Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 03, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | TG THERAPEUTICS, INC. | |
Entity Central Index Key | 0001001316 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Trading Symbol | TGTX | |
Entity Common Stock, Shares Outstanding | 90,835,329 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 64,349 | $ 41,958 |
Short-term investment securities | 28,125 | 26,943 |
Prepaid research and development | 11,120 | 9,691 |
Other current assets | 1,464 | 439 |
Total current assets | 105,058 | 79,031 |
Restricted cash | 1,244 | 1,241 |
Leasehold interest, net | 2,249 | 2,294 |
Equipment, net | 241 | 251 |
Right of use asset | 7,947 | 0 |
Goodwill | 799 | 799 |
Total assets | 117,538 | 83,616 |
Current liabilities: | ||
Accounts payable and accrued expenses | 40,199 | 36,377 |
Other current liabilities | 18,626 | 219 |
Lease liability - current portion | 1,261 | 0 |
Accrued compensation | 854 | 2,258 |
Total current liabilities | 60,940 | 38,854 |
Deferred rent | 0 | 1,462 |
Deferred revenue, net of current portion | 876 | 914 |
Long-term debt | 28,286 | 0 |
Lease liability - non current | 8,182 | 0 |
Long-term liabilities | 0 | 18,350 |
Total liabilities | 98,284 | 59,580 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value per share (10,000,000 shares authorized, none issued and outstanding as of March 31, 2019 and December 31, 2018) | 0 | 0 |
Common stock, $0.001 par value per share (150,000,000 shares authorized, 88,582,227 and 83,911,855 shares issued, 88,540,918 and 83,870,546 shares outstanding at March 31, 2019 and December 31, 2018, respectively) | 89 | 84 |
Additional paid-in capital | 582,900 | 552,531 |
Treasury stock, at cost, 41,309 shares at March 31, 2019 and December 31, 2018 | (234) | (234) |
Accumulated deficit | (563,501) | (528,345) |
Total stockholders' equity | 19,254 | 24,036 |
Total liabilities and stockholders' equity | $ 117,538 | $ 83,616 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
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 | 88,582,227 | 83,911,855 |
Common stock, shares outstanding | 88,540,918 | 83,870,546 |
Treasury stock, shares | 41,309 | 41,309 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Statement [Abstract] | ||
License revenue | $ 38 | $ 38 |
Research and development: | ||
Noncash compensation | 1,489 | 2,859 |
Other research and development | 30,896 | 32,159 |
Total research and development | 32,385 | 35,018 |
General and administrative: | ||
Noncash compensation | 393 | 4,478 |
Other general and administrative | 1,949 | 2,119 |
Total general and administrative | 2,342 | 6,597 |
Total costs and expenses | 34,727 | 41,615 |
Operating loss | (34,689) | (41,577) |
Other (income) expense: | ||
Interest income | (149) | (144) |
Other expense | 616 | 96 |
Total other (income) expense, net | 467 | (48) |
Net loss | $ (35,156) | $ (41,529) |
Basic and diluted net loss per common share | $ (0.43) | $ (0.59) |
Weighted average shares used in computing basic and diluted net loss per common share | 81,174,301 | 70,636,970 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - 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) | 87,500 | ||||
Forfeiture of restricted stock (in shares) | (123,911) | ||||
Issuance of common stock in At-the-Market offering (net of offering costs) (in shares) | 3,989,344 | ||||
Issuance of common stock in At-the-Market offering (net of offering costs) | $ 4 | 52,426 | 52,430 | ||
Compensation in respect of restricted stock and options granted to employees, directors and consultants | 7,337 | 7,337 | |||
Net loss | (41,529) | (41,529) | |||
Balance (in shares) at Mar. 31, 2018 | 77,134,683 | 41,309 | |||
Balance at Mar. 31, 2018 | $ 77 | 481,781 | $ (234) | (396,392) | 85,232 |
Balance (in shares) at Dec. 31, 2018 | 83,911,855 | 41,309 | |||
Balance at Dec. 31, 2018 | $ 84 | 552,531 | $ (234) | (528,345) | 24,036 |
Issuance of restricted stock (in shares) | 23,000 | ||||
Warrants issued with debt financing | 993 | 993 | |||
Forfeiture of restricted stock | $ (67,628) | ||||
Issuance of common stock in At-the-Market offering (net of offering costs) (in shares) | 4,715,000 | ||||
Issuance of common stock in At-the-Market offering (net of offering costs) | $ 5 | 27,494 | 27,499 | ||
Compensation in respect of restricted stock and options granted to employees, directors and consultants | 1,882 | 1,882 | |||
Net loss | (35,156) | (35,156) | |||
Balance (in shares) at Mar. 31, 2019 | 88,582,227 | 41,309 | |||
Balance at Mar. 31, 2019 | $ 89 | $ 582,900 | $ (234) | $ (563,501) | $ 19,254 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (35,156) | $ (41,529) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Noncash stock compensation expense | 1,882 | 7,337 |
Depreciation | 23 | 20 |
Amortization of premium on investment securities | (75) | 2 |
Amortization of debt issuance costs | 77 | 0 |
Non-cash change in lease liability and right-of-use asset | 373 | 0 |
Change in fair value of notes payable and accrued interest | 66 | 96 |
Changes in assets and liabilities: | ||
(Increase) decrease in prepaid research and development and other current assets | (2,454) | 691 |
Decrease in leasehold interest | 46 | 33 |
Decrease in lease liability | (339) | 0 |
Decrease in accrued interest receivable | 14 | 30 |
Increase in accounts payable and accrued expenses | 2,240 | 5,292 |
Increase in interest payable | 549 | 0 |
Decrease in other current liabilities | (559) | 0 |
Increase in deferred rent | 0 | 23 |
Decrease in deferred revenue | (38) | (38) |
Net cash used in operating activities | (33,351) | (28,043) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of equipment | (14) | (24) |
Investment in held-to-maturity securities | (8,171) | (4,184) |
Proceeds from maturity of short-term securities | 7,050 | 6,000 |
Net cash (used in) provided by investing activities | (1,135) | 1,792 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from sale of common stock, net | 27,678 | 52,430 |
Proceeds from debt financings | 29,740 | 0 |
Financing costs paid | (538) | 0 |
Net cash provided by financing activities | 56,880 | 52,430 |
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 22,394 | 26,179 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD | 43,199 | 57,305 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD | 65,593 | 83,484 |
Reconciliation to amounts on consolidated balance sheets: | ||
Total cash, cash equivalents and restricted cash | 65,593 | 57,305 |
NONCASH TRANSACTIONS | ||
Accrued offering costs | 179 | 0 |
Deferred financing costs | 1,157 | 0 |
Warrants issued with debt financing | $ 993 | $ 0 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | Description of Business We are a biopharmaceutical company dedicated to developing and delivering medicines for patients with B-cell mediated diseases, including Chronic Lymphocytic Leukemia (CLL), non-Hodgkin Lymphoma (NHL) and Multiple Sclerosis (MS). We have developed a robust B-cell directed research and development (R&D) platform for identification of key B-cell pathways of interest and rapid clinical testing. Currently, we have five B-cell targeted drug candidates in clinical development, with the lead two therapies, ublituximab (TG-1101) and umbralisib (TGR-1202), in pivotal trials for CLL and NHL, with ublituximab also in pivotal trials for MS. Ublituximab is a novel anti-CD20 monoclonal antibody (mAb) that has been glycoengineered for enhanced potency over first generation antibodies. Umbralisib is an oral, once daily inhibitor of PI3K delta. Umbralisib also uniquely inhibits CK1-epsilon, which may allow it to overcome certain tolerability issues associated with first generation PI3K delta inhibitors. When used together in combination therapy, ublituximab and umbralisib are referred to as "U2". Additionally, we have recently brought into Phase 1 clinical development TG-1501, an anti-PD-L1 monoclonal antibody, TG-1701, a covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, and TG-1801, an anti-CD47/CD19 bispecific antibody. 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, 2018. The accompanying condensed December 31, 2018 balance sheet has been derived from these statements. The results of operations for the three months ended March 31, 2019 are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. Liquidity and Capital Resources We have incurred operating losses since our inception, expect to continue to incur operating losses for the foreseeable future, and may never become profitable. As of March 31, 2019, we have an accumulated deficit of approximately $563.5 million. Our major sources of cash have been proceeds from the private placement and public offering of equity securities, as well as debt financings. We have not yet commercialized any of our drug candidates and cannot be sure if we will ever be able to do so. Even if we commercialize one or more of our drug candidates, we may not become profitable. Our ability to achieve profitability depends on many factors, including our ability to obtain regulatory approval for our drug candidates; successfully complete any post-approval regulatory obligations; and successfully commercialize our drug candidates alone or in partnership. We may continue to incur substantial operating losses even if we begin to generate revenues from our drug candidates. As of March 31, 2019, we had $92.5 million in cash and cash equivalents, and investment securities. The Company believes its cash, cash equivalents, and investment securities on hand as of March 31, 2019 along with the additional capital raised in the second quarter of 2019 (see Note 5) will be sufficient to fund the Company’s planned operations through mid-2020. The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for our drug candidates. We are dependent upon significant future financing to provide the cash necessary to execute our current operations, including the commercialization of any of our drug candidates. Our common stock is 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 lease 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 lease standard will continue to be in accordance with ASC 840, Leases. An entity that elects this additional (and optional) transition method must provide the required ASC 840 disclosures for all periods that continue to be in accordance with ASC 840. The amendments do not change the existing disclosure requirements in ASC 840. 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. The Company adopted ASU 2018-11 on January 1, 2019 using a modified retrospective method and will not restate comparative periods. We elected the package of practical expedients permitted under the transition guidance, which allows us to carryforward our historical lease classification and our assessment on whether a contract is or contains a lease. The adoption of this guidance resulted in the addition of material balances of right of use assets and lease liability to our consolidated balance sheets at January 1, 2019, primarily relating to our lease of office space (see Note 8). The impact to our consolidated statements of operations was not material as a result of this standard. 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. The Company adopted ASU 2018-07 on January 1, 2019. The adoption of ASU 2018-07 did not have a material effect on our consolidated financial statements as of January 1, 2019. The adoption of ASU 2018-07 had no impact on nonemployee performance awards as they are measured based on the outcome that is probable. Other pronouncements issued by the FASB or other authoritative accounting standards group 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 U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the applicable reporting period. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation. Actual results could differ from those estimates. Such differences could be material to the financial statements. Cash and Cash Equivalents We treat liquid investments with original maturities of less than three months when purchased as cash and cash equivalents. Restricted Cash We record cash pledged or held in trust as restricted cash. As of March 31, 2019 and December 31, 2018, we have approximately $1.2 million of restricted cash pledged to secure a line of credit as a security deposit for an Office Agreement Investment Securities Investment securities at March 31, 2019 and December 31, 2018 consist of short-term government securities. We classify these securities as held-to-maturity. Held-to-maturity securities are those securities in which we have the ability and intent to hold the security until maturity. Held-to-maturity securities are recorded at amortized cost, adjusted for the amortization or accretion of premiums or discounts. Premiums and discounts are amortized or accreted over the life of the related held-to-maturity security as an adjustment to yield using the effective interest method. A decline in the market value of any investment security below cost, that is deemed to be other than temporary, results in a reduction in the carrying amount to fair value. The impairment is charged to operations and a new cost basis for the security is established. Other-than-temporary impairment charges are included in interest and other income (expense), net. Unrealized gains, if determined to be temporary, are included in accumulated other comprehensive income in equity. Dividend and interest income are recognized when earned. Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents and short-term investments with high-credit quality financial institutions. At times, such amounts may exceed federally-insured limits. Revenue Recognition Effective January 1, 2018, the Company began recognizing revenue under ASC Topic 606, Revenue from Contracts with Customers ● Step 1: Identify the contract with the customer ● Step 2: Identify the performance obligations in the contract ● Step 3: Determine the transaction price ● Step 4: Allocate the transaction price to the performance obligations in the contract ● Step 5: Recognize revenue when the company satisfies a performance obligation In order to identify the performance obligations in a contract with a customer, a company must assess the promised goods or services in the contract and identify each promised good or service that is distinct. A performance obligation meets ASC 606’s definition of a “distinct” good or service (or bundle of goods or services) if both of the following criteria are met: ● The customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct). ● The entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract). If a good or service is not distinct, the good or service is combined with other promised goods or services until a bundle of goods or services is identified that is distinct. The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The transaction price is allocated to each performance obligation on a relative standalone selling price basis. The transaction price allocated to each performance obligation is recognized when that performance obligation is satisfied, at a point in time or over time as appropriate. Research and Development Costs Generally, research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered or the related services are performed, subject to an assessment of recoverability. We make estimates of costs incurred in relation to external clinical research organizations, or CROs, and clinical site costs. We analyze the progress of clinical trials, including levels of patient enrollment, invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. Significant judgments and estimates must be made and used in determining the accrued balance and expense in any accounting period. We review and accrue CRO expenses and clinical trial study expenses based on work performed and rely upon estimates of those costs applicable to the stage of completion of a study. Accrued CRO costs are subject to revisions as such trials progress to completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. With respect to clinical site costs, the financial terms of these agreements are subject to negotiation and vary from contract to contract. Payments under these contracts may be uneven, and depend on factors such as the achievement of certain events, the successful recruitment of patients, the completion of portions of the clinical trial or similar conditions. The objective of our policy is to match the recording of expenses in our financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical site costs are recognized based on our estimate of the degree of completion of the event or events specified in the specific clinical study or trial contract. Prepaid research and development in our consolidated balance sheets includes, among other things, certain 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 March 31, 2019 and December 31, 2018, we recorded approximately $11.1 million and $9.7 million, respectively, in prepaid research and development related to such advance agreements. Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. If the likelihood of realizing the deferred tax assets or liability is less than “more likely than not,” a valuation allowance is then created. We, and our subsidiaries, file income tax returns in the U.S. Federal jurisdiction and in various states. We have tax net operating loss carryforwards that are subject to examination for a number of years beyond the year in which they were generated for tax purposes. Since a portion of these net operating loss carryforwards may be utilized in the future, many of these net operating loss carryforwards will remain subject to examination. We recognize interest and penalties related to uncertain income tax positions in income tax expense. Stock-Based Compensation We recognize all stock-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 stock-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. In addition, because some of the options, restricted stock and warrants issued to employees, consultants and other third-parties vest upon achievement of certain milestones, the total expense is uncertain. Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such 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 periods presented or because such potentially dilutive securities were out of the money and the Company realized net income during the periods presented. The amounts of potentially dilutive securities excluded from the calculation were 6,768,530 and 4,660,180 for the three months ended March 31, 2019 and 2018, respectively. The following outstanding shares of potentially dilutive securities 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 Months Ended March 31, 2019 2018 Unvested restricted stock 4,039,620 4,159,428 Stock options 2,565,310 485,000 Warrants 147,058 -- Shares issuable upon note conversion 16,542 15,752 Total 6,768,530 4,660,180 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. |
CASH AND CASH EQUIVALENTS
CASH AND CASH EQUIVALENTS | 3 Months Ended |
Mar. 31, 2019 | |
Cash and Cash Equivalents [Abstract] | |
CASH AND CASH EQUIVALENTS | The following tables summarize our cash and cash equivalents at March 31, 2019 and December 31, 2018: (in thousands) March 31, 2019 December 31, 2018 Checking and bank deposits $ 62,671 $ 39,268 Money market funds 1,678 2,690 Total $ 64,349 $ 41,958 |
INVESTMENT SECURITIES
INVESTMENT SECURITIES | 3 Months Ended |
Mar. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
INVESTMENT SECURITIES | Our investments as of March 31, 2019 and December 31, 2018 are classified as held-to-maturity. Held-to-maturity investments are recorded at amortized cost. The following tables summarize our investment securities at March 31, 2019 and December 31, 2018: (in thousands) March 31, 2019 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 April 2019 to March 2020) (held-to-maturity) $ 28,113 $ 15 $ 3 $ 28,125 Total short-term investment securities $ 28,113 $ 15 $ 3 $ 28,125 December 31, 2018 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 2019 and November 2019) (held-to-maturity) $ 26,951 $ 2 $ 10 $ 26,943 Total short-term investment securities $ 26,951 $ 2 $ 10 $ 26,943 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 3 Months Ended |
Mar. 31, 2019 | |
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 March 31, 2019 and December 31, 2018, the fair values of cash and cash equivalents, restricted cash, and notes and interest payable approximate their carrying value. At the time of our merger (we were then known as Manhattan Pharmaceuticals, Inc.) 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 to the Ariston subsidiary including accrued and unpaid interest of the 5% Notes was approximately $18.6 million at March 31, 2019 and $18.4 million at December 31, 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 March 31, 2019 and December 31, 2018. 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 March 31, 2019 and December 31, 2018: Financial liabilities at fair value as of March 31, 2019 (in thousands) Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 133 $ 133 Total $ -- $ -- $ 133 $ 133 Financial liabilities at fair value as of December 31, 2018 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 67 $ 67 Total $ -- $ -- $ 67 $ 67 The Level 3 amounts above represent the fair value of the 5% Notes and related accrued interest. The Company’s financial instruments include cash, cash equivalents consisting of money market funds, accounts payable and debt. Cash, cash equivalents, accounts payable and debt are stated at their respective historical carrying amounts, which approximate fair value due to their short-term nature. The following table summarizes the changes in Level 3 instruments during the three months ended March 31, 2019: (in thousands) Fair value at December 31, 2018 $ 67 Interest accrued on face value of 5% Notes 224 Change in fair value of Level 3 liabilities (158 ) Fair value at March 31, 2019 $ 133 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 | 3 Months Ended |
Mar. 31, 2019 | |
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 March 2019, we completed an underwritten public offering of 4,100,000 shares of our common stock (plus a 30-day underwriter overallotment option to purchase up to an additional 615,000 shares of common stock, which was exercised), at a price of $5.87 per share. Proceeds from this offering, including the overallotment, after underwriting discounts and offering expenses were approximately $27.7 million. Subsequent to the first quarter, through May 10, 2019, we sold an aggregate of 3,030,611 shares of common stock pursuant to the 2017 ATM for total gross proceeds of approximately $24.6 million at an average selling price of $8.11 per share, resulting in net proceeds of approximately $24.2 million after deducting commissions and other transactions costs. The 2017 S-3 is currently our only active shelf registration statement. After deducting shares already sold there is approximately $84.2 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. As of March 31, 2019, 5,539,620 shares of restricted stock and 2,565,310 options were outstanding and up to an additional 2,612,431 shares may be issued under the 2012 Incentive Plan. Effective as of January 1, 2017, we entered into an amendment (the “Amendment”) to the employment agreement entered into as of December 15, 2011 (together with the Amendment, the “Employment Agreement”) with Michael S. Weiss, our Executive Chairman and Chief Executive Officer and President. Under the Amendment, Mr. Weiss will remain as Chief Executive Officer and President, removing the interim status. Simultaneously, we entered into a Strategic Advisory Agreement (the “Advisory Agreement”) with Caribe BioAdvisors, LLC (the “Advisor”) owned by Mr. Weiss to provide the services of Mr. Weiss as Chairman of the Board and as Executive Chairman. As part of the Amendment, Mr. Weiss also agreed to forfeit 3,381,866 restricted shares previously granted under the Employment Agreement that were predominantly subject to time-based vesting over the next three years. Simultaneously, (i) Mr. Weiss was issued 418,371 restricted shares under the Employment Agreement that vest in 2018 and 2019 and (ii) the Advisor was issued 2,960,000 restricted shares under the Advisory Agreement that vested on market capitalization thresholds ranging from $375 million to $750 million. In accordance with GAAP, there was no incremental stock compensation expense recognition as a result of the modification. Stock Options The following table summarizes stock option activity for the three months ended March 31, 2019: Number of shares Weighted-average exercise price Weighted-average Contractual Term Aggregate Intrinsic Value (in years) Outstanding at December 31, 2018 1,916,900 $ 6.50 9.75 $ -- Granted 715,000 6.90 Exercised -- -- Forfeited (66,590 ) 6.80 Expired -- -- Outstanding at March 31, 2019 2,565,310 $ 6.61 9.63 $ 5,800,421 Expected to vest at March 31, 2019 2,565,310 $ 6.61 9.63 $ 5,800,421 Exercisable at March 31, 2019 -- $ -- -- $ -- Total expense associated with the stock options was approximately $0.7 million and zero during the three months ended March 31, 2019 and 2018, respectively. As of March 31, 2019, the stock options outstanding include options granted to both employees and non-employees which are both time-based and milestone-based. Stock-based compensation for milestone-based options will be recorded if and when a milestone occurs. The fair value of the Company's option awards were estimated using the assumptions below: Three months ended March 31, 2019 Volatility 204.59-291.61 Expected term (in years) 5.0-6.25 Risk-free rate 2.40-2.49 % Expected dividend yield -- % 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 three months ended March 31, 2019: Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2018 6,095,692 $ 8.07 Granted 23,000 12.95 Vested (511,444 ) 8.64 Forfeited (67,628 ) 7.54 Outstanding at March 31, 2019 5,539,620 $ 7.95 Total expense associated with restricted stock grants was approximately $1.2 million and $7.3 million during the three months ended March 31, 2019 and 2018, respectively. As of March 31, 2019, there was approximately $5.6 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 1.43 years. This amount does not include, as of March 31, 2019, 3,003,011 shares of restricted stock outstanding which are milestone-based and vest upon certain corporate milestones. Until the measurement date is reached for milestone awards, the total amount of compensation expense remains uncertain. We record compensation expense based on the fair value of the award at the grant date. Warrants The following table summarizes warrant activity for the three months ended March 31, 2019: Warrants Weighted- average exercise price Aggregate Intrinsic Value Outstanding at December 31, 2018 -- $ -- $ -- Issued 147,058 4.08 Exercised -- -- Expired -- -- Outstanding at March 31, 2019 147,058 $ 4.08 $ 582,350 Stock-Based Compensation The following table summarizes stock-based compensation expense information about restricted stock and stock options for the three months ended March 31, 2019 and 2018: Three months ended March 31, (in thousands) 2019 2018 Stock-based compensation expense associated with restricted stock $ 1,177 $ 7,337 Stock-based compensation expense associated with option grants 705 -- Total $ 1,882 $ 7,337 |
OTHER LIABILITIES
OTHER LIABILITIES | 3 Months Ended |
Mar. 31, 2019 | |
Other Liabilities [Abstract] | |
OTHER LIABILITIES | The following is a summary of Notes Payable included in other current liabilities on the Company’s condensed consolidated balance sheet: March 31, 2019 December 31, 2018 (in thousands) Current portion, net Non-current portion, net Total Current portion, net Non-current portion, net Total Convertible 5% Notes Payable $ 133 $ -- $ 133 $ 67 $ -- $ 67 Total $ 133 $ -- $ 133 $ 67 $ -- $ 67 Convertible 5% Notes Payable The 5% Notes and accrued and unpaid interest thereon are convertible at the option of the holder into common stock at the conversion price of $1,125 per share. We have no obligation under the 5% Notes aside from (a) 50% of the net product cash flows from Ariston’s product candidates, if any, payable to noteholders; and (b) the conversion feature, discussed above. The cumulative liability including accrued and unpaid interest of these notes was approximately $18.6 million at March 31, 2019 and $18.4 million at December 31, 2018. No payments have been made on the 5% Notes as of March 31, 2019. 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). Current Liabilities In 2018, we entered into an agreement with a contract manufacturer for the clinical and potential commercial supply of one of our product candidates. As part of this agreement, the contract manufacturer has agreed to defer payment of certain costs and expenses under the agreement in exchange for the payment of an administrative fee. To date we have incurred expenses related to this agreement of approximately $18.6 million as of March 31, 2019 which includes both service fees and raw material costs. No payments have been made to the contract manufacturer as of March 31, 2019. Accordingly, as of March 31, 2019, $17.8 million is included in current liabilities and $0.8 million is included in accounts payable in the Company’s unaudited condensed consolidated balance sheet. As of December 31, 2018, $18.4 million is included in long term liabilities in the Company’s audited consolidated balance sheet. All costs incurred to date are due in the first quarter of 2020. We will incur an administrative fee of six percent (6%) per year starting from the date of invoice issuance. As of March 31, 2019 we have accrued $0.3 million in administrative fees in connection with these costs, which has been included in interest expense in the Company’s unaudited condensed consolidated statements of operations. |
LONG-TERM DEBT
LONG-TERM DEBT | 3 Months Ended |
Mar. 31, 2019 | |
Long-term Debt, Unclassified [Abstract] | |
LONG-TERM DEBT | On February 28, 2019 (the “Closing Date”), the Company (“Borrower”) entered into a term loan facility of up to $60.0 million (“Term Loan”) with Hercules Capital, Inc., (“Hercules”), the proceeds of which will be used for its ongoing research and development programs and for general corporate purposes. The Term Loan is governed by a loan and security agreement, dated February 28, 2019 (the “Loan Agreement”), which provides for up to four separate advances. The first advance of $30.0 million was drawn on the Closing Date. Two additional advances of $10.0 million may be drawn at the Borrower’s option but subject to the clinical trial milestones, and the fourth advance of $10.0 million, available in minimum increments of $5.0 million, is available through December 15, 2020 subject to the approval of Hercules’ investment committee. The Term Loan will mature on March 1, 2022 (the “Loan Maturity Date”). Each advance accrues interest at a per annum rate of interest equal to the greater of either (i) the “prime rate” as reported in The Wall Street Journal plus 4.75%, and (ii) 10.25%. The Term Loan provides for interest-only payments until October 1, 2020. The interest-only period may be extended to April 1, 2021 if the Borrower, on or before September 30, 2020, achieves either the third milestone or the Company has raised at least an amount equal to $150.0 million in unrestricted net cash proceeds from one or more equity financings, subordinated indebtedness and/or upfront proceeds from business development transactions permitted under the Loan Agreement, in each case after February 7, 2019, and prior to September 30, 2020. Thereafter, amortization payments will be payable monthly in eighteen installments (or, if the period requiring interest-only payments has been extended to April 1, 2021, in twelve installments) of principal and interest (subject to recalculation upon a change in prime rates). At its option upon seven business days’ prior written notice to Hercules, the Company may prepay all or any portion greater than or equal to $5.0 million of the outstanding advances by paying the entire principal balance (or portion thereof), all accrued and unpaid interest, subject to a prepayment charge of 3.0%, if such advance is prepaid in any of the first twelve months following the Closing Date, 1.5%, if such advance is prepaid after twelve months following the Closing Date but on or prior to twenty-four months following the Closing Date, and 0% thereafter. In addition, an end of term charge equal to 3.25% of the aggregate principal amount of the loan extended by Hercules is due on the maturity date. Amounts outstanding during an event of default shall be payable on demand and shall accrue interest at an additional rate of 4.0% per annum of the past due amount outstanding. The Term Loan is secured by a lien on substantially all of the assets of the Borrower, other than intellectual property and contains customary covenants and representations, including a liquidity covenant, financial reporting covenant and limitations on dividends, indebtedness, collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, deposit accounts, and subsidiaries. The events of default under the Loan Agreement include, without limitation, and subject to customary grace periods, (1) the Borrower’s failure to make any payments of principal or interest under the Loan Agreement, promissory notes or other loan documents, (2) the Borrower’s breach or default in the performance of any covenant under the Loan Agreement, (3) the occurrence of a material adverse effect, (4) the Borrower making a false or misleading representation or warranty in any material respect, (5) the Borrower’s insolvency or bankruptcy, (6) certain attachments or judgments on the Borrower’s assets, or (7) the occurrence of any material default under certain agreements or obligations of the Borrower involving indebtedness in excess of $750,000. If an event of default occurs, Hercules is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement. The Loan Agreement also contains warrant coverage of 2% of the total amount funded. A warrant (the “Warrant”) was issued by Borrower to Hercules to purchase 147,058 shares of common stock with an exercise price of $4.08. The Warrant shall be exercisable for seven years from the date of issuance. Hercules may exercise the Warrant either by (a) cash or check or (b) through a net issuance conversion. The shares will be registered and freely tradeable within six months of issuance. The Company accounted for the Warrant as an equity instrument since it was indexed to the Company’s common shares and met the criteria for classification in shareholders’ equity. The relative fair value of the Warrant on the date of issuance was approximately $1.0 million and was treated as an offset to the Term Loan. This amount will be amortized to interest expense using the effective interest method over the life of the Term Loan. The Company estimated the fair value of the Warrant using the Black-Scholes model based on the following key assumptions: Exercise Price $ 4.08 Common share price on date of issuance $ 6.80 Volatility 195.9 % Risk-free interest rate 2.63 % Expected dividend yield -- % Contractual term (in years) 7.00 years The Company incurred financing expenses of $2.8 million related to the Hercules Loan Agreement which are recorded as an offset to long-term debt on the Company's condensed consolidated balance sheet. The debt issuance costs are being amortized over the term of the debt using the effective interest method and are included in interest expense in the Company’s unaudited condensed consolidated statements of operations. Amortization of debt issuance costs was $0.1 million and zero for the three months ended March 31, 2019. At March 31, 2019, the remaining unamortized balance of debt issuance costs were $2.7 million. Long-term debt as of as of March 31, 2019, is as follows (in thousands): March 31, 2019 Long-term debt $ 30,000 End of term fee 975 30,975 Less: unamortized debt issuance costs (2,689 ) 28,286 Less: Current portion -- Long-term debt– non-current $ 28,286 |
LEASES
LEASES | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
LEASES | 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 months ended March 31, 2019, we recognized a lease liability of $9.4 million, with a corresponding Right of Use (ROU) asset of $7.9 million based on the present value of the remaining lease payments for all of our leased office spaces, the majority of which is comprised of our New York City office space. Our leases have remaining lease terms of 1 year to 12 years. One lease has a renewal option to extend the lease for an additional term of 2 years. After an initial commitment period 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. Also in connection with this lease, in October 2014 we pledged $0.6 million to secure a line of credit as a security deposit for the Office Agreement, which has been recorded as restricted cash in the accompanying consolidated balance sheets. Additional collateral of $0.6 million was pledged in April 2018 to increase the letter of credit for the office space. The following components of lease expense are included in the Company's consolidated statements of operations for the three months ended March 31, 2019: (in thousands) March 31, 2019 Operating lease cost $ 418 Net lease cost $ 418 As of March 31, 2019, the weighted-average remaining operating lease term was 9.75 years and the weighted-average discount rate for operating leases was 10.25%. Cash paid for amounts included in the measurement of operating lease liabilities in the first quarter of fiscal 2019 was $0.3 million. The balance sheet classification of lease liabilities was as follows: (in thousands) March 31, 2019 Liabilities Lease liability – current portion $ 1,261 Lease liability – non-current 8,182 Total lease liability $ 9,443 As of March 31, 2019, the maturities of lease liabilities were as follows: (in thousands) Operating leases Remainder of 2019 $ 1,023 2020 1,348 2021 1,353 2022 1,376 2023 1,367 After 2023 10,281 Total lease payments 16,748 Less: Interest (7,305 ) Present value of lease liabilities(*) $ 9,443 (*) As our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date and considering the term of the lease to determine the present value of lease payments. We used the incremental borrowing rate of 10.25% on February 28, 2019, for operating leases that commenced prior to that date. |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 3 Months Ended |
Mar. 31, 2019 | |
License Agreement [Abstract] | |
LICENSE AGREEMENTS | TG-1101 (Ublituximab) In November 2012, we entered into an exclusive (within the territory) sublicense agreement with Ildong Pharmaceutical Co. Ltd. (“Ildong”) relating to the development and commercialization of ublituximab 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 ublituximab 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, is being recognized as license revenue on a straight-line basis over the life of the agreement, which is through the expiration of the last licensed patent right or 15 years after the first commercial sale of a product in such country, unless the agreement is earlier terminated, and represents the estimated period over which we will have certain ongoing responsibilities under the sublicense agreement. We recorded license revenue of approximately $38,000 for each of the three months ended March 31, 2019 and 2018, and, at March 31, 2019 and December 31, 2018, have deferred revenue of approximately $1.0 million, and $1.1 million, respectively, associated with this $2 million payment (approximately $152,000 of which has been classified in current liabilities at March 31, 2019 and December 31, 2018). 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 ublituximab in the sublicense territory. TG-1701: BTK In January 2018, we entered into a global exclusive license agreement with Jiangsu Hengrui Medicine Co. (“Hengrui”), 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 Hengrui’s Bruton’s Tyrosine Kinase inhibitors containing the compounds of either TG-1701 (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 recorded to non-cash stock expense associated with in-licensing agreements in our consolidated statement of operations. 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 recorded to non-cash stock expense associated with in-licensing agreements in our consolidated statement of operations. 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 | 3 Months Ended |
Mar. 31, 2019 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | 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 months ended March 31, 2019, we recognized a lease liability of $9.4 million, with a corresponding Right of Use (ROU) asset of $7.9 million based on the present value of the remaining lease payments for all of our leased office spaces, the majority of which is comprised of our New York City office space. 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 build-out costs have been recorded in Leasehold Interest, net on the Company’s consolidated balance sheets and will be amortized over the 15-year term of the Office Agreement. After an initial commitment period 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. Also in connection with this lease, in October 2014 we pledged $0.6 million to secure a line of credit as a security deposit for the Office Agreement, which has been recorded as restricted cash in the accompanying consolidated balance sheets. Additional collateral of $0.6 million was pledged in April 2018 to increase the letter of credit for the office space. 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 $0.2 million and $0.4 million for shared services for the three months ended March 31, 2019 and 2018, respectively, primarily related to shared personnel. In March 2015, we entered into a Global Collaboration Agreement (“Collaboration Agreement”) with Checkpoint for the development and commercialization of anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies. We incurred expenses of approximately $0.3 million and zero for the three months ended March 31, 2019 and 2018, related mainly to manufacturing costs of PD-L1. The relevant expenses are recorded in other research and development in the accompanying condensed consolidated statement of operations. |
LITIGATION
LITIGATION | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
LITIGATION | In October 2018, a purported securities class action complaint was filed in the U.S. District Court for the Southern District of New York (the “Southern District”) 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 was captioned Randall Reinmann v. TG Therapeutics Inc., and Michael S. Weiss, Case No. 1:18-cv-09104-KPF. The complaint alleged 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. In December 2018, the Southern District appointed Co-Lead Plaintiffs to represent the putative class, and approved their selection of Lead Counsel. On March 1, 2019, Co-Lead Plaintiffs filed a notice with the Southern District seeking to voluntarily dismiss the action in its entirety without prejudice, which was so-ordered by the Southern District the same day. In addition, on December 18, 2018, a related shareholder derivative litigation was filed in the Southern District against the Company’s directors and one of its officers in litigation captioned Thessalus Capital v. Weiss, et al., 1:18-cv-11918-KPF. The Company was named only as a nominal defendant. The suit alleged that the officer and directors breached their fiduciary duties to the Company, wasted corporate assets, and violated the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder in connection with the Company’s alleged failure to disclose various facts and circumstances regarding its UNITY-CLL study. The plaintiff asserted that the alleged disclosure violations concerning the Company’s UNITY-CLL study caused the Company to incur losses, including defense costs, and further alleged that the named officer and directors received excessive compensation. On April 17, 2019, the plaintiff filed a notice with the Southern District seeking to voluntarily dismiss the action in its entirety without prejudice, which was so-ordered by the Southern District on April 18, 2019. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Description of Business | We are a biopharmaceutical company dedicated to developing and delivering medicines for patients with B-cell mediated diseases, including Chronic Lymphocytic Leukemia (CLL), non-Hodgkin Lymphoma (NHL) and Multiple Sclerosis (MS). We have developed a robust B-cell directed research and development (R&D) platform for identification of key B-cell pathways of interest and rapid clinical testing. Currently, we have five B-cell targeted drug candidates in clinical development, with the lead two therapies, ublituximab (TG-1101) and umbralisib (TGR-1202), in pivotal trials for CLL and NHL, with ublituximab also in pivotal trials for MS. Ublituximab is a novel anti-CD20 monoclonal antibody (mAb) that has been glycoengineered for enhanced potency over first generation antibodies. Umbralisib is an oral, once daily inhibitor of PI3K delta. Umbralisib also uniquely inhibits CK1-epsilon, which may allow it to overcome certain tolerability issues associated with first generation PI3K delta inhibitors. When used together in combination therapy, ublituximab and umbralisib are referred to as "U2". Additionally, we have recently brought into Phase 1 clinical development TG-1501, an anti-PD-L1 monoclonal antibody, TG-1701, a covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, and TG-1801, an anti-CD47/CD19 bispecific antibody. 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, 2018. The accompanying condensed December 31, 2018 balance sheet has been derived from these statements. The results of operations for the three months ended March 31, 2019 are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. |
Liquidity and Capital Resources | We have incurred operating losses since our inception, expect to continue to incur operating losses for the foreseeable future, and may never become profitable. As of March 31, 2019, we have an accumulated deficit of approximately $563.5 million. Our major sources of cash have been proceeds from the private placement and public offering of equity securities, as well as debt financings. We have not yet commercialized any of our drug candidates and cannot be sure if we will ever be able to do so. Even if we commercialize one or more of our drug candidates, we may not become profitable. Our ability to achieve profitability depends on many factors, including our ability to obtain regulatory approval for our drug candidates; successfully complete any post-approval regulatory obligations; and successfully commercialize our drug candidates alone or in partnership. We may continue to incur substantial operating losses even if we begin to generate revenues from our drug candidates. As of March 31, 2019, we had $92.5 million in cash and cash equivalents, and investment securities. The Company believes its cash, cash equivalents, and investment securities on hand as of March 31, 2019 along with the additional capital raised in the second quarter of 2019 (see Note 5) will be sufficient to fund the Company’s planned operations through mid-2020. The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for our drug candidates. We are dependent upon significant future financing to provide the cash necessary to execute our current operations, including the commercialization of any of our drug candidates. Our common stock is 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 lease 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 lease standard will continue to be in accordance with ASC 840, Leases. An entity that elects this additional (and optional) transition method must provide the required ASC 840 disclosures for all periods that continue to be in accordance with ASC 840. The amendments do not change the existing disclosure requirements in ASC 840. 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. The Company adopted ASU 2018-11 on January 1, 2019 using a modified retrospective method and will not restate comparative periods. We elected the package of practical expedients permitted under the transition guidance, which allows us to carryforward our historical lease classification and our assessment on whether a contract is or contains a lease. The adoption of this guidance resulted in the addition of material balances of right of use assets and lease liability to our consolidated balance sheets at January 1, 2019, primarily relating to our lease of office space (see Note 8). The impact to our consolidated statements of operations was not material as a result of this standard. 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. The Company adopted ASU 2018-07 on January 1, 2019. The adoption of ASU 2018-07 did not have a material effect on our consolidated financial statements as of January 1, 2019. The adoption of ASU 2018-07 had no impact on nonemployee performance awards as they are measured based on the outcome that is probable. Other pronouncements issued by the FASB or other authoritative accounting standards group 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 U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the applicable reporting period. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation. Actual results could differ from those estimates. Such differences could be material to the financial statements. |
Cash and Cash Equivalents | We treat liquid investments with original maturities of less than three months when purchased as cash and cash equivalents. |
Restricted Cash | We record cash pledged or held in trust as restricted cash. As of March 31, 2019 and December 31, 2018, we have approximately $1.2 million of restricted cash pledged to secure a line of credit as a security deposit for an Office Agreement |
Investment Securities | Investment securities at March 31, 2019 and December 31, 2018 consist of short-term government securities. We classify these securities as held-to-maturity. Held-to-maturity securities are those securities in which we have the ability and intent to hold the security until maturity. Held-to-maturity securities are recorded at amortized cost, adjusted for the amortization or accretion of premiums or discounts. Premiums and discounts are amortized or accreted over the life of the related held-to-maturity security as an adjustment to yield using the effective interest method. A decline in the market value of any investment security below cost, that is deemed to be other than temporary, results in a reduction in the carrying amount to fair value. The impairment is charged to operations and a new cost basis for the security is established. Other-than-temporary impairment charges are included in interest and other income (expense), net. Unrealized gains, if determined to be temporary, are included in accumulated other comprehensive income in equity. Dividend and interest income are recognized when earned. |
Credit Risk | Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents and short-term investments with high-credit quality financial institutions. At times, such amounts may exceed federally-insured limits. |
Revenue Recognition | Effective January 1, 2018, the Company began recognizing revenue under ASC Topic 606, Revenue from Contracts with Customers ● Step 1: Identify the contract with the customer ● Step 2: Identify the performance obligations in the contract ● Step 3: Determine the transaction price ● Step 4: Allocate the transaction price to the performance obligations in the contract ● Step 5: Recognize revenue when the company satisfies a performance obligation In order to identify the performance obligations in a contract with a customer, a company must assess the promised goods or services in the contract and identify each promised good or service that is distinct. A performance obligation meets ASC 606’s definition of a “distinct” good or service (or bundle of goods or services) if both of the following criteria are met: ● The customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct). ● The entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract). If a good or service is not distinct, the good or service is combined with other promised goods or services until a bundle of goods or services is identified that is distinct. The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The transaction price is allocated to each performance obligation on a relative standalone selling price basis. The transaction price allocated to each performance obligation is recognized when that performance obligation is satisfied, at a point in time or over time as appropriate. |
Research and Development Costs | Generally, research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered or the related services are performed, subject to an assessment of recoverability. We make estimates of costs incurred in relation to external clinical research organizations, or CROs, and clinical site costs. We analyze the progress of clinical trials, including levels of patient enrollment, invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. Significant judgments and estimates must be made and used in determining the accrued balance and expense in any accounting period. We review and accrue CRO expenses and clinical trial study expenses based on work performed and rely upon estimates of those costs applicable to the stage of completion of a study. Accrued CRO costs are subject to revisions as such trials progress to completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. With respect to clinical site costs, the financial terms of these agreements are subject to negotiation and vary from contract to contract. Payments under these contracts may be uneven, and depend on factors such as the achievement of certain events, the successful recruitment of patients, the completion of portions of the clinical trial or similar conditions. The objective of our policy is to match the recording of expenses in our financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical site costs are recognized based on our estimate of the degree of completion of the event or events specified in the specific clinical study or trial contract. Prepaid research and development in our consolidated balance sheets includes, among other things, certain 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 March 31, 2019 and December 31, 2018, we recorded approximately $11.1 million and $9.7 million, respectively, in prepaid research and development related to such advance agreements. |
Income Taxes | Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. If the likelihood of realizing the deferred tax assets or liability is less than “more likely than not,” a valuation allowance is then created. We, and our subsidiaries, file income tax returns in the U.S. Federal jurisdiction and in various states. We have tax net operating loss carryforwards that are subject to examination for a number of years beyond the year in which they were generated for tax purposes. Since a portion of these net operating loss carryforwards may be utilized in the future, many of these net operating loss carryforwards will remain subject to examination. We recognize interest and penalties related to uncertain income tax positions in income tax expense. |
Stock-Based Compensation | We recognize all stock-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 stock-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. In addition, because some of the options, restricted stock and warrants issued to employees, consultants and other third-parties vest upon achievement of certain milestones, the total expense is uncertain. Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such 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 periods presented or because such potentially dilutive securities were out of the money and the Company realized net income during the periods presented. The amounts of potentially dilutive securities excluded from the calculation were 6,768,530 and 4,660,180 for the three months ended March 31, 2019 and 2018, respectively. The following outstanding shares of potentially dilutive securities 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 Months Ended March 31, 2019 2018 Unvested restricted stock 4,039,620 4,159,428 Stock options 2,565,310 485,000 Warrants 147,058 -- Shares issuable upon note conversion 16,542 15,752 Total 6,768,530 4,660,180 |
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. |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Three Months Ended March 31, 2019 2018 Unvested restricted stock 4,039,620 4,159,428 Stock options 2,565,310 485,000 Warrants 147,058 -- Shares issuable upon note conversion 16,542 15,752 Total 6,768,530 4,660,180 |
CASH AND CASH EQUIVALENTS (Tabl
CASH AND CASH EQUIVALENTS (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash and Cash Equivalents | (in thousands) March 31, 2019 December 31, 2018 Checking and bank deposits $ 62,671 $ 39,268 Money market funds 1,678 2,690 Total $ 64,349 $ 41,958 |
INVESTMENT SECURITIES (Tables)
INVESTMENT SECURITIES (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Held-to-maturity Securities | (in thousands) March 31, 2019 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 April 2019 to March 2020) (held-to-maturity) $ 28,113 $ 15 $ 3 $ 28,125 Total short-term investment securities $ 28,113 $ 15 $ 3 $ 28,125 December 31, 2018 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 2019 and November 2019) (held-to-maturity) $ 26,951 $ 2 $ 10 $ 26,943 Total short-term investment securities $ 26,951 $ 2 $ 10 $ 26,943 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value, Liabilities Measured on Recurring and Nonrecurring Basis | Financial liabilities at fair value as of March 31, 2019 (in thousands) Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 133 $ 133 Total $ -- $ -- $ 133 $ 133 Financial liabilities at fair value as of December 31, 2018 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 67 $ 67 Total $ -- $ -- $ 67 $ 67 |
Change In Level Three Fair Value During Period | (in thousands) Fair value at December 31, 2018 $ 67 Interest accrued on face value of 5% Notes 224 Change in fair value of Level 3 liabilities (158 ) Fair value at March 31, 2019 $ 133 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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, 2018 1,916,900 $ 6.50 9.75 $ -- Granted 715,000 6.90 Exercised -- -- Forfeited (66,590 ) 6.80 Expired -- -- Outstanding at March 31, 2019 2,565,310 $ 6.61 9.63 $ 5,800,421 Expected to vest at March 31, 2019 2,565,310 $ 6.61 9.63 $ 5,800,421 Exercisable at March 31, 2019 -- $ -- -- $ -- |
Schedule of Fair Value Assumptions | Three months ended March 31, 2019 Volatility 204.59-291.61 Expected term (in years) 5.0-6.25 Risk-free rate 2.40-2.49 % Expected dividend yield -- % |
Schedule of Nonvested Restricted Stock Units Activity | Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2018 6,095,692 $ 8.07 Granted 23,000 12.95 Vested (511,444 ) 8.64 Forfeited (67,628 ) 7.54 Outstanding at March 31, 2019 5,539,620 $ 7.95 |
Schedule of Warrant Activity | Warrants Weighted- average exercise price Aggregate Intrinsic Value Outstanding at December 31, 2018 -- $ -- $ -- Issued 147,058 4.08 Exercised -- -- Expired -- -- Outstanding at March 31, 2019 147,058 $ 4.08 $ 582,350 |
Schedule of Stock-Based Compensation | Three months ended March 31, (in thousands) 2019 2018 Stock-based compensation expense associated with restricted stock $ 1,177 $ 7,337 Stock-based compensation expense associated with option grants 705 -- Total $ 1,882 $ 7,337 |
OTHER LIABILITIES (Tables)
OTHER LIABILITIES (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | March 31, 2019 December 31, 2018 (in thousands) Current portion, net Non-current portion, net Total Current portion, net Non-current portion, net Total Convertible 5% Notes Payable $ 133 $ -- $ 133 $ 67 $ -- $ 67 Total $ 133 $ -- $ 133 $ 67 $ -- $ 67 |
LONG-TERM DEBT (Tables)
LONG-TERM DEBT (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Long-term Debt | |
Key Assumptions | Exercise Price $ 4.08 Common share price on date of issuance $ 6.80 Volatility 195.9 % Risk-free interest rate 2.63 % Expected dividend yield -- % Contractual term (in years) 7.00 years |
Schedule of Long-Term Debt | March 31, 2019 Long-term debt $ 30,000 End of term fee 975 30,975 Less: unamortized debt issuance costs (2,689 ) 28,286 Less: Current portion -- Long-term debt– non-current $ 28,286 |
LEASES (Tables)
LEASES (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases | |
Lease Cost | (in thousands) March 31, 2019 Operating lease cost $ 418 Net lease cost $ 418 |
Balance Sheet Classification of Lease Liabilities | (in thousands) March 31, 2019 Liabilities Lease liability – current portion $ 1,261 Lease liability – non-current 8,182 Total lease liability $ 9,443 |
Lease Liability Maturity | (in thousands) Operating leases Remainder of 2019 $ 1,023 2020 1,348 2021 1,353 2022 1,376 2023 1,367 After 2023 10,281 Total lease payments 16,748 Less: Interest (7,305 ) Present value of lease liabilities(*) $ 9,443 |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Significant Accounting Policies [Line Items] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 6,768,530 | 4,660,180 |
Unvested Restricted Shares [Member] | ||
Significant Accounting Policies [Line Items] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 4,039,620 | 4,159,428 |
Stock Options [Member] | ||
Significant Accounting Policies [Line Items] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 2,565,310 | 485,000 |
Warrants [Member] | ||
Significant Accounting Policies [Line Items] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 147,058 | 0 |
Share Issuable Upon Note Conversion [Member] | ||
Significant Accounting Policies [Line Items] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 16,542 | 15,752 |
ORGANIZATION AND SUMMARY OF S_5
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | |||
Accumulated deficit | $ (563,501) | $ (528,345) | |
Restricted cash and investments | 1,200 | 1,200 | |
Prepaid research and development | $ 11,120 | $ 9,691 | |
Potentially dilutive securities excluded from calculation | 6,768,530 | 4,660,180 |
CASH AND CASH EQUIVALENTS (Deta
CASH AND CASH EQUIVALENTS (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 |
Cash and Cash Equivalents [Abstract] | |||
Checking and bank deposits | $ 62,671 | $ 39,268 | |
Money market funds | 1,678 | 2,690 | |
Total | $ 64,349 | $ 41,958 | $ 82,896 |
INVESTMENT SECURITIES (Details)
INVESTMENT SECURITIES (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Schedule of Held-to-maturity Securities [Line Items] | ||
Amortized cost, as adjusted | $ 28,113 | $ 26,951 |
Gross unrealized holding gains | 15 | 2 |
Gross unrealized holding losses | 3 | 10 |
Estimated fair value | 28,125 | 26,943 |
Short-term Investments [Member] | US Government Agencies Debt Securities [Member] | ||
Schedule of Held-to-maturity Securities [Line Items] | ||
Amortized cost, as adjusted | 28,113 | 26,951 |
Gross unrealized holding gains | 15 | 2 |
Gross unrealized holding losses | 3 | 10 |
Estimated fair value | $ 28,125 | $ 26,943 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
5% Notes | $ 133 | $ 67 |
Totals | 133 | 67 |
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 | 133 | 67 |
Totals | $ 133 | $ 67 |
FAIR VALUE MEASUREMENTS (Deta_2
FAIR VALUE MEASUREMENTS (Details 1) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Fair Value Disclosures [Abstract] | |
Fair value, beginning of period | $ 67 |
Interest accrued on face value of 5% Notes | 224 |
Change in fair value of Level 3 liabilities | (158) |
Fair value, end of period | $ 133 |
FAIR VALUE MEASUREMENTS (Deta_3
FAIR VALUE MEASUREMENTS (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Fair Value Measurements | ||
Cumulative Liability | $ 18,600 | $ 18,400 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Statement of Stockholders' Equity [Abstract] | ||
Number of options, Outstanding Beginning Balance | 1,916,900 | |
Number of options, Granted | 715,000 | |
Number of options, Exercised | 0 | |
Number of options, Forfeited | (66,590) | |
Number of options, Expired | 0 | |
Number of options, Outstanding Ending Balance | 2,565,310 | 1,916,900 |
Number of options, Expected to vest at March 31, 2019 | 2,565,310 | |
Number of options, Exercisable at March 31, 2019 | 0 | |
Weighted - average exercise price, Outstanding Beginning Balance | $ 6.50 | |
Weighted - average exercise price, Granted | 6.90 | |
Weighted - average exercise price, Exercised | 0 | |
Weighted - average exercise price, Forfeited | 6.80 | |
Weighted - average exercise price, Expired | 0 | |
Weighted - average exercise price, Outstanding Ending Balance | 6.61 | $ 6.50 |
Weighted - average exercise price, Expected to vest at March 31, 2019 | 6.61 | |
Weighted - average exercise price, Exercisable at March 31, 2019 | $ 0 | |
Weighted - average Contractual Term | 9 years 7 months 17 days | 9 years 9 months |
Weighted - average Contractual Term, Expected to vest at March 31, 2019 | 9 years 7 months 17 days | |
Aggregate Intrinsic Value, Outstanding Ending Balance | $ 5,800,421 | |
Aggregate Intrinsic Value, Expected to vest at March 31, 2019 | $ 5,800,421 |
STOCKHOLDERS' EQUITY (Details 1
STOCKHOLDERS' EQUITY (Details 1) | 3 Months Ended |
Mar. 31, 2019 | |
Volatility, minimum | 204.59% |
Volatility, maximum | 291.61% |
Risk-free rate, minimum | 2.40% |
Risk-free rate, maximum | 2.49% |
Expected dividend yield | 0.00% |
Minimum | |
Expected term (in years) | 5 years |
Maximum | |
Expected term (in years) | 6 years 3 months |
STOCKHOLDERS' EQUITY (Details 2
STOCKHOLDERS' EQUITY (Details 2) - Restricted Stock [Member] | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
EquityIncentivePlansRestrictedStockActivityLineItemLineItems [Line Items] | |
Number of Shares, Outstanding at Beginning Balance | shares | 6,095,692 |
Number of Shares, Granted | shares | 23,000 |
Number of Shares, Vested | shares | (511,444) |
Number of Shares, Forfeited | shares | (67,628) |
Number of Shares, Outstanding at Ending Balance | shares | 5,539,620 |
Weighted Average Grant Date Fair Value, Outstanding at Begining Balance | $ / shares | $ 8.07 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 12.95 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 8.64 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 7.54 |
Weighted Average Grant Date Fair Value, Outstanding at Ending Balance | $ / shares | $ 7.95 |
STOCKHOLDERS' EQUITY (Details 3
STOCKHOLDERS' EQUITY (Details 3) | 3 Months Ended |
Mar. 31, 2019USD ($)$ / sharesshares | |
Stockholders Equity | |
Number of Warrants, Outstanding at Beginning Balance | 0 |
Number of Warrants, Issued | 147,058 |
Number of Warrants, Exercised | 0 |
Number of Warrants, Expired | 0 |
Number of Warrants, Outstanding at Ending Balance | 147,058 |
Weighted Average Exercise Price, Issued | $ / shares | $ 4.08 |
Weighted Average Exercise Price, Outstanding | $ / shares | $ 4.08 |
Aggregate Intrinsic Value, Outstanding | $ | $ 582,350 |
STOCKHOLDERS' EQUITY (Details 4
STOCKHOLDERS' EQUITY (Details 4) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Stockholders Equity Details 4Abstract | ||
Stock-based compensation expense associated with restricted stock | $ 1,177 | $ 7,337 |
Stock-based compensation expense associated with option grants | 705 | 0 |
Total | $ 1,882 | $ 7,337 |
STOCKHOLDERS' EQUITY (Details N
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 | |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |
Options outstanding | 2,565,310 | 1,916,900 | |
Shares forfeited under the Amendment | 66,590 | ||
Options granted | 715,000 | ||
Stock option expense | $ 705 | $ 0 | |
Restricted stock expense | 1,177 | $ 7,337 | |
Unrecognized compensation expense | $ 5,600 | ||
2017 ATM | |||
Shares sold under plan | 3,030,611 | ||
Gross proceeds from sale off common stock | $ 24,600 | ||
Selling price per share | $ 8.11 | ||
Net proceeds from sale off common stock | $ 24,200 | ||
Common stock available for sale | $ 84,200 |
OTHER LIABILITIES (Details)
OTHER LIABILITIES (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Notes Payable [Line Items] | ||
Notes payable, Current portion, net | $ 133 | $ 67 |
Notes payable, Non-current portion, net | 0 | 0 |
Total | 133 | 67 |
Convertible Notes [Member] | ||
Notes Payable [Line Items] | ||
Notes payable, Current portion, net | 133 | 67 |
Notes payable, Non-current portion, net | 0 | 0 |
Total | $ 133 | $ 67 |
OTHER LIABILITIES (Details Narr
OTHER LIABILITIES (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Other Liabilities | ||
Cumulative Liability | $ 18,600 | $ 18,400 |
Agreement costs included in current liabilities | 17,800 | 0 |
Agreement costs included in noncurrent liabilities | 0 | 18,400 |
Accounts payable | 800 | $ 0 |
Interest expense | $ 300 |
LONG-TERM DEBT (Details)
LONG-TERM DEBT (Details) | 3 Months Ended |
Mar. 31, 2019$ / shares | |
Expected dividend yield | 0.00% |
Warrants [Member] | |
Exercise price | $ 4.08 |
Common share price on date of issuance | $ 6.80 |
Volatility | 195.90% |
Risk-free rate | 2.63% |
Expected dividend yield | 0.00% |
Contractual term (in years) | 7 years |
LONG-TERM DEBT (Details 1)
LONG-TERM DEBT (Details 1) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Longterm Debt Details 1Abstract | ||
Long-term debt | $ 30,000 | |
End of term fee | 975 | |
Long-term debt, gross | 30,975 | |
Less: unamortized debt issuance costs | (2,689) | |
Long-term debt, net | 28,286 | |
Less: Current portion | 0 | |
Long-term debt– non-current | $ 28,286 | $ 0 |
LONG-TERM DEBT (Details Narrati
LONG-TERM DEBT (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Longterm Debt Details Narrative Abstract | ||
Financing expenses, Hercules Loan Agreement | $ 2,800 | |
Amortization of debt issuance costs | 77 | $ 0 |
Unamortized balance of debt issuance costs | $ (2,689) | |
Warrant exercise price | $ 4.08 | |
Warrant fair value | $ 1,000 |
LEASES (Details)
LEASES (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Leases Details Abstract | |
Operating lease cost | $ 418 |
Net lease cost | $ 418 |
LEASES (Details 1)
LEASES (Details 1) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Leases Details Abstract | ||
Lease liability - current portion | $ 1,261 | $ 0 |
Lease liability - non-current | 8,182 | 0 |
Total lease liability | $ 9,443 | $ 0 |
LEASES (Details 2)
LEASES (Details 2) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Leases Details 2Abstract | ||
Remainder of 2019 | $ 1,023 | |
2020 | 1,348 | |
2021 | 1,353 | |
2022 | 1,376 | |
2023 | 1,367 | |
After 2023 | 10,281 | |
Total lease payments | 16,748 | |
Less: Interest | (7,305) | |
Present value of lease liabilities | $ 9,443 | $ 0 |
LEASES (Details Narrative)
LEASES (Details Narrative) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019USD ($)ft² | Dec. 31, 2018USD ($) | |
Lease liability | $ 9,443 | $ 0 |
Right-of-use asset | $ 7,947 | $ 0 |
Office Agreement [Member] | ||
Percentage of occupancy | 45.00% | |
Area of land | ft² | 24,000 | |
Average annual rental payments | $ 1,100 | |
Operating lease, initial commitment period | 15 years | |
Lease liability | $ 9,400 | |
Right-of-use asset | 7,900 | |
Line of credit | 600 | |
Additional collateral pledged | $ 600 | |
Weighted-average remaining operating lease term | 9 years 9 months | |
Weighted-average discount rate for operating leases | 10.25% |
LICENSE AGREEMENTS (Details Nar
LICENSE AGREEMENTS (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2012 | Dec. 31, 2018 | |
License Agreement [Line Items] | ||||
License revenue | $ 38 | $ 38 | ||
TG-1701 [Member] | ||||
License Agreement [Line Items] | ||||
Upfront Fee | 1,000 | |||
TG-1801 [Member] | ||||
License Agreement [Line Items] | ||||
Upfront Fee | 3,000 | |||
TG-1101 [Member] | ||||
License Agreement [Line Items] | ||||
Upfront Fee | $ 2,000 | |||
Income taxes | $ 300 | |||
License revenue | 152 | $ 152 | ||
Deferred Revenue | 1,000 | $ 1,100 | ||
Deferred Revenue, current | $ 152 | $ 152 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Narrative) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019USD ($)ft² | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($) | |
Related Party Transaction [Line Items] | |||
Other research and development | $ 30,896 | $ 32,159 | |
Lease liability | 9,443 | $ 0 | |
Right-of-use asset | $ 7,947 | $ 0 | |
Office Agreement [Member] | |||
Related Party Transaction [Line Items] | |||
Percentage of occupancy | 45.00% | ||
Area of land | ft² | 24,000 | ||
Average annual rental payments | $ 1,100 | ||
Operating lease, initial commitment period | 15 years | ||
Lease liability | $ 9,400 | ||
Right-of-use asset | 7,900 | ||
Line of credit | 600 | ||
Additional collateral pledged | 600 | ||
Shared Services Agreement [Member] | |||
Related Party Transaction [Line Items] | |||
Costs and expenses, related party | 200 | 400 | |
Collaboration Agreement [Member] | |||
Related Party Transaction [Line Items] | |||
Costs and expenses, related party | $ 300 | $ 0 |
Uncategorized Items - tgtx-2019
Label | Element | Value |
Restricted Cash | us-gaap_RestrictedCash | $ 1,244,000 |
Restricted Cash | us-gaap_RestrictedCash | $ 588,000 |