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TymeTG THERAPEUTICS, INC. FORM 10-K (Annual Report) Filed 03/16/17 for the Period Ending 12/31/16 Address Telephone CIK Symbol SIC Code Industry 787 SEVENTH AVENUE NEW YORK, NY 10019 (212) 554-4484 0001001316 TGTX 2834 - Pharmaceutical Preparations Biotechnology & Medical Research Sector Healthcare Fiscal Year 12/31 http://www.edgar-online.com © Copyright 2017, EDGAR Online, Inc. All Rights Reserved. Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use. UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549 FORM 10-K ☒☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2016.OR ☐☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from ________ to ________. Commission File Number 1-32639 TG THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware(State or other jurisdiction ofincorporation or organization)36-3898269(I.R.S. EmployerIdentification No.) 2 Gansevoort St.9 th FloorNew York, New York(Address of principal executive offices) 10014(Zip Code) Registrant’s telephone number, including area code: (212) 554-4484 Securities registered pursuant to Section 12(b) of the Act: Common Stock, Par Value $0.001 Per Share(Title of Class)The Nasdaq Capital Market(Name of Each Exchange on Which Registered) Securities registered pursuant to Section 12(g) of the Act:None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.Yes ☐ No ☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.Yes ☐ No ☒ Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirementsfor the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data Filerequired to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant wasrequired to submit and post such files). Yes ☒ No ☐ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to thebest of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form10-K. ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. Seedefinitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act). (Check one): Large accelerated filer ☐ Accelerated filer ☒Non-accelerated filer ☐ Smaller reporting company ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes ☐ No ☒ The aggregate market value of voting common stock held by non-affiliates of the registrant (assuming, for purposes of this calculation, without conceding,that all executive officers and directors are “affiliates”) was $221,001,116 as of June 30, 2016, based on the closing sale price of such stock as reported on theNASDAQ Capital Market . There were 56,908,544 shares of the registrant’s common stock, $0.001 par value, outstanding as of March 1, 2017. DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s Proxy Statement for the 2016 Annual Meeting of Stockholders are incorporated by reference in Part III of this Annual Report on Form10-K. TG THERAPEUTICS, INC.ANNUAL REPORT ON FORM 10-KFOR THE FISCAL YEAR ENDED DECEMBER 31, 2016 TABLE OF CONTENTS Page SPECIAL CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS 1 PART IITEM 1Business 2ITEM 1ARisk Factors 17ITEM 2Properties 35ITEM 3Legal Proceedings 35 PART II ITEM 5Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 35ITEM 6Selected Financial Data 37ITEM 7Management’s Discussion and Analysis of Financial Condition and Results of Operations 38ITEM 7AQuantitative and Qualitative Disclosure About Market Risk 47ITEM 8Financial Statements and Supplementary Data 47ITEM 9Changes in and Disagreements With Accountants on Accounting and Financial Disclosures 47ITEM 9AControls and Procedures 47ITEM 9BOther Information 49 PART III ITEM 10Directors, Executive Officers and Corporate Governance 49 ITEM 11Executive Compensation 49ITEM 12Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 49ITEM 13Certain Relationships and Related Transactions, and Director Independence 49ITEM 14Principal Accountant Fees and Services 49 PART IV ITEM 15Exhibits and Financial Statement Schedules 50 This Annual Report on Form 10-K contains trademarks and trade names of TG Therapeutics, Inc., including our name and logo. All other trademarks, servicemarks, or trade names referenced in this Annual Report on Form 10-K are the property of their respective owners. SPECIAL CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS Certain matters discussed in this report, including matters discussed under the caption “Management’s Discussion and Analysis of Financial Condition andResults of Operations,” may constitute forward-looking statements for purposes of the Securities Act of 1933, as amended, or the Securities Act, and the SecuritiesExchange Act of 1934, as amended, or the Exchange Act, and involve known and unknown risks, uncertainties and other factors that may cause our actual results,performance or achievements to be materially different from the future results, performance or achievements expressed or implied by such forward-lookingstatements. The words "anticipate," "believe," "estimate," "may," "expect" and similar expressions are generally intended to identify forward-looking statements.Our actual results may differ materially from the results anticipated in these forward-looking statements due to a variety of factors, including, without limitation,those discussed under the captions “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere inthis report, as well as other factors which may be identified from time to time in our other filings with the Securities and Exchange Commission, or the SEC, or inthe documents where such forward-looking statements appear. All written or oral forward-looking statements attributable to us are expressly qualified in theirentirety by these cautionary statements. Such forward-looking statements include, but are not limited to, statements about our: ●expectations for increases or decreases in expenses; ●expectations for the clinical and pre-clinical development, manufacturing, regulatory approval, and commercialization of our pharmaceuticalproduct candidates or any other products we may acquire or in-license; ●use of clinical research centers and other contractors; ●expectations as to the timing of commencing or completing pre-clinical and clinical trials and the expected outcomes of those trials; ●expectations for incurring capital expenditures to expand our research and development and manufacturing capabilities; ●expectations for generating revenue or becoming profitable on a sustained basis; ●expectations or ability to enter into marketing and other partnership agreements; ●expectations or ability to enter into product acquisition and in-licensing transactions; ●expectations or ability to build our own commercial infrastructure to manufacture, market and sell our drug candidates; ●acceptance of our products by doctors, patients or payors; ●ability to compete against other companies and research institutions; ●ability to secure adequate protection for our intellectual property; ●ability to attract and retain key personnel; ●availability of reimbursement for our products; ●estimates of the sufficiency of our existing cash and cash equivalents and investments to finance our operating requirements, includingexpectations regarding the value and liquidity of our investments; ●stock price and its volatility; and ●expectations for future capital requirements. The forward-looking statements contained in this report reflect our views and assumptions only as of the date this report is signed. Except as required bylaw, we assume no responsibility for updating any forward-looking statements. We qualify all of our forward-looking statements by these cautionary statements. In addition, with respect to all of our forward-looking statements, weclaim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. 1 PART I Unless the context requires otherwise, references in this report to “TG,” “Company,” “we,” “us” and “our” refer to TG Therapeutics, Inc. and oursubsidiaries. ITEM 1. BUSINESS. OVERVIEW We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies andautoimmune diseases. Currently, the Company is developing two therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel,glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. We are also developingTGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be importantin the proliferation and survival of B-lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. We alsohave pre-clinical programs seeking to develop IRAK4 (interleukin-1 receptor-associated kinase 4) inhibitors, BET (Bromodomain and Extra Terminal) inhibitors,and anti-PD-L1 and anti-GITR antibodies. 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 drugcandidates. CORPORATE INFORMATION We were incorporated in Delaware in 1993. Our executive offices are located at 2 Gansevoort St., 9 th Floor, New York, New York 10014. Our telephonenumber is 212-554-4484, and our e-mail address is info@tgtxinc.com. We maintain a website with the address www.tgtherapeutics.com. We make available free of charge through our Internet website our annual reports onForm 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and any amendments to these reports, as soon as reasonably practicable after weelectronically file such material with, or furnish such material to, the SEC. We are not including the information on our website as a part of, nor incorporating it byreference into, this report. You may read and copy any such reports and amendments thereto at the SEC’s Public Reference Room at 100 F Street, N.E.,Washington, D.C. 20549 on official business days during the hours of 10:00 a.m. to 3:00 p.m. Please call the SEC at 1-800-SEC-0330 for information on the PublicReference Room. Additionally, the SEC maintains a website that contains annual, quarterly, and current reports, proxy statements, and other information thatissuers (including us) file electronically with the SEC. The SEC’s website address is http://www.sec.gov. PRODUCTS UNDER DEVELOPMENT TG-1101 (ublituximab) Overview TG-1101 (ublituximab) is a chimeric, glycoengineered monoclonal antibody that targets a unique epitope on the CD20 antigen found on the surface of B-lymphocytes developed to aid in the depletion of circulating B-cells. We hold exclusive worldwide rights to develop and commercialize TG-1101 for allindications, except for the territories of France and Belgium which have been retained by LFB Biotechnologies (“LFB”), and South Korea and Southeast Asiawhich were licensed by us to Ildong Pharmaceutical Co. Ltd (“Ildong”) in November 2012. Generally, anti-CD20 antibodies are believed to exert their B-cell depleting effects through three primary mechanisms: antibody dependent cell-mediatedcytotoxicity (“ADCC”), complement dependent cytotoxicity (“CDC”), and direct or programmed cell death (“DCD” or “PCD”). TG-1101 has been specificallyglycoengineered to enhance ADCC activity, which should enhance its ability to deplete B-cells and may improve its anti-cancer effects when compared to Rituxan® , the leading anti-CD20 monoclonal antibody, which had worldwide sales in 2015 of more than $7 billion . Two single-agent, dose-escalation, Phase I studies were undertaken with TG-1101 to establish an optimal dose in patients with Non-Hodgkin’s Lymphoma(“NHL”) and Chronic Lymphocytic Leukemia (“CLL”). A two part first-in-human Phase I clinical trial was first completed in France in which TG-1101 wasevaluated in relapsed or refractory CLL patients at doses as high as 450mg per infusion. Subsequently, a single-agent Phase I study was undertaken in the USenrolling patients with both NHL and CLL, dosing patients up to 1200mg per infusion. In both studies, single agent therapy with TG-1101 was deemed welltolerated by treating investigators and displayed promising clinical activity in relapsed and refractory patients. 2 In oncology settings, anti-CD20 therapy is generally used in combination with other anti-cancer agents where it demonstrates maximum activity asopposed to single agent usage. As a result, subsequent clinical development for TG-1101 has focused on combination therapy. Currently, our priority combinationtrials for TG-1101 are:●The GENUINE Trial – a randomized controlled Phase 3 trial evaluating TG-1101 in combination with ibrutinib, for previously treated CLLpatients with high risk cytogenetics;●The UNITY-CLL Trial – a randomized controlled Phase 3 trial evaluating TG-1101 in combination with TGR-1202, the Company’s developmentstage PI3Kd inhibitor, for patients with front line and previously treated CLL;●The UNITY-DLBCL Trial – registration-directed UNITY-DLBCL Phase 2b clinical study evaluating TG-1101, in combination with TGR-1202,as well as TGR-1202 alone, in patients with previously treated Diffuse Large B-Cell Lymphoma (DLBCL); and●TG-1101 + TGR-1202 + Pembrolizumab for patients with CLL. In addition, we have announced our intent of evaluating TG-1101 for the treatment of certain autoimmune diseases. Currently, TG-1101 is being evaluatedin a Phase 2 study for the treatment of Multiple Sclerosis (MS) and in an investigator initiated Phase 1 study for the treatment of acute neuromyelitis optica (NMO)relapses, with additional autoimmune related indications planned to be studied. Preliminary data from this Phase 1 study in NMO was presented at the 32ndCongress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), in London, UK in September 2016. Data from the posterpresentation demonstrated that TG-1101 was well tolerated with minimal adverse events (AEs) observed and rapid and robust B-cell depletion observed following asingle 450 mg infusion of TG-1101. In August 2016, it was also announced that TG-1101 received orphan drug designation for the Treatment of NeuromyelitisOptica and Neuromyelitis Optica Spectrum Disorder. Manufacturing of TG-1101 is currently performed by our partner, LFB Biotechnologies, and a secondary contract manufacturer based in the US. Pre-Clinical Data Overview The mechanism of action of anti-CD20 antibodies, including rituximab and TG-1101 has been elucidated and detailed in numerous academic and clinicalstudies. Upon conjugation of the antibody to the CD20 surface antigen, rituximab has been found to deplete B-lymphocytes through three primary mechanisms:ADCC, CDC, and DCD or PCD. Antibody dependent cellular cytotoxicity, or ADCC, is a mechanism that is dependent on interactions between the Fc region of the antibody and the Fc c Rreceptors on immune system effector cells, most notably the Fc c RIIIA (CD16) receptor found on NK cells. These interactions trigger cells to release cytotoxicmolecules and proteases resulting in B-cell death. TG-1101 is a third generation, type I chimeric IgG1 monoclonal antibody with a glycoengineered Fc regiondesigned specifically to induce higher ADCC activity in comparison to rituximab, which has been demonstrated in pre-clinical models. Clinical Data Overview and Recent Developments Single Agent TG-1101 in Relapsed/Refractory NHL & CLL Our first US based trial entitled "An Open Label Phase I/II Trial of the Efficacy and Safety of TG-1101 in Patients with B-cell Non-Hodgkin’s Lymphomawho have Relapsed or are Refractory After CD20 Directed Antibody Therapy," was launched in the third quarter of 2012. In July 2014, this trial completedenrollment at 35 patients, of which 12 patients were included in the dose escalation component and 23 patients in various expansion cohorts. All enrolled patientswere relapsed or refractory to Rituxan ® or a Rituxan ® containing regimen, and in most cases multiple other lines of therapy. Dr. Owen O'Connor, Professor ofMedicine and Director, Center for Lymphoid Malignancies at New York Presbyterian Columbia Medical Center was the Principal Investigator for the multi-centerstudy. Preliminary data from this study was presented at the 50 th American Society of Clinical Oncology (ASCO) 2014 Annual Meeting in Chicago, IL, and wasrecently published in full in the British Journal of Haematology and is summarized below: TG-1101 was well tolerated at all dose levels tested in the 35 patients evaluable for safety, with Day 1 infusion related reactions (IRR) being the mostfrequently reported adverse event. The combined overall response rate (ORR) for the Phase 1 dose escalation component and expansion cohorts was 45% (32% PR,13% CR) among the 31 rituximab relapsed/refractory patients evaluable for efficacy at the time of the presentation. TG-1101 displayed marked clinical activity as asingle agent in a variety of lymphoma subtypes, reporting a 50% (3/6) response rate in patients with CLL and 53% (10/19) response rate in patients with indolentNHL (21% CR, 32% PR). Responses were durable, with a median duration of response of 9.2 months and duration of progression free survival (PFS) of 7.7 months(n=31) amongst evaluable patients. TG-1101 in Combination with TGR-1202 for Relapsed/Refractory NHL & CLL In November 2013, we initiated a multi-center, Phase I study to evaluate the safety and efficacy of the combination of TG-1101 and TGR-1202, theCompany's novel, once per day, PI3Kd inhibitor, for patients with relapsed and/or refractory CLL and NHL. In this study, dosing of TGR-1202 commenced at800mg (initial formulation) once per day (QD) with dose escalation proceeding in a 3+3 design. Dose-escalation up to 1200mg micronized formulation has beencompleted and expansion cohorts were also evaluated at various doses. Additional cohorts were added to this study to explore the triple therapy combination of TG-1101, TGR-1202, and ibrutinib and the triple therapy of TG-1101, TGR-1202 and bendamustine. The MD Anderson Cancer Center is the lead center for the trial with Nathan Fowler, MD, Assistant Professor and Co-Director of Clinical Research in theDepartment of Lymphoma, as the Study Chair for the NHL patient group and Susan O’Brien, MD, formerly of MD Anderson and now Professor and MedicalDirector for Cancer Clinical Trials and Research at UC Irvine as the Study Chair for the CLL patient group. 3 Preliminary data from this study was presented at the 57th Annual American Society of Hematology (ASH) meeting held in December 2015 and issummarized below: The combination of TG-1101 and TGR-1202 was well tolerated in the 71 patients evaluable for safety, with only 8% of patients discontinuing due to anadverse event. Notably, the only Grade 3/4 adverse event occurring in > 5% of patients was neutropenia. As of the data presentation, twenty-six patients had beenon the combination of TG-1101 plus TGR-1202 for 6+ months, with no events of colitis reported. The combination displayed marked clinical activity in a variety oflymphoma subtypes, reporting an 80% (8/10) response rate in patients with CLL, a 71% (12/17) response rate in patients with indolent NHL, and a 35% (6/17)response rate in patients with DLBCL and Richter’s Transformation. The data from this study supports the current Phase 3 UNITY-CLL study of TG-1101 + TGR-1202 in CLL. Preliminary data from the combination of TG-1101 + TGR-1202 + ibrutinib and TG-1101 + TGR-1202 + bendamustine were presented at the AmericanSociety of Clinical Oncology (ASCO) 2015 meeting and the American Society of Hematology (ASH) 2016 meeting respectively. Both combinations demonstratedacceptable levels of tolerability with promising activity and continue to enroll as of today. TG-1101 in Combination with Ibrutinib for Relapsed/Refractory MCL & CLL In December 2013, we initiated a multi-center Phase 2 clinical trial to evaluate the safety and efficacy of the combination of TG-1101 and ibrutinib forpatients with CLL and MCL. This is the first clinical trial evaluating the combination of TG-1101 and ibrutinib, an oral Bruton’s Tyrosine Kinase (BTK) inhibitor. TG Therapeutics partnered with the US Oncology Network and other select centers throughout the United States on the study, with Jeff Sharman, MD,Medical Director for Hematology Research, US Oncology Network, as the Study Chair. This trial has completed enrollment. Final data from this study was presented on the MCL cohort at the 57th Annual American Society of Hematology (ASH) meeting held in December 2015,and on the CLL cohort at the 13th International Congress on Malignant Lymphoma (ICML), held in June 2015 and recently published in full in the British Journalof Haematology and is summarized below: In the CLL cohort, TG-1101 in combination with ibrutinib was well tolerated in the 45 patients evaluable for safety, with day 1 infusion related reactions(IRR) being the most frequently reported adverse event (regardless of causality). In the MCL cohort, the combination was well tolerated in the 15 patients evaluablefor safety, with fatigue being the most frequently reported adverse event (regardless of causality). Overall, in both CLL and MCL, aside from day 1 IRR, theaddition of TG-1101 did not appear to alter the safety profile seen historically with single agent ibrutinib. Of the 60 patients treated, 41 CLL and 15 MCL patientswere evaluable for response. The combination displayed marked clinical activity, reporting an 88% (35/41) response rate in patients with CLL, a 95% (19/21)response rate in those CLL patients with high-risk cytogenetics, and an 87% (13/15) response rate in patients with MCL. TG-1101 + Ibrutinib Phase 3 Study Program – The GENUINE Trial The GENUINE trial is a randomized controlled clinical trial in patients with previously treated CLL with specific high-risk cytogenetic abnormalities, withpatients randomized to receive either TG-1101 plus ibrutinib or ibrutinib alone. In October 2016, we announced revisions to the design of the GENUINE study toaccelerate its completion. Initially the study was being conducted pursuant to a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration(FDA), and was designed to enroll approximately 330 patients, with a two-part analysis of both overall response rate (ORR) and progression-free survival (PFS).The trial was amended in October 2016 to enroll approximately 120 patients, with the PFS analysis component removed. Following the revisions, the sole primaryendpoint of the study is ORR, and the SPA is no longer in effect. We have communicated with the FDA regarding our intention to file a Biologics LicensingApplication (BLA) for accelerated approval and the FDA has agreed that a pre-BLA meeting can be requested based on ORR data from the GENUINE study. On March 6, 2017, we announced positive topline results from our Phase 3 GENUINE clinical trial of TG-1101 plus ibrutinib in patients with previouslytreated high risk CLL. For the study, high risk was defined as having any one or more of the following: 17p deletion, 11q deletion or p53 mutation.The multicenter,randomized trial (NCT02301156), which assessed the efficacy and safety of TG-1101 plus ibrutinib, met its primary endpoint, demonstrating a statisticallysignificant improvement in Overall Response Rate (ORR) compared to ibrutinib alone in both the Intent to Treat (ITT) population (p=0.001) and Treated population(p < 0.001). The ITT population includes all 126 randomized patients (64 in the TG-1101 + ibrutinib arm and 62 in the ibrutinib alone arm) while the Treatedpopulation includes all ITT patients that received at least one dose of either study drug (59 in the TG-1101 + ibrutinib arm and 58 in the ibrutinib alone arm) . Overall Response Rates TG-1101 plus IbrutinibIbrutinibP-valueTreated Population (n)n=59n=58 Overall Response Rate80%47%P < 0.001 All responses were assessed by independent blinded central review using the iwCLL 2008 guidelines. Per iwCLL guidelines, responders requireconfirmation of response for a minimum duration of 2 months. As of the date of the analysis, each arm had responders that were awaiting confirmation visits whichare scheduled to occur over the next two months. During the study it was infrequent (less than 3% in the combination arm) for initial responses to fail to beconfirmed. Median follow-up for the study was approximately 12 months. In addition to ORR, observed advantages were seen for the combination in a number of secondary and other efficacy measures, including radiographicComplete Response (CR) rate, Progression Free Survival and Time to Response. Sufficient data on MRD negative status and bone marrow confirmation ofradiographic CRs were not available at the time of analysis. From a safety standpoint, the combination was well tolerated with a safety profile consistent with thePhase 2 study of ublituximab plus ibrutinib recently published in the British Journal of Haematology. 4 A full analysis of the Phase 3 GENUINE data along with detailed efficacy and safety results will be submitted for presentation at a medical meeting in thefirst half of 2017 and we plan to request a meeting with the FDA as soon as possible thereafter to discuss the filing of the data for accelerated approval. TG-1101 in Combination with TGR-1202 Phase 3 Study Program – The UNITY-CLL Trial In September 2015, we reached an agreement with the FDA regarding an SPA on the design, endpoints and statistical analysis approach of a Phase 3clinical trial for the proprietary combination of TG-1101 plus TGR-1202, for the treatment of CLL. The SPA provides agreement that the Phase 3 trial designadequately addresses objectives that, if met, would support the regulatory submission for drug approval of both TG-1101 and TGR-1202 in combination . The Phase 3 trial, called the UNITY-CLL trial, is a randomized controlled clinical trial that includes two key objectives: first, to demonstrate contributionof each agent in the TG-1101 + TGR-1202 regimen (the combination sometimes referred to as "1303"), and second, to demonstrate superiority in Progression FreeSurvival (PFS) over the standard of care to support the submission for full approval of the combination. The study will randomize patients into four treatment arms:TG-1101 + TGR-1202, TG-1101 alone, TGR-1202 alone, and an active control arm of obinutuzumab (GAZYVA ® ) + chlorambucil. An early interim analysis willassess contribution of each single agent in the TG-1101 + TGR-1202 combination regimen, which, if successful, will allow early termination of both single agentarms. A second interim analysis will be conducted following full enrollment into the study, which, if positive, we plan to utilize for accelerated approval. Assumingearly termination of the TG-1101 and TGR-1202 single agent arms, the study will enroll approximately 450 patients . TG-1101 in Combination with TGR-1202 Phase 2b Registration-Directed Program – The UNITY-DLBCL Trial In June 2016, we commenced a registration-directed UNITY-DLBCL Phase 2b clinical study evaluating TG-1101 in combination with TGR-1202, as wellas TGR-1202 alone, in patients with previously treated DLBCL. The study, entitled "A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 and TGR-1202alone in Patients with Previously Treated Diffuse Large B-Cell Lymphoma," is being led by Owen A. O'Connor, MD, PhD, Professor of Medicine andExperimental Therapeutics, and Director of the Center for Lymphoid Malignancies at Columbia University Medical Center. The primary objective of the study is toassess the efficacy of TGR-1202 alone and in combination with TG-1101 in patients with previously treated DLBCL as measured by Overall Response Rate (ORR).The study will also provide important information as to the contribution of each agent, TGR-1202 and TG-1101, to the combination regimen of both agents. Inaddition to monitoring for safety and efficacy this study will analyze the impact of cell of origin (GCB vs. non-GCB), mutational status and select biomarkers ofefficacy. Single Agent TG-1101 in Relapsing Forms of Multiple Sclerosis In May 2016, we commenced our first study of TG-1101 in patients with relapsing remitting multiple sclerosis (RRMS), a chronic demyelinating diseaseof the central nervous system (CNS). The study, entitled "A Placebo-Controlled Multi-Center Phase 2 Dose Finding Study of Ublituximab, a Third-Generation Anti-CD20 MonoclonalAntibody, in Patients with Relapsing Forms of Multiple Sclerosis," is being led by Edward Fox, MD, PhD, Director of the Multiple Sclerosis Clinic of CentralTexas and Clinical Assistant Professor at the University of Texas Medical Branch in Round Rock, TX. The primary objective of the study is to determine theoptimal dosing regimen for TG-1101 with a focus on accelerating infusion times. In addition to monitoring for safety and tolerability at each dosing cohort, B-celldepletion and established MS efficacy endpoints will also be evaluated. In January 2017, we announced the completion of enrollment into Part 1 of this study and B-cell depletion data from patients treated to date. Part 1 of thestudy explored TG-1101 at an initial dose of 600 mg administered as a 150 mg infusion on day 1 and 450 mg infusion on day 15, followed by either 450 mg or 600mg at week 24. The day 15 and week 24 doses were subject to accelerated infusion times by cohort, down to a 1-hour infusion by cohort 3. The median B-celldepletion for all patients in Part 1 was 99% and TG-1101 was well-tolerated with no grade 3/4 adverse events reported, including in patients receiving the one-hourinfusion at the target Phase 3 dose and infusion rate. For Part 2 of the trial, the Company has added expansion cohorts and will explore accelerated dosing of theinitial 150mg dose. TGR-1202 Overview The phosphoinositide-3-kinases (“PI3Ks”) are a family of enzymes involved in various cellular functions, including cell proliferation and survival, celldifferentiation, intracellular trafficking, and immunity. There are four isoforms of PI3K (alpha, beta, delta, and gamma), of which the delta (d) isoform is stronglyexpressed in cells of hematopoietic origin, and often implicated in B-cell related lymphomas. TGR-1202 is an orally available PI3K delta inhibitor with nanomolar potency to the delta isoform and high selectivity over the alpha, beta, and gammaisoforms. TGR-1202 has demonstrated activity in several pre-clinical models and primary cells from patients with various hematologic malignancies. We hold exclusive rights to develop and commercialize TGR-1202 for all indications worldwide, except India which has been retained by RhizenPharmaceuticals, SA. The Company’s Investigational New Drug (“IND”) application for TGR-1202 was accepted by the FDA in December 2012 and a first in-human Phase Iclinical trial was initiated in January 2013. 5 Updates for TGR-1202 In August 2016, we announced that TGR-1202 had received orphan drug designation for the treatment of CLL. In October 2016, a manuscript titled, "Silencing c-Myc Translation as a Therapeutic Strategy through Targeting PI3K Delta and CK1 Epsilon inHematological Malignancies," was published online in the First Edition section of Blood, the Journal of the American Society of Hematology. The publicationpresents preclinical data describing the synergy of TGR-1202 with the proteasome inhibitor carfilzomib and the unique effects of the combination to silence c-Mycin various preclinical lymphoma and myeloma models. In addition, the manuscript for the first time reports on TGR-1202's unique complimentary mechanism ofinhibiting the protein kinase casein kinase-1 (CK1) epsilon, which may contribute to the silencing of c-Myc and explain TGR-1202's clinical activity in aggressivelymphoma, including Diffuse Large B-cell Lymphoma (DLBCL). Clinical Data Overview and Recent Developments Initial clinical development of TGR-1202 was focused on establishing preliminary safety and efficacy in a wide variety of hematologic malignancies.Upon identification of safe and active doses of TGR-1202, a combination clinical trial program was opened, exploring TGR-1202 in combination with a variety ofagents. In addition to the previously described studies in combination with TG-1101, our current combination clinical trials that are ongoing or have been completedfor TGR-1202 included :●TGR-1202 in combination with the anti-CD20 antibody, obinutuzumab (GAZYVA ® ) and chlorambucil in patients with CLL;●TGR-1202 in combination with the anti-CD30 antibody drug conjugate, brentuximab vedotin (ADCETRIS ® ), in patients with relapsed orrefractory Hodgkin’s lymphoma;●TGR-1202 in combination with the BTK inhibitor, ibrutinib, in patients with previously treated CLL and MCL; and●TGR-1202 in combination with the JAK inhibitor, ruxolitinib (JAKAFI ® ), in patients with previously treated Myelofibrosis or PolycythemiaVera. In addition, given the favorable safety profile demonstrated to date, a trial of TGR-1202 monotherapy in patients with CLL who were previously intolerantto prior BTK or PI3K inhibitor therapy is also underway. Single Agent TGR-1202 in Patients with Relapsed/Refractory Hematologic Malignancies In January 2013, the Company initiated a Phase I, open label, multi-center, first-in-human clinical trial of TGR-1202 in patients with hematologicmalignancies. The study entitled TGR-1202-101, "A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR-1202 in Patients with Relapsed orRefractory Hematologic Malignancies," is being run in collaboration with the Sarah Cannon Research Institute in Nashville, TN with Howard “Skip” Burris, MD,Executive Director, Drug Development as the acting Study Chair. Enrollment is open to patients with relapsed or refractory NHL, CLL, and other selecthematologic malignancies. As of February 2016, this study has closed to enrollment. Data from this ongoing Phase I study was most recently presented at the 57th Annual American Society of Hematology (ASH) meeting held in December2015, with updated data presented as part of an integrated analysis as described below. TGR-1202 Long-term Follow-up Integrated Analysis in Patients with Relapsed/Refractory Hematologic Malignancies In June 2016, at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) and at the 21st Congress of the European HematologyAssociation (EHA), the Company presented integrated data with long term follow-up from 165 patients exposed to TGR-1202 monotherapy or the combination ofTGR-1202 plus TG-1101, which continued to demonstrate high response rates in CLL, NHL, and DLBCL coupled with a favorable safety profile. 6 TGR-1202 in Combination with obinutuzumab and chlorambucil in patients with CLL In March 2014, the Company initiated a Phase I/Ib, open label, multi-center, clinical trial of TGR-1202 in combination with obinutuzumab andchlorambucil in patients with CLL, both treatment naïve and relapsed. The study entitled TGR-GA-106, " A Multi-center Phase I/Ib Study Evaluating the Efficacyand Safety of TGR-1202, a Novel PI3K Delta Inhibitor, in Combination with Obinutuzumab and Chlorambucil in Patients with Chronic Lymphocytic Leukemia(CLL)," is being led by Dr. Daruka Mahadevan of the West Clinic in Memphis, TN. As of February 2016, this study has completed enrollment. Data from this study was presented at the 57th Annual American Society of Hematology (ASH) meeting held in December 2015. TGR-1202 Combination Trials TGR-1202 is being evaluated in combination with the anti-CD30 antibody drug conjugate, brentuximab vedotin, in patients with relapsed or refractoryHodgkin’s lymphoma; in combination with the BTK inhibitor, ibrutinib, in patients with CLL and MCL; and in combination with the JAK inhibitor, ruxolitinib, inpatients with Myelofibrosis or Polycythemia Vera. Additional investigator sponsored trials are also underway which are combining TGR-1202 with other approvedagents for the treatment of B-cell malignancies. Preliminary data from studies evaluating TGR-1202 + brentuximab vedotin and TGR-1202 + ibrutinib were presented at the 58th Annual AmericanSociety of Hematology (ASH) meeting held in December 2016. Both combinations appeared well tolerated. In particular, the combination of TGR-1202 + ibrutinibresulted in an 88% (15 of 17) Overall Response Rate (ORR) (including Complete Response (CR), Partial Response (PR), and Partial Response with lymphocytosis(PR-L)) in patients with CLL, with 1 patient achieving a bone marrow confirmed CR and 5 patients with a > 80% nodal reduction, nearing radiographic CR. It is anticipated that results from these studies will be presented or updated at future medical conferences. TGR-1202 in Solid Tumors In addition to the exploration of TGR-1202 in various hematologic malignancies, a study was opened in October 2015 to evaluate TGR-1202 as a singleagent as well as in combination with various chemotherapies for the treatment of select solid tumors. The study, entitled TGR-1202-102, “A Phase I StudyEvaluating the Safety and Efficacy of TGR-1202 Alone and in Combination with either nab-paclitaxel + Gemcitabine or with FOLFOX in Patients with SelectRelapsed or Refractory Solid Tumors” is being run in collaboration with the Sarah Cannon Research Institute in Nashville, TN with Johanna Bendell, MD, Directorof GI Oncology Research as the acting study chair. Market Opportunity for TG-1101 & TGR-1202 Our lead products under development, TG-1101 and TGR-1202 are for the treatment of B-cell hematologic malignancies. Hematologic malignanciesinclude cancers derived from the bone marrow and lymph tissue. The non-Hodgkin’s lymphomas (NHL) represent a heterogeneous subset of these malignancies.Underneath the single rubric of lymphoma exist some of the most aggressive growing cancers (Burkitt’s lymphoma, lymphoblastic lymphoma, diffuse large-B-celllymphoma), as well as some of the most indolent (small lymphocytic lymphoma, follicular lymphoma, and marginal zone lymphoma). In the United States, NHLrepresents 4-5% of all new cancer cases, and is the eighth leading cause of cancer death. According to the American Cancer Society, it is estimated in 2017 thatthere will be 72,240 new cases in the United States, and 20,140 deaths from NHL, despite improvements in treatment. Chronic lymphocytic leukemia (CLL) affectsmainly older adults and accounts for one quarter of all diagnosed cases of leukemia, of which there are estimated to be about 62,130 new cases and about 24,500deaths (all kinds of leukemia) according to American Cancer Society estimates. Despite improvements in therapy, up to one third of patients with aggressive NHLcontinue to die from their disease, and indolent lymphomas remain incurable in the absence of allogeneic stem cell transplant. The treatment paradigm forhematologic malignancies is well standardized in front line settings, with the anti-CD20 monoclonal antibody, rituximab, administered generally in combinationwith chemotherapeutic agents. While front line therapies are generally efficacious, there are numerous downsides, including a high rate of toxicity associated withexposure to chemotherapeutic agents. While initially responsive, most patients with hematologic malignancies will eventually relapse and require second, third, andsometimes more lines of therapy. As a result, there is a pressing need for new, innovative, targeted therapies for the treatment of this heterogeneous group ofdiseases. Anti-CD20 antibodies have been approved and studied in a variety of diseases falling into several therapeutic areas including oncology, autoimmunedisorders, and neurologic disease. NHL and CLL are the most common B-cell proliferative diseases for which rituximab, the first anti-CD20 antibody approved bythe FDA, is the current gold standard treatment. While the addition of rituximab to chemotherapeutic treatment of NHL has dramatically improved patientoutcomes, many patients will relapse or become refractory to rituximab containing regimens. Rituximab resistance is becoming an increasing concern for clinicians as relapsing patients are exposed to multiple lines of rituximab containing regimensto treat recurrence of disease. It is estimated that over half of patients initially responsive to their first exposure to rituximab do not respond upon retreatment (Daviset al, 2000). 7 We believe these factors contribute to an immediate and sustained need for an anti-CD20 monoclonal antibody that is differentiated and potentiallytherapeutically superior to the gold standard rituximab in order to extend and enhance CD20 therapy as it stands today. In addition to anti-CD20 therapy, novel targeted agents are now being introduced which target specific signaling pathways and enzymes known to exhibitaberrant activity and overexpression in B-cell malignancies such as Bruton’s Tyrosine Kinase (BTK), and Phosphoinositide-3-Kinase delta (PI3K delta). ThePI3K/AKT/mTOR pathway has been the target of numerous pharmaceutical agents, both approved and in development, however only recently has the delta isoformof PI3K been identified as a potential target for the treatment of hematologic malignancies and other B-cell lymphoproliferative disorders. Idelalisib (ZYDELIG™),a PI3K delta specific inhibitor from Gilead Pharmaceuticals, was approved by the FDA in 2014 for patients with CLL and indolent NHL. Other agents targetingkinases downstream of the B-cell receptor, such as the BTK inhibitor, ibrutinib, have displayed high rates of response in patients with relapsed and refractory B-cellmalignancies and have been recently approved for these indications. While these agents have demonstrated high levels of single agent activity in B-cell disorders,their clinical activity has been shown to be greatly enhanced when utilized in combination with anti-CD20 agents. As novel targeted agents gain FDA approval for the treatment of relapsed and refractory disease, it is anticipated that the size of this market will expandgreatly as branded drugs enter use in multiple lines of therapy. Given the nature of the disease state for patients with hematologic malignancies, characterized byindolent disease progression and chronic relapses, the Company anticipates a great and growing need for novel agents that can be used alone or in combination withapproved agents, and those currently under development to enhance the quality of life and extend the length of survival for patients suffering from hematologicmalignancies. IRAK4 Interleukin-1 Receptor Associated Kinase 4, referred to as IRAK4, is a key signaling kinase that becomes inappropriately activated in tumors that carrycertain oncogenic mutations of MYD88, which can be found in most patients with Waldenström's Macroglobulinemia, a rare B-cell cancer, as well as in a sub-set ofpatients with Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia. Additionally, IRAK4 is a key component of signaling pathways which regulateimmune and inflammatory processes suggesting that inhibition of IRAK4 may also be useful in the treatment of autoimmune related disorders. We hold globalrights to develop and commercialize the IRAK4 program, which was licensed from Ligand Pharmaceuticals. Our IRAK4 program is currently in pre-clinicaldevelopment. In April 2015, we presented pre-clinical data on the IRAK4 compounds at the 2015 American Association for Cancer Research (AACR) AnnualMeeting held in Philadelphia, PA. PD-L1 and GITR In March 2015, we entered into a global collaboration agreement for the development and commercialization of anti-PD-L1 and anti-GITR antibodyresearch programs in the field of hematological malignancies. Our anti-PD-L1 and anti-GITR programs are currently in pre-clinical development. BET In May 2016, as part of a broader agreement with Jubilant Biosys (“Jubilant”), an India-based biotechnology company, we entered into a sub-licenseagreement (“JBET Agreement”) with Checkpoint Therapeutics, Inc. (“Checkpoint”), a subsidiary of Fortress Biotech, Inc. (“FBIO”), for the development andcommercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies. The BET inhibitor program is the subject of a family ofpatents covering compounds that inhibit BRD4, a member of the BET (Bromodomain and Extra Terminal) domain for cancer treatment. Our BET inhibitor programis currently in pre-clinical development. O ur Executive Chairman and CEO, is also Executive Vice Chairman of FBIO. COSTS AND TIME TO COMPLETE PRODUCT DEVELOPMENT The information below provides estimates regarding the costs associated with the completion of the current development phase and our current estimatedrange of the time that will be necessary to complete that development phase for our key pipeline products. We also direct your attention to the risk factors whichcould significantly affect our ability to meet these cost and time estimates found in this report in Item 1A under the heading “Risks Related to the Company’sBusiness and Industry.” 8 Product candidateTarget indicationDevelopment status Completion ofphase Estimated cost to complete phaseTG-1101 & TGR-1202 In combination in CLL patients Phase III 2018* Approximately $20 million TG-1101 & TGR-1202 In combination in relapsed/refractoryDLBCL patients Phase IIb 2018 Approximately $5 million *Completion of phase for this study indicates completion of portion of study, which, if successful, would support an accelerated approval Completion dates and costs in the above table are estimates due to the uncertainties associated with clinical trials and the related requirements ofdevelopment. In the cases where the requirements for clinical trials and development programs have not been fully defined, or are dependent on the success of othertrials, we cannot estimate trial completion or cost with any certainty. The actual spending on each trial during the year is also dependent on funding. We thereforedirect your attention to Item 7 under the heading “Liquidity and Capital Resources.” INTELLECTUAL PROPERTY AND PATENTS General Our goal is to obtain, maintain and enforce patent protection for our products, formulations, processes, methods and other proprietary technologies,preserve our trade secrets, and operate without infringing on the proprietary rights of other parties, both in the United States and in other countries. Our policy is toactively seek to obtain, where appropriate, the broadest intellectual property protection possible for our product candidates, proprietary information and proprietarytechnology through a combination of contractual arrangements and patents, both in the U.S. and elsewhere in the world. We also depend upon the skills, knowledge and experience of our scientific and technical personnel, as well as that of our advisors, consultants and othercontractors. This knowledge and experience we call “know-how.” To help protect our proprietary know-how which is not patentable, and for inventions for whichpatents may be difficult to enforce, we rely on trade secret protection and confidentiality agreements to protect our interests. To this end, we require all employees,consultants, advisors and other contractors to enter into confidentiality agreements which prohibit the disclosure of confidential information and, where applicable,require disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business. Patents and other proprietary rights are crucial to the development of our business. We will be able to protect our proprietary technologies fromunauthorized use by third parties only to the extent that our proprietary rights are covered by valid and enforceable patents, supported by regulatory exclusivity orare effectively maintained as trade secrets. We have a number of patents and patent applications related to our compounds and other technology, but we cannotguarantee the scope of protection of the issued patents, or that such patents will survive a validity or enforceability challenge, or that any of the pending patentapplications will issue as patents. Generally, patent applications in the U.S. are maintained in secrecy for a period of 18 months or more. Since publication of discoveries in the scientific orpatent literature often lag behind actual discoveries, we are not certain that we were the first to make the inventions covered by each of our pending patentapplications or that we were the first to file those patent applications. The patent positions of biotechnology and pharmaceutical companies are highly uncertain andinvolve complex legal and factual questions. Therefore, we cannot predict the breadth of claims allowed in biotechnology and pharmaceutical patents, or theirenforceability. To date, there has been no consistent policy regarding the breadth of claims allowed in biotechnology patents. Third parties or competitors maychallenge or circumvent our patents or patent applications, if issued. If our competitors prepare and file patent applications in the U.S. that claim technology alsoclaimed by us, we may have to participate in interference proceedings declared by the U.S. Patent and Trademark Office to determine priority of invention, whichcould result in substantial cost, even if the eventual outcome is favorable to us. Because of the extensive time required for development, testing and regulatoryreview of a potential product, it is possible that before we commercialize any of our products, any related patent may expire or remain in existence for only a shortperiod following commercialization, thus reducing any advantage of the patent. However, the life of a patent covering a product that has been subject to regulatoryapproval may have the ability to be extended through the patent restoration program, although any such extension could still be minimal. 9 If a patent is issued to a third party containing one or more preclusive or conflicting claims, and those claims are ultimately determined to be valid andenforceable, we may be required to obtain a license under such patent or to develop or obtain alternative technology. In the event of litigation involving a third partyclaim, an adverse outcome in the litigation could subject us to significant liabilities to such third party, require us to seek a license for the disputed rights from suchthird party, and/or require us to cease use of the technology. Further, our breach of an existing license or failure to obtain a license to technology required tocommercialize our products may seriously harm our business. We also may need to commence litigation to enforce any patents issued to us or to determine thescope and validity of third-party proprietary rights. Litigation would involve substantial costs. TG-1101 Pursuant to our license for TG-1101 (ublituximab) with LFB Biotechnologies, GTC Biotherapeutics, and LFB/GTC LLC, we have the exclusivecommercial rights to a series of patents and patent applications in the U.S. and in multiple countries around the world, as well as a non-exclusive license toadditional background patent rights. These patents and patent protections include composition of matter patents relating to the structure and mechanism of actionfor TG-1101 as well as method of use patents which cover use of TG-1101 in combination with various agents and for various therapeutic indications. In the United States, we have, through our license agreement, access to 12 issued patents and 6 patent applications covering TG-1101 which expirebetween 2021 and 2033, excluding any patent term extensions, as well as granted and pending foreign counterpart patent filings related to these patent families. These patents include claims related to the manufacture and use of TG-1101. The composition of matter patent for TG-1101 has been issued in the United States,which affords patent protection until 2029, exclusive of patent term extensions. Additionally, we have over 30 granted patents outside the US, and over 25 patentapplications pending worldwide also including claims directed to the composition of matter and methods of treatment with TG-1101 in various settings. TGR-1202 Pursuant to our license for TGR-1202 with Rhizen, we have the exclusive commercial rights to a series of patent applications in the U.S. and abroad. Thepatent applications include composition of matter patents relating to the structure, mechanism of action, and formulation for TGR-1202 as well as method of usepatents which cover use of TGR-1202 in combination with various agents and for various therapeutic indications. Our composition of matter patent for TGR-1202has been issued in the United States, which affords patent protection until 2033, exclusive of patent term extensions. All other patent applications currently filed forTG-1202 are currently pending. Because the dates for any potential regulatory approval are currently unknown we cannot predict the expected expiration date, andit is possible that the life of these patents following regulatory approval could be minimal. IRAK4 Pursuant to our license for the IRAK4 program with Ligand, we have the exclusive commercial rights to a patent family which covers the composition ofmatter and proposed methods of use for various therapeutic indications. All patent applications currently filed for the IRAK4 program are currently pending.Because the date for any potential regulatory approval is currently unknown we cannot predict the expected expiration date, and it is possible that the life of thesepatents following regulatory approval could be minimal. PD-L1 and GITR Pursuant to our Global Collaboration with Checkpoint, the intellectual property includes issued patents in a number of countries, including the UnitedStates and Europe, as well as pending patent applications in several countries elsewhere. The PD-L1 segment of the portfolio includes patent applications pendingin the United States, Australia, Canada, Europe, Israel and Korea. Any patents maturing from these pending applications will expire no sooner than October 2033. The GITR segment of the portfolio includes an International Application No. PCT/US2015/054010, filed in October 2015. Any national stage applications, whichare pursued off of this international application (including one in the United States Patent and Trademark Office), would expire no earlier than October 2035. BET Pursuant to our JBET Agreement with Checkpoint, the in-licensed patent estate includes two international (PCT) applications filed in March 2016 (WO2016/157221) and September 2016, respectively, claiming the benefit of two earlier-filed Indian provisional applications. Any patents maturing from this patentestate are expected to expire no sooner than March 2036. The patent rights that we own or have licensed relating to our product candidates are limited in ways that may affect our ability to exclude third partiesfrom competing against us if we obtain regulatory approval to market these product candidates. See “Item 1A – Risk Factors -- Risks Related to the Company’sIntellectual Property. ” 10 Proof of direct infringement by a competitor for method of use patents can prove difficult because the competitors making and marketing a producttypically do not engage in the patented use. Additionally, proof that a competitor contributes to or induces infringement of a patented method of use by another canalso prove difficult because an off-label use of a product could prohibit a finding of contributory infringement and inducement of infringement requires proof ofintent by the competitor. Moreover, physicians may prescribe such a competitive identical product for indications other than the one for which the product has been approved, oroff-label indications, that are covered by the applicable patents. Although such off-label prescriptions may directly infringe or contribute to or induce infringementof method of use patents, such infringement is difficult to prevent or prosecute. In addition, the limited patent protection described above may adversely affect the value of our product candidates and may inhibit our ability to obtain acorporate partner at terms acceptable to us, if at all. Other Intellectual Property Rights We depend upon trademarks, trade secrets, know-how and continuing technological advances to develop and maintain our competitive position. Tomaintain the confidentiality of trade secrets and proprietary information, we require our employees, scientific advisors, consultants and collaborators, uponcommencement of a relationship with us, to execute confidentiality agreements and, in the case of parties other than our research and development collaborators, toagree to assign their inventions to us. These agreements are designed to protect our proprietary information and to grant us ownership of technologies that aredeveloped in connection with their relationship with us. These agreements may not, however, provide protection for our trade secrets in the event of unauthorizeddisclosure of such information. In addition to patent protection, we may utilize orphan drug regulations or other provisions of the Food, Drug and Cosmetic Act of 1938, as amended, orFDCA, to provide market exclusivity for certain of our drug candidates. Orphan drug regulations provide incentives to pharmaceutical and biotechnologycompanies to develop and manufacture drugs for the treatment of rare diseases, currently defined as diseases that exist in fewer than 200,000 individuals in the U.S.,or, diseases that affect more than 200,000 individuals in the U.S. but that the sponsor does not realistically anticipate will generate a net profit. Under theseprovisions, a manufacturer of a designated orphan-drug can seek tax benefits, and the holder of the first FDA approval of a designated orphan product will begranted a seven-year period of marketing exclusivity for such FDA-approved orphan product. Pursuant to these regulations, TG-1101 (ublituximab) has received Orphan-Drug designation from the FDA for the treatment of Marginal Zone Lymphoma(Nodal and Extranodal) in September 2013, for the treatment of CLL in August of 2010, and Orphan-Drug designation by the European Medicines Agency(“EMA”) for the treatment of CLL in November of 2009. We believe that TG-1101 may be eligible for additional orphan drug designations; however, we cannotassure you that TG-1101, or any other drug candidates we may acquire or in-license, will obtain such orphan drug designations. Additionally, upon FDA approval,we believe that TG-1101 would qualify as a New Chemical Entity, or NCE, which provides for five years of exclusivity following approval. We cannot assure you that any other drug candidates we may acquire or in-license, will obtain such orphan drug designation or that we will be the first toreceive FDA approval for such drugs so as to be eligible for market exclusivity protection. LICENSING AGREEMENTS AND COLLABORATIONS We have formed strategic alliances with a number of companies for the manufacture and commercialization of our products. Our current key strategicalliances are discussed below. TG-1101 LFB Biotechnologies S.A.S, GTC Biotherapeutics, LFB/GTC LLC. In January 2012, we entered into an exclusive license agreement with LFB Biotechnologies, GTC Biotherapeutics, and LFB/GTC LLC, all wholly-ownedsubsidiaries of LFB Group, relating to the development of TG-1101. Under the license agreement, we have acquired the exclusive worldwide rights (exclusive ofFrance/Belgium) for the development and commercialization of TG-1101 (ublituximab). To date, we have made no payments to LFB Group and LFB Group iseligible to receive payments of up to an aggregate of approximately $31.0 million upon our successful achievement of certain clinical development, regulatory andsales milestones, in addition to royalty payments on net sales of TG-1101 at a royalty rate that escalates from mid-single digits to high-single digits. The license willterminate on a country by country basis upon 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 (i) by LFB if the Company challenges any of the licensed patent rights, (ii) by either party due to a breach of theagreement, or (iii) by either party in the event of the insolvency of the other party. 11 Ildong Pharmaceutical Co. Ltd. In November 2012, we entered into an exclusive (within the territory) sublicense agreement with Ildong relating to the development andcommercialization of TG-1101 in South Korea and Southeast Asia. Under the terms of the sublicense agreement, Ildong has been granted a royalty bearing,exclusive right, including the right to grant sublicenses, to develop and commercialize TG-1101 in South Korea, Taiwan, Singapore, Indonesia, Malaysia, Thailand,Philippines, Vietnam, and Myanmar. To date, we have received $2 million in the form of an upfront payment from Ildong, and are eligible to receive sales basedmilestone payments up to an aggregate of $5 million and royalty payments on net sales of TG-1101 at a royalty rate that escalates from mid-teens to high-teensupon approval in South Korea and/or Southeast Asia. The license will terminate on a country by country basis upon the expiration of the last licensed patent right or15 years after the first commercial sale of a product in such country, unless the agreement is earlier terminated (i) by Ildong if the Company challenges any of thelicensed patent rights, (ii) by either party due to a breach of the agreement, or (iii) by either party in the event of the insolvency of the other party. TGR-1202 In September 2014, we exercised our option to license the global rights to TGR-1202, thereby entering into an exclusive licensing agreement (the “TGR-1202 License”) with Rhizen Pharmaceuticals, S A (“Rhizen”) for the development and commercialization of TGR-1202. Prior to this, we had been jointlydeveloping TGR-1202 in a 50:50 joint venture with Rhizen. Under the terms of the TGR-1202 License, Rhizen received a $4.0 million cash payment and 371,530 shares of our common stock as an upfront licensefee. With respect to TGR-1202, Rhizen will be eligible to receive regulatory filing, approval and sales based milestone payments in the aggregate of approximately$175 million, a small portion of which will be payable on the first New Drug Application (NDA) filing and the remainder on approval in multiple jurisdictions forup to two oncology indications and one non-oncology indication and attaining certain sales milestones. In addition, if TGR-1202 is co-formulated with another drugto create a new product (a "New Product"), Rhizen will be eligible to receive similar regulatory approval and sales based milestone payments for such New Product.Additionally, Rhizen will be entitled to tiered royalties that escalate from high single digits to low double digits on our future net sales of TGR-1202 and any NewProduct. In lieu of sales milestones and royalties on net sales, Rhizen shall also be eligible to participate in sublicensing revenue, if any, based on a percentage thatdecreases as a function of the number of patients treated in clinical trials following the exercise of the license option. Rhizen will retain global manufacturing rightsto TGR-1202, provided that they are price competitive with alternative manufacturers. The license will terminate on a country by country basis upon the expirationof the last licensed patent right or any other exclusivity right in such country, unless the agreement is earlier terminated (i) by us for any reason, (ii) by either partydue to a breach of the agreement. IRAK4In June 2014, we entered into an exclusive licensing agreement with Ligand Pharmaceuticals Incorporated ("Ligand") for the development andcommercialization of Ligand's interleukin-1 receptor associated kinase-4 ("IRAK4") inhibitor technology, which currently is in preclinical development forpotential use against certain cancers and autoimmune diseases. IRAK4 is a serine/threonine protein kinase that is a key downstream signaling component of theinterleukin-1 receptor and multiple toll-like receptors. Under the terms of the license agreement, Ligand received 125,000 shares of our common stock as an upfront license fee. Ligand will also be eligible toreceive maximum potential milestone payments of approximately $207 million upon the achievement of specific clinical, regulatory and commercial milestoneevents. Additionally, Ligand will be entitled to royalties on our future net sales of licensed products containing IRAK4 inhibitors. The basic royalty rate for licensedproducts covered by Ligand's issued patents will be 6% for annual sales of up to $1 billion and 9.5% for annual sales in excess of that threshold. The license willterminate on a country by country basis upon the expiration of the last licensed patent right or 10 years after the first commercial sale of a product in such country,unless the agreement is earlier terminated by either party due to a breach of the agreement in the event of the insolvency of the other party. PD-L1 and GITR In March 2015, we entered into a Global Collaboration (the “Collaboration”) with Checkpoint Therapeutics, Inc. (“Checkpoint”), a subsidiary of FBIO forthe development and commercialization of Checkpoint’s anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies. 12 Under the terms of the Collaboration, we made an up-front payment of $500,000, will make development and sales-based milestone payments up to anaggregate of $164 million, and will pay a tiered single digit royalty on net sales. The royalty term will terminate on a country by country basis upon the later of (i)ten years after the first commercial sale of any applicable licensed product in such country, or (ii) the expiration of the last-to-expire patent held by Dana Farbercontaining a valid claim to any licensed product in such country. BET In May 2016, as part of a broader agreement with Jubilant Biosys (“Jubilant”), an India-based biotechnology company, we entered into a sub-licenseagreement (“JBET Agreement”) with Checkpoint for the development and commercialization of Jubilant’s novel BET inhibitor program in the field ofhematological malignancies. The BET inhibitor program is the subject of a family of patents covering compounds that inhibit BRD4, a member of the BET(Bromodomain and Extra Terminal) domain for cancer treatment. Our BET inhibitor program is currently in pre-clinical development. Under the terms of the agreement, we paid Checkpoint an up-front licensing fee of $1.0 million and will make additional payments contingent on certainpreclinical, clinical, and regulatory milestones, including commercial milestones totaling up to approximately $177 million and a single-digit royalty on netsales. TG will also provide funding to support certain targeted research efforts at Jubilant. COMPETITION Competition in the pharmaceutical and biotechnology industries is intense. Our competitors include pharmaceutical companies and biotechnologycompanies, as well as universities and public and private research institutions. In addition, companies that are active in different but related fields representsubstantial competition for us. Many of our competitors have significantly greater capital resources, larger research and development staffs and facilities and greaterexperience in drug development, regulation, manufacturing and marketing than we do. These organizations also compete with us to recruit qualified personnel,attract partners for joint ventures or other collaborations, and license technologies that are competitive with ours. To compete successfully in this industry we mustidentify novel and unique drugs or methods of treatment and then complete the development of those drugs as treatments in advance of our competitors. The drugs that we are attempting to develop will have to compete with existing therapies. In addition, a large number of companies are pursuing thedevelopment of pharmaceuticals that target the same diseases and conditions that we are targeting. Other companies have products or drug candidates in variousstages of pre-clinical or clinical development to treat diseases for which we are also seeking to discover and develop drug candidates. Some of these potentialcompeting drugs are further advanced in development than our drug candidates and may be commercialized earlier. If approved, we expect TG-1101 to compete directly with Roche Group’s Rituxan ® (rituximab) and Gazyva ® (obinutuzumab), and Novartis' Arzerra ®(ofatumumab) among others, each of which is currently approved for the treatment of various diseases including NHL and CLL. In addition, other pharmaceuticalcompanies are developing anti-CD20 antibodies which, if approved, would potentially compete with TG-1101. New developments, including the development ofother pharmaceutical technologies and methods of treating disease, occur in the pharmaceutical and life sciences industries at a rapid pace. With respect to TGR-1202, if approved, we expect to compete directly with Gilead’s Zydelig™ (idelalisib), as well as with other PI3K delta inhibitorswhich are currently in development, which, if approved, would potentially compete with TGR-1202, such as Verastem's duvelisib. In addition, there are numerousother novel therapies targeting similar pathways to TGR-1202 in development, which would also compete with TGR-1202 in similar indications, such as the BTKinhibitor, ibrutinib (FDA approved for Mantle Cell Lymphoma, CLL, Marginal Zone Lymphoma and Waldenstrom’s Macroglobulinemia marketed by AbbVie andJanssen), the BTK inhibitor acalabrutinib or ACP-196 (under clinical development by AstraZeneca), or the BCL-2 inhibitor venetoclax or ABT-199 (FDA approvedfor CLL and marketed by AbbVie and Roche), among others. Additional information can be found under Item “1A - Risk Factors – Other Risks Related to Our Business” within this report. 13 SUPPLY AND MANUFACTURING We have limited experience in manufacturing products for clinical or commercial purposes. We currently do not have any manufacturing capabilities. Wehave established contract manufacturing relationships for the supply of TG-1101 as part of our license agreement with LFB Biotechnologies. We have alsoestablished contract manufacturing relationships for the supply of TGR-1202 as part of our licensing agreement with Rhizen, and contract manufacturingrelationships to support our IRAK4 development program. As with any supply program, obtaining pre-clinical and clinical materials of sufficient quality andquantity to meet the requirements of our development programs cannot be guaranteed and we cannot ensure that we will be successful in this endeavor. In addition,we anticipate the need for the current scale of production for each of our products to be significantly expanded as we enter later stages of development. There can beno assurance given that such scale-up will be successful in providing pharmaceutical product that is of sufficient quantity, or of a quality that is consistent with ourpreviously established specifications, or that meets the requirements set by regulatory agencies under which we may seek approval of our product candidates. At the time of commercial sale, to the extent possible and commercially practicable, we would seek to engage a back-up supplier for each of our productcandidates. Until such time, we expect that we will rely on a single contract manufacturer to produce each of our product candidates under current GoodManufacturing Practice, or cGMP, regulations. Our third-party manufacturers have a limited number of facilities in which our product candidates can be producedand will have limited experience in manufacturing our product candidates in quantities sufficient for commercialization. Our third-party manufacturers will haveother clients and may have other priorities that could affect their ability to perform the work satisfactorily and/or on a timely basis. Both of these occurrences wouldbe beyond our control. We expect to similarly rely on contract manufacturing relationships for any products that we may in-license or acquire in the future. However, there can beno assurance that we will be able to successfully contract with such manufacturers on terms acceptable to us, or at all. Contract manufacturers are subject to ongoing periodic and unannounced inspections by the FDA, the Drug Enforcement Administration andcorresponding state agencies to ensure strict compliance with cGMP and other state and federal regulations. Our contractors outside of the United States facesimilar challenges from the numerous local and regional agencies and authorized bodies. We do not have control over third-party manufacturers’ compliance withthese regulations and standards, other than through contractual obligations. If they are deemed out of compliance with cGMPs, product recalls could result,inventory could be destroyed, production could be stopped and supplies could be delayed or otherwise disrupted. If we need to change manufacturers after commercialization, the FDA and corresponding foreign regulatory agencies must approve these newmanufacturers in advance, which will involve testing and additional inspections to ensure compliance with FDA regulations and standards and may requiresignificant lead times and delay. Furthermore, switching manufacturers may be difficult because the number of potential manufacturers is limited. It may bedifficult or impossible for us to find a replacement manufacturer quickly or on terms acceptable to us, or at all. GOVERNMENT AND INDUSTRY REGULATION Numerous governmental authorities, principally the FDA and corresponding state and foreign regulatory agencies, impose substantial regulations upon theclinical development, manufacture and marketing of our drug candidates, as well as our ongoing research and development activities. None of our drug candidateshave been approved for sale in any market in which we have marketing rights. Before marketing in the U.S., any drug that we develop must undergo rigorous pre-clinical testing and clinical trials and an extensive regulatory approval process implemented by the FDA under the FDCA. The FDA regulates, among other things,the pre-clinical and clinical testing, safety, efficacy, approval, manufacturing, record keeping, adverse event reporting, packaging, labeling, storage, advertising,promotion, export, sale and distribution of biopharmaceutical products. The regulatory review and approval process is lengthy, expensive and uncertain. We are required to submit extensive pre-clinical and clinical data andsupporting information to the FDA for each indication or use to establish a drug candidate’s safety and efficacy before we can secure FDA approval to market orsell a product in the U.S. The approval process takes many years, requires the expenditure of substantial resources and may involve ongoing requirements for post-marketing studies or surveillance. Before commencing clinical trials in humans, we must submit an IND to the FDA containing, among other things, pre-clinicaldata, chemistry, manufacturing and control information, and an investigative plan. Our submission of an IND may not result in FDA authorization to commence aclinical trial. 14 The FDA may permit expedited development, evaluation, and marketing of new therapies intended to treat persons with serious or life-threateningconditions for which there is an unmet medical need under its fast track drug development programs. A sponsor can apply for fast track designation at the time ofsubmission of an IND, or at any time prior to receiving marketing approval of the new drug application, or NDA. To receive Fast Track designation, an applicantmust demonstrate: ●that the drug is intended to treat a serious or life-threatening condition; ●that the drug is intended to treat a serious aspect of the condition; and ●that the drug has the potential to address unmet medical needs, and this potential is being evaluated in the planned drug development program. The FDA must respond to a request for fast track designation within 60 calendar days of receipt of the request. Over the course of drug development, aproduct in a fast track development program must continue to meet the criteria for fast track designation. Sponsors of products in fast track drug developmentprograms must be in regular contact with the reviewing division of the FDA to ensure that the evidence necessary to support marketing approval will be developedand presented in a format conducive to an efficient review. Sponsors of products in fast track drug development programs ordinarily are eligible for priority reviewof a completed application in six months or less and also may be permitted to submit portions of a New Drug Application (“NDA”) to the FDA for review beforethe complete application is submitted. Sponsors of drugs designated as fast track also may seek approval under the FDA’s accelerated approval regulations. Under this authority, the FDA maygrant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on asurrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis ofan effect on a clinical endpoint other than survival or irreversible morbidity. Approval will be subject to the requirement that the applicant study the drug further toverify and describe its clinical benefit where there is uncertainty as to the relation of the surrogate endpoint to clinical benefit or uncertainty as to the relation of theobserved clinical benefit to ultimate outcome. Post-marketing studies are usually underway at the time an applicant files the NDA. When required to be conducted,such post-marketing studies must also be adequate and well-controlled. The applicant must carry out any such post-marketing studies with due diligence. Manycompanies who have been granted the right to utilize an accelerated approval approach have failed to obtain approval. Moreover, negative or inconclusive resultsfrom the clinical trials we hope to conduct or adverse medical events could cause us to have to repeat or terminate the clinical trials. Accordingly, we may not beable to complete the clinical trials within an acceptable time frame, if at all, and, therefore, could not submit the NDA to the FDA or foreign regulatory authoritiesfor marketing approval. In addition, sponsors may also apply to the FDA for Breakthrough Therapy Designation. The Breakthrough Therapy Designation is intended to expeditethe development and review of a potential new drug for serious or life-threatening diseases where “preliminary clinical evidence indicates that the drug maydemonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early inclinical development.” The designation of a drug as a Breakthrough Therapy was enacted as part of the 2012 Food and Drug Administration Safety and InnovationAct. Clinical testing must meet requirements for institutional review board oversight, informed consent and good clinical practices, and must be conductedpursuant to an IND, unless exempted. For purposes of NDA approval, clinical trials are typically conducted in the following sequential phases: ●Phase 1 : The drug is administered to a small group of humans, either healthy volunteers or patients, to test for safety, dosage tolerance, absorption,metabolism, excretion, and clinical pharmacology. ●Phase 2 : Studies are conducted on a larger number of patients to assess the efficacy of the product, to ascertain dose tolerance and the optimal doserange, and to gather additional data relating to safety and potential adverse events. ●Phase 3 : Studies establish safety and efficacy in an expanded patient population. ●Phase 4 : The FDA may require Phase 4 post-marketing studies to find out more about the drug’s long-term risks, benefits, and optimal use, or to testthe drug in different populations. 15 The length of time necessary to complete clinical trials varies significantly and may be difficult to predict. Clinical results are frequently susceptible tovarying interpretations that may delay, limit or prevent regulatory approvals. Additional factors that can cause delay or termination of our clinical trials, or that mayincrease the costs of these trials, include: ●slow patient enrollment due to the nature of the clinical trial plan, the proximity of patients to clinical sites, the eligibility criteria for participation inthe study or other factors; ●inadequately trained or insufficient personnel at the study site to assist in overseeing and monitoring clinical trials or delays in approvals from a studysite’s review board; ●longer treatment time required to demonstrate efficacy or determine the appropriate product dose; ●insufficient supply of the drug candidates; ●adverse medical events or side effects in treated patients; and ●ineffectiveness of the drug candidates. In addition, the FDA, equivalent foreign regulatory authority, or a data safety monitoring committee for a trial may place a clinical trial on hold orterminate it if it concludes that subjects are being exposed to an unacceptable health risk, or for futility. Any drug is likely to produce some toxicity or undesirableside effects in animals and in humans when administered at sufficiently high doses and/or for a sufficiently long period of time. Unacceptable toxicity or sideeffects may occur at any dose level at any time in the course of studies in animals designed to identify unacceptable effects of a drug candidate, known astoxicological studies, or clinical trials of drug candidates. The appearance of any unacceptable toxicity or side effect could cause us or regulatory authorities tointerrupt, limit, delay or abort the development of any of our drug candidates and could ultimately prevent approval by the FDA or foreign regulatory authorities forany or all targeted indications. Sponsors of drugs may apply for an SPA from the FDA. The SPA process is a procedure by which the FDA provides official evaluation and writtenguidance on the design and size of proposed protocols that are intended to form the basis for a new drug application. However, final marketing approval depends onthe results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 trial. The SPA agreement may only bechanged through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product safety orefficacy. Before receiving FDA approval to market a product, we must demonstrate that the product is safe and effective for its intended use by submitting to theFDA an NDA or BLA containing the pre-clinical and clinical data that have been accumulated, together with chemistry and manufacturing and controlsspecifications and information, and proposed labeling, among other things. The FDA may refuse to accept an NDA/BLA for filing if certain content criteria are notmet and, even after accepting an NDA/BLA, the FDA may often require additional information, including clinical data, before approval of marketing a product. It is also becoming more common for the FDA to request a Risk Evaluation and Mitigation Strategy, or REMS, as part of a NDA/BLA. The REMS plancontains post-market obligations of the sponsor to train prescribing physicians, monitor off-label drug use, and conduct sufficient Phase 4 follow-up studies andregistries to ensure the continued safe use of the drug. As part of the approval process, the FDA must inspect and approve each manufacturing facility. Among the conditions of approval is the requirement thata manufacturer’s quality control and manufacturing procedures conform to cGMP. Manufacturers must expend significant time, money and effort to ensurecontinued compliance, and the FDA conducts periodic inspections to certify compliance. It may be difficult for our manufacturers or us to comply with theapplicable cGMP, as interpreted by the FDA, and other FDA regulatory requirements. If we, or our contract manufacturers, fail to comply, then the FDA may notallow us to market products that have been affected by the failure. 16 If the FDA grants approval, the approval will be limited to those disease states, conditions and patient populations for which the product is safe andeffective, as demonstrated through clinical studies. Further, a product may be marketed only in those dosage forms and for those indications approved in theNDA/BLA. Certain changes to an approved NDA/BLA, including, with certain exceptions, any significant changes to labeling, require approval of a supplementalapplication before the drug may be marketed as changed. Any products that we manufacture or distribute pursuant to FDA approvals are subject to continuingmonitoring and regulation by the FDA, including compliance with cGMP and the reporting of adverse experiences with the drugs. The nature of marketing claimsthat the FDA will permit us to make in the labeling and advertising of our products will generally be limited to those specified in FDA approved labeling, and theadvertising of our products will be subject to comprehensive monitoring and regulation by the FDA. Drugs whose review was accelerated may carry additionalrestrictions on marketing activities, including the requirement that all promotional materials are pre-submitted to the FDA. Claims exceeding those contained inapproved labeling will constitute a violation of the FDCA. Violations of the FDCA or regulatory requirements at any time during the product development process,approval process, or marketing and sale following approval may result in agency enforcement actions, including withdrawal of approval, recall, seizure of products,warning letters, injunctions, fines and/or civil or criminal penalties. Any agency enforcement action could have a material adverse effect on our business. Should we wish to market our products outside the U.S., we must receive marketing authorization from the appropriate foreign regulatory authorities. Therequirements governing the conduct of clinical trials, marketing authorization, pricing and reimbursement vary widely from country to country. At present,companies are typically required to apply for foreign marketing authorizations at a national level. However, within the European Union, registration procedures areavailable to companies wishing to market a product in more than one European Union member state. Typically, if the regulatory authority is satisfied that acompany has presented adequate evidence of safety, quality and efficacy, then the regulatory authority will grant a marketing authorization. This foreign regulatoryapproval process, however, involves risks similar or identical to the risks associated with FDA approval discussed above, and therefore we cannot guarantee that wewill be able to obtain the appropriate marketing authorization for any product in any particular country. Failure to comply with applicable federal, state and foreign laws and regulations would likely have a material adverse effect on our business. In addition,federal, state and foreign laws and regulations regarding the manufacture and sale of new drugs are subject to future changes. We cannot predict the likelihood,nature, effect or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad. EMPLOYEES As of March 1, 2017, we had sixty-four full and part-time employees. None of our employees are represented by a collective bargaining agreement, andwe have never experienced a work stoppage. We consider our relations with our employees to be good. ITEM 1A. RISK FACTORS. You should carefully consider the following risks and uncertainties. If any of the following occurs, our business, financial condition or operating resultscould be materially harmed. An investment in our securities is speculative in nature, involves a high degree of risk, and should not be made by an investor whocannot bear the economic risk of its investment for an indefinite period of time and who cannot afford the loss of its entire investment. You should carefully considerthe following risk factors and the other information contained elsewhere in this Annual Report before making an investment in our securities. Risks Related to Our Business and Industry Because we have in-licensed our product candidates from third parties, any dispute with or non-performance by our licensors will adversely affect our ability todevelop and commercialize the applicable product candidates. Our product candidates have been in-licensed from third parties. Under the terms of our license agreements, the licensors generally will have the right toterminate such agreement in the event of a material breach by us. The licensors will also have the right to terminate the agreement in the event we fail to use diligentand reasonable efforts to develop and commercialize the product candidate worldwide. 17 If there is any conflict, dispute, disagreement or issue of non-performance between us and our licensing partners regarding our rights or obligations underthe license agreements, including any such conflict, dispute or disagreement arising from our failure to satisfy payment obligations under such agreement, ourability to develop and commercialize the affected product candidate and our ability to enter into collaboration or marketing agreements for the affected productcandidate may be adversely affected. Any loss of our rights under these license agreements would delay or completely terminate its product development efforts forthe affected product candidate. We do not have full internal development capabilities, and are thus reliant upon our partners and third parties to generate clinical, preclinical and quality datanecessary to support the regulatory applications needed to conduct clinical trials and file for marketing approval. In order to submit and maintain an IND, Biologics License Application (“BLA”), or New Drug Application (“NDA”) to the FDA, it is necessary to submitall information on the clinical, non-clinical, chemistry, manufacturing, controls and quality aspects of the product candidate. We rely on our third party contractorsand our licensing partners to provide a significant portion of this data. If we are unable to obtain this data, or the data is not sufficient to meet the regulatoryrequirements, we may experience significant delays in our development programs. Additionally, an IND must be active in each division in which we intend toconduct clinical trials. Currently we do not have an active IND for any of the IRAK4 or BET inhibitors, nor for our anti-PD-L1 and anti-GITR antibodies.Additionally, there can be no assurance given that any of the molecules under development in our IRAK4 or BET inhibitor program or in our anti-PD-L1 and anti-GITR antibody research program will demonstrate sufficient pharmacologic properties during pre-clinical evaluation to advance to IND enabling studies, or thatsuch IND enabling studies, if any are conducted, will provide data sufficient to support the filing of an IND, or that such IND, if filed, would be accepted by anyFDA division under which we would seek to develop any product candidate. While we maintain an active IND for TG-1101 and TGR-1202 enabling the conduct ofstudies in the FDA’s Division of Hematology and Oncology, and an active IND for TG-1101 under the FDA’s Division of Neurology, there can be no assurancethat we will be successful in obtaining an active IND for TG-1101 or TGR-1202 in any other division under whose supervision we may seek to develop our productcandidates, or that the FDA will allow us to continue the development of our product candidates in those divisions where we maintain an active IND. We are highly dependent on the success of our product candidates and cannot give any assurance that these or any future product candidates will besuccessfully commercialized. We are a development-stage biopharmaceutical company, and do not currently have any commercial products that generate revenues or any other sourcesof revenue. We may never be able to successfully develop marketable products. Our pharmaceutical development methods are unproven and may not lead tocommercially viable products for any of several reasons. If we are unable to develop, or receive regulatory approval for or successfully commercialize any of our product candidates, we will not be able togenerate product revenues. Because the results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance into clinicaltrials may not have favorable results in later clinical trials, if any, or receive regulatory approval. Pharmaceutical development has inherent risk. We will be required to demonstrate through adequate and well-controlled clinical trials that our productcandidates are effective with a favorable benefit-risk profile for use in diverse populations for their target indications before we can seek regulatory approvals fortheir commercial sale. Success in early clinical trials does not mean that later clinical trials will be successful because product candidates in later-stage clinical trialsmay fail to demonstrate sufficient safety or efficacy despite having progressed through initial clinical testing. Companies frequently suffer significant setbacks inadvanced clinical trials, even after earlier clinical trials have shown promising results. In addition, there is typically an extremely high rate of failure ofpharmaceutical candidates proceeding through clinical trials. We plan on conducting additional Phase I, II and III clinical trials for TG-1101 and TGR-1202. Early clinical results seen with TG-1101 and TGR-1202 ina small number of patients may not be reproduced in expanded or larger clinical trials. Additionally, individually reported outcomes of patients treated in clinicaltrials may not be representative of the entire population of treated patients in such studies. If the results from expansion cohorts or later trials are different fromthose found in the earlier studies of TG-1101 and TGR-1202, we may need to terminate or revise our clinical development plan, which could extend the time forconducting our development program and could have a material adverse effect on our business. Our IRAK4, BET, anti-PD-L1 and anti-GITR programs are all inpre-clinical development and no assurance can be given that they will advance into clinical development. If the results from additional pre-clinical studies or earlyclinical trials differ from those found in earlier studies, our clinical development plans and timelines for this program could be adversely affected which could havea material adverse effect on our business. Many drugs fail in the early stages of clinical development for safety and tolerability issues, accordingly if our pre-clinicalassets advance into clinical development, no assurance can be made that a safe and efficacious dose can be found. 18 If we are unable to successfully complete our clinical trial programs, or if such clinical trials take longer to complete than we project, our ability to execute ourcurrent business strategy will be adversely affected. Whether or not and how quickly we complete clinical trials is dependent in part upon the rate at which we are able to engage clinical trial sites and,thereafter, the rate of enrollment of patients, and the rate we collect, clean, lock and analyze the clinical trial database. Patient enrollment is a function of manyfactors, including the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the study, the existence of competitiveclinical trials, and whether existing or new drugs are approved for the indication we are studying. We are aware that other companies are currently conducting orplanning clinical trials that seek to enroll patients with the same diseases that we are studying. Certain clinical trials are designed to continue until a pre-determinednumber of events have occurred in the patients enrolled. Trials such as this are subject to delays stemming from patient withdrawal and from lower than expectedevent rates. They may also incur additional costs if enrollment is increased in order to achieve the desired number of events. If we experience delays in identifyingand contracting with sites and/or in patient enrollment in our clinical trial programs, we may incur additional costs and delays in our development programs, andmay not be able to complete our clinical trials in a cost-effective or timely manner. In addition, conducting multi-national studies adds another level of complexityand risk. We are subject to events affecting countries outside the U.S. Negative or inconclusive results from the clinical trials we conduct or unanticipated adversemedical events could cause us to have to repeat or terminate the clinical trials. In September 2014, we announced a Phase 3 clinical trial for TG-1101 in previously treated patients with high-risk CLL, and in September 2015 weannounced a Phase 3 clinical trial for the combination of TG-1101 + TGR-1202 for patients with CLL, each of which are being conducted pursuant to SPAs withthe FDA. Many companies which have been granted SPAs and/or the right to utilize the FDA’s Fast Track or accelerated approval process have ultimately failed toobtain final approval to market their drugs. Since we are seeking approvals under SPAs for some of our product registration strategies, based on protocol designsnegotiated with the FDA, we may be subject to enhanced scrutiny. Further, any changes or amendments to a protocol that is being conducted under SPA will haveto be reviewed and approved by the FDA to verify that the SPA agreement is still valid. Even if the primary endpoint in a Phase 3 clinical trial is achieved, a SPAdoes not guarantee approval. The FDA may raise issues of safety, study conduct, bias, deviation from the protocol, statistical power, patient completion rates,changes in scientific or medical parameters or internal inconsistencies in the data prior to making its final decision. The FDA may also seek the guidance of anoutside advisory committee prior to making its final decision.The sufficiency of our GENUINE trial design and results are subject to FDA’s discretion. On March 6, 2017, we announced topline data from our Phase 3 “GENUINE” clinical trial of TG-1101 in combination with ibrutinib as a treatment forpatients with previously treated high risk Chronic Lymphocytic Leukemia, or CLL. This trial, as originally designed, was prepared under FDA’s SPA procedures, inwhich FDA agrees in advance of commencement of a Phase III clinical trial that the trial’s design, clinical endpoints and statistical analyses will constitute a pivotalstudy for purposes of regulatory approval, assuming that the resulting data is sufficiently favorable. In October 2016, we amended the protocol, which had the effectof reducing the number of enrolled patients to approximately 120 and eliminating progression-free survival as a primary endpoint, leaving overall response rate asthe sole primary endpoint. In doing so, we invalidated the trial’s SPA. We believe that the trial design and the resulting data could support FDA approval, but that is a question wholly within FDA’s discretion to determine.Whether or not FDA accepts the data for filing will depend on FDA’s views on the adequacy of the filing. Consequently, there can be no assurance that FDA willapprove TG-1101, or even whether FDA will agree to meet with us to discuss the matter. A critical area of inquiry in the GENUINE clinical trial will be the overall response rate observed. As per applicable guidelines, responders requireconfirmation of response for a minimum duration of two months. As of the date of analysis, nine patients that demonstrated a response in the combination therapyarm of the trial were awaiting confirmation visits, which are expected to occur over the next two months. During the study, less than 3% of patients whodemonstrated a response in the combination therapy arm of the trial failed to be a confirmed response at subsequent follow-up. Nevertheless, if one or more of thenine patients awaiting confirmation do not maintain their response at the next checkpoint, our previously reported results could be adversely affected, perhapsmaterially so, which could adversely affect the likelihood of regulatory approval. Any product candidates we may advance ithroughclinical development are subject to extensive regulation, which can be costly and time consuming, causeunanticipated delays or prevent the receipt of the required approvals or any accelerated or "fast track" status to commercialize our product candidates. The clinical development, manufacturing, labeling, storage, record-keeping, advertising, promotion, import, export, marketing and distribution of ourproduct candidates or any future product candidates are subject to extensive regulation by the FDA in the United States and by comparable health authoritiesworldwide or in foreign markets. In the United States, we are not permitted to market our product candidates until we receive approval of a BLA or NDA from theFDA. The process of obtaining BLA and NDA approval is expensive, often takes many years and can vary substantially based upon the type, complexity andnovelty of the products involved. Approval policies or regulations may change and the FDA has substantial discretion in the pharmaceutical approval process,including the ability to delay, limit or deny approval of a product candidate for many reasons. Even with “fast track” or “priority review” status which we intend toseek for our product candidates where possible, including with regard to TG-1101, such designations do not necessarily mean a faster development process orregulatory review process or necessarily confer any advantage with respect to approval compared to conventional FDA procedures. In addition, the FDA mayrequire post-approval clinical trials or studies which also may be costly. The FDA approval for a limited indication or approval with required warning language,such as a boxed warning, could significantly impact our ability to successfully market our product candidates. Finally, the FDA may require adoption of a RiskEvaluation and Mitigation Strategy (“REMS”) requiring prescriber training, post-market registries, or otherwise restricting the marketing and dissemination of theseproducts. Despite the time and expense invested in clinical development of product candidates, regulatory approval is never guaranteed. Assuming successfulclinical development, we intend to seek product approvals in countries outside the United States. As a result, we would be subject to regulation by the EuropeanMedicines Agency (“EMA”), as well as the other regulatory agencies in many of these countries, and other regulatory agencies around the world. 19 Approval procedures vary among countries and can involve additional product testing and additional administrative review periods. The time required toobtain approval in other countries might differ from that required to obtain FDA approval. Regulatory approval in one country does not ensure regulatory approvalin another, but a failure or delay in obtaining regulatory approval in one country may negatively impact the regulatory process in others. As in the United States, theregulatory approval process in Europe and in other countries is a lengthy and challenging process. The FDA, and any other regulatory body around the world candelay, limit or deny approval of a product candidate for many reasons, including:●the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;●we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe andeffective for any indication;●the FDA may not accept clinical data from trials which are conducted by individual investigators or in countries where the standard of care ispotentially different from the United States;●the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities forapproval;●we may be unable to demonstrate that a product candidate's clinical and other benefits outweigh its safety risks;●the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;●the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a BLA, NDA or other submission orto obtain regulatory approval in the United States or elsewhere;●the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers withwhich we or our collaborators contract for clinical and commercial supplies; or●the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering ourclinical data insufficient for approval. In addition, recent events raising questions about the safety of certain marketed pharmaceuticals may result in increased cautiousness by the FDA andother regulatory authorities in reviewing new pharmaceuticals based on safety, efficacy or other regulatory considerations and may result in significant delays inobtaining regulatory approvals. Regulatory approvals for our product candidates may not be obtained without lengthy delays, if at all. Any delay in obtaining, orinability to obtain, applicable regulatory approvals would prevent us from commercializing our product candidates. Any product candidate we advance into clinical trials may cause unacceptable adverse events or have other properties that may delay or prevent their regulatoryapproval or commercialization or limit their commercial potential. Unacceptable adverse events caused by any of our product candidates that we take into clinical trials could cause either us or regulatory authorities tointerrupt, delay, modify or halt clinical trials and could result in the denial of regulatory approval by the FDA or other regulatory authorities for any or all targetedindications. This, in turn, could prevent us from commercializing the affected product candidate and generating revenues from its sale. We have not completed testing of any of our product candidates for the treatment of the indications for which we intend to seek product approval inhumans, and we currently do not know the extent that adverse events, if any, will be observed in patients who receive any of our product candidates. To date,clinical trials using TG-1101 and TGR-1202 have demonstrated a toxicity profile that was deemed acceptable by the investigators performing such studies. Suchinterpretation may not be shared by future investigators or by the FDA and in the case of TG-1101 and TGR-1202, even if deemed acceptable for oncologyapplications, it may not be acceptable for diseases outside the oncology setting, and likewise for any other product candidates we may develop. Additionally, theseverity, duration and incidence of adverse events may increase in larger study populations. With respect to both TG-1101 and TGR-1202, the toxicity whenmanufactured under different conditions and in different formulations is not known, and it is possible that additional and/or different adverse events may appearupon the human use of those formulations and those adverse events may arise with greater frequency, intensity and duration than in the current formulation. Further,with respect to TGR-1202, although more than 300 patients have been dosed amongst all ongoing TGR-1202 studies, the full adverse effect profile of TGR-1202 isnot known. It is unknown as the additional patients are exposed for longer durations to TGR-1202, whether greater frequency and/or severity of adverse events arelikely to occur. Common toxicities of other drugs in the same class as TGR-1202 include high levels of liver toxicity, infections and colitis, the latter of whichnotably has presented with later onset, with incidence increasing with duration of exposure. To date, the incidence of these events has been limited for TGR-1202,however no assurance can be given that this safety and tolerability profile will continue to be demonstrated in the future as higher doses, longer durations ofexposure, and multiple drug combinations are explored. If any of our product candidates cause unacceptable adverse events in clinical trials, we may not be able toobtain marketing approval and generate revenues from its sale, or even if approved for sale may lack differentiation from competitive products, which could have amaterial adverse impact on our business and operations. 20 Additionally, in combination clinical development, there is an inherent risk of drug-drug interactions between combination agents which may affect eachcomponent’s individual pharmacologic properties and the overall efficacy and safety of the combination regimen. Both TG-1101 and TGR-1202 are beingevaluated in combination together, as well as with a variety of other active anti-cancer agents, which may cause unforeseen toxicity, or impact the severity,duration, and incidence of adverse events observed compared to those seen in the single agent studies of these agents. Further, with multi-drug combinations, it isoften difficult to interpret or properly assign attribution of an adverse event to any one particular agent, introducing the risk that toxicity caused by a component of acombination regimen could have a material adverse impact on the development of our product candidates. There can be no assurances given that the combinationregimens being studied will display tolerability or efficacy suitable to warrant further testing or produce data that is sufficient to obtain marketing approval. If any of our product candidates receives marketing approval and we, or others, later identify unacceptable adverse events caused by the product, a numberof significant negative consequences could result, including:●regulatory authorities may withdraw their approval of the affected product;●regulatory authorities may require a more significant clinical benefit for approval to offset the risk;●regulatory authorities may require the addition of labeling statements that could diminish the usage of the product or otherwise limit the commercialsuccess of the affected product;●we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product;●we may choose to discontinue sale of the product;●we could be sued and held liable for harm caused to patients;●we may not be able to enter into collaboration agreements on acceptable terms and execute on our business model; and●our reputation may suffer. Any one or a combination of these events could prevent us from obtaining or maintaining regulatory approval and achieving or maintaining marketacceptance of the affected product or could substantially increase the costs and expenses of commercializing the affected product, which in turn could delay orprevent us from generating any revenues from the sale of the affected product. We may experience delays in the commencement of our clinical trials or in the receipt of data from preclinical and clinical trials conducted by third parties,which could result in increased costs and delay our ability to pursue regulatory approval. Delays in the commencement of clinical trials and delays in the receipt of data from preclinical or clinical trials conducted by third parties couldsignificantly impact our product development costs. Before we can initiate clinical trials in the United States for our product candidates, we need to submit theresults of preclinical testing, usually in animals, to the FDA as part of an IND, along with other information including information about product chemistry,manufacturing and controls and its proposed clinical trial protocol for our product candidates. We plan to rely on preclinical and clinical trial data from third parties, if any, for the IND submissions for our product candidates. If receipt of that data isdelayed for any reason, including reasons outside of our control, it will delay our plans for IND filings, and clinical trial plans. This, in turn, will delay our ability tomake subsequent regulatory filings and ultimately, to commercialize our products if regulatory approval is obtained. If those third parties do not make this dataavailable to us, we will likely, on our own, have to develop all the necessary preclinical and clinical data which will lead to additional delays and increase the costsof our development of our product candidates. Before we can test any product candidate in human clinical trials the product candidate enters the preclinical testing stage. Preclinical tests includelaboratory evaluations of product chemistry, toxicity and formulation, as well as in-vitro and animal studies to assess the potential safety and activity of thepharmaceutical product candidate. The conduct of the preclinical tests must comply with federal regulations and requirements including good laboratory practices(“GLP”). We must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and aproposed clinical protocol, to the FDA as part of the IND. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA places theIND on a clinical hold within that 30-day time period. In such a case, we must work with the FDA to resolve any outstanding concerns before the clinical trials canbegin. The FDA may also impose clinical holds on a product candidate at any time before or during clinical trials due to safety concerns or non-compliance.Accordingly, we cannot be sure that submission of an IND will result in the FDA allowing clinical trials to begin, or that, once begun, issues will not arise thatsuspend or terminate such clinical trial. 21 The FDA may require that we conduct additional preclinical testing for any product candidate before it allows us to initiate the clinical testing under anyIND, which may lead to additional delays and increase the costs of our preclinical development. Even assuming an active IND for a product candidate, we do not know whether our planned clinical trials for any such product candidate will begin ontime, or at all. The commencement of clinical trials can be delayed for a variety of reasons, including delays in:●obtaining regulatory clearance to commence a clinical trial;●identifying, recruiting and training suitable clinical investigators;●reaching agreement on acceptable terms with prospective contract research organizations (“CROs”) and trial sites, the terms of which can be subjectto extensive negotiation, may be subject to modification from time to time and may vary significantly among different CROs and trial sites;●obtaining sufficient quantities of a product candidate for use in clinical trials;●obtaining institutional review board (“IRB”) or ethics committee approval to conduct a clinical trial at a prospective site;●identifying, recruiting and enrolling patients to participate in a clinical trial;●retaining patients who have initiated a clinical trial but may withdraw due to adverse events from the therapy, insufficient efficacy, fatigue with theclinical trial process or personal issues; and●unexpected safety findings. Any delays in the commencement of our clinical trials will delay our ability to pursue regulatory approval for our product candidates. In addition, many ofthe factors that cause, or lead to, a delay in the commencement of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Delays in the completion of clinical testing could result in increased costs and delay our ability to generate product revenues. Once a clinical trial has begun, patient recruitment and enrollment may be slower than we anticipate. Clinical trials may also be delayed as a result ofambiguous or negative interim results. Further, a clinical trial may be suspended or terminated by us, an IRB, an ethics committee or a Data Safety and MonitoringCommittee overseeing the clinical trial, any of our clinical trial sites with respect to that site or the FDA or other regulatory authorities due to a number of factors,including:●failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;●inspection of the clinical trial operations or clinical trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;●unforeseen safety issues or any determination that the clinical trial presents unacceptable health risks; and●lack of adequate funding to continue the clinical trial. Changes in regulatory requirements and guidance also may occur and we may need to amend clinical trial protocols to reflect these changes. Amendmentsmay require us to resubmit our clinical trial protocols to IRBs for re-examination, which may impact the costs, timing and successful completion of a clinical trial.If we experience delays in the completion of, or if we must terminate, any clinical trial of any product candidate that we advance into clinical trials, our ability toobtain regulatory approval for that product candidate will be delayed and the commercial prospects, if any, for the product candidate may be harmed. In addition,many of these factors may also ultimately lead to the denial of regulatory approval of a product candidate. Even if we ultimately commercialize any of our productcandidates, other therapies for the same indications may have been introduced to the market during the period we have been delayed and such therapies may haveestablished a competitive advantage over our product candidates. We intend to rely on third parties to help conduct our planned clinical trials. If these third parties do not meet their deadlines or otherwise conduct the trials asrequired, we may not be able to obtain regulatory approval for or commercialize our product candidates when expected or at all. We intend to use CROs to assist in the conduct of our planned clinical trials and will rely upon medical institutions, clinical investigators and contractlaboratories to conduct our trials in accordance with our clinical protocols. Our future CROs, investigators and other third parties may play a significant role in theconduct of these trials and the subsequent collection and analysis of data from the clinical trials. There is no guarantee that any CROs, investigators and other third parties will devote adequate time and resources to our clinical trials or perform ascontractually required. If any third parties upon whom we rely for administration and conduct of our clinical trials fail to meet expected deadlines, fail to adhere toits clinical protocols or otherwise perform in a substandard manner, our clinical trials may be extended, delayed or terminated, and we may not be able tocommercialize our product candidates. 22 If any of our clinical trial sites terminate for any reason, we may experience the loss of follow-up information on patients enrolled in our ongoing clinicaltrials unless we are able to transfer the care of those patients to another qualified clinical trial site. In addition, principal investigators for our clinical trials mayserve as scientific advisors or consultants to us from time to time and receive cash or equity compensation in connection with such services. If these relationshipsand any related compensation result in perceived or actual conflicts of interest, the integrity of the data generated at the applicable clinical trial site may bejeopardized. As all of our product candidates are still under development, manufacturing and process improvements implemented in the production of those productcandidates may affect their ultimate activity or function. Our product candidates are in the initial stages of development and are currently manufactured in small batches for use in pre-clinical and clinical studies.Process improvements implemented to date have changed, and process improvements in the future may change, the activity profile of the product candidates, whichmay affect the safety and efficacy of the products. No assurance can be given that the material manufactured from any of the optimized processes will performcomparably to the product candidates as manufactured to date and used in currently available pre-clinical data and or in early clinical trials reported in this or anyprevious filing. Additionally, future clinical trial results will be subject to the same level of uncertainty if, following such trials, additional process improvementsare made. In addition, we have recently engaged a secondary manufacturer for TG-1101 to meet our current clinical and future commercial needs and anticipateengaging additional manufacturing sources for TGR-1202 to meet expanded clinical trial and commercial needs. While material produced from this secondarymanufacturer for TG-1101 has to date demonstrated acceptable comparability, no assurance can be given that any additional manufacturers will be successful orthat material manufactured by the additional manufacturers will perform comparably to TG-1101 or TGR-1202 as manufactured to date and used in currentlyavailable pre-clinical data and or in early clinical trials reported in this or any previous filing. If a secondary manufacturer is not successful in replicating theproduct or experiences delays, or if regulatory authorities impose unforeseen requirements with respect to product comparability from multiple manufacturingsources, we may experience delays in clinical development. If we fail to adequately understand and comply with the local laws and customs as we expand into new international markets, these operations may incur lossesor otherwise adversely affect our business and results of operations. We expect to operate a portion of our business in certain countries through subsidiaries or through supply and marketing arrangements. In those countries,where we have limited experience in operating subsidiaries and in reviewing equity investees, we will be subject to additional risks related to complying with awide variety of national and local laws, including restrictions on the import and export of certain intermediates, drugs, technologies and multiple and possiblyoverlapping tax structures. In addition, we may face competition in certain countries from companies that may have more experience with operations in suchcountries or with international operations generally. We may also face difficulties integrating new facilities in different countries into our existing operations, aswell as integrating employees hired in different countries into our existing corporate culture. If we do not effectively manage our operations in these subsidiariesand review equity investees effectively, or if we fail to manage our alliances, we may lose money in these countries and it may adversely affect our business andresults of our operations. If our competitors develop treatments for the target indications for which any of our product candidates may be approved, and they are approved more quickly,marketed more effectively or demonstrated to be more effective than our product candidates, our commercial opportunity will be reduced or eliminated. We operate in a highly competitive segment of the biotechnology and biopharmaceutical market. We face competition from numerous sources, includingcommercial pharmaceutical and biotechnology enterprises, academic institutions, government agencies, and private and public research institutions. Many of ourcompetitors have significantly greater financial, product development, manufacturing and marketing resources. Large pharmaceutical companies have extensiveexperience in clinical testing and obtaining regulatory approval for drugs. Additionally, many universities and private and public research institutes are active incancer research, some in direct competition with us. We may also compete with these organizations to recruit scientists and clinical development personnel. Smalleror early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. The cancer indications for which we are developing our products have a number of established therapies with which we will compete. Most majorpharmaceutical companies and many biotechnology companies are aggressively pursuing new cancer development programs for the treatment of NHL, CLL, andother B-cell proliferative malignancies, including both therapies with traditional, as well as novel, mechanisms of action. Additionally, numerous establishedtherapies exist for the autoimmune disorders for which we are developing TG-1101, including and in particular, multiple sclerosis (MS). 23 If approved, we expect TG-1101 to compete directly with Roche Group’s Rituxan® (rituximab) and Gazyva® (obinutuzumab or GA-101), and Novartis’Arzerra® (ofatumumab) among others, each of which is currently approved for the treatment of various diseases including NHL and CLL. In addition, a number ofpharmaceutical companies are developing antibodies targeting CD20, CD19, and other B-cell associated targets, chimeric antigen receptor T-cell (CAR-T)immunotherapy, and other B-cell ablative therapy which, if approved, would potentially compete with TG-1101 both in oncology settings as well as in autoimmunedisorders. Recently, positive Phase 3 data was announced for the Roche Group’s anti-CD20 antibody ocrelizumab in the treatment of MS, which we anticipate willbe filed for approval in the near term. Genmab and GSK’s (ofatumumab) is also under clinical development for patients with MS. New developments, including thedevelopment of other pharmaceutical technologies and methods of treating disease, occur in the pharmaceutical and life sciences industries at a rapid pace. With respect to TGR-1202, there are several PI3K delta targeted compounds both approved, such as Gilead’s Zydelig™ (idelalisib), and in development,including, but not limited to, Verastem's duvelisib which if approved we would expect to compete directly with TGR-1202. In addition, there are numerous othernovel therapies targeting similar pathways to TGR-1202 both approved and in development, which could also compete with TGR-1202 in similar indications, suchas the BTK inhibitor, ibrutinib (FDA approved for MCL, CLL, Marginal Zone Lymphoma and WM and marketed by AbbVie and Janssen), the BTK inhibitorACP-196 (under development by AstraZeneca), or the BCL-2 inhibitor ABT-199 (FDA approved for CLL and marketed by AbbVie and Roche). These developments may render our product candidates obsolete or noncompetitive. Compared to us, many of our potential competitors have substantiallygreater:●research and development resources, including personnel and technology;●regulatory experience;●pharmaceutical development, clinical trial and pharmaceutical commercialization experience;●experience and expertise in exploitation of intellectual property rights; and●capital resources. As a result of these factors, our competitors may obtain regulatory approval of their products more rapidly than us or may obtain patent protection or otherintellectual property rights that limit our ability to develop or commercialize our product candidates. Our competitors may also develop products for the treatmentof lymphoma, CLL, or other B-cell and autoimmune related disorders that are more effective, better tolerated, more useful and less costly than ours and may also bemore successful in manufacturing and marketing their products. Our competitors may succeed in obtaining approvals from the FDA and foreign regulatoryauthorities for their product candidates sooner than we do for our products. We will also face competition from these third parties in recruiting and retaining qualified personnel, establishing clinical trial sites and enrolling patientsfor clinical trials and in identifying and in-licensing new product candidates. We rely completely on third parties to manufacture our preclinical and clinical pharmaceutical supplies and we intend to rely on third parties to producecommercial supplies of any approved product candidate, and our commercialization of any of our product candidates could be stopped, delayed or made lessprofitable if those third parties fail to obtain approval of the FDA, fail to provide us with sufficient quantities of pharmaceutical product or fail to do so atacceptable quality levels or prices. The facilities used by our contract manufacturers to manufacture our product candidates must be approved by the FDA pursuant to inspections that will beconducted only after we submit a BLA or NDA to the FDA, if at all. We do not control the manufacturing process of our product candidates and are completelydependent on our contract manufacturing partners for compliance with the FDA’s requirements for manufacture of finished pharmaceutical products (goodmanufacturing practices, GMP). If our contract manufacturers cannot successfully manufacture material that conforms to our target product specifications, patentspecifications, and/or the FDA’s strict regulatory requirements of safety, purity and potency, we will not be able to secure and/or maintain FDA approval for ourproduct candidates. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance andqualified personnel. If our contract manufacturers cannot meet FDA standards, we may need to find alternative manufacturing facilities, which would significantlyimpact our ability to develop, obtain regulatory approval for or market our product candidates. No assurance can be given that a long-term, scalable manufacturercan be identified or that they can make clinical and commercial supplies of our product candidates that meets the product specifications of previously manufacturedbatches, or is of a sufficient quality, or at an appropriate scale and cost to make it commercially feasible. If they are unable to do so, it could have a material adverseimpact on our business. 24 In addition, we do not have the capability to package finished products for distribution to hospitals and other customers. Prior to commercial launch, weintend to enter into agreements with one or more alternate fill/finish pharmaceutical product suppliers so that we can ensure proper supply chain management oncewe are authorized to make commercial sales of our product candidates. If we receive marketing approval from the FDA, we intend to sell pharmaceutical productfinished and packaged by such suppliers. We have not entered into long-term agreements with our current contract manufacturers or with any fill/finish suppliers,and though we intend to do so prior to commercial launch of our product candidates in order to ensure that we maintain adequate supplies of finished product, wemay be unable to enter into such an agreement or do so on commercially reasonable terms, which could have a material adverse impact upon our business. In most cases, our manufacturing partners are single source suppliers. It is expected that our manufacturing partners will be sole source suppliers fromsingle site locations for the foreseeable future. Given this, any disruption of supply from these partners could have a material, long-term impact on our ability tosupply products for clinical trials or commercial sale. If our suppliers do not deliver sufficient quantities of our product candidates on a timely basis, or at all, and inaccordance with applicable specifications, there could be a significant interruption of our supply, which would adversely affect clinical development andcommercialization of our products. In addition, if our current or future supply of any or our product candidates should fail to meet specifications during its stabilityprogram there could be a significant interruption of our supply of drug, which would adversely affect the clinical development and commercialization of theproduct. We currently have no marketing and sales organization and no experience in marketing pharmaceutical products. If we are unable to establish sales andmarketing capabilities or fail to enter into agreements with third parties to market and sell any products we may develop, we may not be able to effectivelymarket and sell our products and generate product revenue. We do not currently have the infrastructure for the sales, marketing and distribution of our biotechnology products, and we must build this infrastructure ormake arrangements with third parties to perform these functions in order to commercialize our products. We plan to either develop internally or enter intocollaborations or other commercial arrangements to develop further, promote and sell all or a portion of our product candidates. The establishment and development of a sales force, either by us or jointly with a development partner, or the establishment of a contract sales force tomarket any products we may develop will be expensive and time-consuming and could delay any product launch, and we cannot be certain that we or ourdevelopment partners would be able to successfully develop this capability. If we or our development partners are unable to establish sales and marketing capabilityor any other non-technical capabilities necessary to commercialize any products we may develop, we will need to contract with third parties to market and sell suchproducts. We currently possess limited resources and may not be successful in establishing our own internal sales force or in establishing arrangements with thirdparties on acceptable terms, if at all. If any product candidate that we successfully develop does not achieve broad market acceptance among physicians, patients, healthcare payors, and the medicalcommunity, the revenues that we generate from its sales will be limited. Even if our product candidates receive regulatory approval, they may not gain market acceptance among physicians, patients, healthcare payors, and themedical community. Coverage and reimbursement of our product candidates by third-party payors, including government payors, generally is also necessary forcommercial success. The degree of market acceptance of any of our approved products will depend on a number of factors, including:●the efficacy and safety as demonstrated in clinical trials;●the clinical indications for which the product is approved;●acceptance by physicians, major operators of cancer clinics and patients of the product as a safe and effective treatment;●the potential and perceived advantages of product candidates over alternative treatments;●the safety of product candidates seen in a broader patient group, including its use outside the approved indications;●the cost of treatment in relation to alternative treatments;●the availability of adequate reimbursement and pricing by third parties and government authorities;●relative convenience and ease of administration;●the prevalence and severity of adverse events; and●the effectiveness of our sales and marketing efforts. If any product candidate is approved but does not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, we maynot generate sufficient revenue from these products and we may not become or remain profitable. 25 If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our productcandidates. We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials, and will face an even greaterrisk if we sell our product candidates commercially. Although we are not aware of any historical or anticipated product liability claims against us, if we cannotsuccessfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to cease clinical trials of our drug candidates orlimit commercialization of any approved products. An individual may bring a liability claim against us if one of our product candidates causes, or merely appears tohave caused, an injury. If we cannot successfully defend our self against product liability claims, we will incur substantial liabilities. Regardless of merit or eventualoutcome, liability claims may result in:●decreased demand for our product candidates;●impairment to our business reputation;●withdrawal of clinical trial participants;●costs of related litigation;●distraction of management’s attention from our primary business;●substantial monetary awards to patients or other claimants;●the inability to commercialize our product candidates; and●loss of revenues. We believe that we have obtained sufficient product liability insurance coverage for our clinical trials. We intend to expand our insurance coverage toinclude the sale of commercial products if marketing approval is obtained for any of our product candidates. However, we may be unable to obtain this productliability insurance on commercially reasonable terms and with insurance coverage that will be adequate to satisfy any liability that may arise. On occasion, largejudgments have been awarded in class action or individual lawsuits relating to marketed pharmaceuticals. A successful product liability claim or series of claimsbrought against us could cause our stock price to decline and, if judgments exceed our insurance coverage, could decrease our cash and adversely affect ourbusiness. Reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our productsprofitably. We intend to seek approval to market our future products in both the United States and in countries and territories outside the United States. If we obtainapproval in one or more foreign countries, we will be subject to rules and regulations in those countries relating to our product. In some foreign countries,particularly in the European Union, the pricing of prescription pharmaceuticals and biologics is subject to governmental control. In these countries, pricingnegotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product candidate. In addition, marketacceptance and sales of our product candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for anyof our product candidates and may be affected by existing and future healthcare reform measures. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which pharmaceuticals theywill pay for and establish reimbursement levels. Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’sdetermination that use of a product is:●a covered benefit under its health plan;●safe, effective and medically necessary;●appropriate for the specific patient;●cost-effective; and●neither experimental nor investigational. Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time consuming and costly process thatcould require that we provide supporting scientific, clinical and cost-effectiveness data for the use of our products to the payor. We may not be able to provide datasufficient to gain acceptance with respect to coverage and reimbursement. If reimbursement of our future products is unavailable or limited in scope or amount, or ifpricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability. Additionally, while we may seek approval of our products in combinationwith each other, there can be no guarantee that we will obtain coverage and reimbursement for any of our products together, or that such reimbursement willincentivize the use of our products in combination with each other as opposed to in combination with other agents which may be priced more favorably to themedical community. 26 In both the United States and certain foreign countries, there have been a number of legislative and regulatory changes to the healthcare system that couldimpact our ability to sell our products profitably. In particular, the Medicare Modernization Act of 2003 revised the payment methodology for many productsreimbursed by Medicare, resulting in lower rates of reimbursement for many types of drugs, and added a prescription drug benefit to the Medicare program thatinvolves commercial plans negotiating drug prices for their members. Since 2003, there have been a number of other legislative and regulatory changes to thecoverage and reimbursement landscape for pharmaceuticals. Most recently, the Patient Protection and Affordable Care Act, as amended by the Health Care andEducation Reconciliation Act of 2010, collectively, the “Affordable Care Act,” was enacted. The Affordable Care Act contains a number of provisions, includingthose governing enrollment in federal healthcare programs, the increased use of comparative effectiveness research on healthcare products, reimbursement andfraud and abuse changes, and a new regulatory pathway for the approval of biosimilar biological products, all of which will impact existing government healthcareprograms and will result in the development of new programs. An expansion in the government’s role in the U.S. healthcare industry may further lower rates ofreimbursement for pharmaceutical and biotechnology products. There have been, and likely will continue to be, legislative and regulatory proposals at the federal and state levels directed at broadening the availability ofhealthcare and containing or lowering the cost of healthcare products and services. We cannot predict the initiatives that may be adopted in the future. Thecontinuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs ofhealthcare may adversely affect:●the demand for any products for which we may obtain regulatory approval;●our ability to set a price that we believe is fair for our products;●our ability to generate revenues and achieve or maintain profitability;●the level of taxes that we are required to pay; and●the availability of capital. In addition, governments may impose price controls, which may adversely affect our future profitability. We will need to increase the size of our organization and the scope of our outside vendor relationships, and we may experience difficulties in managing thisgrowth. As of March 1, 2017, we had sixty-four full and part time employees. Over time, we will need to expand our managerial, operational, financial and otherresources in order to manage and fund our operations and clinical trials, continue research and development activities, and commercialize our product candidates.Our management and scientific personnel, systems and facilities currently in place may not be adequate to support our future growth. Our need to effectivelymanage our operations, growth, and various projects requires that we:●manage our clinical trials effectively;●manage our internal development efforts effectively while carrying out our contractual obligations to licensors, contractors and other third parties;●continue to improve our operational, financial and management controls and reporting systems and procedures; and●attract and retain sufficient numbers of talented employees. We may utilize the services of outside vendors or consultants to perform tasks including clinical trial management, statistics and analysis, regulatoryaffairs, formulation development, chemistry, manufacturing, controls, and other pharmaceutical development functions. Our growth strategy may also entailexpanding our group of contractors or consultants to implement these tasks going forward. Because we rely on a substantial number of consultants, effectivelyoutsourcing many key functions of our business, we will need to be able to effectively manage these consultants to ensure that they successfully carry out theircontractual obligations and meet expected deadlines. However, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of theservices provided by consultants is compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtainregulatory approval for our product candidates or otherwise advance its business. There can be no assurance that we will be able to manage our existing consultantsor find other competent outside contractors and consultants on economically reasonable terms, or at all. If we are not able to effectively expand our organization byhiring new employees and expanding our groups of consultants and contractors, we may be unable to successfully implement the tasks necessary to further developand commercialize our product candidates and, accordingly, may not achieve our research, development and commercialization goals. 27 If we fail to attract and keep key management and clinical development personnel, we may be unable to successfully develop or commercialize our productcandidates. We will need to expand and effectively manage our managerial, operational, financial and other resources in order to successfully pursue our clinicaldevelopment and commercialization efforts for our product candidates and future product candidates. We are highly dependent on the development, regulatory,commercial and financial expertise of the members of our senior management. The loss of the services of any of our senior management could delay or prevent thefurther development and potential commercialization of our product candidates and, if we are not successful in finding suitable replacements, could harm ourbusiness. We do not maintain “key man” insurance policies on the lives of these individuals. We will need to hire additional personnel as we continue to expand ourmanufacturing, research and development activities. Our success depends on our continued ability to attract, retain and motivate highly qualified management and scientific personnel and we may not be ableto do so in the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses. Our industry hasexperienced a high rate of turnover of management personnel in recent years. If we are not able to attract and retain the necessary personnel to accomplish ourbusiness objectives, we may experience constraints that will impede significantly the achievement of our development objectives, our ability to raise additionalcapital, and our ability to implement our business strategy. If we fail to comply with healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adverselyaffected. In addition to FDA restrictions on the marketing of pharmaceutical and biotechnology products, several other types of state and federal laws have beenapplied to restrict certain marketing practices in the pharmaceutical and medical device industries in recent years, as well as consulting or other service agreementswith physicians or other potential referral sources. These laws include anti-kickback statutes and false claims statutes that prohibit, among other things, knowinglyand willfully offering, paying, soliciting or receiving remuneration to induce, or, in return for, purchasing, leasing, ordering or arranging for the purchase, lease ororder of any healthcare item or service reimbursable under Medicare, Medicaid or other federally-financed healthcare programs, and knowingly presenting, orcausing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to get a false claimpaid. The majority of states also have statutes or regulations similar to the federal anti-kickback law and false claims laws, which apply to items and servicesreimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor. Although there are a number of statutory exemptions andregulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly, and any practices we adoptmay not, in all cases, meet all of the criteria for safe harbor protection from anti-kickback liability. Sanctions under these federal and state laws may include civilmonetary penalties, exclusion of a manufacturer’s products from reimbursement under government programs, criminal fines and imprisonment. Any challenge to itsbusiness practices under these laws could have a material adverse effect on our business, financial condition, and results of operations. We use biological and hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming orcostly. We use hazardous materials, including chemicals and biological agents and compounds, which could be dangerous to human health and safety or theenvironment. Our operations also produce hazardous waste products. Federal, state and local laws and regulations govern the use, generation, manufacture, storage,handling and disposal of these materials and wastes. Compliance with applicable environmental laws and regulations may be expensive, and current or futureenvironmental laws and regulations may impair our pharmaceutical development efforts. In addition, we cannot entirely eliminate the risk of accidental injury or contamination from these materials or wastes. If one of our employees wasaccidentally injured from the use, storage, handling or disposal of these materials or wastes, the medical costs related to his or her treatment would be covered byour workers’ compensation insurance policy. However, we do not carry specific biological or hazardous waste insurance coverage and our property and casualtyand general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination.Accordingly, in the event of contamination or injury, we could be held liable for damages or penalized with fines in an amount exceeding our resources, and ourclinical trials or regulatory approvals could be suspended, or operations otherwise affected. 28 All product candidate development timelines and projections in this report are based on the assumption of further financing. The timelines and projections in this report are predicated upon the assumption that we will raise additional financing in the future to continue thedevelopment of our product candidates. In the event we do not successfully raise subsequent financing, our product development activities will necessarily becurtailed commensurate with the magnitude of the shortfall. If our product development activities are slowed or stopped, we would be unable to meet the timelinesand projections outlined in this filing. Failure to progress our product candidates as anticipated will have a negative effect on our business, future prospects, andability to obtain further financing on acceptable terms (if at all), and the value of the enterprise. Risks Relating to Acquisitions Acquisitions, investments and strategic alliances that we may make in the future may use significant resources, result in disruptions to our business ordistractions of our management, may not proceed as planned, and could expose us to unforeseen liabilities. We may seek to expand our business through the acquisition of, investments in and strategic alliances with companies, technologies, products, andservices. Acquisitions, investments and strategic alliances involve a number of special problems and risks, including, but not limited to:●difficulty integrating acquired technologies, products, services, operations and personnel with the existing businesses;●diversion of management’s attention in connection with both negotiating the acquisitions and integrating the businesses;●strain on managerial and operational resources as management tries to oversee larger operations;●difficulty implementing and maintaining effective internal control over financial reporting at businesses that we acquire, particularly if they are notlocated near our existing operations;●exposure to unforeseen liabilities of acquired companies;●potential costly and time-consuming litigation, including stockholder lawsuits;●potential issuance of securities to equity holders of the company being acquired with rights that are superior to the rights of holders of our commonstock or which may have a dilutive effect on our stockholders;●risk of loss of invested capital;●the need to incur additional debt or use cash; and●the requirement to record potentially significant additional future operating costs for the amortization of intangible assets. As a result of these or other problems and risks, businesses we acquire may not produce the revenues, earnings, or business synergies that we anticipated,and acquired products, services, or technologies might not perform as we expected. As a result, we may incur higher costs and realize lower revenues than we hadanticipated. We may not be able to successfully address these problems and we cannot assure you that the acquisitions will be successfully identified and completedor that, if acquisitions are completed, the acquired businesses, products, services, or technologies will generate sufficient revenue to offset the associated costs orother negative effects on our business. Any of these risks can be greater if an acquisition is large relative to our size. Failure to effectively manage our growth through acquisitions couldadversely affect our growth prospects, business, results of operations, financial condition and cash flows. Risks Relating to Our Intellectual Property Our success depends upon our ability to protect our intellectual property and proprietary technologies, and the intellectual property protection for our productcandidates depends significantly on third parties. Our commercial success depends on obtaining and maintaining patent protection and trade secret protection for our product candidates and theirformulations and uses, as well as successfully defending these patents against third-party challenges. If any of our licensors or partners fails to appropriatelyprosecute and maintain patent protection for these product candidates, our ability to develop and commercialize these product candidates may be adversely affectedand we may not be able to prevent competitors from making, using and selling competing products. This failure to properly protect the intellectual property rightsrelating to these product candidates could have a material adverse effect on our financial condition and results of operations. 29 Currently, the composition of matter patent and several method of use patents for TG-1101 and TGR-1202 in various indications and settings have beenapplied for but have not yet been issued, or have been issued in certain territories but not under all jurisdictions in which such applications have been filed. Whilecomposition of matter patents have been granted in the US for TG-1101 and TGR-1202, no patents to date have been issued for our IRAK4 inhibitor and anti-PD-L1 and anti-GITR programs. There can be no guarantee that any of these patents for which an application has already been filed, nor any patents filed in the futurefor our product candidates will be granted in any or all jurisdictions in which there were filed, or that all claims initially included in such patent applications will beallowed in the final patent that is issued. The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or ourpartners will be successful in protecting our product candidates by obtaining and defending patents. These risks and uncertainties include the following:●the patent applications that we or our partners file may not result in any patents being issued;●patents that may be issued or in-licensed may be challenged, invalidated, modified, revoked or circumvented, or otherwise may not provide anycompetitive advantage;●as of March 16, 2013, the U.S. converted from a “first to invent” to a “first to file” system. If we do not win the filing race, we will not be entitled toinventive priority;●our competitors, many of which have substantially greater resources than we do, and many of which have made significant investments in competingtechnologies, may seek, or may already have obtained, patents that will limit, interfere with, or eliminate its ability to make, use, and sell our potentialproducts either in the United States or in international markets;●there may be significant pressure on the U.S. government and other international governmental bodies to limit the scope of patent protection bothinside and outside the United States for disease treatments that prove successful as a matter of public policy regarding worldwide health concerns; and●countries other than the United States may have less restrictive patent laws than those upheld by United States courts, allowing foreign competitorsthe ability to exploit these laws to create, develop, and market competing products. If patents are not issued that protect our product candidates, it could have a material adverse effect on our financial condition and results of operations. In addition to patents, we and our partners also rely on trade secrets and proprietary know-how. Although we have taken steps to protect our trade secretsand unpatented know-how, including entering into confidentiality agreements with third parties, and confidential information and inventions agreements withemployees, consultants and advisors, third parties may still obtain this information or we may be unable to protect its rights. If any of these events occurs, or weotherwise lose protection for our trade secrets or proprietary know-how, the value of this information may be greatly reduced. Patent protection and other intellectual property protection are crucial to the success of our business and prospects, and there is a substantial risk that suchprotections will prove inadequate. If we or our partners are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome inthat litigation would have a material adverse effect on our business. Our commercial success also depends upon our ability and the ability of any of our future collaborators to develop, manufacture, market and sell ourproduct candidates without infringing the proprietary rights of third parties. Numerous United States and foreign issued patents and pending patent applications,which are owned by third parties, exist in the fields in which we are developing products, some of which may be directed at claims that overlap with the subjectmatter of our intellectual property. For example, Roche has the Cabilly patents in the U.S. that block the commercialization of antibody products derived from asingle cell line, like TG-1101. Also, Roche, Biogen Idec, and Genentech hold patents for the use of anti-CD20 antibodies utilized in the treatment of CLL in theU.S. While these patents have been challenged, to the best of our knowledge, those matters were settled in a way that permitted additional anti-CD20 antibodies tobe marketed for CLL. If those patents are still enforced at the time we are intending to launch TG-1101, then we will need to either prevail in a litigation tochallenge those patents or negotiate a settlement agreement with the patent holders. If we are unable to do so we may be forced to delay the launch of TG-1101 orlaunch at the risk of litigation for patent infringement, which may have a material adverse effect on our business and results of operations. In addition, because patent applications can take many years to issue, there may be currently pending applications, unknown to us, which may later resultin issued patents that our product candidates or proprietary technologies may infringe. Similarly, there may be issued patents relevant to our product candidates ofwhich we are not aware. 30 There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and biopharmaceutical industriesgenerally. If a third party claims that we or any collaborators of ours infringe their intellectual property rights, we may have to:●obtain licenses, which may not be available on commercially reasonable terms, if at all;●abandon an infringing product candidate or redesign its products or processes to avoid infringement;●pay substantial damages, including treble damages and attorneys’ fees, which we may have to pay if a court decides that the product or proprietarytechnology at issue infringes on or violates the third party’s rights;●pay substantial royalties, fees and/or grant cross licenses to our technology; and/or●defend litigation or administrative proceedings which may be costly whether we win or lose, and which could result in a substantial diversion of ourfinancial and management resources. No assurance can be given that patents issued to third parties do not exist, have not been filed, or could not be filed or issued, which contain claimscovering its products, technology or methods that may encompass all or a portion of our products and methods. Given the number of patents issued and patentapplications filed in our technical areas or fields, we believe there is a risk that third parties may allege they have patent rights encompassing our products ormethods. Other product candidates that we may in-license or acquire could be subject to similar risks and uncertainties. We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful. Competitors may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we may be required to file infringementclaims, which typically are very expensive, time-consuming and disruptive of day-to-day business operations. In addition, in an infringement proceeding, a courtmay decide that a patent of ours or our licensors is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on thegrounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents atrisk of being invalidated, held unenforceable, or interpreted narrowly. The adverse result could also put related patent applications at risk of not issuing. Interference proceedings provoked by third parties or brought by the U.S. Patent and Trademark Office (“PTO”) may be necessary to determine thepriority of inventions with respect to our patents or patent applications or those of our collaborators or licensors. An unfavorable outcome could require us to ceaseusing the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us alicense on commercially reasonable terms. Litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract ourmanagement and other employees. We may not be able to prevent, alone or with our licensors, misappropriation of our trade secrets or confidential information,particularly in countries where the laws may not protect those rights as fully as in the United States. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of ourconfidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results ofhearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantialadverse effect on the price of our common stock. We may be subject to claims that our consultants or independent contractors have wrongfully used or disclosed alleged trade secrets of their other clients orformer employers to it. As is common in the biotechnology and pharmaceutical industry, we engage the services of consultants to assist us in the development of our productcandidates. Many of these consultants were previously employed at, may have previously been, or are currently providing consulting services to, otherbiotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may besubject to claims that these consultants or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their formeremployers or their former or current customers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against theseclaims, litigation could result in substantial costs and be a distraction to management and day-to-day business operations. 31 Risks Relating to Our Finances and Capital Requirements We will need to raise additional capital to continue to operate our business. As of December 31, 2016, we had approximately $45.0 million in cash, cash equivalents, investment securities, and interest receivable. The Companybelieves its cash, cash equivalents, investment securities, and interest receivable on hand as of December 31, 2016 combined with the additional capital raised in thefirst quarter of 2017 will be sufficient to fund the Company’s planned operations for approximately the next 24 months. As a result, we will need additional capitalto continue our operations beyond that time. Required additional sources of financing to continue our operations in the future might not be available on favorableterms, if at all. If we do not succeed in raising additional funds on acceptable terms, we might be unable to complete planned preclinical and clinical trials or obtainapproval of any of our product candidates from the FDA or any foreign regulatory authorities. In addition, we could be forced to discontinue product development,reduce or forego sales and marketing efforts and forego attractive business opportunities. Any additional sources of financing will likely involve the issuance of ourequity securities, which would have a dilutive effect to stockholders. Currently, none of our product candidates have been approved by the FDA or any foreign regulatory authority for sale. Therefore, for the foreseeablefuture, we will have to fund all of our operations and capital expenditures from cash on hand and amounts raised in future offerings or financings. We have a history of operating losses, expect to continue to incur losses, and are unable to predict the extent of future losses or when we will become profitable,if ever. We have not yet applied for or demonstrated an ability to obtain regulatory approval for or commercialize a product candidate. Our short operating historymakes it difficult to evaluate our business prospects and consequently, any predictions about our future performance may not be as accurate as they could be if wehad a history of successfully developing and commercializing pharmaceutical or biotechnology products. Our prospects must be considered in light of theuncertainties, risks, expenses and difficulties frequently encountered by companies in the early stages of operations and the competitive environment in which weoperate. We have never been profitable and, as of December 31, 2016, we had an accumulated deficit of $236.4 million. We have generated operating losses in allperiods since we were incorporated. We expect to make substantial expenditures resulting in increased operating costs in the future and our accumulated deficit willincrease significantly as we expand development and clinical trial efforts for our product candidates. Our losses have had, and are expected to continue to have, anadverse impact on our working capital, total assets and stockholders’ equity. Because of the risks and uncertainties associated with product development, we areunable to predict the extent of any future losses or when we will become profitable, if ever. Even if we achieve profitability, we may not be able to sustain orincrease profitability on an ongoing basis. We have not generated any revenue from our product candidates and may never become profitable. Our ability to become profitable depends upon our ability to generate significant continuing revenues. To obtain significant continuing revenues, we mustsucceed, either alone or with others, in developing, obtaining regulatory approval for and manufacturing and marketing our product candidates (or utilize earlyaccess programs to generate such revenue). To date, our product candidates have not generated any revenues, and we do not know when, or if, we will generate anyrevenue. Our ability to generate revenue depends on a number of factors, including, but not limited to:●successful completion of preclinical studies of our product candidates;●successful commencement and completion of clinical trials of our product candidates and any future product candidates we advance into clinicaltrials;●achievement of regulatory approval for our product candidates and any future product candidates we advance into clinical trials (unless wesuccessfully utilize early access programs which allow for revenue generation prior to approval);●manufacturing commercial quantities of our products at acceptable cost levels if regulatory approvals are obtained;●successful sales, distribution and marketing of our future products, if any; and●our entry into collaborative arrangements or co-promotion agreements to market and sell our products. If we are unable to generate significant continuing revenues, we will not become profitable and we may be unable to continue our operations withoutcontinued funding. 32 We will need substantial additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate ourdevelopment programs or commercialization efforts. We expect to spend substantial amounts on development, including significant amounts on conducting clinical trials for our product candidates,manufacturing clinical supplies and expanding our pharmaceutical development programs. We expect that our monthly cash used by operations will continue toincrease for the next several years. We anticipate that we will continue to incur operating losses for the foreseeable future. We will require substantial additional funds to support our continued research and development activities, as well as the anticipated costs of preclinicalstudies and clinical trials, regulatory approvals, and eventual commercialization. We anticipate that we will incur operating losses for the foreseeable future. Wehave based these estimates, however, on assumptions that may prove to be wrong, and we could expend our available financial resources much faster than wecurrently expect. Further, we will need to raise additional capital to fund our operations and continue to conduct clinical trials to support potential regulatoryapproval of marketing applications. Future capital requirements will also depend on the extent to which we acquire or in-license additional product candidates. Wecurrently have no commitments or agreements relating to any of these types of transactions. The amount and timing of our future funding requirements will depend on many factors, including, but not limited to, the following:●the progress of our clinical trials, including expenses to support the trials and milestone payments that may become payable under our licenseagreements;●the costs and timing of regulatory approvals;●the costs and timing of clinical and commercial manufacturing supply arrangements for each product candidate;●the costs of establishing sales or distribution capabilities;●the success of the commercialization of our products;●our ability to establish and maintain strategic collaborations, including licensing and other arrangements;●the costs involved in enforcing or defending patent claims or other intellectual property rights; and●the extent to which we in-license or invest in other indications or product candidates. Until we can generate a sufficient amount of product revenue and achieve profitability, we expect to finance future cash needs through public or privateequity offerings, debt financings or corporate collaboration and licensing arrangements, as well as through interest income earned on cash balances. If we were to beunable to raise additional capital, we would have to significantly delay, scale back or discontinue one or more of our pharmaceutical development programs. Wealso may be required to relinquish, license or otherwise dispose of rights to product candidates or products that it would otherwise seek to develop or commercializeitself on terms that are less favorable than might otherwise be available . Raising additional funds by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict ouroperations or require us to relinquish proprietary rights. We may raise additional funds through public or private equity offerings, debt financings or licensing arrangements. To the extent that we raise additionalcapital by issuing equity securities, the share ownership of existing stockholders will be diluted. Any future debt financing we enter into may involve covenants thatrestrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, redeem our stock, make certain investments and engagein certain merger, consolidation or asset sale transactions, among other restrictions. In addition, if we raise additional funds through licensing arrangements, it may be necessary to relinquish potentially valuable rights to our productcandidates, or grant licenses on terms that are not favorable to us. If adequate funds are not available, our ability to achieve profitability or to respond to competitivepressures would be significantly limited and we may be required to delay, significantly curtail or eliminate the development of one or more of our productcandidates. Risks Related to Our Common Stock We are controlled by current officers, directors and principal stockholders. Our directors, executive officers, their affiliates, and our principal stockholders beneficially own approximately 48% percent of our outstanding votingstock, including shares underlying outstanding options and warrants. Our directors, officers and principal stockholders, taken as a whole, have the ability to exertsubstantial influence over the election of our Board of Directors and the outcome of issues submitted to our stockholders. 33 Our stock price is, and we expect it to remain, volatile, which could limit investors’ ability to sell stock at a profit. The trading price of our common stock is likely to be highly volatile and subject to wide fluctuations in price in response to various factors, many of whichare beyond our control. These factors include:●publicity regarding actual or potential clinical results relating to products under development by our competitors or us;●delay or failure in initiating, completing or analyzing nonclinical or clinical trials or the unsatisfactory design or results of these trials;●achievement or rejection of regulatory approvals by our competitors or us;●announcements of technological innovations or new commercial products by our competitors or us;●developments concerning proprietary rights, including patents;●developments concerning our collaborations;●regulatory developments in the United States and foreign countries;●economic or other crises and other external factors;●period-to-period fluctuations in our revenues and other results of operations;●changes in financial estimates by securities analysts; and●sales of our common stock. We will not be able to control many of these factors, and we believe that period-to-period comparisons of our financial results will not necessarily beindicative of our future performance. In addition, the stock market in general, and the market for biotechnology companies in particular, has experienced extreme price and volume fluctuationsthat may have been unrelated or disproportionate to the operating performance of individual companies. These broad market and industry factors may seriouslyharm the market price of our common stock, regardless of our operating performance. We have not paid dividends in the past and do not expect to pay dividends in the future, and any return on investment may be limited to the value of your stock. We have never paid dividends on our common stock and do not anticipate paying any dividends for the foreseeable future. You should not rely on aninvestment in our stock if you require dividend income. Further, you will only realize income on an investment in our stock in the event you sell or otherwisedispose of your shares at a price higher than the price you paid for your shares. Such a gain would result only from an increase in the market price of our commonstock, which is uncertain and unpredictable. Certain anti-takeover provisions in our charter documents and Delaware law could make a third-party acquisition of us difficult. This could limit the priceinvestors might be willing to pay in the future for our common stock. Provisions in our amended and restated certificate of incorporation and restated bylaws could have the effect of making it more difficult for a third party toacquire, or of discouraging a third party from attempting to acquire, or control us. These factors could limit the price that certain investors might be willing to pay inthe future for shares of our common stock. Our amended and restated certificate of incorporation allows us to issue preferred stock without the approval of ourstockholders. The issuance of preferred stock could decrease the amount of earnings and assets available for distribution to the holders of our common stock orcould adversely affect the rights and powers, including voting rights, of such holders. In certain circumstances, such issuance could have the effect of decreasing themarket price of our common stock. Our restated bylaws eliminate the right of stockholders to call a special meeting of stockholders, which could make it moredifficult for stockholders to effect certain corporate actions. Any of these provisions could also have the effect of delaying or preventing a change in control. On July 18, 2014, the Board of Directors declared a distribution of one right for each outstanding share of common stock. The rights may have certainanti-takeover effects. The rights will cause substantial dilution to a person or group that attempts to acquire us on terms not approved by the Board of Directorsunless the offer is conditioned on a substantial number of rights being acquired. However, the rights should not interfere with any merger, statutory share exchangeor other business combination approved by the Board of Directors since the rights may be terminated by us upon resolution of the Board of Directors. Thus, therights are intended to encourage persons who may seek to acquire control of the Company to initiate such an acquisition through negotiations with the Board ofDirectors. However, the effect of the rights may be to discourage a third party from making a partial tender offer or otherwise attempting to obtain a substantialequity position in the equity securities of, or seeking to obtain control of, the Company. To the extent any potential acquirers are deterred by the rights, the rightsmay have the effect of preserving incumbent management in office. 34 ITEM 2. PROPERTIES. Our corporate and executive office is located in New York, New York. Our New York facility consists of leased office space at 2 Gansevoort Street, 9 thFloor, New York, New York 10014. We are also currently leasing small office spaces in Cary, North Carolina and Kingsport, Tennessee to accommodate ourclinical operations groups. We believe that our existing facilities are adequate to meet our current requirements. We do not own any real property. ITEM 3. LEGAL PROCEEDINGS. On January 6, 2017, a purported securities class action complaint was filed in New York federal court against the Company and certain of its directors,officers or consultants on behalf of all shareholders who purchased or otherwise acquired TG Therapeutics common stock between September 15, 2014 and October12, 2016 (the “Class Period”). The case is captioned John Lyon v. TG Therapeutics, Michael S. Weiss, Sean A. Power and Robert Niecestro, Case No. 1:17-cv-00112-VM (S.D.N.Y.). The complaint alleges that, throughout the Class Period and including on October 13, 2016, that the Company had filed an “amendedprotocol for its GENUINE Phase 3 trial,” various statements made by the Company regarding its GENUINE Phase 3 trial were materially false or misleading whenmade in violation of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. On January 24, 2017, a second purported class action complaintwas filed in New York federal court against the Company and certain of its directors, officers or consultants also on behalf of all shareholders who purchased orotherwise acquired TG Therapeutics common stock between September 15, 2014 and October 12, 2016. The case is captioned Kenneth C. Wyzgoski v. TGTherapeutics, Michael S. Weiss, Sean A. Power and Robert Niecestro, Case No. 1:17-cv-00508-VM (S.D.N.Y.). The claims and allegations in the Wyzgoskicomplaint are substantially identical to those in the Lyon case. Both actions remain pending and are in the early stages of litigation. PART II ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITYSECURITIES. Market Information Our common stock is listed on the Nasdaq Capital Market and trades under the symbol “TGTX”. Prior to May 30, 2013 our stock was listed on the Overthe Counter Bulletin Board. The following table sets forth the high and low closing sale prices of our common stock for the periods indicated. Fiscal Year Ended December 31, 2016 High Low Fourth Quarter $ 9.33 $ 4.65 Third Quarter $ 7.98 $ 5.49 Second Quarter $ 10.23 $ 5.97 First Quarter $ 11.41 $ 7.83 Fiscal Year Ended December 31, 2015 High Low Fourth Quarter $ 14.42 $ 10.22 Third Quarter $ 18.74 $ 9.76 Second Quarter $ 17.17 $ 13.24 First Quarter $ 18.82 $ 12.77 Holders The number of record holders of our common stock as of March 1, 2017 was 276. Dividends We have never declared or paid any cash dividends on our common stock and do not anticipate paying any cash dividends in the foreseeable future. Anyfuture determination to pay dividends will be at the discretion of our board of directors. Securities Authorized for Issuance Under Equity Compensation Plans The following table provides information as of December 31, 2016, regarding the securities authorized for issuance under our equity compensation plan,the TG Therapeutics, Inc. Amended and Restated 2012 Incentive Plan. 35 Equity Compensation Plan Information Plan Category Number ofsecurities tobe issued uponexercise ofoutstandingoptions Weighted-averageexercise priceof outstandingoptions Number ofsecuritiesremainingavailable forfutureissuanceunder equitycompensationplans(excludingsecuritiesreflected incolumn (a)) (a) (b) (c) Equity compensation plans approved by security holders -- $-- 2,286,764 Equity compensation plans not approved by security holders -- -- -- Total -- $-- 2,286,764 For information about all of our equity compensation plans see Note 5 to our Consolidated Financial Statements included in this report. COMMON STOCK PERFORMANCE GRAPH The following graph compares the cumulative total stockholder return on our common stock for the period from December 31, 2011 (1) through December31, 2016, with the cumulative total return over such period on (i) the U.S. Index of The Nasdaq Stock Market and (ii) the Biotechnology Index of The Nasdaq StockMarket. The graph assumes an investment of $100 on December 31, 2011, in our common stock (at the adjusted closing market price) and in each of the indiceslisted above, and assumes the reinvestment of all dividends. Measurement points are December 31 of each year. (1) In connection with the Company having entered into and consummated an exchange transaction agreement (the “Exchange Transaction”) with OpusPoint Partners, LLC (“Opus”) and TG Biologics, Inc. (formerly known as TG Therapeutics, Inc.) (“TG Bio”), we used the start date of December 31, 2011 to be inagreement with this transaction. (2) $100 invested on 12/31/11 in stock or index, including reinvestment of dividends. Fiscal Years ending December 31. 36 ITEM 6. SELECTED FINANCIAL DATA The following Statement of Operations Data for the years ended December 31, 2016, 2015, 2014, 2013 and 2012, and Balance Sheet Data as of December31, 2016, 2015, 2014, 2013 and 2012, as set forth below are derived from our audited consolidated financial statements. This financial data should be read inconjunction with “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Item 8. Financial Statements andSupplementary Data.” Years ended December 31, 2016 2015 2014 2013 2012 License revenue $ 152,381 $ 152,381 $ 152,381 $ 152,381 $ 19,048 Costs and expenses: Research and development: Noncash stock expense associated with in-licensing agreements -- -- 5,350,094 -- 16,578,000 Noncash compensation 2,742,354 4,261,406 8,731,566 1,041,519 455,809 Other research and development 66,489,820 43,445,817 26,004,687 12,621,161 3,994,182 Total research and development 69,232,174 47,707,223 40,086,347 13,662,680 21,027,991 General and administrative: N oncash compensation 4,767,645 11,435,686 12,373,726 4,161,629 2,966,373 Other general and administrative 5,121,690 4,189,488 3,413,400 2,496,461 1,815,083 Total general and administrative 9,889,335 15,625,174 15,787,126 6,658,090 4,781,456 Impairment of in-process research and development -- -- -- 2,797,600 1,104,700 Total costs and expenses 79,121,509 63,332,397 55,873,473 23,118,370 26,914,147 Operating loss (78,969,128 ) (63,180,016 ) (55,721,092 ) (22,965,989 ) (26,895,099 ) Other (income) expense: Interest income (323,032 ) (174,653 ) (55,049 ) (30,822 ) (15,787 )Other (income) expense (393,202 ) (56,717 ) 115,234 (2,456,957 ) (1,026,360 )Total other (income) expense, net (716,234 ) (231,370 ) 60,185 (2,487,779 ) (1,042,147 ) Loss before income taxes (78,252,894 ) (62,948,646 ) (55,781,277 ) (20,478,210 ) (25,852,952 )Income taxes -- -- -- -- 330,000 (78,252,894 (62,948,646 (55,781,277 (20,478,210 (26,182,952 Consolidated net loss))))) Net loss attributable to non-controlling interest -- -- -- -- (8,110,233 )Net loss attributable to TG Therapeutics, Inc. and Subsidiaries $ (78,252,894 ) $ (62,948,646 ) $ (55,781,277 ) $ (20,478,210 ) $ (18,072,719 ) Basic and diluted net loss per common share $ (1.60 ) $ (1.38 ) $ (1.64 ) $ (0.81 ) $ (1.38 ) Balance Sheet Information: December 31, 2016 2015 2014 2013 2012 Cash, cash equivalents, investment securities and interest receivable $ 44,968,992 $ 102,416,894 $ 78,861,334 $ 45,431,532 $ 16,455,995 Total assets 54,781,547 113,473,201 86,746,890 48,112,390 22,074,037 Accumulated deficit (236,386,820 ) (158,133,926 ) (95,185,280 ) (39,404,003 ) (18,925,793 )Total equity 35,867,802 101,573,302 80,101,884 40,054,492 15,550,301 37 ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. The following discussion and analysis contains forward-looking statements about our plans and expectations of what may happen in the future. Forward-looking statements are based on a number of assumptions and estimates that are inherently subject to significant risks and uncertainties, and our results could differmaterially from the results anticipated by our forward-looking statements as a result of many known or unknown factors, including, but not limited to, those factorsdiscussed in “Item 1A. Risk Factors.” See also the “Special Cautionary Notice Regarding Forward-Looking Statements” set forth at the beginning of this report . You should read the following discussion and analysis in conjunction with “Item 8. Financial Statements and Supplementary Data,” and our consolidatedfinancial statements beginning on page F-1 of this report. Overview We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies andautoimmune diseases. Currently, the Company is developing two therapies targeting hematologic malignancies. TG-1101 (ublituximab) is a novel, glycoengineeredmonoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. We are also developing TGR-1202, an orallyavailable PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferationand survival of B-lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. We also have pre-clinicalprograms to develop IRAK4 (interleukin-1 receptor-associated kinase 4) inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies . 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 drugcandidates. Our license revenues currently consist of license fees arising from our agreement with Ildong. We recognize upfront license fee revenues ratably over theestimated period in which we will have certain significant ongoing responsibilities under the sublicense agreement, with unamortized amounts recorded as deferredrevenue. We have not earned any revenues from the commercial sale of any of our drug candidates. Our research and development expenses consist primarily of expenses related to in-licensing of new product candidates, fees paid to consultants andoutside service providers for clinical and laboratory development, facilities-related and other expenses relating to the design, development, manufacture, testing andenhancement of our drug candidates and technologies. We expense our research and development costs as they are incurred. Research and development expensesfor the years ended December 31, 2016, 2015 and 2014 were $66,489,820, $43,445,817 and $31,354,781, respectively, excluding non-cash compensation expensesrelated to research and development. The following table sets forth the research and development expenses per project, exclusive of non-cash compensation expenses, for the periods presented. 38 2016 2015 2014 TG-1101 $40,839,899 $29,816,042 $15,410,925 TGR-1202 21,394,427 11,671,889 14,249,856 IRAK4 200,457 1,068,466 1,694,000 PD-L1/GITR 987,369 500,300 -- BET 1,551,032 -- -- BTK 925,581 -- -- Other 591,055 389,120 -- Total $66,489,820 $43,445,817 $31,354,781 Our general and administrative expenses consist primarily of salaries and related expenses for executive, finance and other administrative personnel,recruitment expenses, professional fees and other corporate expenses, including investor relations, legal activities and facilities-related expenses such as rentexpense and amortization of leasehold interest. Our results of operations include non-cash compensation expenses as a result of the grants of stock options and restricted stock. Compensation expense forawards of options and restricted stock granted to employees and directors represents the fair value of the award recorded over the respective vesting periods of theindividual awards. The expense is included in the respective categories of expense in the consolidated statements of operations. We expect to continue to incursignificant non-cash compensation expenses. For awards of options and restricted stock to consultants and other third-parties, compensation expense is determined at the “measurement date.” Theexpense is recognized over the vesting period of the award. Until the measurement date is reached, the total amount of compensation expense remains uncertain.We record compensation expense based on the fair value of the award at the reporting date. The awards to consultants and other third-parties are then revalued, orthe total compensation is recalculated based on the then current fair value, at each subsequent reporting date. This results in a change to the amount previouslyrecorded in respect of the equity award grant, and additional expense or a reversal of expense may be recorded in subsequent periods based on changes in theassumptions used to calculate fair value, such as changes in market price, until the measurement date is reached and the compensation expense is finalized. In addition, certain restricted stock issued to employees vest upon the achievement of certain milestones; therefore, the total expense is uncertain until themilestone is probable. Our clinical trials will be lengthy and expensive. Even if these trials show that our drug candidates are effective in treating certain indications, there is noguarantee that we will be able to record commercial sales of any of our drug candidates in the near future. In addition, we expect losses to continue as we continueto fund in-licensing and development of new drug candidates. As we continue our development efforts, we may enter into additional third-party collaborativeagreements and may incur additional expenses, such as licensing fees and milestone payments. In addition, we may need to establish the commercial infrastructurerequired to manufacture, market and sell our drug candidates following approval, if any, by the FDA, which would result in us incurring additional expenses. As aresult, our quarterly results may fluctuate and a quarter-by-quarter comparison of our operating results may not be a meaningful indication of our futureperformance. 39 RESULTS OF OPERATIONS Years Ended December 31, 2016, 2015 and 2014 Years Ended December 31, 2016 2015 2014 License revenue $ 152,381 $ 152,381 $ 152,381 Costs and expenses: Research and development: Noncash stock expense associated with in-licensing agreements -- -- 5,350,094 Noncash compensation 2,742,354 4,261,406 8,731,566 Other research and development 66,489,820 43,445,817 26,004,687 Total research and development 69,232,174 47,707,223 40,086,347 General and administrative: Noncash compensation 4,767,645 11,435,686 12,373,726 Other general and administrative 5,121,690 4,189,488 3,413,400 Total general and administrative 9,889,335 15,625,174 15,787,126 Total costs and expenses 79,121,509 63,332,397 55,873,473 Operating loss (78,969,128 ) (63,180,016 ) (55,721,092 ) Other expense (income), net (716,234 ) (231,370 ) 60,185 Net loss $ (78,252,894 ) $ (62,948,646 ) $ (55,781,277 ) Years Ended December 31, 2016 and 2015 License Revenue. License revenue was $152,381 for each of the years ended December 31, 2016 and 2015. License revenue is related to the amortizationof an upfront payment of $2.0 million associated with our license agreement with Ildong. The upfront payment from Ildong will be recognized as license revenue ona straight-line basis through December 2025, which represents the estimated period over which the Company will have certain ongoing responsibilities under thesublicense agreement. Noncash Compensation Expense (Research and Development). Noncash compensation expense (research and development) related to equity incentivegrants totaled $2,742,354 for the year ended December 31, 2016, as compared to $4,261,406 during the comparable period in 2015. The decrease in noncashcompensation expense was primarily related to milestone-based vesting of restricted stock grants to non-executive personnel during the year ended December 31,2015, and a decrease in the measurement date fair value of certain consultant restricted stock during the year ended December 31, 2016 . Other Research and Development Expenses . Other research and development expenses increased by $23,044,003 from $43,445,817 for the year endedDecember 31, 2015 to $66,489,820 for the year ended December 31, 2016. The increase in other research and development expenses was due primarily to a $1.0million licensing fee for the Jubilant sub-license agreement, as well as the ongoing clinical development programs and related manufacturing costs for TG-1101 andTGR-1202 during the year ended December 31, 2016. We expect our other research and development costs to increase modestly during 2017 as enrollment ofadditional patients in our Phase 3 clinical trials increases and we prepare for a commercial launch . Noncash Compensation Expense (General and Administrative). Noncash compensation expense (general and administrative) related to equity incentivegrants decreased by $6,668,041 from $11,435,686 for the year ended December 31, 2015 to $4,767,645 during the year ended December 31, 2016. The decrease innoncash compensation expense was primarily related to greater measurement date fair values of certain consultant restricted stock during the year ended December31, 2015 . 40 Other General and Administrative Expenses . Other general and administrative expenses increased by $932,202 from $4,189,488 for the year endedDecember 31, 2015 to $5,121,690 for the year ended December 31, 2016. The increase was due primarily to the straight-line rent expense of our new office space,as well as increased personnel and other general and administrative costs . We expect our other general and administrative expenses to increase modestly during2017. Other Expense (Income), Net . Other income increased by $484,864 from $231,370 for the year ended December 31, 2015 to $716,234 for the year endedDecember 31, 2016. The increase is mainly due to the receipt of a New York City biotechnology tax credit of approximately $0.3 million and an increase in interestincome for the year ended December 31, 2016. Years Ended December 31, 2015 and 2014 License Revenue. License revenue was $152,381 for each of the years ended December 31, 2015 and 2014. License revenue is related to the amortizationof an upfront payment of $2.0 million associated with our license agreement with Ildong. The upfront payment from Ildong will be recognized as license revenue ona straight-line basis through December 2025, which represents the estimated period over which the Company will have certain ongoing responsibilities under thesublicense agreement. Noncash Stock Expense Associated with In-licensing Agreements. Noncash stock expense associated with in-licensing agreements amounted to $5,350,094for the year ended December 31, 2014. The expense during the year ended December 31, 2014 was recorded in conjunction with the stock issued to Rhizen ofapproximately $4,100,000 in connection with our license for TGR-1202, and approximately $1,200,000 for the common stock issued to Ligand Pharmaceuticals asan upfront payment for the license to the IRAK4 inhibitors program. Noncash Compensation Expense (Research and Development). Noncash compensation expense (research and development) related to equity incentivegrants totaled $4,261,406 for the year ended December 31, 2015, as compared to $8,731,566 during the comparable period in 2014. The decrease in noncashcompensation expense was primarily related to milestone-based vesting of restricted stock grants to personnel during the year ended December 31, 2014 and adecrease in the measurement date fair value of certain consultant restricted stock during the period ended December 31, 2015. Other Research and Development Expenses . Other research and development expenses increased by $17,441,130 from $26,004,687 for the year endedDecember 31, 2014 to $43,445,817 for the year ended December 31, 2015. The increase in other research and development expenses was due primarily to increasesof approximately $11.7 million and $3.4 million for manufacturing and clinical trial expenses related to TG-1101 and TGR-1202, respectively, offset by a decreaseof $4.0 million related to the upfront cash milestone payment to Rhizen to exercise the license option for TGR-1202 during the year ended December 31, 2014. Noncash Compensation Expense (General and Administrative). Noncash compensation expense (general and administrative) related to equity incentivegrants decreased by $938,040 from $12,373,726 for the year ended December 31, 2014 to $11,435,686 during the year ended December 31, 2015. The decrease innoncash compensation expense was primarily related to milestone-based vesting of restricted stock grants to personnel during the year ended December 31, 2014. Other General and Administrative Expenses . Other general and administrative expenses increased by $776,088 from $3,413,400 for the year endedDecember 31, 2014 to $4,189,488 for the year ended December 31, 2015. The increase was due primarily to increased personnel and other general andadministrative costs. Other Expense (Income), Net . Other income increased by $291,555 from $60,185 of expense for the year ended December 31, 2014 to $231,370 ofincome for the year ended December 31, 2015. The increase is mainly due to an increase in interest income for the year ended December 31, 2015. LIQUIDITY AND CAPITAL RESOURCES Our primary sources of cash have been from the sale of equity securities, the upfront payment from our Sublicense Agreement with Ildong, and warrantand option exercises. 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 oneor more of our drug candidates, we may not become profitable. Our ability to achieve profitability depends on a number of factors, including our ability to obtainregulatory approval for our drug candidates, successfully complete any post-approval regulatory obligations and successfully commercialize our drug candidatesalone or in partnership. We may continue to incur substantial operating losses even if we begin to generate revenues from our drug candidates. On March 9, 2017, we announced the pricing of an underwritten public offering of 5,128,206 shares of our common stock (plus a 30-day option topurchase up to an additional 769,230 shares of common stock, which has been exercised) at a price of $9.75 per share, with expected gross proceeds to TGTherapeutics of $57.5 million, less underwriting discounts and commissions. Total net proceeds from this offering, including the overallotment, are expected to beapproximately $54 million, net of underwriting discounts and estimated offering expenses of approximately $3.5 million. The shares were sold under a shelfregistration statement on Form S-3 (File No. 333-201339) that was previously filed and declared effective by the SEC in January 2015. The offering closed onMarch 14, 2017. As of December 31, 2016, we had $45.0 million in cash and cash equivalents, investment securities, and interest receivable. Subsequent to the year endedDecember 31, 2016, we sold a total of approximately 3,000,000 shares of common stock under the 2015 ATM for aggregate net proceeds of approximately $30.2million. 41 We anticipate that our cash and cash equivalents as of December 31, 2016 combined with the additional capital raised in the first quarter of 2017 will besufficient to fund the Company’s planned operations for approximately the next 24 months. The actual amount of cash that we will need to operate is subject tomany factors, including, but not limited to, the timing, design and conduct of clinical trials for our drug candidates. We are dependent upon significant financing toprovide the cash necessary to execute our current operations, including the commercialization of any of our drug candidates. Cash used in operating activities for the year ended December 31, 2016 was $61,591,330 as compared to $44,690,272 for the year ended December 31,2015. The increase in cash used in operating activities was due primarily to increased expenditures associated with our clinical development programs for TG-1101and TGR-1202. For the year ended December 31, 2016, net cash provided by investing activities was $26,545,312 as compared to cash used in investing activities of$24,685,869 for the year ended December 31, 2015. The increase in net cash provided by investing activities was primarily due to proceeds from maturity of short-term securities and the sale of long-term securities during the year ended December 31, 2016. For the year ended December 31, 2016, net cash provided by financing activities of $5,015,969 related to our program under an At-the-Market IssuanceSales Agreement (the “ATM Program”), as well as proceeds from the exercise of warrants. For the year ended December 31, 2015, net cash provided by financingactivities of $68,723,686 related to our ATM Program, as well as proceeds from the exercise of warrants. ATM Program On June 21, 2013, we entered into an At-the-Market Issuance Sales Agreement (the ?2013 ATM?) with MLV & Co. LLC (?MLV?) under which we couldissue and sell shares of our common stock, having aggregate offering proceeds of up to $50.0 million, from time to time through MLV, acting as the sales agent.Under the agreement we would pay MLV a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock sold through MLV. During the year ended December 31, 2014, we sold a total of 4,850,055 shares of common stock under this arrangement for aggregate total gross proceedsof approximately $50.0 million at an average selling price of $10.31 per share. Net proceeds were approximately $48.8 million after deducting commissions andother transaction costs. We have fully utilized the capacity under the 2013 ATM and, accordingly, no further sales can be made under the 2013 ATM. In December 2014, we amended our 2013 ATM with MLV (the “2015 ATM”) such that we could issue and sell additional shares of our common stock,having an aggregate offering price of up to $75.0 million, from time to time through MLV, acting as the sales agent. Under the 2015 ATM, we would pay MLV acommission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock sold through MLV. During the year ended December 31, 2015, we sold a total of 4,094,498 shares of common stock under the 2015 ATM for aggregate total gross proceeds ofapproximately $68.2 million at an average selling price of $16.66 per share, resulting in net proceeds of approximately $67.0 million after deducting commissionsand other transaction costs. During the year ended December 31, 2016, we sold a total of 570,366 shares of common stock under the 2015 ATM for aggregate total gross proceeds ofapproximately $4.5 million at an average selling price of $7.88 per share, resulting in net proceeds of approximately $4.4 million after deducting commissions andother transaction costs. Equity Financings On March 11, 2014, we announced the pricing of an underwritten sale of 2,702,809 shares of our common stock at a price of $6.71 per share for grossproceeds of approximately $18.1 million. Net proceeds from this offering were approximately $16.8 million, net of underwriting discounts and offering expenses ofapproximately $1.3 million. On July 18, 2013, we announced the pricing of an underwritten public offering of 5,700,000 shares of our common stock at a price of $6.15 per share forgross proceeds of approximately $35 million. We also granted to the underwriters a 30-day option to acquire an additional 855,000 shares to cover overallotmentsin connection with the offering, which they exercised. Total net proceeds from this offering, including the overallotment, were approximately $37.6 million, net ofunderwriting discounts and offering expenses of approximately $2.7 million. 42 OFF-BALANCE SHEET ARRANGEMENTS We have not entered into any transactions with unconsolidated entities whereby we have financial guarantees, subordinated retained interests, derivativeinstruments or other contingent arrangements that expose us to material continuing risks, contingent liabilities, or any other obligations under a variable interest inan unconsolidated entity that provides us with financing, liquidity, market risk or credit risk support. OBLIGATIONS AND COMMITMENTS As of December 31, 2016, we have known contractual obligations, commitments and contingencies of $18.0 million related to our operating leaseobligations. (in thousands) Payment due by period Total Less than 1year 1-3 years 3-5 years More than5 years Contractual obligations Operating leases $ 18,020 $ 1,185 $ 2,281 $ 2,286 $ 12,268 Total $ 18,020 $ 1,185 $ 2,281 $ 2,286 $ 12,268 Leases In October 2014, we entered into an agreement (the “Office Agreement”) with FBIO, to occupy approximately 45% of the 24,000 square feet of New YorkCity office space leased by FBIO, which is now our corporate headquarters. The Office Agreement requires us to pay our respective share of the average annualrent 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 thisnew space in April 2016, with rental payments beginning in the third quarter of 2016. During the year ended December 31, 2016, we recorded rent expense ofapproximately $1.4 million and at December 31, 2016, have deferred rent of approximately $0.8 million . Mr. Weiss, our Executive Chairman and CEO, is alsoExecutive Vice Chairman of FBIO . During the year ended December 31, 2016, we agreed to pay FBIO $2.2 million for our portion of the build out costs, which have been allocated to us atthe 45% rate mentioned above. The allocated build-out costs have been recorded in leasehold interest and will be amortized over the 15-year term of the OfficeAgreement. 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 annuallyand if our utilization differs from the amount we have been billed, we will either receive credits or be assessed incremental utilization charges. Also in connectionwith 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 asrestricted cash in the accompanying consolidated balance sheets. Total rental expense was approximately $1.6 million, $0.3 million and $0.1 million for the years ended December 31, 2016, 2015 and 2014, respectively. Future minimum lease commitments as of December 31, 2016 total, in the aggregate, approximately $18.0 million through December 31, 2031. Thepreceding table shows future minimum lease commitments, which include our office leases in New York, North Carolina and Tennessee, by period as ofDecember 31, 2016. CRITICAL ACCOUNTING POLICIES The discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements, which have beenprepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates andjudgments that affect the reported amount of assets and liabilities and related disclosure of contingent assets and liabilities at the date of our financial statements andthe reported amounts of revenues and expenses during the applicable period. Actual results may differ from these estimates under different assumptions orconditions. We define critical accounting policies as those that are reflective of significant judgments and uncertainties and which may potentially result in materiallydifferent results under different assumptions and conditions. In applying these critical accounting policies, our management uses its judgment to determine theappropriate assumptions to be used in making certain estimates. These estimates are subject to an inherent degree of uncertainty. Our critical accounting policiesinclude the following: 43 Revenue Recognition . We recognize license revenue in accordance with the revenue recognition guidance of the Financial Accounting Standards Board(“FASB”) Accounting Standards Codification (“ASC”), or Codification. We analyze each element of our licensing agreement to determine the appropriate revenuerecognition. The terms of the license agreement may include payments to us of non-refundable up-front license fees, milestone payments if specified objectives areachieved, and/or royalties on product sales. We recognize revenue from upfront payments over the period of significant involvement under the related agreementsunless the fee is in exchange for products delivered or services rendered that represent the culmination of a separate earnings process and no further performanceobligation exists under the contract. We recognize milestone payments as revenue upon the achievement of specified milestones only if (1) the milestone payment isnon-refundable, (2) substantive effort is involved in achieving the milestone, (3) the amount of the milestone is reasonable in relation to the effort expended or therisk associated with achievement of the milestone, and (4) the milestone is at risk for both parties. If any of these conditions are not met, we defer the milestonepayment and recognize it as revenue over the estimated period of performance under the contract. Stock Compensation . We have granted stock options and restricted stock to employees, directors and consultants, as well as warrants to other third parties.For employee and director grants, the value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model. The Black-Scholesmodel takes into account volatility in the price of our stock, the risk-free interest rate, the estimated life of the option, the closing market price of our stock and theexercise price. We base our estimates of our stock price volatility on the historical volatility of our common stock and our assessment of future volatility; however,these estimates are neither predictive nor indicative of the future performance of our stock. For purposes of the calculation, we assumed that no dividends would bepaid during the life of the options and warrants. The estimates utilized in the Black-Scholes calculation involve inherent uncertainties and the application ofmanagement judgment. In addition, we are required to estimate the expected forfeiture rate and only recognize expense for those equity awards expected to vest. Asa result, if other assumptions had been used, our recorded stock-based compensation expense could have been materially different from that reported. In addition,because some of the options, restricted stock and warrants issued to employees, consultants and other third-parties vest upon the 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 suchmilestone becomes probable. Total compensation expense for options and restricted stock issued to consultants is determined at the “measurement date.” The expense is recognized overthe vesting period for the options and restricted stock. Until the measurement date is reached, the total amount of compensation expense remains uncertain. Werecord stock-based compensation expense based on the fair value of the equity awards at the reporting date. These equity awards are then revalued, or the totalcompensation is recalculated based on the then current fair value, at each subsequent reporting date. This results in a change to the amount previously recorded inrespect of the equity award grant, and additional expense or a reversal of expense may be recorded in subsequent periods based on changes in the assumptions usedto calculate fair value, such as changes in market price, until the measurement date is reached and the compensation expense is finalized. In-process Research and Development . All acquired research and development projects are recorded at their fair value as of the date acquisition. The fairvalues are assessed as of the balance sheet date to ascertain if there has been any impairment of the recorded value. If there is an impairment the asset is writtendown to its current fair value by the recording of an expense. Accruals for Clinical Research Organization and Clinical Site Costs. We make estimates of costs incurred in relation to external clinical researchorganizations, or CROs, and clinical site costs. We analyze the progress of clinical trials, including levels of patient enrollment, invoices received and contractedcosts when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. Significant judgments and estimates must be madeand used in determining the accrued balance and expense in any accounting period. We review and accrue CRO expenses and clinical trial study expenses based onwork 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 trialsprogress 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 sitecosts, the financial terms of these agreements are subject to negotiation and vary from contract to contract. Payments under these contracts may be uneven, anddepend on factors such as the achievement of certain events, the successful recruitment of patients, the completion of portions of the clinical trial or similarconditions. The objective of our policy is to match the recording of expenses in our financial statements to the actual services received and efforts expended. Assuch, 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 specificclinical study or trial contract. 44 Accounting Related to Goodwill. As of December 31, 2016 and 2015, there was $799,391 of goodwill on our consolidated balance sheets. Goodwill isreviewed for impairment annually, or when events arise that could indicate that an impairment exists. We test for goodwill impairment using a two-step process.The first step compares the fair value of the reporting unit with the unit's carrying value, including goodwill. When the carrying value of the reporting unit is greaterthan 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. Inthe 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 greaterthan the implied fair value, the carrying value of the goodwill must be written down to its implied fair value. We are required to perform impairment tests annually, at December 31, and whenever events or changes in circumstances suggest that the carrying valueof an asset may not be recoverable. For all of our acquisitions, various analyses, assumptions and estimates were made at the time of each acquisition that were usedto determine the valuation of goodwill and intangibles. In future years, the possibility exists that changes in forecasts and estimates from those used at theacquisition date could result in impairment indicators. Accounting For Income Taxes . In preparing our consolidated financial statements, we are required to estimate our income taxes in each of the jurisdictionsin which we operate. This process involves management estimation of our actual current tax exposure and assessment of temporary differences resulting fromdiffering treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities. We must then assess the likelihood thatour deferred tax assets will be recovered from future taxable income and, to the extent we believe that recovery is not likely, we must establish a valuationallowance. To the extent we establish a valuation allowance or increase this allowance in a period, we must include an expense within the tax provision in theconsolidated statements of operations. Significant management judgment is required in determining our provision for income taxes, our deferred tax assets andliabilities and any valuation allowance recorded against our net deferred tax assets. We have fully offset our deferred tax assets with a valuation allowance. Our lackof earnings history and the uncertainty surrounding our ability to generate taxable income prior to the reversal or expiration of such deferred tax assets were theprimary factors considered by management in maintaining the valuation allowance. Fair Value of 5% Notes Payable. We measure certain financial assets and liabilities at fair value on a recurring basis in the financial statements. Thehierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires financial assets and liabilities carried at fairvalue to be classified and disclosed in one of three categories. We elected the fair value option for valuing the 5% Notes. We elected the fair value option in order to reflect in our financial statements the assumptionsthat market participants use in evaluating these financial instruments. RECENTLY ISSUED ACCOUNTING STANDARDS In January 2017, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update (“ASU”) No. 2017-04, “Simplifying the Testfor Goodwill Impairment” (“ASU 2017-04”). ASU 2017-04 removes the requirement to compare the implied fair value of goodwill with its carrying amount as partof step 2 of the goodwill impairment test. As a result, under ASU 2017-04, an entity should perform its annual, or interim, goodwill impairment test by comparingthe fair value of a reporting unit with its carrying amount and should recognize an impairment charge for the amount by which the carrying amount exceeds thereporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. In addition, ASU 2017-04:●Clarifies the requirements for excluding and allocating foreign currency translation adjustments to reporting units in connection with an entity’stesting of reporting units for goodwill impairment.●Clarifies that an entity should consider income tax effects from any tax deductible goodwill on the carrying amount of the reporting unit whenmeasuring the goodwill impairment loss, if applicable.●Makes minor changes to the overview and background sections of certain Accounting Standards Codification (“ASC” or “Codification”) subtopicsand topics as part of the Board’s initiative to unify and improve those sections throughout the Codification. ASU 2017-04 is effective prospectively for annual and interim periods beginning on or after December 15, 2019, and early adoption is permitted on testingdates after January 1, 2017. We are currently evaluating the impact the adoption of ASU 2017-04 will have on our consolidated financial statements. 45 In November 2016, the FASB issued ASU 2016-18, “Restricted Cash – a consensus of the FASB Emerging Issues Task Force” (“ASU 2016-18”). ASU2016-18 amends ASC 230 to add or clarify guidance on the classification and presentation of restricted cash in the statement of cash flows. Key requirements of theASU are as follows:●An entity should include in its cash and cash-equivalent balances in the statement of cash flows those amounts that are deemed to be restricted cashand restricted cash equivalents. The ASU does not define the terms “restricted cash” and “restricted cash equivalents” but states that an entity shouldcontinue to provide appropriate disclosures about its accounting policies pertaining to restricted cash in accordance with other GAAP. The ASU alsostates that any change in accounting policy will need to be assessed under ASC 250.●A reconciliation between the statement of financial position and the statement of cash flows must be disclosed when the statement of financialposition includes more than one line item for cash, cash equivalents, restricted cash, and restricted cash equivalents.●Changes in restricted cash and restricted cash equivalents that result from transfers between cash, cash equivalents, and restricted cash and restrictedcash equivalents should not be presented as cash flow activities in the statement of cash flows.●An entity with a material balance of amounts generally described as restricted cash and restricted cash equivalents must disclose information about thenature of the restrictions. ASU 2016-18 is effective for annual and interim periods beginning after December 15, 2017, and early adoption is permitted for all entities. We arecurrently evaluating the impact the adoption of ASU 2016-18 will have on our consolidated financial statements. In August 2016, the FASB issued ASU No. 2016-15, “Classification of Certain Cash Receipts and Cash Payments” (“ASU 2016-15”). ASU 2016-15amends the guidance in ASC 230 on the classification of certain cash receipts and payments in the statement of cash flows. The primary purpose of ASU 2016-15 isto reduce the diversity in practice that has resulted from the lack of consistent principles on this topic. The amendments in ASU 2016-15 add or clarify guidance oneight cash flow issues:●Debt prepayment or debt extinguishment costs.●Settlement of zero-coupon debt instruments or other debt instruments with coupon interest rates that are insignificant in relation to the effectiveinterest rate of the borrowing.●Contingent consideration payments made after a business combination.●Proceeds from the settlement of insurance claims.●Proceeds from the settlement of corporate-owned life insurance policies, including bank-owned life insurance policies.●Distributions received from equity method investees.●Beneficial interests in securitization transactions.●Separately identifiable cash flows and application of the predominance principle. ASU 2016-15 is effective for annual and interim periods beginning after December 15, 2017, and early adoption is permitted for all entities. Entities mustapply the guidance retrospectively to all periods presented but may apply it prospectively from the earliest date practicable if retrospective application would beimpracticable. The provisions of this standard are not expected to significantly impact the Company. In May 2016, the FASB issued ASU No. 2016-11, “Rescission of SEC Guidance Because of Accounting Standards Update 2014-09 and 2014-16 Pursuantto Staff Announcements at the March 3, 2016 EITF Meeting” (“ASU 2016-11”). ASU 2016-11 rescinds certain SEC guidance from the FASB Codification inresponse to announcements made by the SEC staff at the Emerging Issues Task Force’s March 3, 2016 meeting. Specifically, ASU 2016-11 supersedes SECobserver comments on the following topics: ●Upon the adoption of ASU 2014-09:oRevenue and expense recognition for freight services in process (ASC 605-20-S99-2)oAccounting for shipping and handling fees and costs (ASC 605-45-S99-1)oAccounting for consideration given by a vendor to a customer (ASC 605-50-S99-1)oAccounting for gas-balancing arrangements (ASC 932-10-S99-5) ●Upon the adoption of ASU 2014-16:oDetermining the nature of a host contract related to a hybrid financial instrument issued in the form of a share under ASC 815 (ASC 815-10-S99-3). ASU 2016-11 is effective upon the adoption of ASU 2014-09 and ASU 2014-16. The adoption of ASU 2016-11 is not expected to have a material impacton the Company’s consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-09, “Simplifying the Accounting for Share-Based Payments” (“ASU 2016-09”). ASU 2016-09 simplifiesseveral aspects of the accounting for employee share-based payment transactions for both public and nonpublic entities, including the accounting for income taxes,forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. ASU 2016-09 is effective for annual reportingperiods beginning after December 15, 2016, including interim periods within those annual reporting periods. The provisions of this standard are not expected tosignificantly impact the Company. In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” which requires lessees to recognize assets and liabilities for the rights andobligations created by most leases on their balance sheet. The guidance is effective for fiscal years beginning after December 15, 2018, including interim periodswithin those fiscal years. Early application is permitted. ASU 2016-02 requires modified retrospective adoption for all leases existing at, or entered into after, thedate of initial application, with an option to use certain transition relief. The Company is currently evaluating the impact the standard may have on its consolidatedfinancial statements and related disclosures. 46 In August 2014, the FASB issued ASU No. 2014-15, “Presentation of Financial Statements - Going Concern (Subtopic 205-40)”, which will requiremanagement to assess an entity’s ability to continue as a going concern at each annual and interim period. Related footnote disclosures will be required if conditionsgive rise to substantial doubt about an entity’s ability to continue as a going concern within one year of the report issuance date. If conditions do not give rise tosubstantial doubt, no disclosures will be required specific to going concern uncertainties. The guidance defines substantial doubt using a likelihood threshold of“probable” similar to the current use of that term in U.S. GAAP for loss contingencies and provides example indicators. The guidance is effective for reportingperiods ending after December 15, 2016, and early adoption is permitted. Therefore, the Company has adopted this new standard on December 15, 2016. Theadoption of this standard did not have a material impact on our consolidated financial statements as of December 31, 2016. Other pronouncements issued by the FASB or other authoritative accounting standards group with future effective dates are either not applicable or notsignificant to our consolidated financial statements. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK. The primary objective of our investment activities is to preserve principal while maximizing our income from investments and minimizing our market risk.We currently invest in government and investment-grade corporate debt in accordance with our investment policy, which we may change from time to time. Thesecurities in which we invest have market risk. This means that a change in prevailing interest rates, and/or credit risk, may cause the fair value of the investment tofluctuate. For example, if we hold a security that was issued with a fixed interest rate at the then-prevailing rate and the prevailing interest rate later rises, the fairvalue of our investment will probably decline. As of December 31, 2016, our portfolio of financial instruments consists of cash equivalents and short-term interestbearing securities, including government debt and money market funds. The average duration of all of our held-to-maturity investments held as of December 31,2016, was less than 12 months. Due to the relative short-term nature of these financial instruments, we believe there is no material exposure to interest rate risk,and/or credit risk, arising from our portfolio of financial instruments. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. Our consolidated financial statements and the notes thereto, included in Part IV, Item 15(a), part 1, are incorporated by reference into this Item 8. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING ANDFINANCIAL DISCLOSURES. Not applicable. ITEM 9A. CONTROLS AND PROCEDURES. Evaluation of Disclosure Controls and Procedures. As of December 31, 2016, management carried out an evaluation, under the supervision and with theparticipation of our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls andprocedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)). Our disclosure controls andprocedures are designed to provide reasonable assurance that information we are required to disclose in the reports that we file or submit under the Exchange Act isrecorded, processed, summarized and reported within the time periods specified in applicable rules and forms. Based upon that evaluation, our Chief Executive andChief Financial Officers concluded that, as of December 31, 2016, our disclosure controls and procedures were effective. Management's Report on Internal Control over Financial Reporting. Our management is responsible for establishing and maintaining adequate internalcontrol over financial reporting (as defined in Rule 13a-15(f) or Rule 15d-15(f) under the Exchange Act). Our management assessed the effectiveness of ourinternal control over financial reporting as of December 31, 2016. In making this assessment, our management used the criteria established in Internal Control –Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO Framework. Our management hasconcluded that, as of December 31, 2016, our internal control over financial reporting was effective based on these criteria. The effectiveness of our internal control over financial reporting as of December 31, 2016 was audited by CohnReznick LLP, our independent registeredpublic accounting firm, as stated in their report appearing below, which expressed an unqualified opinion on the effectiveness of our internal control over financialreporting as of December 31, 2016. Changes in Internal Control Over Financial Reporting. There were no changes in our internal control over financial reporting during the quarter endedDecember 31, 2016 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Limitations on the Effectiveness of Controls. Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that ourdisclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how wellconceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a controlsystem must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherentlimitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Companyhave been detected. 47 Report of Independent Registered Public Accounting Firm To The Board of Directors and StockholdersTG Therapeutics, Inc. We have audited TG Therapeutics, Inc. and Subsidiaries’ internal control over financial reporting as of December 31, 2016, based on criteria established in InternalControl-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). TG Therapeutics, Inc.’smanagement is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control overfinancial reporting included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion onTG Therapeutics, Inc.’s internal control over financial reporting based on our audit. We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we planand perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Ouraudit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating thedesign and operating effectiveness of internal control based on the assessed risk and performing such other procedures as we considered necessary in thecircumstances. We believe that our audit provides a reasonable basis for our opinion. A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and thepreparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America. A company’sinternal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accuratelyand fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary topermit preparation of financial statements in accordance with accounting principles generally accepted in the United States of America, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonableassurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on thefinancial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation ofeffectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance withthe policies or procedures may deteriorate. In our opinion, TG Therapeutics, Inc. and Subsidiaries has maintained, in all material respects, effective internal control over financial reporting as of December 31,2016 based on the criteria established in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the TreadwayCommission (COSO). We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated financial statementsof TG Therapeutics, Inc. and Subsidiaries as of December 31, 2016 and 2015, and for each of the three years in the period ended December 31, 2016 and our reportdated March 15, 2017, expressed an unqualified opinion. /s/ CohnReznick LLP New York, New York March 15, 2017 48 ITEM 9B. OTHER INFORMATION. None. PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE. The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2017 Annual Meeting of Stockholders. ITEM 11. EXECUTIVE COMPENSATION. The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2017 Annual Meeting of Stockholders. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS. The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2017 Annual Meeting of Stockholders. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE. The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2017 Annual Meeting of Stockholders. ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES. The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2017 Annual Meeting of Stockholders. 49 PART IV ITEM 15. EXHIBITS and FINANCIAL STATEMENT SCHEDULES. 1. Consolidated Financial StatementsThe following consolidated financial statements of TG Therapeutics, Inc. are filed as part of this report. ContentsPage Report of Independent Registered Public Accounting FirmF-1 Consolidated Balance Sheets as of December 31, 2016 and 2015F-2 Consolidated Statements of Operations for the years ended December 31, 2016, 2015 and 2014F-3 Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2016, 2015 and 2014F-4 Consolidated Statements of Cash Flows for the years ended December 31, 2016, 2015 and 2014F-5 Notes to Consolidated Financial StatementsF-6 2. Consolidated Financial Statement Schedules All schedules are omitted as the information required is inapplicable or the information is presented in the consolidated financial statements or the relatednotes. 3. Exhibits Exhibit NumberExhibit Description 3.1Amended and Restated Certificate of Incorporation of TG Therapeutics, Inc. dated April 26, 2012 (incorporated by reference to Exhibit 3.2 tothe Registrant’s Form 10-Q for the quarter ended June 30, 2012). 3.2Certificate of Amendment to Amended and Restated Certificate of Incorporation of TG Therapeutics, Inc. dated June 9, 2014 (incorporated byreference to Exhibit 3.2 to the Registrant’s Form 10-Q for the quarter ended June 30, 2014). 3.3Amended and Restated Bylaws of TG Therapeutics, Inc. dated July 18, 2014 (incorporated by reference to Exhibit 3.1 to the Registrant’sCurrent Report on Form 8-K filed on July 21, 2014). 4.1Specimen common stock certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Form 10-K for the year ended December 31,2011). 4.2Form of warrant to purchase common stock of TG Therapeutics, Inc. (incorporated by reference to Exhibit 4.1 to the Registrant’s CurrentReport on Form 8-K filed on November 13, 2012). 4.3Form of Warrant issued to stockholders (incorporated by reference to Exhibit 10.34 to the Registrant’s Form 10-K for the fiscal year endedDecember 31, 2011). 4.4Stockholder Protection Rights Agreement, dated July 18, 2014 between TG Therapeutics, Inc. and American Stock Transfer & Trust Company,LLC, as Rights Agent (incorporated by reference to Exhibit 4.1 to the Registrant?s Current Report on Form 8-K filed on July 21, 2014). 10.1Amended and Restated Convertible Promissory Note, dated March 1, 2011 (incorporated by reference to Exhibit 10.1 to the Registrant’sCurrent Report on Form 8-K filed on March 7, 2011). 50 10.2Employment Agreement, effective December 29, 2011, between the Registrant and Michael Weiss (incorporated by reference to Exhibit 10.30to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). † 10.3Restricted Stock Subscription Agreement, effective December 29, 2011, between the Registrant and Michael Weiss (incorporated by referenceto Exhibit 10.31 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). † 10.4Amendment to Restricted Stock Agreement, dated July 12, 2013, by and between TG Therapeutics, Inc. and Michael S. Weiss (incorporated byreference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on July 16, 2013). † 10.5Amendment to Restricted Stock Agreements, dated December 31, 2014, by and between TG Therapeutics, Inc. and Michael S. Weiss(incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 7, 2015). † 10.6Employment Agreement, effective December 29, 2011, between the Registrant and Sean Power (incorporated by reference to Exhibit 10.32 tothe Registrant’s Form 10-K for the fiscal year ended December 31, 2011). † 10.7Restricted Stock Subscription Agreement, effective December 29, 2011 between the Registrant and Sean Power (incorporated by reference toExhibit 10.33 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). † 10.8Amendment to Restricted Stock Agreement, dated July 12, 2013, by and between TG Therapeutics, Inc. and Sean A. Power (incorporated byreference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on July 16, 2013). † 10.9Amendment to Restricted Stock Agreements, dated December 31, 2014, by and between TG Therapeutics, Inc. and Sean A. Power(incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on January 7, 2015). † 10.10License Agreement, dated January 30, 2012, by and among the Registrant, GTC Biotherapeutics, Inc., LFB Biotechnologies S.A.S. andLFB/GTC LLC (incorporated by reference to Exhibit 10.35 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). * 10.11TG Therapeutics, Inc. Amended and Restated 2012 Incentive Plan, dated May 14, 2012 (incorporated by reference to Exhibit 10.1 to theRegistrant’s Form 10-Q/A for the quarter ended March 31, 2012). 10.12First Amendment to TG Therapeutics, Inc. Amended and Restated 2012 Incentive Plan, filed with the Registrant’s Definitive Proxy Statementfor the Annual Meeting of Stockholders on June 4, 2015, filed on April 24, 2015, and incorporated herein by reference. 10.13Sublicense Agreement between TG Therapeutics, Inc. and Ildong Pharmaceutical Co. Ltd., dated November 13, 2012 (incorporated byreference to Exhibit 10.37 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2012). * 10.14License Agreement between TG Therapeutics, Inc. and Ligand Pharmaceuticals Incorporated, dated June 23, 2014 (incorporated by referenceto Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2014).* 10.15Licensing Agreement between TG Therapeutics, Inc. and Rhizen Pharmaceuticals SA, dated September 22, 2014 (incorporated by reference toExhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 20, 2015). * 10.16Collaboration Agreement between TG Therapeutics, Inc. and Checkpoint Therapeutics, Inc., dated March 3, 2015 (incorporated by reference toExhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended March 31, 2015). * 21.1Subsidiaries of TG Therapeutics, Inc. 23.1Consent of Independent Registered Public Accounting Firm 31.1Certification of Principal Executive Officer 31.2Certification of Principal Financial Officer 32.1Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 32.2Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 101The following financial information from TG Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2016,formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations,(iii) Consolidated Statements of Stockholders’ Equity, (iv) Consolidated Statements of Cash Flows, (v) the Notes to Consolidated FinancialStatements. † Indicates management contract or compensatory plan or arrangement.* Confidential treatment has been requested with respect to omitted portions of this exhibit. 51 TG Therapeutics, Inc.Consolidated Financial Statements Page Report of Independent Registered Public Accounting FirmF-1 Consolidated Balance Sheets as of December 31, 2016 and 2015F-2 Consolidated Statements of Operations for the years ended December 31, 2016, 2015 and 2014F-3 Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2016, 2015 and 2014F-4 Consolidated Statements of Cash Flows for the years ended December 31, 2016, 2015 and 2014F-5 Notes to Consolidated Financial StatementsF-6 52 Report of Independent Registered Public Accounting Firm To The Board of Directors and StockholdersTG Therapeutics, Inc. We have audited the accompanying consolidated balance sheets of TG Therapeutics, Inc. and Subsidiaries (the “Company”) as of December 31, 2016 and 2015, andthe related consolidated statements of operations, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2016. TGTherapeutics, Inc.’s management is responsible for these consolidated financial statements. Our responsibility is to express an opinion on these consolidatedfinancial statements based on our audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that weplan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit also includesexamining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significantestimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for ouropinion. In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of TG Therapeutics, Inc. andSubsidiaries as of December 31, 2016 and 2015, and their results of operations and cash flows for each of the three years in the period ended December 31, 2016, inconformity with accounting principles generally accepted in the United States of America. We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), TG Therapeutics, Inc. andSubsidiaries’ internal control over financial reporting as of December 31, 2016 based on criteria established in Internal Control – Integrated Framework(2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) and our report dated March 15, 2017 expressed anunqualified opinion. /s/ CohnReznick LLP New York, New YorkMarch 15, 2017 F-1 TG Therapeutics, Inc. and SubsidiariesConsolidated Balance Sheets as of December 31, 2016 and 2015 2016 2015 Assets Current assets: Cash and cash equivalents $ 25,031,280 $ 55,061,329 Short-term investment securities 19,853,860 22,166,512 Interest receivable 83,852 186,021 Prepaid research and development 5,678,755 9,151,142 Other current assets 216,397 308,327 Total current assets 50,864,144 86,873,331 Restricted cash 583,208 579,143 Long-term investment securities -- 25,003,032 Leasehold interest, net 2,042,281 -- Equipment, net 328,148 47,122 Goodwill 799,391 799,391 Other assets 164,375 171,182 Total assets $ 54,781,547 $ 113,473,201 Liabilities and stockholders’ equity Current liabilities: Accounts payable and accrued expenses $ 15,267,668 $ 9,346,068 Accrued compensation 1,389,516 818,472 Current portion of deferred revenue 152,381 152,381 Notes payable 68,875 211,549 Total current liabilities 16,878,440 10,528,470 Deferred rent 816,257 -- Deferred revenue, net of current portion 1,219,048 1,371,429 Total liabilities 18,913,745 11,899,899 Commitments and contingencies Stockholders’ equity: Preferred stock, $0.001 par value per share (10,000,000 shares authorized, none issued and outstanding as of December31, 2016 and 2015) -- -- Common stock, $0.001 par value per share (150,000,000 shares authorized, 56,820,423 and 54,095,110 shares issued, 56,820 54,095 56,779,114 and 54,053,801 shares outstanding at December 31, 2016 and 2015, respectively) Contingently issuable shares -- 6 Additional paid-in capital 272,432,139 259,887,464 Treasury stock, at cost, 41,309 shares at December 31, 2016 and 2015 (234,337 ) (234,337 )Accumulated deficit (236,386,820 ) (158,133,926 )Total stockholders’ equity 35,867,802 101,573,302 Total liabilities and stockholders’ equity $ 54,781,547 $ 113,473,201 The accompanying notes are an integral part of the consolidated financial statements. F-2 TG Therapeutics, Inc. and SubsidiariesConsolidated Statements of Operations for the Years Ended December 31, 2016, 2015 and 2014 2016 2015 2014 License revenue $ 152,381 $ 152,381 $ 152,381 Costs and expenses: Research and development: Noncash stock expense associated with in-licensing agreements -- -- 5,350,094 Noncash compensation 2,742,354 4,261,406 8,731,566 Other research and development 66,489,820 43,445,817 26,004,687 Total research and development 69,232,174 47,707,223 40,086,347 General and administrative: Noncash compensation 4,767,645 11,435,686 12,373,726 Other general and administrative 5,121,690 4,189,488 3,413,400 Total general and administrative 9,889,335 15,625,174 15,787,126 Total costs and expenses 79,121,509 63,332,397 55,873,473 Operating loss (78,969,128 ) (63,180,016 ) (55,721,092 ) Other (income) expense: Interest income (323,032 ) (174,653 ) (55,049 )Other (income) expense (393,202 ) (56,717 ) 115,234 Total other (income) expense, net (716,234 ) (231,370 ) 60,185 Net loss $ (78,252,894 ) $ (62,948,646 ) $ (55,781,277 ) Basic and diluted net loss per common share $ (1.60 ) $ (1.38 ) $ (1.64 ) Weighted average shares used in computing basic and diluted net loss per common share 49,041,354 45,646,414 34,068,926 The accompanying notes are an integral part of the consolidated financial statements.F-3 TG Therapeutics, Inc. and SubsidiariesConsolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2016, 2015 and 2014 Common Stock Contingentlyissuable AdditionalPaid-in Treasury Stock Accumulated Shares Amount Shares Capital Shares Amount Deficit Total Balance at January 1, 2014 34,336,235 $34,336 6 $79,658,490 41,309 $(234,337 ) $39,404,003 $40,054,492 Issuance of common stock inconnection with exercise ofwarrants 1,560,826 1,561 3,555,063 3,556,624 Issuance of common stock inconnection with exercise of options 46,000 46 202,354 202,400 Issuance of restricted stock 982,793 983 (983 ) -- Forfeiture of restricted stock (1,000 ) (1 ) 1 -- Issuance of common stock in publicoffering (net of offering costs of$1,344,440) 2,702,809 2,703 16,788,705 16,791,408 Issuance of common stock in At theMarket offering (net of offeringcosts of $1,101,572) 4,850,055 4,850 48,818,002 48,822,852 Compensation in respect of restrictedstock and stock options granted toemployees, directors andconsultants 21,105,292 21,105,292 Common stock issued in connectionwith in-licensing agreements 496,530 496 5,349,597 5,350,093 Net loss (55,781,277 ) (55,781,277 )Balance at December 31, 2014 44,974,248 44,974 6 175,476,521 41,309 (234,337 ) (95,185,280 ) 80,101,884 Issuance of common stock inconnection with exercise of warrants 2,946,703 2,946 1,064,393 1,067,339 Issuance of common stock inconnection with cashless exercise ofwarrants 2,915 3 (3 ) -- Issuance of common stock inconnection with conversion of notespayable 522 1 6,924 6,925 Issuance of restricted stock 1,992,535 1,993 (1,993 ) -- Forfeiture of restricted stock (31,166 ) (31 ) 31 -- Issuance of common stock to relatedparty for cash (See Note 9) 114,855 115 749,890 750,005 Issuance of common stock in At-the-Market offering (net of offering costsof $1,310,591) 4,094,498 4,094 66,894,609 66,898,703 Compensation in respect of restrictedstock granted to employees, directorsand consultants 15,697,092 15,697,092 Net loss (62,948,646 ) (62,948,646 )Balance at December 31, 2015 54,095,110 54,095 6 259,887,464 41,309 (234,337 ) (158,133,926 ) 101,573,302 Issuance of common stock inconnection with exercise of warrants 273,370 273 617,969 618,242 Issuance of common stock inconnection with conversion of notespayable 3,710 4 33,013 33,017 Issuance of restricted stock 1,924,639 1,925 (1,925 ) -- Forfeiture of restricted stock (46,773 ) (47 ) 47 -- Issuance of common stock in At-the-Market offering (net of offering costsof $108,185) 570,366 570 4,385,566 4,386,136 Compensation in respect of restrictedstock granted to employees, directorsand consultants 7,509,999 7,509,999 Adjustment to contingently issuableshares (6 ) 6 -- Net loss (78,252,894 ) (78,252,894 )Balance at December 31, 2016 56,820,422 $56,820 $-- $272,432,139 41,309 $(234,337 ) $(236,386,820 ) $35,867,802 The accompanying notes are an integral part of the consolidated financial statements.F-4 TG Therapeutics, Inc. and SubsidiariesConsolidated Statements of Cash Flows for the Years Ended December 31, 2016, 2015 and 2014 2016 2015 2014 CASH FLOWS FROM OPERATING ACTIVITIES Consolidated net loss $(78,252,894 ) $(62,948,646 ) $(55,781,277 )Adjustments to reconcile consolidated net loss to net cash used in operating activities: Gain on settlement of notes payable -- -- (95,427 )Gain on sale of long-term securities (33,042 ) -- -- Noncash stock compensation expense 7,509,999 15,697,092 21,105,292 Noncash stock expense associated with in-licensing agreements -- -- 5,350,094 Depreciation 62,960 15,452 3,931 Amortization of premium on investment securities 459,429 536,142 193,581 Change in fair value of notes payable and accrued interest (109,657 ) (56,717 ) 210,661 Changes in assets and liabilities: Increase in restricted cash (4,065 ) (4,131 ) (575,012 )Decrease (increase) in other current assets 3,564,316 (3,105,771 ) (4,563,067 )Increase in leasehold interest (2,042,281 ) -- -- Decrease (increase) in accrued interest receivable 102,169 (100,505 ) (58,347 )Increase in other assets (4,784 ) (41,722 ) -- Increase (decrease) in accounts payable and accrued expenses 6,492,644 5,470,915 (603,377 )Decrease in interest payable -- -- (94,590 )Increase in deferred rent 816,257 -- -- Decrease in deferred revenue (152,381 ) (152,381 ) (152,381 )Net cash used in operating activities (61,591,330 ) (44,690,272 ) (35,059,919 ) CASH FLOWS FROM INVESTING ACTIVITIES Purchases of equipment (343,985 ) (42,217 ) (18,570 )Investment in held-to-maturity securities (15,199,922 ) (48,993,652 ) (18,336,719 )Proceeds from maturity of short-term securities 29,500,000 24,350,000 -- Proceeds from the sale of long-term securities 12,589,219 -- -- Net cash provided by (used in) investing activities 26,545,312 (24,685,869 ) (18,355,289 ) CASH FLOWS FROM FINANCING ACTIVITIES Proceeds from the exercise of warrants 618,242 1,067,339 3,556,624 Proceeds from the exercise of options -- -- 202,400 Payment of notes payable -- -- (677,778 )Proceeds from sale of common stock, net 4,411,233 67,760,517 65,614,260 Deferred financing costs paid (13,506 ) (104,170 ) (51,980 )Net cash provided by financing activities 5,015,969 68,723,686 68,643,526 NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS (30,030,049 ) (652,455 ) 15,228,318 Cash and cash equivalents at beginning of year 55,061,329 55,713,784 40,485,466 CASH AND CASH EQUIVALENTS AT END OF YEAR $25,031,280 $55,061,329 $55,713,784 NONCASH TRANSACTIONS Reclassification of deferred financing costs to additional paid-in capital $(25,097 ) $(111,810 ) -- Conversion of convertible notes payable to common stock $33,017 $6,924 -- The accompanying notes are an integral part of the consolidated financial statements. F-5TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements Unless the context requires otherwise, references in this report to “TG,” “Company,” “we,” “us” and “our” refer to TG Therapeutics, Inc. and our subsidiaries. NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES DESCRIPTION OF BUSINESS We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies andautoimmune diseases. Currently, the Company is developing two therapies targeting hematologic malignancies. TG-1101 (ublituximab) is a novel, glycoengineeredmonoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. We are also developing TGR-1202, an orallyavailable PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferationand survival of B-lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. The Company also has pre-clinical programs to develop IRAK4 (interleukin-1 receptor-associated kinase 4) inhibitors, BET (Bromodomain and Extra Terminal) inhibitors, and anti-PD-L1and anti-GITR antibodies . 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 drugcandidates. LIQUIDITY AND CAPITAL RESOURCES We have incurred operating losses since our inception, and expect to continue to incur operating losses for the foreseeable future and may never becomeprofitable. As of December 31, 2016, we have an accumulated deficit of $236.4 million. Our major sources of cash have been proceeds from the private placement and public offering of equity securities. We have not yet commercialized any ofour 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 becomeprofitable. Our ability to achieve profitability depends on many factors, including our ability to obtain regulatory approval for our drug candidates; successfullycomplete any post-approval regulatory obligations; and successfully commercialize our drug candidates alone or in partnership. We may continue to incursubstantial operating losses even if we begin to generate revenues from our drug candidates. As of December 31, 2016, we had $45.0 million in cash and cash equivalents, investment securities, and interest receivable. The Company believes itscash, cash equivalents, investment securities, and interest receivable on hand as of December 31, 2016 combined with the additional capital raised in the firstquarter of 2017 (see Note 13) will be sufficient to fund the Company’s planned operations for approximately the next 24 months. The actual amount of cash that wewill 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 aredependent upon significant future financing to provide the cash necessary to execute our current operations, including the commercialization of any of our drugcandidates. Our common stock is quoted on the Nasdaq Capital Market and trades under the symbol “TGTX.” RECENTLY ISSUED ACCOUNTING STANDARDS In January 2017, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update (“ASU”) No. 2017-04, “Simplifying the Testfor Goodwill Impairment” (“ASU 2017-04”). ASU 2017-04 removes the requirement to compare the implied fair value of goodwill with its carrying amount as partof step 2 of the goodwill impairment test. As a result, under ASU 2017-04, an entity should perform its annual, or interim, goodwill impairment test by comparingthe fair value of a reporting unit with its carrying amount and should recognize an impairment charge for the amount by which the carrying amount exceeds thereporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. In addition, ASU 2017-04:●Clarifies the requirements for excluding and allocating foreign currency translation adjustments to reporting units in connection with an entity’stesting of reporting units for goodwill impairment.●Clarifies that an entity should consider income tax effects from any tax deductible goodwill on the carrying amount of the reporting unit whenmeasuring the goodwill impairment loss, if applicable.●Makes minor changes to the overview and background sections of certain Accounting Standards Codification (“ASC” or “Codification”) subtopicsand topics as part of the Board’s initiative to unify and improve those sections throughout the Codification. ASU 2017-04 is effective prospectively for annual and interim periods beginning on or after December 15, 2019, and early adoption is permitted on testingdates after January 1, 2017. We are currently evaluating the impact the adoption of ASU 2017-04 will have on our consolidated financial statements. F-6TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements In November 2016, the FASB issued ASU 2016-18, “Restricted Cash – a consensus of the FASB Emerging Issues Task Force” (“ASU 2016-18”). ASU2016-18 amends ASC 230 to add or clarify guidance on the classification and presentation of restricted cash in the statement of cash flows. Key requirements of theASU are as follows:●An entity should include in its cash and cash-equivalent balances in the statement of cash flows those amounts that are deemed to be restricted cashand restricted cash equivalents. The ASU does not define the terms “restricted cash” and “restricted cash equivalents” but states that an entity shouldcontinue to provide appropriate disclosures about its accounting policies pertaining to restricted cash in accordance with other GAAP. The ASU alsostates that any change in accounting policy will need to be assessed under ASC 250.●A reconciliation between the statement of financial position and the statement of cash flows must be disclosed when the statement of financialposition includes more than one line item for cash, cash equivalents, restricted cash, and restricted cash equivalents.●Changes in restricted cash and restricted cash equivalents that result from transfers between cash, cash equivalents, and restricted cash and restrictedcash equivalents should not be presented as cash flow activities in the statement of cash flows.●An entity with a material balance of amounts generally described as restricted cash and restricted cash equivalents must disclose information about thenature of the restrictions. ASU 2016-18 is effective for annual and interim periods beginning after December 15, 2017, and early adoption is permitted for all entities. We arecurrently evaluating the impact the adoption of ASU 2016-18 will have on our consolidated financial statements. In August 2016, the FASB issued ASU No. 2016-15, “Classification of Certain Cash Receipts and Cash Payments” (“ASU 2016-15”). ASU 2016-15amends the guidance in ASC 230 on the classification of certain cash receipts and payments in the statement of cash flows. The primary purpose of ASU 2016-15 isto reduce the diversity in practice that has resulted from the lack of consistent principles on this topic. The amendments in ASU 2016-15 add or clarify guidance oneight cash flow issues: ●Debt prepayment or debt extinguishment costs.●Settlement of zero-coupon debt instruments or other debt instruments with coupon interest rates that are insignificant in relation to the effectiveinterest rate of the borrowing.●Contingent consideration payments made after a business combination.●Proceeds from the settlement of insurance claims.●Proceeds from the settlement of corporate-owned life insurance policies, including bank-owned life insurance policies.●Distributions received from equity method investees.●Beneficial interests in securitization transactions.●Separately identifiable cash flows and application of the predominance principle. ASU 2016-15 is effective for annual and interim periods beginning after December 15, 2017, and early adoption is permitted for all entities. Entities mustapply the guidance retrospectively to all periods presented but may apply it prospectively from the earliest date practicable if retrospective application would beimpracticable. The provisions of this standard are not expected to significantly impact the Company. F-7TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements In May 2016, the FASB issued ASU No. 2016-11, “Rescission of SEC Guidance Because of Accounting Standards Update 2014-09 and 2014-16 Pursuantto Staff Announcements at the March 3, 2016 EITF Meeting” (“ASU 2016-11”). ASU 2016-11 rescinds certain SEC guidance from the FASB Codification inresponse to announcements made by the SEC staff at the Emerging Issues Task Force’s March 3, 2016 meeting. Specifically, ASU 2016-11 supersedes SECobserver comments on the following topics: ●Upon the adoption of ASU 2014-09:oRevenue and expense recognition for freight services in process (ASC 605-20-S99-2)oAccounting for shipping and handling fees and costs (ASC 605-45-S99-1)oAccounting for consideration given by a vendor to a customer (ASC 605-50-S99-1)oAccounting for gas-balancing arrangements (ASC 932-10-S99-5) ●Upon the adoption of ASU 2014-16:oDetermining the nature of a host contract related to a hybrid financial instrument issued in the form of a share under ASC 815 (ASC 815-10-S99-3). ASU 2016-11 is effective upon the adoption of ASU 2014-09 and ASU 2014-16. The adoption of ASU 2016-11 is not expected to have a material impacton the Company’s consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-09, “Simplifying the Accounting for Share-Based Payments” (“ASU 2016-09”). ASU 2016-09 simplifiesseveral aspects of the accounting for employee share-based payment transactions for both public and nonpublic entities, including the accounting for income taxes,forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. ASU 2016-09 is effective for annual reportingperiods beginning after December 15, 2016, including interim periods within those annual reporting periods. The provisions of this standard are not expected tosignificantly impact the Company. In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” which requires lessees to recognize assets and liabilities for the rights andobligations created by most leases on their balance sheet. The guidance is effective for fiscal years beginning after December 15, 2018, including interim periodswithin those fiscal years. Early application is permitted. ASU 2016-02 requires modified retrospective adoption for all leases existing at, or entered into after, thedate of initial application, with an option to use certain transition relief. The Company is currently evaluating the impact the standard may have on its consolidatedfinancial statements and related disclosures. In August 2014, the FASB issued ASU No. 2014-15, “Presentation of Financial Statements - Going Concern (Subtopic 205-40)”, which will requiremanagement to assess an entity’s ability to continue as a going concern at each annual and interim period. Related footnote disclosures will be required if conditionsgive rise to substantial doubt about an entity’s ability to continue as a going concern within one year of the report issuance date. If conditions do not give rise tosubstantial doubt, no disclosures will be required specific to going concern uncertainties. The guidance defines substantial doubt using a likelihood threshold of“probable” similar to the current use of that term in U.S. GAAP for loss contingencies and provides example indicators. The guidance is effective for reportingperiods ending after December 15, 2016, and early adoption is permitted. Therefore, the Company has adopted this new standard on December 15, 2016. Theadoption of this standard did not have a material impact on our consolidated financial statements as of December 31, 2016. Other pronouncements issued by the FASB or other authoritative accounting standards group with future effective dates are either not applicable or notsignificant to our consolidated financial statements. F-8TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements USE OF ESTIMATES The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to makeestimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financialstatements and the reported amounts of revenues and expenses during the applicable reporting period. Actual results could differ from those estimates. Suchdifferences could be material to the financial statements. CASH AND CASH EQUIVALENTS We treat liquid investments with original maturities of less than three months when purchased as cash and cash equivalents. RESTRICTED CASH We record cash pledged or held in trust as restricted cash. As of December 31, 2016, we have approximately $0.6 million of restricted cash pledged tosecure a line of credit as a security deposit for an Office Agreement (see Note 9). INVESTMENT SECURITIES Investment securities at December 31, 2016 consist of short-term government securities and at December 31, 2015 consist of short-term and long-termgovernment securities. We classify these securities as held-to-maturity. Held-to-maturity securities are those securities in which we have the ability and intent tohold 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 carryingamount to fair value. The impairment is charged to operations and a new cost basis for the security is established. Other-than-temporary impairment charges areincluded in interest and other income (expense), net. Unrealized gains, if determined to be temporary, are included in accumulated other comprehensive income inequity. 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-terminvestments. The Company maintains its cash and cash equivalents with high-credit quality financial institutions. At times, such amounts may exceed federally-insured limits. REVENUE RECOGNITION We recognize license revenue in accordance with the revenue recognition guidance of the FASB Accounting Standards Codification, or Codification. Weanalyze each element of our licensing agreement to determine the appropriate revenue recognition. The terms of the license agreement may include payments to usof non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. We recognize revenue fromupfront payments over the period of significant involvement under the related agreements unless the fee is in exchange for products delivered or services renderedthat represent the culmination of a separate earnings process and no further performance obligation exists under the contract. We recognize milestone payments asrevenue upon the achievement of specified milestones only if (1) the milestone payment is non-refundable, (2) substantive effort is involved in achieving themilestone, (3) the amount of the milestone is reasonable in relation to the effort expended or the risk associated with achievement of the milestone, and (4) themilestone is at risk for both parties. If any of these conditions are not met, we defer the milestone payment and recognize it as revenue over the estimated period ofperformance under the contract. F-9TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements 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 renderedfor future research and development activities are deferred and amortized over the period that the goods are delivered or the related services are performed, subjectto an assessment of recoverability. We make estimates of costs incurred in relation to external clinical research organizations, or CROs, and clinical site costs. Weanalyze the progress of clinical trials, including levels of patient enrollment, invoices received and contracted costs when evaluating the adequacy of the amountexpensed and the related prepaid asset and accrued liability. Significant judgments and estimates must be made and used in determining the accrued balance andexpense in any accounting period. We review and accrue CRO expenses and clinical trial study expenses based on work performed and rely upon estimates of thosecosts 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 toexpense 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 aresubject to negotiation and vary from contract to contract. Payments under these contracts may be uneven, and depend on factors such as the achievement of certainevents, the successful recruitment of patients, the completion of portions of the clinical trial or similar conditions. The objective of our policy is to match therecording of expenses in our financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical site costs arerecognized based on our estimate of the degree of completion of the event or events specified in the specific clinical study or trial contract. Prepaid research and development in our consolidated balance sheets includes, among other things, certain fees related to development and manufacturingservices. These development and manufacturing agreements often require payments in advance of services performed or goods received. Accordingly, as ofDecember 31, 2016 and 2015, we recorded approximately $5.7 million and $9.2 million, respectively, in prepaid research and development related to such advanceagreements. INCOME TAXES Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequencesattributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operatinglosses 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 whichthose 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 inoperations 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,” avaluation 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 thatare 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 losscarryforwards may be utilized in the future, many of these net operating loss carryforwards will remain subject to examination. We recognize interest and penaltiesrelated to uncertain income tax positions in income tax expense. STOCK-BASED COMPENSATION We recognize all share-based payments to employees and non-employee directors (as compensation for service) as noncash compensation expense in theconsolidated financial statements based on the fair values of such payments. Stock-based compensation expense recognized each period is based on the value of theportion of share-based payment awards that is ultimately expected to vest during the period. Forfeitures are estimated at the time of grant and revised, if necessary,in subsequent periods if actual forfeitures differ from those estimates. F-10TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements For share-based payments to consultants and other third-parties (including related parties), noncash compensation expense is determined at the“measurement date.” The expense is recognized over the vesting period of the award. Until the measurement date is reached, the total amount of compensationexpense remains uncertain. We record compensation expense based on the fair value of the award at the reporting date. The awards to consultants and other third-parties (including related parties) are then revalued, or the total compensation is recalculated based on the then current fair value, at each subsequent reporting date. In addition, because some of the options, restricted stock and warrants issued to employees, consultants and other third-parties vest upon achievement ofcertain milestones, the total expense is uncertain. Compensation expense for such awards that vest upon the achievement of milestones is recognized when theachievement of such milestone becomes probable. BASIC AND DILUTED NET LOSS PER COMMON SHARE Basic net loss per common share is calculated by dividing net loss applicable to common shares by the weighted-average number of common sharesoutstanding for the period. Diluted net loss per common share is the same as basic net loss per common share, since potentially dilutive securities from stockoptions, stock warrants and convertible notes would have an antidilutive effect either because the Company incurred a net loss during the period presented orbecause such potentially dilutive securities were out of the money and the Company realized net income during the period presented. The amounts of potentiallydilutive securities excluded from the calculation were 8,033,779, 7,064,396 and 8,890,796 at December 31, 2016, 2015 and 2014, respectively. During the yearsended December 31, 2016, 2015 and 2014 the Company incurred a net loss, therefore, all of the securities are antidilutive and excluded from the computation ofdiluted loss per share. December 31, 2016 2015 2014 Unvested restricted stock 7,142,055 5,859,914 4,725,001 Warrants 876,912 1,186,749 4,148,228 Shares issuable upon note conversion 14,812 17,733 17,373 Options -- -- 194 Total 8,033,779 7,064,396 8,890,796 LONG-LIVED ASSETS AND GOODWILL Long-lived assets are reviewed for an impairment loss when circumstances indicate that the carrying value of long-lived tangible and intangible assets withfinite lives may not be recoverable. Management’s policy in determining whether an impairment indicator, a triggering event, exists comprises measurableoperating performance criteria as well as qualitative measures. If an analysis is necessitated by the occurrence of a triggering event, we make certain assumptions indetermining the impairment amount. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized. Goodwill is reviewed for impairment annually, or when events arise that could indicate that an impairment exists. We test for goodwill impairment using atwo-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 thereporting 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 goodwillimpairment 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. Ifthe 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 toperform impairment tests annually, at December 31, and whenever events or changes in circumstances suggest that the carrying value of an asset may not berecoverable. F-11TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements NOTE 2 – CASH AND CASH EQUIVALENTS The following tables summarize our cash and cash equivalents at December 31, 2016 and 2015: December 31,2016 December 31,2015 Money market funds $ 20,978,947 $ 8,265,583 Checking and bank deposits 4,052,333 46,795,746 Total $ 25,031,280 $ 55,061,329 NOTE 3 – INVESTMENT SECURITIES Our investments as of December 31, 2016 and 2015 are classified as held-to-maturity. Held-to-maturity investments are recorded at amortized cost. Duringthe year ended December 31, 2016, we liquidated our long-term investment securities with a net carrying amount of approximately $12.6 million, realizing a gain ofapproximately $33,000 on the sale. The decision to sell our long-term securities was made due to market rate conditions on long-term securities coupled with therecognized gain we were able to yield on the sale of the securities . The following tables summarize our investment securities at December 31, 2016 and 2015: December 31, 2016 Amortizedcost, asadjusted Grossunrealizedholding gains Grossunrealizedholding losses Estimated fairvalue Short-term investments: Obligations of domestic governmental agencies (maturing between February 2017and September 2017) (held-to-maturity) $ 19,853,860 $ 3,270 $ 2,492 $ 19,854,638 Total short-term investment securities $ 19,853,860 $ 3,270 $ 2,492 $ 19,854,638 December 31, 2015 Amortizedcost, asadjusted Grossunrealizedholding gains Grossunrealizedholding losses Estimated fairvalue Short-term investments: Obligations of domestic governmental agencies (maturing between January 2016 andDecember 2016) (held-to-maturity) $ 22,166,512 $ -- $ 22,822 $ 22,143,690 Long-term investments: Obligations of domestic governmental agencies (maturing between January 2017 andDecember 2017) (held-to-maturity) 25,003,032 -- 85,846 24,917,186 Total short-term and long-term investment securities $ 47,169,544 $ -- $ 108,668 $ 47,060,876 NOTE 4 – FAIR VALUE MEASUREMENTS We measure certain financial assets and liabilities at fair value on a recurring basis in the financial statements. The fair value hierarchy ranks the qualityand 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 anddisclosed 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. F-12TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements As of December 31, 2016 and 2015, the fair values of cash and cash equivalents, restricted cash, and notes and interest payable approximate their carryingvalue. At the time of our merger (we were then known as Manhattan Pharmaceuticals, Inc. (“Manhattan”)) with Ariston Pharmaceuticals, Inc. (“Ariston”) inMarch 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 andaccrued 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 tomake quarterly payments on the 5% Notes equal to 50% of the net product cash flow received from the exploitation or commercialization of Ariston’s productcandidates, 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 productcandidates, if any, payable to noteholders; and b) the conversion feature, discussed above. The cumulative liability including accrued and unpaid interest of the 5% Notes was approximately $16.7 million at December 31, 2016 and $19.9 millionat December 31, 2015. No payments have been made on the 5% Notes as of December 31, 2016. In December 2011, we elected the fair value option for valuing the 5% Notes. The fair value option was elected in order to reflect in our financialstatements 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-726were 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 wasused to estimate the 5% Notes’ fair value as of December 31, 2016 and 2015. The assumptions, assessments and projections of future revenues are subject touncertainties, difficult to predict, and require significant judgment. The use of different assumptions, applying different judgment to inherently subjective mattersand changes in future market conditions could result in significantly different estimates of fair value and the differences could be material to our consolidatedfinancial statements. The following tables provide the fair value measurements of applicable financial liabilities as of December 31, 2016 and 2015: Financial liabilities at fair value as of December 31, 2016 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 68,875 $ 68,875 Totals $ -- $ -- $ 68,875 $ 68,875 Financial liabilities at fair value as of December 31, 2015 Level 1 Level 2 Level 3 Total 5% Notes $ -- $ -- $ 211,549 $ 211,549 Totals $ -- $ -- $ 211,549 $ 211,549 The Level 3 amounts above represent the fair value of the 5% Notes and related accrued interest. F-13TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements The following table summarizes the changes in Level 3 instruments for the years ended December 31, 2015 and 2016: Balance at January 1, 2015 $ 275,190 Interest accrued on face value of 5% Notes 972,736 Conversion of 5% Notes (6,924 ) Change in fair value of Level 3 liabilities (1,029,453 )Balance at December 31, 2015 211,549 Interest accrued on face value of 5% Notes 886,084 Conversion of 5% Notes (33,017 ) Change in fair value of Level 3 liabilities (995,741 )Balance at December 31, 2016 $ 68,875 The change in the fair value of the Level 3 liabilities is reported in other (income) expense in the accompanying consolidated statements of operations. NOTE 5 – 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 rightssenior to those of our common stock, issuable in one or more series. Upon issuance, the Company can determine the rights, preferences, privileges and restrictionsthereof. 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 commonstock. Stockholder Rights Plan On July 18, 2014, we adopted a stockholder rights plan. The stockholder rights plan is embodied in the Stockholder Protection Rights Agreement dated asof July 18, 2014 (the "Rights Agreement"), between us and American Stock Transfer & Trust Company, LLC, as rights agent (the "Rights Agent"). Accordingly, the Board of Directors declared a distribution of one right (a “Right”) for each outstanding share of common stock, to stockholders of recordat the close of business on July 28, 2014, for each share of common stock issued (including shares distributed from treasury) by us thereafter and prior to theSeparation Time (as defined in the Rights Agreement), and for certain shares of common stock issued after the Separation Time. Following the Separation Time,each Right entitles the registered holder to purchase from us one one-thousandth (1/1,000) of a share of Series A Junior Participating Preferred Stock, par value$0.001 per share (the "Preferred Stock"), at a purchase price of $100.00 (the "Exercise Price"), subject to adjustment. The description and terms of the Rights are setforth in the Rights Agreement. Each one one-thousandth of a share of Preferred Stock has substantially the same rights as one share of common stock. Subject to theterms and conditions of the Rights Agreement, Rights become exercisable ten days after the public announcement that a “Person” has become an “AcquiringPerson” (as each such term is defined in the Rights Agreement). Any Rights held by an Acquiring Person are void and may not be exercised. If a Person becomes an Acquiring Person, all holders of Rights, except the Acquiring Person, may purchase at the Right’s then-current exercise price,common stock having a market value equal to twice the exercise price. Moreover, at any time after a Person becomes an Acquiring Person (unless such Personacquires 50 percent or more of our common stock then outstanding, as more fully described in the Rights Agreement), the Board of Directors may exchange all (butnot less than all) of the then outstanding Rights (other than rights owned by such Person, which would have become void) for shares of common stock at anexchange ratio of one share of common stock per Right, appropriately adjusted in order to protect the interests of holders of Rights.F-14TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements The Rights Agreement was approved by our Board of Directors on July 18, 2014. The Rights will expire at the close of business on its ten yearanniversary, unless earlier exchanged or terminated by us. Common Stock Our amended and restated certificate of incorporation authorizes the issuance of up to 150,000,000 shares of $0.001 par value common stock. On June 21, 2013, we entered into an At-the-Market Issuance Sales Agreement (the "2013 ATM") with MLV & Co. LLC ("MLV") under which we couldissue and sell shares of our common stock, having an aggregate offering price of up to $50.0 million, from time to time through MLV, acting as the sales agent.Under the agreement we would pay MLV a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock sold through MLV. During the year ended December 31, 2014, we sold a total of 4,850,055 shares of common stock under the 2013 ATM for aggregate total gross proceeds ofapproximately $50.0 million at an average selling price of $10.31 per share. Net proceeds were approximately $48.9 million after deducting commissions and othertransactions costs. In December 2014, we filed a shelf registration statement on Form S-3 (the "2015 S-3"), which was declared effective in January 2015. Under the 2015 S-3, the Company may sell up to a total of $250 million of its securities. In connection with the 2015 S-3, we amended our 2013 At-the-Market Issuance SalesAgreement with MLV (the "2015 ATM") such that we may issue and sell additional shares of our common stock, having an aggregate offering price of up to $175.0million, from time to time through MLV and FBR Capital Markets & Co. ("FBR", each of MLV and FBR individually an "Agent" and collectively the "Agents"),acting as the sales agents. Under the 2015 ATM we pay the Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of commonstock sold through the Agents . During the year ended December 31, 2016, we sold a total of 570,366 shares of common stock under the 2015 ATM for aggregate total gross proceeds ofapproximately $4.5 million at an average selling price of $7.88 per share, resulting in net proceeds of approximately $4.4 million after deducting commissions andother transaction costs. During the year ended December 31, 2015, we sold a total of 4,094,498 shares of common stock under the 2015 ATM for aggregate totalgross proceeds of approximately $68.2 million at an average selling price of $16.66 per share, resulting in net proceeds of approximately $67.0 million afterdeducting commissions and other transaction costs. The 2015 S-3 is currently our only active shelf registration statement. After deducting shares already sold, including under the 2015 ATM, there isapproximately $177.3 million of common stock that remains available for sale under the 2015 S-3. We may offer the securities under the 2015 S-3 from time totime 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 the2015 S-3 provides us with the flexibility to raise additional capital to finance our operations as needed . Treasury Stock As of December 31, 2016 and 2015, 41,309 shares of common stock are being held in Treasury, at a cost of approximately $234,000, representing the fairmarket value on the date the shares were surrendered to the Company to satisfy employee tax obligations. Equity Incentive Plans The TG Therapeutics, Inc. Amended and Restated 2012 Incentive Plan (“2012 Incentive Plan”) was approved by stockholders in June 2015. As ofDecember 31, 2016 and 2015, no options were outstanding and up to an additional 2,286,764 shares may be issued under the 2012 Incentive Plan . F-15TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements Stock Options The following table summarizes stock option activity for the years ended December 31, 2016, 2015 and 2014: Numberof shares Weighted-averageexercise price Weighted-averagecontractualterm Aggregateintrinsic value (in years) Outstanding at January 1, 2014 46,591 $ 46.37 8.50 $ -- Granted -- -- Exercised (46,000 ) 4.40 Forfeited -- -- Expired (397 ) 4,457.57 Outstanding at December 31, 2014 194 971.70 3.50 $ -- Granted -- -- Exercised -- -- Forfeited (152 ) 463.32 Expired (42 ) 2,811.53 Outstanding at December 31, 2015 -- -- -- $ -- Granted -- -- Exercised -- -- Forfeited -- -- Expired -- -- Outstanding at December 31, 2016 -- $ -- -- $ -- Exercisable at December 31, 2016 -- $ -- -- $ -- As of December 31, 2016, there are no unvested option awards and no unrecognized compensation cost related to option awards. Restricted Stock Certain employees, directors and consultants have been awarded restricted stock. The restricted stock vesting consists of milestone and time-based vesting.The following table summarizes restricted share activity for the years ended December 31, 2016, 2015 and 2014: Number ofShares WeightedAverageGrant DateFair Value Outstanding at January 1, 2014 7,034,957 $ 4.60 Granted 982,793 13.55 Vested (1,616,749 ) 6.53 Forfeited (1,000 ) 6.60 Outstanding at December 31, 2014 6,400,001 5.86 Granted 1,992,535 12.89 Vested (1,001,455 ) 5.04 Forfeited (31,166 ) 16.76 Outstanding at December 31, 2015 7,359,915 7.83 Granted 1,924,639 4.99 Vested (595,726 ) 7.38 Forfeited (46,773 ) 10.34 Outstanding at December 31, 2016 8,642,055 $ 7.20 F-16TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements Total expense associated with restricted stock grants was $7,509,999, $15,697,092 and $20,726,512 during the years ended December 31, 2016, 2015 and2014, respectively. As of December 31, 2016, there was approximately $18.8 million of total unrecognized compensation cost related to unvested time-basedrestricted stock, which is expected to be recognized over a weighted-average period of 1.6 years. This amount does not include, as of December 31, 2016, 696,172shares of restricted stock outstanding which are milestone-based and vest upon certain corporate milestones; and 2,477,958 shares of restricted stock outstandingissued to non-employees. Milestone-based non-cash compensation expense will be measured and recorded if and when a milestone becomes probable. The expensefor non-employee shares is determined at the “measurement date.” The expense is recognized over the vesting period of the award. Until the measurement date isreached, the total amount of compensation expense remains uncertain. We record compensation expense based on the fair value of the award at the reporting date. Warrants The following table summarizes warrant activity for the years ended December 31, 2016, 2015 and 2014: Warrants Weighted-averageexercise price Aggregateintrinsic value Outstanding at January 1, 2014 5,718,947 $ 1.34 $ 14,809,030 Issued -- -- Exercised (1,560,826 ) 2.28 Expired (9,893 ) 20.74 Outstanding at December 31, 2014 4,148,228 0.94 $ 61,792,184 Issued -- -- Exercised (2,950,115 ) 0.36 Expired (11,364 ) 2.25 Outstanding at December 31, 2015 1,186,749 2.37 $ 11,341,452 Issued -- -- Exercised (273,370 ) 2.26 Expired (36,467 ) 2.25 Outstanding at December 31, 2016 876,912 $ 2.41 $ 1,961,403 Stock-Based Compensation The fair value of stock options granted is estimated at the date of grant using the Black-Scholes pricing model. The expected term of options granted isderived from historical data and the expected vesting period. Expected volatility is based on the historical volatility of our common stock. The risk-free interest rateis based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. We have assumed no expecteddividend yield, as dividends have never been paid to stock or option holders and will not be paid for the foreseeable future. The Company did not grant any stockoptions during the years ended December 31, 2016, 2015 and 2014. The following table summarizes stock-based compensation expense information about stock options and restricted stock for the years ended December 31,2016, 2015 and 2014: 2016 2015 2014 Stock-based compensation expense associated with restricted stock $7,509,999 $15,697,092 $20,726,512 Stock-based compensation expense associated with stock options -- -- 378,780 $7,509,999 $15,697,092 $21,105,292 F-17TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements NOTE 6 – NOTES PAYABLE The following is a summary of notes payable: December 31, 2016 December 31, 2015 Currentportion, net Non-currentportion, net Total Currentportion, net Non-currentportion, net Total Convertible 5% Notes Payable $ 68,875 $ - $ 68,875 $ 211,549 $ - $ 211,549 Totals $ 68,875 $ - $ 68,875 $ 211,549 $ - $ 211,549 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 pershare. 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 tonoteholders; and (b) the conversion feature, discussed above. Interest accrues monthly, is added to principal on an annual basis, every March 8, and is payable atmaturity, which was March 8, 2015 (see Note 4 for further details) . The cumulative liability including accrued and unpaid interest of these notes was approximately $16.7 million at December 31, 2016 and $19.9 million atDecember 31, 2015. No payments have been made on the 5% Notes as of December 31 , 2016. In December 2011, we elected the fair value option for valuing the 5% Notes. The fair value option was elected in order to reflect in our financialstatements the assumptions that market participants use in evaluating these financial instruments (see Note 4 for further details). NOTE 7 – INCOME TAXES We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are determined based on differences between thefinancial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences areexpected to reverse. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. In determining theneed for a valuation allowance, management reviews both positive and negative evidence, including current and historical results of operations, future incomeprojections and the overall prospects of our business. Based upon management's assessment of all available evidence, we believe that it is more-likely-than-not thatthe deferred tax assets will not be realizable, and therefore, a valuation allowance has been established. The valuation allowance for deferred tax assets wasapproximately $116,172,000 and $86,359,000 as of December 31, 2016 and 2015, respectively. As of December 31, 2016, we have U.S. net operating loss carryforwards ('NOLs") of approximately $271,828,000 and research and development creditcarryforwards (?R&D credits?) of approximately $7,327,000. For income tax purposes, these NOLs and R&D credits will expire in various amounts through 2036.The Tax Reform Act of 1986 contains provisions which limit the ability to utilize net operating loss carryforwards and R&D credit carryforwards in the case ofcertain events including significant changes in ownership interests. The Exchange Transaction with TG Bio may have resulted in a "change in ownership" asdefined by IRC Section 382 of the Internal Revenue Code of 1986, as amended. Additionally, stock issuance activities may have resulted in a "change inownership" as defined by IRC Section 382 of the Internal Revenue Code of 1986, as amended. Accordingly, a substantial portion of the Company's NOLs abovemay be subject to annual limitations in reducing any future year's taxable income, and a substantial portion of the R&D Credit carryforwards may be subject toannual limitations in reducing any future year's tax. F-18TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2016and 2015 are presented below. 2016 2015 Deferred tax assets (liabilities): Net operating loss carryforwards $ 95,329,928 $ 68,700,379 Research and development credit 7,326,715 4,962,298 Noncash compensation 12,915,672 12,087,968 Other 599,514 608,205 Deferred tax asset, excluding valuation allowance 116,171,829 86,358,850 Less valuation allowance (116,171,829 ) (86,358,850 )Net deferred tax assets $ -- $ -- There was no current or deferred income tax expense for the year ended December 31, 2016. Income tax expense differed from amounts computed byapplying the US Federal income tax rate of 34% to pretax loss as follows: For the year ended December 31, 2016 2015 2014 Loss before income taxes, as reported in the consolidated statements of operations $ (78,252,894 ) $ (62,948,646 ) $ (55,781,277 ) Computed “expected” tax benefit $ (26,605,984 ) $ (21,402,540 ) $ (18,965,634 ) Increase (decrease) in income taxes resulting from: Expected benefit from state and local taxes (835,072 ) (672,306 ) (2,533,156 ) Research and development credits (2,364,417 ) (1,603,364 ) (1,092,767 ) Other (7,506 ) 566,310 35,459 Permanent difference related to contingent note payable -- -- (244,814 ) Impact of change in state tax rates on deferred taxes -- 5,836,819 -- Change in the balance of the valuation allowance for deferred tax assets 29,812,979 17,275,081 22,800,912 $ -- $ -- $ -- We file income tax returns in the U.S Federal and various state and local jurisdictions. With certain exceptions, the Company is no longer subject to U.S.Federal and state income tax examinations by tax authorities for years prior to 2013. However, NOLs and tax credits generated from those prior years could still beadjusted upon audit. The Company would recognize interest and penalties, if any, to uncertain tax position in income tax expense in the statement of operations. There was noaccrual for interest and penalties related to uncertain tax positions for 2016. We do not believe that there will be a material change in our unrecognized tax positionsover the next twelve months. All of the unrecognized tax benefits, if recognized, would be offset by the valuation allowance. NOTE 8 – LICENSE AGREEMENTS BET In May 2016, as part of a broader agreement with Jubilant Biosys (“Jubilant”), an India-based biotechnology company, we entered into a sub-licenseagreement (“JBET Agreement”) with Checkpoint Therapeutics, Inc. (“Checkpoint”) (see Note 9), for the development and commercialization of Jubilant’s novelBET inhibitor program in the field of hematological malignancies.F-19TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements Under the terms of the agreement, we paid Checkpoint an up-front licensing fee of $1.0 million and will make additional payments contingent on certainpreclinical, clinical, and regulatory milestones, including commercial milestones totaling up to approximately $177 million and a single-digit royalty on net sales.TG will also provide funding to support certain targeted research efforts at Jubilant. Anti-PD-L1 and anti-GITR On March 3, 2015, we entered into a Global Collaboration Agreement (the “Collaboration”) with Checkpoint, a subsidiary of Fortress Biotech, Inc.(“FBIO”), a related party, for the development and commercialization of Checkpoint’s anti-PD-L1 and anti-GITR antibody research programs in the field ofhematological malignancies. Checkpoint retains the rights to develop and commercialize these antibodies in solid tumors. Under the terms of the Collaboration, we made an up-front payment of $0.5 million, will make development and sales-based milestone payments up to anaggregate of $164 million, and will pay a tiered single digit royalty on net sales. The royalty term will terminate on a country by country basis upon the later of (i)ten years after the first commercial sale of any applicable licensed product in such country, or (ii) the expiration of the last-to-expire patent held by the Dana FarberCancer Institute containing a valid claim to any licensed product in such country. Michael Weiss, our Executive Chairman, CEO and President is also the Executive Vice Chairman of FBIO and the Executive Chairman of Checkpoint(see Note 9). TGR-1202 On September 22, 2014, we exercised our option to license the global rights to TGR-1202, thereby entering into an exclusive licensing agreement (the“TGR-1202 License”) with Rhizen Pharmaceuticals, SA (“Rhizen”) for the development and commercialization of TGR-1202. Prior to this, we had been jointlydeveloping TGR-1202 in a 50:50 joint venture with Rhizen. Under the terms of the TGR-1202 License, Rhizen received a $4.0 million cash payment and 371,530 shares of our common stock as an upfront licensefee. With respect to TGR-1202, Rhizen will be eligible to receive regulatory filing, approval and sales-based milestone payments in the aggregate of approximately$175 million, a small portion of which will be payable on the first New Drug Application (NDA) filing and the remainder on approval in multiple jurisdictions forup to two oncology indications and one non-oncology indication and attaining certain sales milestones. In addition, if TGR-1202 is co-formulated with another drugto create a new product (a "New Product"), Rhizen will be eligible to receive similar regulatory approval and sales-based milestone payments for such New Product.Additionally, Rhizen will be entitled to tiered royalties on our future net sales of TGR-1202 and any New Product. In lieu of sales milestones and royalties on netsales, Rhizen shall also be eligible to participate in sublicensing revenue, if any, based on a percentage that decreases as a function of the number of patients treatedin clinical trials following the exercise of the license option. Rhizen will retain global manufacturing rights to TGR-1202, provided that they are price competitivewith alternative manufacturers. In connection with the TGR-1202 License, we recognized $4.1 million of noncash research and development expense during the year ended December 31,2014 related to the issuance of the above mentioned common stock. In addition, we recognized $4.0 million of other research and development expense during theyear ended December 31, 2014 related to the cash milestone payment. IRAK4 On June 23, 2014, we entered into an exclusive licensing agreement with Ligand Pharmaceuticals Incorporated ("Ligand") for the development andcommercialization of Ligand's interleukin-1 receptor associated kinase-4 ("IRAK4") inhibitor technology, which currently is in preclinical development forpotential use against certain cancers and autoimmune diseases. IRAK4 is a serine/threonine protein kinase that is a key downstream signaling component of theinterleukin-1 receptor and multiple toll-like receptors. F-20TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements Under the terms of the license agreement, Ligand received 125,000 shares of our common stock as an upfront license fee. Ligand will also be eligible toreceive maximum potential milestone payments of approximately $207 million upon the achievement of specific clinical, regulatory and commercial milestoneevents. Additionally, Ligand will be entitled to royalties on our future net sales of licensed products containing IRAK4 inhibitors. The basic royalty rate for licensedproducts covered by Ligand's issued patents will be 6% for annual sales of up to $1 billion and 9.5% for annual sales in excess of that threshold. In connection with the license agreement, we recognized $1,211,250 of noncash research and development expense during the year ended December 31,2014 in connection with the issuance of the above mentioned common stock. Additionally, Opus Point Partners, LLC, who identified the opportunity and advised us on the transaction, will also be entitled to receive a 1% royalty forannual sales of up to $1 billion. Michael S. Weiss, our Executive Chairman and Chief Executive Officer, is a Managing Member of Opus Point Partners, LLC. TG-1101 In November 2012, we entered into an exclusive (within the territory) sublicense agreement with Ildong relating to the development andcommercialization of TG-1101 in South Korea and Southeast Asia. Under the terms of the sublicense agreement, Ildong has been granted a royalty bearing,exclusive right, including the right to grant sublicenses, to develop and commercialize TG-1101 in South Korea, Taiwan, Singapore, Indonesia, Malaysia, Thailand,Philippines, Vietnam, and Myanmar. An upfront payment of $2.0 million, which was received in December 2012, net of $0.3 million of income tax withholdings , is being recognized as licenserevenue 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 commercialsale of a product in such country, unless the agreement is earlier terminated, and represents the estimated period over which we will have certain ongoingresponsibilities under the sublicense agreement. We recorded license revenue of approximately $152,000 for each of the years ended December 31 , 2016, 2015 and2014, and, at December 31 , 2016, 2015 and 2014, have deferred revenue of approximately $1,371,000, $1,524,000 and $1,676,000, respectively, associated withthis $2,000,000 payment (approximately $152,000 of which has been classified in current liabilities at December 31, 2016). We may receive up to an additional $5.0 million in payments upon the achievement of pre-specified milestones. In addition, upon commercialization,Ildong will make royalty payments to us on net sales of TG-1101 in the sublicense territory. NOTE 9 – RELATED PARTY TRANSACTIONS LFB Biotechnologies On January 30, 2012, we entered into an exclusive license agreement with LFB Biotechnologies, GTC Biotherapeutics and LFB/GTC LLC, all wholly-owned subsidiaries of LFB Group, relating to the development of ublituximab (the “LFB License Agreement”). In connection with the LFB License Agreement,LFB Group was issued 5,000,000 shares of common stock, and a warrant to purchase 2,500,000 shares of common stock at a purchase price of $0.001 per share. Inaddition, on November 9, 2012, we nominated Dr. Yann Echelard to our Board of Directors as LFB Group’s nominee. LFB Group maintains the right to nominate aboard member until such time as LFB Group owns less than 10% of the outstanding common stock. In connection with the LFB License Agreement, LFB Group maintained the right to purchase at least $750,000 in additional shares of common stock at apurchase price per share as defined in a November 2012 securities exchange agreement. Accordingly, in February 2015, LFB Group purchased 114,855 shares ofour common stock at a price of $6.53 per share for net proceeds of $750,000. In May 2015, LFB Group exercised its warrant to purchase 2,500,000 shares ofcommon stock at a purchase price of $0.001 per share.F-21TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements Under the terms of the LFB License Agreement, we utilize LFB Group for certain development and manufacturing services. We incurred approximately$8,100,000, $9,300,000 and $5,200,000 in expenses for such services during the years ended December 31 , 2016, 2015 and 2014, respectively, which have beenincluded in other research and development expenses in the accompanying consolidated statements of operations. As of December 31 , 2016, and 2015, we hadapproximately $0.4 million and $2.1 million, respectively, recorded in accounts payable related to the LFB License Agreement. In conjunction with thedevelopment and manufacturing services discussed above, certain agreements between us and LFB Group require payments in advance of services performed orgoods delivered. Accordingly, as of December 31, 2016 and 2015, we recorded $1.3 million and $3.0 million, respectively, in prepaid research and development forsuch advance payments. Other Parties In March 2014, we entered into a shared services agreement (the “Opus Shared Services Agreement”) with Opus Point Partners Management, LLC(“Opus”) in which the parties agreed to share a rented facility and costs for certain other services. Michael S. Weiss, our Executive Chairman and CEO, is aManaging Member of Opus. During the years ended December 31 , 2016 and 2015, we incurred expenses of approximately $0.3 million and $0.1 million,respectively, principally for rent, related to this Opus Shared Services Agreement. As of December 31 , 2016 and 2015, we had $0 and approximately $0.1 million,respectively, recorded in accounts payable related to this Opus Shared Services Agreement . The Opus Shared Services Agreement is no longer in effect as webegan occupying new space in April 2016. In October 2014, we entered into an agreement (the “Office Agreement”) with FBIO to occupy approximately 45% of the 24,000 square feet of New YorkCity office space leased by FBIO, which is now our corporate headquarters. The Office Agreement requires us to pay our respective share of the average annualrent 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 thisnew space in April 2016, with rental payments beginning in the third quarter of 2016. During the year ended December 31, 2016, we recorded rent expense ofapproximately $1.4 million and at December 31, 2016, have deferred rent of approximately $0.8 million . Mr. Weiss, our Executive Chairman and CEO, is alsoExecutive Vice Chairman of FBIO. During the year ended December 31, 2016, we agreed to pay FBIO $2.2 million for our portion of the build-out costs, which have been allocated to us atthe 45% rate mentioned above. The allocated build-out costs have been recorded in Leasehold Interest on the Company’s consolidated balance sheet and will beamortized 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 willdetermine actual office space utilization annually and if our utilization differs from the amount we have been billed, we will either receive credits or be assessedincremental 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 theOffice Agreement, which has been recorded as restricted cash in the accompanying consolidated balance sheets . In July 2015, we entered into a Shared Services Agreement (the “Shared Services Agreement”) with FBIO to share the cost of certain services such asfacilities use, personnel costs and other overhead and administrative costs. This Shared Services Agreement requires us to pay our respective share of servicesutilized. In connection with the Shared Services Agreement, we incurred expenses of approximately $0.8 million and $0.1 million for shared services for the yearsended December 31, 2016 and 2015, primarily related to shared personnel. As of December 31, 2016, we had approximately $0.4 million recorded in accountspayable related mostly to the Shared Services Agreement, and no amounts were due at December 31, 2015. In May 2016, as part of a broader agreement with Jubilant, an India-based biotechnology company, we entered into the JBET Agreement with Checkpoint,a subsidiary of FBIO, for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies. We paidCheckpoint an up-front licensing fee of $1.0 million as part of the JBET Agreement which was recorded in other research and development in the accompanyingconsolidated statement of operations. As of December 31, 2016, we had approximately $0.8 million recorded in accounts payable, related mostly to the JBETAgreement. Mr. Weiss is also the Executive Chairman of Checkpoint .F-22TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements For the year ended December 31, 2016, we incurred expenses of approximately $4,000 to AOI Communications, L.P. for manuscript services related toTG-1101. Mr. Weiss is the owner of AOI Communications, L.P. NOTE 10 – COMMITMENTS AND CONTINGENCIES As of December 31, 2016, we have known contractual obligations, commitments and contingencies of approximately $18.0 million related to ouroperating lease obligations. (in thousands) Payment due by period Total Less than 1year 1-3 years 3-5 years More than5 years Contractual obligations Operating leases $ 18,020 $ 1,185 $ 2,281 $ 2,286 $ 12,268 Total $ 18,020 $ 1,185 $ 2,281 $ 2,286 $ 12,268 LeasesSee Note 9 for a detailed description of our lease arrangements. Total rental expense was approximately $1.6 million, $0.3 million and $0.1 million for theyears ended December 31, 2016, 2015 and 2014, respectively. Future minimum lease commitments as of December 31, 2016, in the aggregate total approximately $18.0 million through December 31, 2031. Thepreceding table shows future minimum lease commitments, which include our office leases in New York, North Carolina and Tennessee, by period as ofDecember 31, 2016. F-23TG Therapeutics, Inc. and SubsidiariesNotes to Consolidated Financial Statements NOTE 11 – QUARTERLY FINANCIAL INFORMATION (UNAUDITED) 3 Months Ended March 31,2016 June 30, 2016 September 30,2016 December 31,2016 License revenue $ 38,095 $ 38,095 $ 38,096 $ 38,095 Total costs and expenses 14,030,251 16,061,538 24,963,567 24,066,153 Net loss $ (13,848,662 ) $ (15,899,062 ) $ (24,831,027 ) $ (23,674,143 ) Basic and diluted net loss per common share $ (0.28 ) $ (0.33 ) $ (0.50 ) $ (0.48 ) 3 Months Ended March 31,2015 June 30, 2015 September 30,2015 December 31,2015 License revenue $ 38,095 $ 38,095 $ 38,096 $ 38,095 Total costs and expenses 14,640,946 17,149,675 13,863,680 17,678,096 Net loss $ (14,577,735 ) $ (17,103,183 ) $ (13,655,916 ) $ (17,611,812 ) Basic and diluted net loss per common share $ (0.35 ) $ (0.38 ) $ (0.28 ) $ (0.37 ) NOTE 12 – LITIGATION On January 6, 2017, a purported securities class action complaint was filed in New York federal court against the Company and certain of its directors,officers or consultants on behalf of all shareholders who purchased or otherwise acquired TG Therapeutics common stock between September 15, 2014 and October12, 2016 (the “Class Period”). The case is captioned John Lyon v. TG Therapeutics, Michael S. Weiss, Sean A. Power and Robert Niecestro, Case No. 1:17-cv-00112-VM (S.D.N.Y.). The complaint alleges that, throughout the Class Period and including on October 13, 2016, that the Company had filed an “amendedprotocol for its GENUINE Phase 3 trial,” various statements made by the Company regarding its GENUINE Phase 3 trial were materially false or misleading whenmade in violation of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. On January 24, 2017, a second purported class action complaintwas filed in New York federal court against the Company and certain of its directors, officers or consultants also on behalf of all shareholders who purchased orotherwise acquired TG Therapeutics common stock between September 15, 2014 and October 12, 2016. The case is captioned Kenneth C. Wyzgoski v. TGTherapeutics, Michael S. Weiss, Sean A. Power and Robert Niecestro, Case No. 1:17-cv-00508-VM (S.D.N.Y.). The claims and allegations in the Wyzgoskicomplaint are substantially identical to those in the Lyon case. Both actions remain pending and are in the early stages of litigation. NOTE 13 - SUBSEQUENT EVENTS During the first quarter of 2017, we sold a total of 3,104,253 shares of common stock under the 2015 ATM for aggregate total gross proceeds ofapproximately $31.6 million at an average selling price of $10.18 per share. Net proceeds were approximately $31 million after deducting commissions and othertransactions costs. On March 9, 2017, we announced the pricing of an underwritten public offering of 5,128,206 shares of our common stock (plus a 30-day underwriteroption to purchase up to an additional 769,230 shares of common stock, which has been exercised) at a price of $9.75 per share, with expected gross proceeds to TGTherapeutics of $57.5 million, less underwriting discounts and commissions. Total net proceeds from this offering, including the overallotment, are $54 million, netof underwriting discounts and estimated offering expenses of approximately $3.5 million. The shares were sold under a shelf registration statement on Form S-3(File No. 333-201339) that was previously filed and declared effective by the SEC in January 2015. The offering closed on March 14, 2017. F-24 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on itsbehalf by the undersigned, thereunto duly authorized. Date: March 15, 2017 TG THERAPEUTICS, INC. By: /s/ Michael S. Weiss Michael S. Weiss Executive Chairman, Chief Executive Officer and President POWER OF ATTORNEY KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints each of Michael S. Weiss and SeanA. Power, his true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him and his name, place and stead, in any and allcapacities, to sign any or all amendments to this annual report on Form 10-K, and to file the same, with all exhibits thereto and other documents in connectiontherewith, with the SEC, granting unto said attorney-in-fact and agent, full power and authority to do and perform each and every act and thing requisite andnecessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that saidattorney-in-fact and agent or any of his substitutes, may lawfully do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Form 10-K has been signed by the following persons on behalf ofthe Registrant on March 15, 2017, and in the capacities indicated: SignaturesTitle /s/ Michael S. WeissMichael S. Weiss Executive Chairman, Chief Executive Officer and President(principal executive officer)/s/ Sean A. PowerSean A. Power Chief Financial Officer(principal financial and accounting officer)/s/ Laurence N. CharneyLaurence N. Charney Director /s/ Yann EchelardYann Echelard Director /s/ Kenneth HobermanKenneth Hoberman Director /s/ Daniel HumeDaniel Hume Director /s/ William J. KennedyWilliam J. Kennedy Director /s/ Mark Schoenebaum, M.D.Mark Schoenebaum, M.D. Director EXHIBIT INDEX Exhibit NumberExhibit Description 21.1 Subsidiaries of TG Therapeutics, Inc. 23.1Consent of Independent Registered Public Accounting Firm 31.1Certification of Principal Executive Officer 31.2Certification of Principal Financial Officer 32.1Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 32.2Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 Exhibit 23.1 Consent of Independent Registered Public Accounting Firm We consent to the incorporation by reference in registration statement No. 333-181439 on Form S-8 and registration statement Nos. 333-189015 and 333-201339on Form S-3 of our report dated March 15, 2017 on our audits of the consolidated financial statements of TG Therapeutics, Inc. and Subsidiaries as of December31, 2016 and 2015, and for each of the three years in the period ended December 31, 2016, and our report on our audit of internal control over financial reporting ofTG Therapeutics, Inc. and Subsidiaries as of December 31, 2016, dated March 16, 2017, included in this Annual Report on Form 10-K of TG Therapeutics, Inc. andSubsidiaries for the year ended December 31, 2016. /s/ CohnReznick LLP New York, New YorkMarch 15, 2017 Exhibit 21.1 Subsidiaries of TG Therapeutics, Inc. Ariston Pharmaceuticals, Inc. TG Biologics, Inc. Exhibit 31.1 CERTIFICATION OF PERIODIC REPORTPURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Michael S. Weiss, certify that: 1.I have reviewed this annual report on Form 10-K of TG Therapeutics, Inc.; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statementsmade, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3.Based on my knowledge, the consolidated financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange ActRules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant andhave: a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure thatmaterial information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularlyduring the period in which this report is being prepared; b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, toprovide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordancewith generally accepted accounting principles; c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of thedisclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscalquarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, theregistrant’s internal control over financial reporting; and 5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’sauditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely toadversely affect the registrant’s ability to record, process, summarize and report financial information; and b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control overfinancial reporting. Date: March 15, 2017 /s/ Michael S. Weiss Michael S. Weiss Executive Chairman, Chief Executive Officer and President Principal Executive Officer Exhibit 31.2 CERTIFICATION OF PERIODIC REPORTPURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Sean A. Power, certify that: 1.I have reviewed this annual report on Form 10-K of TG Therapeutics, Inc.; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statementsmade, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3.Based on my knowledge, the consolidated financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange ActRules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant andhave: a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure thatmaterial information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularlyduring the period in which this report is being prepared; b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, toprovide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordancewith generally accepted accounting principles; c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of thedisclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscalquarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, theregistrant’s internal control over financial reporting; and 5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’sauditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely toadversely affect the registrant’s ability to record, process, summarize and report financial information; and b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control overfinancial reporting. Date: March 15, 2017 /s/ Sean A. Power Sean A. Power Chief Financial OfficerPrincipal Financial and Accounting Officer Exhibit 32.1 STATEMENT OF CHIEF EXECUTIVE OFFICER OF TG THERAPEUTICS, INC. PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the annual report of TG Therapeutics, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2016 as filed with theSecurities and Exchange Commission (the “Report”), I, Michael S. Weiss, Executive Chairman, Chief Executive Officer and President of the Company, certify,pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that, based on my knowledge: 1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and 2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. Date: March 15, 2017 /s/ Michael S. Weiss Michael S. Weiss Executive Chairman, Chief Executive Officer and President Principal Executive Officer Exhibit 32.2 STATEMENT OF CHIEF FINANCIAL OFFICER OF TG THERAPEUTICS, INC. PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the annual report of TG Therapeutics, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2016 as filed with theSecurities and Exchange Commission (the “Report”), I, Sean A. Power, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adoptedpursuant to §906 of the Sarbanes-Oxley Act of 2002, that, based on my knowledge: 1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and 2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. Date: March 15, 2017 /s/ Sean A. Power Sean A. Power Chief Financial OfficerPrincipal Financial and Accounting Officer
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