Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Nov. 05, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
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 | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Trading Symbol | TGTX | |
Entity Common Stock, Shares Outstanding | 82,897,273 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 70,718 | $ 56,718 |
Short-term investment securities | 27,024 | 27,999 |
Interest receivable | 80 | 108 |
Prepaid research and development | 11,389 | 8,056 |
Other current assets | 526 | 437 |
Total current assets | 109,737 | 93,318 |
Restricted cash | 1,239 | 587 |
Leasehold interest, net | 2,331 | 2,429 |
Equipment, net | 268 | 248 |
Goodwill | 799 | 799 |
Total assets | 114,374 | 97,381 |
Current liabilities: | ||
Accounts payable and accrued expenses | 37,917 | 25,877 |
Accrued compensation | 2,082 | 1,800 |
Current portion of deferred revenue | 152 | 152 |
Notes payable | 91 | 128 |
Total current liabilities | 40,242 | 27,957 |
Deferred rent | 1,436 | 1,364 |
Deferred revenue, net of current portion | 952 | 1,067 |
Total liabilities | 42,630 | 30,388 |
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, 2018 and December 31, 2017) | 0 | 0 |
Common stock, $0.001 par value per share (150,000,000 shares authorized, 82,973,332 and 73,181,750 shares issued; 82,932,023 and 73,140,441 shares outstanding at September 30, 2018 and December 31, 2017, respectively) | 83 | 73 |
Additional paid-in capital | 546,380 | 422,017 |
Treasury stock, at cost, 41,309 shares at September 30, 2018 and December 31, 2017 | (234) | (234) |
Accumulated deficit | (474,485) | (354,863) |
Total stockholders' equity | 71,744 | 66,993 |
Total liabilities and stockholders' equity | $ 114,374 | $ 97,381 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2018 | Dec. 31, 2017 |
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 | 82,973,332 | 73,181,750 |
Common stock, shares outstanding | 82,932,023 | 73,140,441 |
Treasury stock, shares | 41,309 | 41,309 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Income Statement [Abstract] | ||||
License revenue | $ 38 | $ 38 | $ 114 | $ 114 |
Research and development: | ||||
Non-cash stock expense associated with in-licensing agreements | 0 | 0 | 4,000 | 0 |
Noncash compensation | 644 | 1,814 | 4,391 | 5,387 |
Other research and development | 32,754 | 25,335 | 98,724 | 71,150 |
Total research and development | 33,398 | 27,149 | 107,115 | 76,537 |
General and administrative: | ||||
Noncash compensation | (817) | 3,076 | 7,037 | 6,988 |
Other general and administrative | 1,785 | 1,398 | 6,212 | 4,266 |
Total general and administrative | 968 | 4,474 | 13,249 | 11,254 |
Total costs and expenses | 34,366 | 31,623 | 120,364 | 87,791 |
Operating loss | (34,328) | (31,585) | (120,250) | (87,677) |
Other (income) expense: | ||||
Interest income | (258) | (79) | (591) | (174) |
Other (income) expense | (119) | 30 | (37) | 113 |
Total other income, net | (377) | (49) | (628) | (61) |
Net loss | $ (33,951) | $ (31,536) | $ (119,622) | $ (87,616) |
Basic and diluted net loss per common share | $ (0.43) | $ (0.48) | $ (1.61) | $ (1.45) |
Weighted average shares used in computing basic and diluted net loss per common share | 78,221,069 | 65,079,128 | 74,399,243 | 60,552,084 |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Stockholders' Equity - 9 months ended Sep. 30, 2018 - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] | Total | ||
Balance (in shares) at Dec. 31, 2017 | 73,181,750 | 41,309 | |||||
Balance at Dec. 31, 2017 | $ 73 | $ 422,017 | $ (234) | $ (354,863) | $ 66,993 | ||
Issuance of restricted stock (in shares) | 1,521,211 | ||||||
Issuance of restricted stock | $ 2 | (2) | |||||
Forfeiture of restricted stock (in shares) | (155,446) | ||||||
Forfeiture of restricted stock | [1] | ||||||
Issuance of common stock in At-the-Market offerings (net of offering costs of $2.0 million) (in shares) | 8,091,949 | ||||||
Issuance of common stock in At-the-Market offerings (net of offering costs of $2.0 million) | $ 8 | 108,937 | 108,945 | ||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 11,428 | 11,428 | |||||
Shares issued in connection with in-licensing agreements (in shares) | 333,868 | ||||||
Shares issued in connection with in-licensing agreements | [1] | 4,000 | 4,000 | ||||
Net loss | (119,622) | (119,622) | |||||
Balance (in shares) at Sep. 30, 2018 | 82,973,332 | 41,309 | |||||
Balance at Sep. 30, 2018 | $ 83 | $ 546,380 | $ (234) | $ (474,485) | $ 71,744 | ||
[1] | Amount less than one thousand dollars. |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (119,622) | $ (87,616) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Noncash stock compensation expense | 11,428 | 12,375 |
Noncash licensing expense | 4,000 | 0 |
Depreciation | 64 | 62 |
Amortization of premium on investment securities | (51) | 54 |
Change in fair value of notes payable | (37) | 113 |
Changes in assets and liabilities: | ||
(Increase) decrease in other current assets | (3,421) | 148 |
Decrease in leasehold interest | 98 | 88 |
Decrease in accrued interest receivable | 28 | 84 |
Decrease in other assets | 0 | 162 |
Increase in accounts payable and accrued expenses | 12,321 | 2,666 |
Increase in deferred rent | 71 | 73 |
Decrease in deferred revenue | (114) | (114) |
Net cash used in operating activities | (95,235) | (71,905) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property, plant and equipment | (84) | (2) |
Investment in held-to-maturity securities | (24,574) | 0 |
Proceeds from maturity of short-term securities | 25,600 | 19,800 |
Net cash provided by investing activities | 942 | 19,798 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the exercise of warrants | 0 | 2,143 |
Proceeds from sale of common stock, net | 108,945 | 116,778 |
Net cash provided by financing activities | 108,945 | 118,921 |
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 14,652 | 66,814 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD | 57,305 | 25,614 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD | 71,957 | 92,428 |
Reconciliation to amounts on consolidated balance sheets: | ||
Total cash, cash equivalents and restricted cash | 71,957 | 25,614 |
NONCASH TRANSACTIONS | ||
Reclassification of deferred financing costs to additional paid-in capital | $ 0 | $ (3) |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2018 | |
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. Our lead therapeutic candidates are TG-1101 (ublituximab), a novel, glycoengineered monoclonal antibody that targets a unique epitope on the CD20 antigen found on mature B-lymphocytes and 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, we have recently brought our anti-PD-L1 monoclonal antibody (TG-1501) into Phase 1 development and aim 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, 2017. The accompanying condensed consolidated December 31, 2017 balance sheet has been derived from these statements. The results of operations for the nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. Certain reclassifications have been made to the prior period unaudited condensed consolidated financial statements to conform to the current period presentation, including: ● Presentation of restricted cash on the condensed consolidated statements of cash flows for the nine months ended September 30, 2017, as a result of the adoption of Accounting Standards Update No. 2016-18, “Statement of Cash Flows – Restricted Cash” (“ASU 2016-18”) in the first quarter of 2018. 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, 2018, we have an accumulated deficit of approximately $474.5 million. Our major source of cash has been proceeds from the 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, 2018, we had approximately $97.8 million in cash, cash equivalents, investment securities, and interest receivable. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of September 30, 2018 will be sufficient to fund the Company’s planned operations through the end of 2019. The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for our drug candidates. We are dependent upon significant future financing to provide the cash necessary to execute our current 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 July 2018, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update (“ASU”) No. 2018-11, “Leases - Targeted Improvements” (“ASU 2018-11”) as an update to ASU 2016-02, Leases (“ASU 2016-02” or “Topic 842”) issued on February 25, 2016. ASU 2016-02 is effective for public business entities for fiscal years beginning January 1, 2019. ASU 2016-02 required companies to adopt the new leases standard at the beginning of the earliest period presented in the financial statements, which is January 1, 2017, using a modified retrospective transition method where lessees must recognize lease assets and liabilities for all leases even though those leases may have expired before the effective date of January 1, 2017. Lessees must also provide the new and enhanced disclosures for each period presented, including the comparative periods. ASU 2018-11 provides an entity with an additional (and optional) transition method to adopt the new leases standard. Under this new transition method, an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Consequently, an entity’s reporting for the comparative periods presented in the financial statements in which it adopts the new leases standard will continue to be in accordance with current GAAP (Topic 840, Leases). An entity that elects this additional (and optional) transition method must provide the required Topic 840 disclosures for all periods that continue to be in accordance with Topic 840. The amendments do not change the existing disclosure requirements in Topic 840. An entity shall apply the effects of modification using one of the following two methods: ● Retrospectively to each prior reporting period presented in the financial statements with the cumulative effect of initially applying ASU 2018-11 recognized at the beginning of the earliest comparative period presented. Under this transition method, the application date shall be the later of the beginning of the earliest period presented in the financial statements and the commencement date of the lease. ● Retrospectively at the beginning of the period of adoption through a cumulative-effect adjustment. Under this transition method, the application date shall be the beginning of the reporting period in which the entity first applies ASU 2018-11. ASU 2018-11 is effective for public business entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, with earlier adoption permitted. We are currently evaluating the impact the adoption of ASU 2018-11 will have on our consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, “Improvements to Nonemployee Share-Based Payment Accounting” (“ASU 2018-07”). ASU 2018-07 expands the scope of FASB Topic 718, Compensation – Stock Compensation (“Topic 718”) to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should only remeasure equity-classified awards for which a measurement date has not been established through a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year of adoption. Upon transition, the entity is required to measure these nonemployee awards at fair value as of the adoption date. The entity must not remeasure assets that are completed. Disclosures required at transition include the nature of and reason for the change in accounting principle and, if applicable, quantitative information about the cumulative effect of the change on retained earnings or other components of equity. ASU 2018-07 is effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. We expect the impact to our consolidated statements of operations could be material given potential fluctuations in our stock price as of the adoption date. In May 2017, the FASB issued ASU No. 2017-09, “Scope of Modification Accounting” (“ASU 2017-09”). ASU 2017-09 provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. An entity should account for the effects of a modification unless all the following are met: ● The fair value (or calculated value or intrinsic value, if such an alternative measurement method is used) of the modified award is the same as the fair value (or calculated value or intrinsic value, if such an alternative measurement method is used) of the original award immediately before the original award is modified. If the modification does not affect any of the inputs to the valuation technique that the entity uses to value the award, the entity is not required to estimate the value immediately before and after the modification. ● The vesting conditions of the modified award are the same as the vesting conditions of the original award immediately before the original award is modified. ● The classification of the modified award as an equity instrument or a liability instrument is the same as the classification of the original award immediately before the original award is modified. ASU 2017-09 is effective for annual and interim periods beginning on or after December 15, 2017. Early adoption is permitted for public business entities for reporting periods for which financial statements have not yet been issued, and all other entities for reporting periods for which financial statements have not yet been made available for issuance. The amendments should be applied prospectively to an award modified on or after the adoption date. The Company adopted ASU 2017-09 on January 1, 2018. The adoption of ASU 2017-09 did not have a material effect on our consolidated financial statements as of September 30, 2018. In November 2016, the FASB issued ASU No. 2016-18, “Statement of Cash Flows – Restricted Cash” (“ASU 2016-18”). ASU 2016-18 requires that a statement of cash flows explain the change during the period for the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. ASU 2016-18 does not provide a definition of restricted cash or restricted cash equivalents, and does not change the balance sheet presentation for such items. The Company adopted ASU 2016-18 on January 1, 2018. The adoption of ASU 2016-18 did not have a material effect on our consolidated financial statements as of September 30, 2018. In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers” (Topic 606) (“ASU 2014-09” or “ASC 606”), which supersedes all existing revenue recognition requirements, including most industry-specific guidance. ASU 2014-09 provides a single set of criteria for revenue recognition among all industries. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the Company expects to receive for those goods or services. ASU 2014-09 includes guidance for determining whether a license transfers to a customer at a point in time or over time based on the nature of the entity’s promise to the customer. To determine whether the entity’s promise is to provide a right to access its intellectual property or a right to use its intellectual property, the entity should consider the nature of the intellectual property to which the customer will have rights. ASU 2014-09 is effective for interim and annual periods beginning after December 15, 2017. The standard allows for two transition methods - full retrospective, in which the standard is applied to each prior reporting period presented, or modified retrospective, in which the cumulative effect of initially applying the standard is recognized at the date of initial adoption. The Company adopted ASU 2014-09 on January 1, 2018, using the modified retrospective approach. The adoption of ASU 2014-09 did not have a material effect on our 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 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 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, 2018 and December 31, 2017, we have approximately $1.2 million and $0.6 million, respectively, of restricted cash pledged to secure a line of credit as a security deposit for an Office Agreement Investment Securities Investment securities at September 30, 2018 and December 31, 2017 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. Credit Risk 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. 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 ASC 606. 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 a promise to transfer more than one good or service to the customer, in which case the Company would account for each promised good or service as a performance obligation only if it is (1) distinct or (2) a series of distinct goods or services that are substantially the same and have the same pattern of transfer. For each performance obligation, the Company would determine whether we satisfy the performance obligation over time by transferring control of a good or service over time. To determine whether the Company’s promise is to provide a right to access its intellectual property or a right to use its intellectual property, the Company would consider the nature of the intellectual property to which the customer will have rights. The Company has symbolic intellectual property, derived from its association with the Company’s ongoing activities, including its ordinary business activities. 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 CRO’s, 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, 2018 and December 31, 2017, we recorded approximately $11.4 million and $8.1 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. 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 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, 2018 2017 Unvested restricted shares 4,604,775 4,141,680 Stock options 610,000 -- Shares issuable upon note conversion 16,147 15,372 Total 5,230,922 4,157,052 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, 2018 | |
Cash and Cash Equivalents [Abstract] | |
CASH AND CASH EQUIVALENTS | The following tables summarize our cash and cash equivalents at September 30, 2018 and December 31, 2017: (in thousands) September 30, 2018 December 31, 2017 Checking and bank deposits $ 68,352 $ 55,682 Money market funds 2,366 1,036 Total $ 70,718 $ 56,718 |
INVESTMENT SECURITIES
INVESTMENT SECURITIES | 9 Months Ended |
Sep. 30, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
INVESTMENT SECURITIES | Our investments as of September 30, 2018 and December 31, 2017 are classified as held-to-maturity. Held-to-maturity investments are recorded at amortized cost. The following tables summarize our investment securities at September 30, 2018 and December 31, 2017: September 30, 2018 (in thousands) 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 October 2018 and September 2019) (held-to-maturity) $ 27,024 $ — $ 19 $ 27,005 Total short-term investment securities $ 27,024 $ — $ 19 $ 27,005 December 31, 2017 (in thousands) Amortized cost, as adjusted Gross unrealized holding gains Gross unrealized holding losses Estimated fair value Short-term investments: Obligations of domestic governmental agencies (maturing between January 2018 and November 2018) (held-to-maturity) $ 27,999 -- $ 35 $ 27,964 Total short-term investment securities $ 27,999 -- $ 35 $ 27,964 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2018 | |
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, 2018 and December 31, 2017, the fair values of cash and cash equivalents, restricted cash, accounts payable, and notes and interest payable, approximate their carrying value. At the time of our merger (we were then known as Manhattan Pharmaceuticals, Inc. (“Manhattan”)) with Ariston Pharmaceuticals, Inc. (“Ariston”) in March 2010, Ariston issued $15.5 million of five-year 5% notes payable (the “5% Notes”) in satisfaction of several note payable issuances. The 5% Notes and accrued and unpaid interest thereon are convertible at the option of the holder into common stock at the conversion price of $1,125 per share. Ariston agreed to make quarterly payments on the 5% Notes equal to 50% of the net product cash flow received from the exploitation or commercialization of Ariston’s product candidates, AST-726 and AST-915. We have no obligations under the 5% Notes aside from (a) 50% of the net product cash flows from Ariston’s product candidates, if any, payable to noteholders; and (b) the conversion feature, discussed above. The cumulative liability including accrued and unpaid interest of the 5% Notes was approximately $18.2 million at September 30, 2018 and $17.5 million at December 31, 2017. No payments have been made on the 5% Notes as of September 30, 2018. 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, 2018 and December 31, 2017. 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, 2018 and December 31, 2017: (in thousands) Financial liabilities at fair value as of September 30, 2018 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 91 $ 91 Total $ -- $ -- $ 91 $ 91 Financial liabilities at fair value as of December 31, 2017 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 128 $ 128 Total $ -- $ -- $ 128 $ 128 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, 2018: Fair value at December 31, 2017 $ 128 Interest accrued on face value of 5% Notes 213 Change in fair value of Level 3 liabilities (117 ) Fair value at March 31, 2018 224 Interest accrued on face value of 5% Notes 223 Change in fair value of Level 3 liabilities (237 ) Fair value at June 30, 2018 210 Interest accrued on face value of 5% Notes 221 Change in fair value of Level 3 liabilities (340 ) Fair value at September 30, 2018 $ 91 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, 2018 | |
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 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. In July 2018, we filed a shelf registration statement on Form S-3 (the “2018 S-3”) pursuant to the Joint Venture and License Option Agreement, dated June 18, 2018, by and between TG Therapeutics, Inc. and Novimmune S.A. (“Novimmune”), pursuant to which we issued 216,294 common shares to Novimmune. The 2018 S-3 was declared effective in July 2018. During the nine months ended September 30, 2018, we sold a total of 8,091,949 shares of common stock under the 2017 ATM for aggregate total gross proceeds of approximately $111.0 million at an average selling price of $13.72 per share, resulting in net proceeds of approximately $109.0 million after deducting commissions and other transactions costs. The 2017 S-3 is currently our only active shelf registration statement, pursuant to which we can issue shares in an offering. After deducting shares already sold there is approximately $141.3 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 2018. Pursuant to this amendment, 6,000,000 shares were added to the 2012 Incentive Plan. As of September 30, 2018, 610,000 options were outstanding and up to an additional 4,528,363 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 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 of the Company. Under the Amendment, Mr. Weiss will remain as Chief Executive Officer and President, removing the interim status. Simultaneously, we entered into a Strategic Advisory Agreement (the “Advisory Agreement”) with Caribe BioAdvisors, LLC (the “Advisor”) owned by Mr. Weiss to provide the services of Mr. Weiss as Chairman of the Board and as Executive Chairman. As part of the Amendment, Mr. Weiss also agreed to forfeit 3,381,866 restricted shares previously granted under the Employment Agreement that were predominantly subject to time-based vesting over the next three years. Simultaneously, (i) Mr. Weiss was issued 418,371 restricted shares under the Employment Agreement that vest in 2018 and 2019 and (ii) the Advisor was issued 2,960,000 restricted shares under the Advisory Agreement that vested on market capitalization thresholds ranging from $375 million to $750 million. In accordance with GAAP, there was no incremental stock compensation expense recognition as a result of the modification. Stock Options The fair value of stock options granted is estimated at the date of grant using the Black-Scholes pricing model. The expected term of options granted is derived from historical data and the expected vesting period. Expected volatility is based on the historical volatility of our common stock. The risk-free interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. We have assumed no expected dividend yield, as dividends have never been paid to stock or option holders and will not be paid for the foreseeable future. We granted 610,000 and zero stock options during the nine months ended September 30, 2018 and 2017, respectively. The following table summarizes stock option activity for the nine months ended September 30, 2018: Number of shares Weighted- average exercise price Weighted- average Contractual Term Aggregate Intrinsic Value (in years) Outstanding at December 31, 2017 -- $ -- -- $ -- Granted 610,000 11.65 Exercised -- -- Forfeited -- -- Expired -- -- Outstanding at September 30, 2018 610,000 $ 11.65 9.44 $ -- Exercisable at September 30, 2018 -- $ 11.65 -- $ -- As of September 30, 2018, the stock options outstanding include options granted to both employees and non-employees which are milestone-based and vest upon certain corporate milestones. Stock-based compensation will be recorded if and when a milestone occurs. 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, 2018: Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2017 6,321,643 $ 7.17 Granted 1,521,211 13.28 Vested (1,582,633 ) 9.41 Forfeited (155,446 ) 8.23 Outstanding at September 30, 2018 6,104,775 $ 8.08 Total expense associated with restricted stock grants was approximately negative $(0.2) million and $4.9 million during the three months ended September 30, 2018 and 2017, respectively, and $11.4 million, and $12.4 million during the nine months ended September 30, 2018 and 2017, respectively. As of September 30, 2018, there was approximately $10.2 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 1.1 years. The unrecognized compensation amount does not include, as of September 30, 2018, 1,128,011 shares of restricted stock outstanding which are milestone-based and vest upon certain corporate milestones; and 2,103,750 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. |
NOTES PAYABLE
NOTES PAYABLE | 9 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
NOTES PAYABLE | The following is a summary of notes payable: September 30, 2018 December 31 2017 Current portion, net Non-current portion, net Total Current portion, net Non-current portion, net Total Convertible 5% Notes Payable $ 91 $ - $ 91 $ 128 $ - $ 128 Total $ 91 $ - $ 91 $ 128 $ - $ 128 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, would be 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 $18.2 million at September 30, 2018 and $17.5 million at December 31, 2017. No payments have been made on the 5% Notes as of September 30, 2018. 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, 2018 | |
License Agreement [Abstract] | |
LICENSE AGREEMENTS | 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. TG-1701: BTK In January 2018, we entered into a global exclusive license agreement with Jiangsu Hengrui Medicine Co. (“Jiangsu”), to acquire worldwide intellectual property rights, excluding Asia but including Japan, and for the research, development, manufacturing, and commercialization of products containing or comprising of any of Jiangsu’s Bruton’s Tyrosine Kinase inhibitors containing the compounds of either TG1701 (SHR1459 or EBI1459) or TG1702 (SHR1266 or EBI1266). Pursuant to the agreement, in April 2018, we paid Jiangsu an upfront fee of $1.0 million in our common stock. Jiangsu is eligible to receive milestone payments totaling approximately $350 million upon and subject to the achievement of certain milestones. Various provisions allow for payments in conjunction with the agreement to be made in cash or our common stock, while others limit the form of payment. Royalty payments in the low double digits are due on net sales of licensed products and revenue from sublicenses. TG-1801: anti-CD47/anti-CD19 In June 2018, we entered into a Joint Venture and License Option Agreement with Novimmune SA (“Novimmune”) to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701). The companies will jointly develop the product on a worldwide basis, focusing on indications in the area of hematologic B-cell malignancies. We serve as the primary responsible party for the development, manufacturing and commercialization of the product. Pursuant to the agreement, in June 2018 we paid Novimmune an upfront payment of $3.0 million in our common stock. Further milestone payments will be paid based on early clinical development, and the Company will be responsible for the costs of clinical development of the product through the end of the Phase 2 clinical trials, after which the Company and Novimmune will be jointly responsible for all development and commercialization costs. The Company and Novimmune will each maintain an exclusive option, exercisable at specific times during development, for the Company to license the rights to TG-1801, in which case Novimmune is eligible to receive additional milestone payments totaling approximately $185 million as well as tiered royalties on net sales in the high single to low double digits upon and subject to the achievement of certain milestones. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 9 Months Ended |
Sep. 30, 2018 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | LFB Biotechnologies On January 30, 2012, we entered into an exclusive license agreement with LFB Biotechnologies, GTC Biotherapeutics and LFB/GTC LLC, all wholly-owned subsidiaries of LFB Group, relating to the development of ublituximab (the “LFB License Agreement”). In connection with the LFB License Agreement, LFB Group was issued 5,000,000 shares of common stock, and a warrant to purchase 2,500,000 shares of common stock at a purchase price of $0.001 per share. Under the terms of the LFB License Agreement, we utilize LFB Group for certain development and manufacturing services. We incurred expenses of zero and $1.8 million during the three months ended September 30, 2018 and 2017, respectively, and $0.2 million and $2.3 million during the nine months ended September 30, 2018 and 2017, respectively, which have been included in other research and development expenses in the accompanying condensed consolidated statements of operations. As of September 30, 2018 and December 31, 2017, we had approximately zero recorded in accounts payable related to the LFB License Agreement. Other Parties In October 2014, we entered into an agreement (the “Office Agreement”) with Fortress Biotech, Inc. (“FBIO”), to occupy approximately 45% of the 24,000 square feet of New York City office space leased by FBIO, which is now our corporate headquarters. The Office Agreement requires us to pay our respective share of the average annual rent and other costs of the 15-year lease. We approximate an average annual rental obligation of $1.1 million under the Office Agreement. We began to occupy this new space in April 2016, with rental payments beginning in the third quarter of 2016. During the three and nine months ended September 30, 2018, we recorded rent expense of approximately $0.3 million and $0.9 million, respectively, and at September 30, 2018, have deferred rent of approximately $1.4 million. As of September 30, 2018 and December 31, 2017, we have approximately $1.2 million and $0.6 million, respectively, of restricted cash pledged to secure a line of credit as a security deposit related to the Office Agreement. Mr. Weiss, our Executive Chairman and CEO, is also Executive Vice Chairman of FBIO. Under the Office Agreement, we agreed to pay FBIO our portion of the build out costs, which have been allocated to us at the 45% rate mentioned above. The allocated buildout 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 FBIO 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, 2018, we had approximately $0.1 million recorded in accounts payable related to FBIO, none of which related to rent and build-out costs. In July 2015, we entered into a Shared Services Agreement (the “Shared Services Agreement”) with FBIO to share the cost of certain services such as facilities use, personnel costs and other overhead and administrative costs. This Shared Services Agreement requires us to pay our respective share of services utilized. In connection with the Shared Services Agreement, we incurred expenses of approximately $1.4 million and $1.0 million for shared services for the nine months ended September 30, 2018 and 2017, respectively, and expenses of approximately $0.2 million and $0.3 million for the three months ended September 30, 2018 and 2017, primarily related to shared personnel. In May 2016, as part of a broader agreement with Jubilant Biosys (“Jubilant”), an India-based biotechnology company, we entered into a sublicense agreement (“JBET Agreement”) with Checkpoint Therapeutics, Inc. (“Checkpoint”), a subsidiary of FBIO, for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies. We paid Checkpoint an up-front licensing fee of $1.0 million in July 2016 and incurred expenses of $0.2 million in March 2017 for the first milestone achievement as part of the JBET Agreement which is recorded in other research and development in the accompanying consolidated statement of operations. As of September 30, 2018 and December 31, 2017, we had approximately zero and $0.3 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, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
LITIGATION | In October 2018, a purported securities class action complaint was filed in the US District Court for the Southern District of New York against the Company and one of its officers on behalf of all shareholders who purchased or otherwise acquired TG Therapeutics common stock between June 4, 2018 and September 25, 2018 (the “Class Period”). The case is captioned Randall Reinmann v. TG Therapeutics Inc., and Michael S. Weiss, Case No. 1:18-cv-09104-KPF. The complaint alleges that, throughout the Class Period, the Company made false and/or misleading statements and/or failed to disclose various facts and circumstances regarding its UNITY-CLL study allegedly in violation of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. The action remains pending and is in the early stages of litigation, and the Company intends to vigorously contest the claims in the complaint. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
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. Our lead therapeutic candidates are TG-1101 (ublituximab), a novel, glycoengineered monoclonal antibody that targets a unique epitope on the CD20 antigen found on mature B-lymphocytes and 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, we have recently brought our anti-PD-L1 monoclonal antibody (TG-1501) into Phase 1 development and aim 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, 2017. The accompanying condensed consolidated December 31, 2017 balance sheet has been derived from these statements. The results of operations for the nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. Certain reclassifications have been made to the prior period unaudited condensed consolidated financial statements to conform to the current period presentation, including: ● Presentation of restricted cash on the condensed consolidated statements of cash flows for the nine months ended September 30, 2017, as a result of the adoption of Accounting Standards Update No. 2016-18, “Statement of Cash Flows – Restricted Cash” (“ASU 2016-18”) in the first quarter of 2018. |
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, 2018, we have an accumulated deficit of approximately $474.5 million. Our major source of cash has been proceeds from the 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, 2018, we had approximately $97.8 million in cash, cash equivalents, investment securities, and interest receivable. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of September 30, 2018 will be sufficient to fund the Company’s planned operations through the end of 2019. The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for our drug candidates. We are dependent upon significant future financing to provide the cash necessary to execute our current 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 July 2018, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update (“ASU”) No. 2018-11, “Leases - Targeted Improvements” (“ASU 2018-11”) as an update to ASU 2016-02, Leases (“ASU 2016-02” or “Topic 842”) issued on February 25, 2016. ASU 2016-02 is effective for public business entities for fiscal years beginning January 1, 2019. ASU 2016-02 required companies to adopt the new leases standard at the beginning of the earliest period presented in the financial statements, which is January 1, 2017, using a modified retrospective transition method where lessees must recognize lease assets and liabilities for all leases even though those leases may have expired before the effective date of January 1, 2017. Lessees must also provide the new and enhanced disclosures for each period presented, including the comparative periods. ASU 2018-11 provides an entity with an additional (and optional) transition method to adopt the new leases standard. Under this new transition method, an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Consequently, an entity’s reporting for the comparative periods presented in the financial statements in which it adopts the new leases standard will continue to be in accordance with current GAAP (Topic 840, Leases). An entity that elects this additional (and optional) transition method must provide the required Topic 840 disclosures for all periods that continue to be in accordance with Topic 840. The amendments do not change the existing disclosure requirements in Topic 840. An entity shall apply the effects of modification using one of the following two methods: ● Retrospectively to each prior reporting period presented in the financial statements with the cumulative effect of initially applying ASU 2018-11 recognized at the beginning of the earliest comparative period presented. Under this transition method, the application date shall be the later of the beginning of the earliest period presented in the financial statements and the commencement date of the lease. ● Retrospectively at the beginning of the period of adoption through a cumulative-effect adjustment. Under this transition method, the application date shall be the beginning of the reporting period in which the entity first applies ASU 2018-11. ASU 2018-11 is effective for public business entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, with earlier adoption permitted. We are currently evaluating the impact the adoption of ASU 2018-11 will have on our consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, “Improvements to Nonemployee Share-Based Payment Accounting” (“ASU 2018-07”). ASU 2018-07 expands the scope of FASB Topic 718, Compensation – Stock Compensation (“Topic 718”) to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should only remeasure equity-classified awards for which a measurement date has not been established through a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year of adoption. Upon transition, the entity is required to measure these nonemployee awards at fair value as of the adoption date. The entity must not remeasure assets that are completed. Disclosures required at transition include the nature of and reason for the change in accounting principle and, if applicable, quantitative information about the cumulative effect of the change on retained earnings or other components of equity. ASU 2018-07 is effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. We expect the impact to our consolidated statements of operations could be material given potential fluctuations in our stock price as of the adoption date. In May 2017, the FASB issued ASU No. 2017-09, “Scope of Modification Accounting” (“ASU 2017-09”). ASU 2017-09 provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. An entity should account for the effects of a modification unless all the following are met: ● The fair value (or calculated value or intrinsic value, if such an alternative measurement method is used) of the modified award is the same as the fair value (or calculated value or intrinsic value, if such an alternative measurement method is used) of the original award immediately before the original award is modified. If the modification does not affect any of the inputs to the valuation technique that the entity uses to value the award, the entity is not required to estimate the value immediately before and after the modification. ● The vesting conditions of the modified award are the same as the vesting conditions of the original award immediately before the original award is modified. ● The classification of the modified award as an equity instrument or a liability instrument is the same as the classification of the original award immediately before the original award is modified. ASU 2017-09 is effective for annual and interim periods beginning on or after December 15, 2017. Early adoption is permitted for public business entities for reporting periods for which financial statements have not yet been issued, and all other entities for reporting periods for which financial statements have not yet been made available for issuance. The amendments should be applied prospectively to an award modified on or after the adoption date. The Company adopted ASU 2017-09 on January 1, 2018. The adoption of ASU 2017-09 did not have a material effect on our consolidated financial statements as of September 30, 2018. In November 2016, the FASB issued ASU No. 2016-18, “Statement of Cash Flows – Restricted Cash” (“ASU 2016-18”). ASU 2016-18 requires that a statement of cash flows explain the change during the period for the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. ASU 2016-18 does not provide a definition of restricted cash or restricted cash equivalents, and does not change the balance sheet presentation for such items. The Company adopted ASU 2016-18 on January 1, 2018. The adoption of ASU 2016-18 did not have a material effect on our consolidated financial statements as of September 30, 2018. In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers” (Topic 606) (“ASU 2014-09” or “ASC 606”), which supersedes all existing revenue recognition requirements, including most industry-specific guidance. ASU 2014-09 provides a single set of criteria for revenue recognition among all industries. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the Company expects to receive for those goods or services. ASU 2014-09 includes guidance for determining whether a license transfers to a customer at a point in time or over time based on the nature of the entity’s promise to the customer. To determine whether the entity’s promise is to provide a right to access its intellectual property or a right to use its intellectual property, the entity should consider the nature of the intellectual property to which the customer will have rights. ASU 2014-09 is effective for interim and annual periods beginning after December 15, 2017. The standard allows for two transition methods - full retrospective, in which the standard is applied to each prior reporting period presented, or modified retrospective, in which the cumulative effect of initially applying the standard is recognized at the date of initial adoption. The Company adopted ASU 2014-09 on January 1, 2018, using the modified retrospective approach. The adoption of ASU 2014-09 did not have a material effect on our 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 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 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, 2018 and December 31, 2017, we have approximately $1.2 million and $0.6 million, respectively, of restricted cash pledged to secure a line of credit as a security deposit for an Office Agreement |
Investment Securities | Investment securities at September 30, 2018 and December 31, 2017 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. |
Credit Risk | 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. 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 ASC 606. 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 a promise to transfer more than one good or service to the customer, in which case the Company would account for each promised good or service as a performance obligation only if it is (1) distinct or (2) a series of distinct goods or services that are substantially the same and have the same pattern of transfer. For each performance obligation, the Company would determine whether we satisfy the performance obligation over time by transferring control of a good or service over time. To determine whether the Company’s promise is to provide a right to access its intellectual property or a right to use its intellectual property, the Company would consider the nature of the intellectual property to which the customer will have rights. The Company has symbolic intellectual property, derived from its association with the Company’s ongoing activities, including its ordinary business activities. 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 CRO’s, 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, 2018 and December 31, 2017, we recorded approximately $11.4 million and $8.1 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. |
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 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, 2018 2017 Unvested restricted shares 4,604,775 4,141,680 Stock options 610,000 -- Shares issuable upon note conversion 16,147 15,372 Total 5,230,922 4,157,052 |
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 S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Three and Nine Months Ended September 30, 2018 2017 Unvested restricted shares 4,604,775 4,141,680 Stock options 610,000 -- Shares issuable upon note conversion 16,147 15,372 Total 5,230,922 4,157,052 |
CASH AND CASH EQUIVALENTS (Tabl
CASH AND CASH EQUIVALENTS (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash and Cash Equivalents | (in thousands) September 30, 2018 December 31, 2017 Checking and bank deposits $ 68,352 $ 55,682 Money market funds 2,366 1,036 Total $ 70,718 $ 56,718 |
INVESTMENT SECURITIES (Tables)
INVESTMENT SECURITIES (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
Held-to-maturity Securities | September 30, 2018 (in thousands) 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 October 2018 and September 2019) (held-to-maturity) $ 27,024 $ — $ 19 $ 27,005 Total short-term investment securities $ 27,024 $ — $ 19 $ 27,005 December 31, 2017 (in thousands) Amortized cost, as adjusted Gross unrealized holding gains Gross unrealized holding losses Estimated fair value Short-term investments: Obligations of domestic governmental agencies (maturing between January 2018 and November 2018) (held-to-maturity) $ 27,999 -- $ 35 $ 27,964 Total short-term investment securities $ 27,999 -- $ 35 $ 27,964 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value, Liabilities Measured on Recurring and Nonrecurring Basis | (in thousands) Financial liabilities at fair value as of September 30, 2018 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 91 $ 91 Total $ -- $ -- $ 91 $ 91 Financial liabilities at fair value as of December 31, 2017 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 128 $ 128 Total $ -- $ -- $ 128 $ 128 |
Change In Level Three Fair Value During Period | Fair value at December 31, 2017 $ 128 Interest accrued on face value of 5% Notes 213 Change in fair value of Level 3 liabilities (117 ) Fair value at March 31, 2018 224 Interest accrued on face value of 5% Notes 223 Change in fair value of Level 3 liabilities (237 ) Fair value at June 30, 2018 210 Interest accrued on face value of 5% Notes 221 Change in fair value of Level 3 liabilities (340 ) Fair value at September 30, 2018 $ 91 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Stockholders' Equity Note [Abstract] | |
Schedule Of Stock Options Activity | Number of shares Weighted- average exercise price Weighted- average Contractual Term Aggregate Intrinsic Value (in years) Outstanding at December 31, 2017 -- $ -- -- $ -- Granted 610,000 11.65 Exercised -- -- Forfeited -- -- Expired -- -- Outstanding at September 30, 2018 610,000 $ 11.65 9.44 $ -- Exercisable at September 30, 2018 -- $ 11.65 -- $ -- |
Schedule of Nonvested Restricted Stock Units Activity | Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2017 6,321,643 $ 7.17 Granted 1,521,211 13.28 Vested (1,582,633 ) 9.41 Forfeited (155,446 ) 8.23 Outstanding at September 30, 2018 6,104,775 $ 8.08 |
NOTES PAYABLE (Tables)
NOTES PAYABLE (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | September 30, 2018 December 31 2017 Current portion, net Non-current portion, net Total Current portion, net Non-current portion, net Total Convertible 5% Notes Payable $ 91 $ - $ 91 $ 128 $ - $ 128 Total $ 91 $ - $ 91 $ 128 $ - $ 128 |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Significant Accounting Policies [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 5,230,922 | 4,157,052 | 5,230,922 | 4,157,052 |
Unvested Restricted Shares [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 4,604,775 | 4,141,680 | 4,604,775 | 4,141,680 |
Stock Options [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 610,000 | 0 | 610,000 | 0 |
Share Issuable Upon Note Conversion [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 16,147 | 15,372 | 16,147 | 15,372 |
ORGANIZATION AND SUMMARY OF S_5
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Accounting Policies [Abstract] | ||
Accumulated deficit | $ (474,485) | $ (354,863) |
Restricted cash and investments | 1,200 | 600 |
Prepaid research and development | $ 11,389 | $ 8,056 |
CASH AND CASH EQUIVALENTS (Deta
CASH AND CASH EQUIVALENTS (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 | Sep. 30, 2017 |
Cash and Cash Equivalents [Abstract] | |||
Checking and bank deposits | $ 68,352 | $ 55,682 | |
Money market funds | 2,366 | 1,036 | |
Total | $ 70,718 | $ 56,718 | $ 91,842 |
INVESTMENT SECURITIES (Details)
INVESTMENT SECURITIES (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Schedule of Held-to-maturity Securities [Line Items] | ||
Amortized cost, as adjusted | $ 27,024 | $ 27,999 |
Gross unrealized holding gains | 0 | 0 |
Gross unrealized holding losses | 19 | 35 |
Estimated fair value | 27,005 | 27,964 |
Short-term Investments [Member] | US Government Agencies Debt Securities [Member] | ||
Schedule of Held-to-maturity Securities [Line Items] | ||
Amortized cost, as adjusted | 27,024 | 27,999 |
Gross unrealized holding gains | 0 | 0 |
Gross unrealized holding losses | 19 | 35 |
Estimated fair value | $ 27,005 | $ 27,964 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
5% Notes | $ 91 | $ 128 |
Totals | 91 | 128 |
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 | 91 | 128 |
Totals | $ 91 | $ 128 |
FAIR VALUE MEASUREMENTS (Deta_2
FAIR VALUE MEASUREMENTS (Details 1) - USD ($) $ in Thousands | 3 Months Ended | ||
Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | |
Fair Value Disclosures [Abstract] | |||
Fair value, beginning of period | $ 210 | $ 224 | $ 128 |
Interest accrued on face value of 5% Notes | 221 | 223 | 213 |
Change in fair value of Level 3 liabilities | (340) | (237) | (117) |
Fair value, end of period | $ 91 | $ 210 | $ 224 |
FAIR VALUE MEASUREMENTS (Deta_3
FAIR VALUE MEASUREMENTS (Details Narrative) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Fair Value Measurements | ||
Cumulative Liability | $ 18,200 | $ 17,500 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2018USD ($)$ / sharesshares | |
Statement of Stockholders' Equity [Abstract] | |
Number of options, Outstanding Beginning Balance | shares | 0 |
Number of options, Granted | shares | 610,000 |
Number of options, Exercised | shares | 0 |
Number of options, Forfeited | shares | 0 |
Number of options, Expired | shares | 0 |
Number of options, Outstanding Ending Balance | shares | 610,000 |
Number of options, Exercisable at September 30, 2018 | shares | 0 |
Weighted - average exercise price, Outstanding Beginning Balance | $ / shares | $ 0 |
Weighted - average exercise price, Granted | $ / shares | 11.65 |
Weighted - average exercise price, Exercised | $ / shares | 0 |
Weighted - average exercise price, Forfeited | $ / shares | 0 |
Weighted - average exercise price, Expired | $ / shares | 0 |
Weighted - average exercise price, Outstanding Ending Balance | $ / shares | 11.65 |
Weighted - average exercise price, Exercisable at September 30, 2018 | $ / shares | $ 11.65 |
Weighted - average Contractual Term (in years) | 9 years 160 days |
Aggregate Intrinsic Value, Outstanding Ending Balance | $ | $ 0 |
Aggregate Intrinsic Value, Exercisable at September 30, 2018 | $ | $ 0 |
STOCKHOLDERS' EQUITY (Details 1
STOCKHOLDERS' EQUITY (Details 1) - Restricted Stock [Member] | 9 Months Ended |
Sep. 30, 2018$ / sharesshares | |
EquityIncentivePlansRestrictedStockActivityLineItemLineItems [Line Items] | |
Number of Shares, Outstanding at Begining Balance | shares | 6,321,643 |
Number of Shares, Granted | shares | 1,521,211 |
Number of Shares, Vested | shares | (1,582,633) |
Number of Shares, Forfeited | shares | (155,446) |
Number of Shares, Outstanding at Ending Balance | shares | 6,104,775 |
Weighted Average Grant Date Fair Value, Outstanding at Begining Balance | $ / shares | $ 7.17 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 13.28 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 9.41 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 8.23 |
Weighted Average Grant Date Fair Value, Outstanding at Ending Balance | $ / shares | $ 8.08 |
STOCKHOLDERS' EQUITY (Details N
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
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, Shares Authorized | 150,000,000 | 150,000,000 | 150,000,000 | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||
Options outstanding | 610,000 | 610,000 | 0 | ||
Shares forfeited under the Amendment | 0 | ||||
Share-based Compensation, Total | $ 11,428 | $ 12,375 | |||
Unrecognized compensation expense | $ 10,200 | $ 10,200 | |||
Period of recognition | 1 year 2 months 12 days | ||||
Options granted | 610,000 | ||||
Non Employee Restricted Stock [Member] | |||||
Share-based Compensation, Total | $ (200) | $ 4,900 | $ 11,400 | $ 12,400 | |
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 | 8,091,949 | ||||
Gross proceeds from sale off common stock | $ 111,000 | ||||
Selling price per share | $ 13.72 | ||||
Net proceeds from sale off common stock | $ 109,000 | ||||
2012 Incentive Plan | |||||
Shares added to 2012 Plan | 6,000,000 | 6,000,000 |
NOTES PAYABLE (Details)
NOTES PAYABLE (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Notes Payable [Line Items] | ||
Notes payable, Current portion, net | $ 91 | $ 128 |
Notes payable, Non-current portion, net | 0 | 0 |
Total | 91 | 128 |
Convertible Notes [Member] | ||
Notes Payable [Line Items] | ||
Notes payable, Current portion, net | 91 | 128 |
Notes payable, Non-current portion, net | 0 | 0 |
Total | $ 91 | $ 128 |
NOTES PAYABLE (Details Narrativ
NOTES PAYABLE (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2011 | |
Cumulative Liability | $ 18,200 | $ 17,500 | |
Convertible Notes Payable [Member] | |||
Debt Instrument, Interest Rate During Period | 5.00% | 5.00% | |
Debt Instrument, Convertible, Conversion Price | $ 1,125 | ||
Debt Instrument, Maturity Date | Mar. 8, 2015 | ||
Cumulative Liability | $ 18,200 | $ 17,500 | |
Convertible Notes Payable [Member] | 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 ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Jun. 30, 2018 | Jan. 31, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2012 | Dec. 31, 2017 | |
License Agreement [Line Items] | ||||||||
License revenue | $ 38 | $ 38 | $ 114 | $ 114 | ||||
Deferred Revenue, current | 152 | 152 | $ 152 | |||||
TG-1101 [Member] | ||||||||
License Agreement [Line Items] | ||||||||
Upfront Fee | $ 2,000 | |||||||
Income taxes | $ 300 | |||||||
Deferred Revenue | $ 1,100 | $ 1,100 | $ 1,200 | |||||
TG-1701 [Member] | ||||||||
License Agreement [Line Items] | ||||||||
Upfront Fee | $ 1,000 | |||||||
Milestone payments | $ 350,000 | |||||||
TG-1801 [Member] | ||||||||
License Agreement [Line Items] | ||||||||
Upfront Fee | $ 3,000 | |||||||
Milestone payments | $ 185,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Narrative) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018USD ($)ft² | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($)ft²$ / sharesshares | Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($) | |
Related Party Transaction [Line Items] | |||||
Other research and development | $ 32,754 | $ 25,335 | $ 98,724 | $ 71,150 | |
Office Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Percentage of occupancy | 45.00% | 45.00% | |||
Area of land | ft² | 24,000 | 24,000 | |||
Average annual rental payments | $ 1,100 | $ 1,100 | |||
Rent expense | 300 | 900 | |||
Deferred rent | $ 1,400 | 1,400 | |||
Operating lease, initial commitment period | 15 years | ||||
JBET Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Accounts payable | $ 300 | ||||
LFB License Agreement [] [Member] | |||||
Related Party Transaction [Line Items] | |||||
Other research and development | $ 0 | 1,800 | $ 200 | 2,300 | |
Common stock issued | shares | 5,000,000 | ||||
Warrant to purchase common stock | shares | 2,500,000 | ||||
Price per share | $ / shares | $ 0.001 | ||||
Shared Services Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Costs and expenses, related party | $ 200 | $ 300 | $ 1,400 | $ 1,000 |
Uncategorized Items - tgtx-2018
Label | Element | Value |
Restricted Cash | us-gaap_RestrictedCash | $ 1,239,000 |
Restricted Cash | us-gaap_RestrictedCash | $ 586,000 |