maturity Securities [Line Items] | |
Amortized cost, as adjusted | $ 19,853,860 |
Gross unrealized holding gains | 3,270 |
Gross unrealized holding losses | 2,492 |
Estimated fair value | 19,854,638 |
Short-term Investments [Member] | US Government Agencies Debt Securities [Member] | |
Schedule of Held-to-maturity Securities [Line Items] | |
Amortized cost, as adjusted | 19,853,860 |
Gross unrealized holding gains | 3,270 |
Gross unrealized holding losses | 2,492 |
Estimated fair value | $ 19,854,638 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Sep. 30, 2017 | Dec. 31, 2016 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
5% Notes | $ 182,156 | $ 68,875 |
Totals | 182,156 | 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 | 182,156 | 68,875 |
Totals | $ 182,156 | $ 68,875 |
FAIR VALUE MEASUREMENTS (Deta28
FAIR VALUE MEASUREMENTS (Details 1) | 9 Months Ended |
Sep. 30, 2017USD ($) | |
Fair Value Disclosures [Abstract] | |
Fair value at December 31, 2016 | $ 68,875 |
Interest accrued on face value of 5% Notes | 630,003 |
Conversion of 5% notes | 0 |
Change in fair value of Level 3 liabilities | (516,722) |
Fair value at September 30, 2017 | $ 182,156 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - Unvested Restricted Shares [Member] | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Equity Incentive Plans Restricted Stock Activity [Line Items] | |
Number of Shares, Outstanding at Beginning Balance | shares | 8,642,055 |
Number of Shares, Granted | shares | 1,112,131 |
Number of Shares, Vested | shares | (4,085,881) |
Number of Shares, Forfeited | shares | (26,625) |
Number of Shares, Outstanding at Ending Balance | shares | 5,641,680 |
Weighted Average Grant Date Fair Value, Outstanding at Beginning Balance | $ / shares | $ 7.20 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 6.10 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 5.23 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 6.72 |
Weighted Average Grant Date Fair Value, Outstanding at Ending Balance | $ / shares | $ 7.06 |
STOCKHOLDERS' EQUITY (Details 1
STOCKHOLDERS' EQUITY (Details 1) - Warrant [Member] | 9 Months Ended |
Sep. 30, 2017USD ($)$ / sharesshares | |
Equity Incentive Plans Warrant Activity [Line Items] | |
Warrants, Outstanding at Beginning Balance | shares | 913,381 |
Warrants, Issued | shares | 0 |
Warrants, Exercised | shares | (887,585) |
Warrants, Expired | shares | (25,796) |
Warrants, Outstanding at Ending Balance | shares | 0 |
Weighted - average exercise price, Outstanding at Beginning Balance (in dollars per share) | $ / shares | $ 2.41 |
Weighted - average exercise price, Issued (in dollars per share) | $ / shares | 0 |
Weighted - average exercise price, Exercised (in dollars per share) | $ / shares | 2.41 |
Weighted - average exercise price, Expired (in dollars per share) | $ / shares | 0 |
Weighted - average exercise price, Outstanding at Ending Balance (in dollars per share) | $ / shares | $ 0 |
Aggregate Intrinsic Value, Outstanding at Beginning Balance (in dollars) | $ | $ 1,961,403 |
Aggregate Intrinsic Value, Outstanding at Ending Balance (in dollars) | $ | $ 0 |
STOCKHOLDERS' EQUITY (Details 2
STOCKHOLDERS' EQUITY (Details 2) - Unvested Restricted Shares [Member] - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense associated with restricted stock | $ 4,890,123 | $ 2,834,038 | $ 12,375,306 | $ 6,181,400 |
Allocated Share-based Compensation Expense | $ 4,890,123 | $ 2,834,038 | $ 12,375,306 | $ 6,181,400 |
STOCKHOLDERS' EQUITY (Details N
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($) | Mar. 09, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 |
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 | |||
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 | 150,000,000 | |||
Share-based Compensation, Total | $ 12,375,306 | $ 6,181,400 | ||||
Shares issued, public offering | 5,128,206 | |||||
Underwriter option to purchase shares | 769,230 | |||||
Public offering price per share | $ 9.75 | |||||
Proceeds from public offering | $ 54,000,000 | |||||
Underwriting discounts and offering expenses | $ 3,600,000 | |||||
Mr. Weiss | ||||||
Shares forfeited under the Amendment | 3,381,866 | |||||
Restricted shares issued under the Amendment | 418,371 | |||||
Advisor | ||||||
Restricted shares issued under the Amendment | 2,960,000 | |||||
2017 ATM | ||||||
Shares sold under plan | 2,898,374 | |||||
Gross proceeds from sale off common stock | $ 32,700,000 | |||||
Net proceeds from sale off common stock | $ 32,200,000 | |||||
Selling price per share | $ 11.30 | |||||
Common stock available for sale | $ 267,300,000 | |||||
2015 ATM | ||||||
Shares sold under plan | 3,104,253 | |||||
Gross proceeds from sale off common stock | $ 31,600,000 | |||||
Net proceeds from sale off common stock | $ 31,000,000 | |||||
Selling price per share | $ 10.18 | |||||
2012 Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,201,258 | 1,201,258 | ||||
Non Employee Restricted Stock | ||||||
Restricted Stock Outstanding (Non-employees) | 2,289,917 | 2,289,917 | ||||
Share-based Compensation, Total | $ 4,900,000 | $ 2,800,000 | $ 12,400,000 | $ 6,200,000 |
NOTES PAYABLE (Details)
NOTES PAYABLE (Details) - USD ($) | Sep. 30, 2017 | Dec. 31, 2016 |
Notes Payable [Line Items] | ||
Notes payable, Current portion, net | $ 182,156 | $ 68,875 |
Notes payable, Non-current portion, net | 0 | 0 |
Total | 182,156 | 68,875 |
Convertible Notes [Member] | ||
Notes Payable [Line Items] | ||
Notes payable, Current portion, net | 182,156 | 68,875 |
Notes payable, Non-current portion, net | 0 | 0 |
Total | $ 182,156 | $ 68,875 |
NOTES PAYABLE (Details Narrativ
NOTES PAYABLE (Details Narrative) - Convertible Notes Payable [Member] - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2017 | Dec. 31, 2016 | Dec. 31, 2011 | |
Debt Instrument, Convertible, Conversion Price | $ 1,125 | ||
Debt Instrument, Interest Rate During Period | 5.00% | 5.00% | |
Debt Instrument, Maturity Date | Mar. 8, 2015 | ||
Cumulative Liability | $ 17,300,000 | $ 16,700,000 | |
Ariston [Member] | |||
Percentage Of Cash Proceeds From Operation To Repay Interest On Convertible Debt | 50.00% |
LICENSE AGREEMENTS (Details Nar
LICENSE AGREEMENTS (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2012 | Dec. 31, 2016 | |
License Agreement [Line Items] | ||||||
License revenue | $ 38,096 | $ 38,096 | $ 114,286 | $ 114,286 | ||
JBET Agreement [Member] | ||||||
License Agreement [Line Items] | ||||||
Upfront Fee | 1,000,000 | |||||
Additional Amount Receivable On Achievement Of Pre Specified Milestones | 177,000,000 | |||||
TG-1101 [Member] | ||||||
License Agreement [Line Items] | ||||||
License revenue | 38,000 | $ 38,000 | 114,000 | $ 114,000 | ||
Deferred Revenue | $ 1,300,000 | $ 1,300,000 | $ 1,400,000 | |||
Licensing Agreements [Member] | ||||||
License Agreement [Line Items] | ||||||
Upfront Fee | $ 2,000,000 | |||||
Income taxes | $ 300,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Narrative) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017USD ($)ft²shares | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($)ft²shares | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($)shares | |
Related Party Transaction [Line Items] | |||||
Other research and development | $ 25,334,762 | $ 20,878,108 | $ 71,150,033 | $ 45,075,097 | |
Prepaid Research And Development | $ 5,022,846 | $ 5,022,846 | $ 5,678,755 | ||
Common stock issued | shares | 70,693,576 | 70,693,576 | 56,820,422 | ||
LFB License Agreement [] [Member] | |||||
Related Party Transaction [Line Items] | |||||
Other research and development | $ 1,800,000 | 1,900,000 | $ 2,300,000 | 4,300,000 | |
Accounts Payable | 0 | 0 | $ 400,000 | ||
Prepaid Research And Development | 0 | 0 | 1,300,000 | ||
Shared Services Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Costs and Expenses, Related Party | 300,000 | 300,000 | 1,000,000 | 500,000 | |
Office Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Accounts Payable | 131,000 | 131,000 | |||
Average Annual Rental Payments | $ 1,100,000 | $ 1,100,000 | |||
Percentage of Occupancy | 45.00% | 45.00% | |||
Area of Land | ft² | 24,000 | 24,000 | |||
Operating Lease, Initial Commitment Period | 15 years | ||||
Rent expense | $ 900,000 | ||||
Deferred rent | $ 1,300,000 | 1,300,000 | |||
Build out costs | 30,000 | ||||
JBET Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Accounts Payable | $ 200,000 | $ 200,000 | $ 800,000 | ||
Sublicense Fee paid | 1,000,000 | ||||
Opus [Member] | |||||
Related Party Transaction [Line Items] | |||||
Costs and Expenses, Related Party | $ 20,000 | $ 100,000 |