Certain matters discussed in this report, including matters discussed under the ~~caption~~captions “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” may constitute forward-looking statements for purposes of the Securities Act of 1933, as amended, or the Securities Act, and the Securities Exchange 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-looking statements. ~~The words "anticipate," "believe," "estimate," "may," "expect" and similar expressions are generally intended to~~In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would” or the negative of these words or other comparable terminology, although not all forward-looking statements contain these identifying words.. All written or oral forward-looking statements attributable to us are expressly qualified in their entirety by these cautionary statements. In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

●

expectations for increases or decreases in expenses;

●

expectations for the clinical and pre-clinical development, manufacturing, regulatory approval, and commercialization of our pharmaceutical product 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;

●

products being accepted 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, including expectations regarding the value and liquidity of our investments;

●

stock price and its volatility; and

●

expectations for future capital requirements.

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 in this 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 in the documents where such forward-looking statements appear. ~~All written or oral~~Given these uncertainties, you should not place undue reliance on these forward-looking statements. Our forward-looking statements ~~attributable~~do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make or enter into.

You should read this Annual Report on Form 10-K and the documents that we have filed as exhibits to ~~us are expressly qualified~~this Annual Report on Form 10-K completely and with the understanding that our actual future results, performance or achievements may be materially different from what we expect. Any forward-looking statements in ~~their entirety~~this Annual Report on Form 10-K reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these ~~cautionary~~forward-looking statements. ~~Such forward-looking statements include, but are not limited to, statements about our:~~

●

~~expectations for increases or decreases in expenses;~~

●

~~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;~~

●

~~products being accepted 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;~~

●

~~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~~Except as required by law, we assume no ~~responsibility~~obligation to update or revise these forward-looking statements for ~~updating~~ any ~~forward-looking statements.~~reason, even if new information becomes available in the future.

~~We qualify all~~This Annual Report on Form 10-K also contains estimates, projections and other information concerning our industry, our business and the markets for certain diseases, including data regarding the estimated size of ~~our forward-looking statements~~those markets, and the incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by these cautionary statements. In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.market research firms and other third parties, industry, medical and general publications, government data and similar sources.

PART I

Unless the context requires otherwise, references in this report to “TG,” “Company,” “we,” “us” and “our” refer to TG Therapeutics, Inc. and our subsidiaries.

ITEM 1. BUSINESS.

OVERVIEW

We are a biopharmaceutical company ~~focused on the acquisition,~~dedicated to developing and delivering medicines for patients with B-cell mediated diseases, including Chronic Lymphocytic Leukemia (CLL), non-Hodgkin’s Lymphoma (NHL) and Multiple Sclerosis (MS). We have developed a robust B-cell directed research and development (R&D) platform for identification of key B-cell pathways of interest and ~~commercialization of novel treatments for B-cell malignancies and autoimmune diseases.~~rapid clinical testing. Currently, we ~~are developing~~have five B-cell targeted drug candidates in clinical development, with the lead two therapies, ~~targeting hematologic malignancies. TG-1101 (ublituximab)~~ublituximab (TG-1101) and umbralisib (TGR-1202), in pivotal trials for CLL, NHL and MS. Ublituximab is a novel ~~glycoengineered~~anti-CD20 monoclonal antibody (mAb) that ~~targets a unique epitope on the CD20 antigen found on mature B-lymphocytes. We are~~has been glycoengineered for enhanced potency over first generation antibodies. Umbralisib is an oral, once daily inhibitor of PI3K delta. Umbralisib also ~~developing TGR-1202 (umbralisib), an orally available~~uniquely inhibits CK1-epsilon, which may allow it to overcome certain tolerability issues associated with first generation PI3K delta ~~inhibitor. The delta isoform of PI3K is strongly expressed~~inhibitors. When used together in ~~cells of hematopoietic origin~~combination therapy, ublituximab and ~~is believed to be important in the proliferation and survival of B-lymphocytes. Both TG-1101 and TGR-1202, or the combination which is~~umbralisib are referred to as ~~"U2," are~~("U2"), or "1303". Additionally, in ~~Phase 3~~early clinical development ~~for patients with hematologic malignancies, with TG-1101 also in Phase 3 clinical development for patients with multiple sclerosis. Additionally, the Company has recently brought its~~we have an anti-PD-L1 monoclonal antibody ~~into Phase 1 development~~referred to as TG-1501, an oral Bruton’s Tyrosine Kinase (“BTK”) inhibitor referred to as TG-1701, and ~~aims~~an anti-CD47/CD19 bispecific antibody referred to ~~bring additional pipeline assets into the clinic in the future.~~ as TG-1801.

We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities. To date, we have not received approval for the sale of any of our drug candidates in any market and, therefore, have not generated any product sales from our drug candidates.

Current Phase 3 or Registration Directed Clinical Trial Highlights:

●

Umbralisib Single Agent Cohorts of UNITY-NHL Phase 2b Trial:UNITY-NHL is a Phase 2b registration-directed clinical trial evaluating umbralisib monotherapy and the U2 combination in previously treated patients with NHL. Currently the follicular lymphoma (FL)/ small lymphocytic leukemia (SLL) and marginal zone lymphoma (MZL) single agent umbralisib cohorts of this trial have been fully enrolled. In February 2019, we announced that the MZL cohort met the primary endpoint of Overall Response Rate (ORR) as determined by Independent Review Committee (IRC) for all treated patients (n=69). The results met the Company’s target guidance of 40-50% ORR. Interim safety and efficacy data from the MZL cohort will be presented in an oral presentation at the upcoming American Association for Cancer Research (AACR) annual meeting on April 1, 2019. Previously, in January 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for umbralisib for the treatment of adult patients with MZL who have received at least one prior anti-CD20 regimen, the same population currently being evaluated in the UNITY-NHL MZL cohort. We plan to discuss the results with the FDA regarding a potential new drug application (NDA) filing for accelerated approval. For the FL/SLL cohort, we are targeting topline data readout in second half-2019.

●

Umbralisib plus Ublituximab UNITY-CLL Phase 3 Trial:UNITY-CLL is a global Phase 3 randomized controlled clinical trial comparing the U2 combination, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment naïve and relapsed or refractory CLL. The primary endpoint for this study is to demonstrate superiority in Progression Free Survival (PFS) for the U2 combination over the control arm to support the submission for full approval of the U2 combination in CLL. We cannot predict precisely when the PFS readout will occur, however our current estimate is PFS readout may be available by year-end 2019 or first half 2020. This trial is being conducted under Special Protocol Assessment (SPA) with FDA.

●

Ublituximab Single Agent ULTIMATE I & II Trials: ULTIMATE I and ULTIMATE II are two independent Phase 3 trials. Each trial is a global, randomized, multi-center, double-blinded, double-dummy, active-controlled study comparing ublituximab to teriflunomide in subjects with relapsing forms of Multiple Sclerosis (RMS). The primary endpoint for each study is Annualized Relapse Rate (ARR) following 96 weeks of treatment over the control arm to support the submission for full approval of ublituximab in RMS. We are targeting topline data from this trial in mid-2020. These trials are being conducted under an SPA with the FDA.

CORPORATE INFORMATION

We were incorporated in Delaware in 1993. Our executive offices are located at 2 Gansevoort ~~St., 9~~thStreet, 9th Floor, New York, New York 10014. Our telephone number is ~~212-554-4484,~~1-212-554-4484, and our e-mail address is info@tgtxinc.com.

We maintain a website with the address ~~www.tgtherapeutics.com.~~www.tgtherapeutics.com and maintain a twitter account. We make available free of charge through our ~~Internet~~corporate website our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, ~~and~~as well as any amendments to these reports, as soon as reasonably practicable after we electronically file such material with, or furnish such material to, the SEC. We are not including the information on our website or our twitter account as a part of, nor incorporating iteither by reference 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 Public Reference Room. Additionally, the SEC maintains a website that contains annual, quarterly, and current reports, proxy statements, and other information that issuers (including us) file electronically with the SEC. The SEC’s website address is http://www.sec.gov.

In addition, we intend to use our ~~media and investor relations~~corporate website, SEC filings, press releases, public conference calls and webcasts as well as social media to communicate with our subscribers and the public about the Company, its services and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, in light of the SEC’s guidance, we encourage investors, the media and others interested in the Company to review the information we post on the U.S. social media channels listed on our website.

STRATEGY

Our Strategy

Our goal is to become a fully-integrated, B-cell targeted biopharmaceutical company capable of delivering multi-drug combination treatments for patients with diseases resulting from cancerous or aberrant B-cells. The key tenets of our strategy include the following:

●

Successfully completing our current Phase 3 and registration-directed trials for umbralisib and ublituximab, including, UNITY-CLL, UNITY-NHL, and the ULTIMATE Phase 3 Program in MS;

●

Rapidly gaining regulatory approval for umbralisib in NHL, umbralisib plus ublituximab (“U2”) in CLL, and ublituximab in MS;

●

Efficiently and effectively prepare for commercial launch and build commercial capability to ensure, when approved, broad access to patients for the approved indications for umbralisib and ublituximab;

●

Rapidly add ublituximab to umbralisib in NHL to advance U2 in NHL;

●

Advance TG-1501, TG-1701, and TG-1801 through clinical development and define potential regulatory paths for these drug candidates both as single agents and in combination with umbralisib, ublituximab, and/or U2;

●

Build upon the MS program to expand ublituximab into additional MS indications and other autoimmune diseases;

●

Continue to expand our pipeline with mechanisms of importance to B-cell mediated diseases;

●

Evaluate potential strategic collaborations to maximize the value of our programs and B-cell directed platform; and

●

Maintain our “patient first” culture as we grow our business.

Our Approach and Platform

Our approach is to systematically identify targets that have proven activity in the treatment of B-cell diseases. Our preference is to identify targets for which there is human clinical proof of concept that the mechanism is active in B-cell diseases and then to identify drug candidates that effectively modulate the desired molecular target. We identify these drug candidates at academic centers of excellence or in development at biotech companies or pharmaceutical companies globally. Our current drug candidates were acquired through license agreements, collaborations, or joint ventures with biopharmaceutical companies located in the US, France, Switzerland, India, and China. This approach enables us to minimize target risk while looking for the best available drug candidates around the world. By focusing on B-cell diseases and targets with a known activity profile, we believe that we can quickly identify the patients most likely to respond, resulting in a more efficient development path with a greater likelihood of success. Importantly, since all our drug candidates are focused in one disease area, we can rapidly explore combination therapies, which we believe is essential to providing best outcomes for patients and holds the key to identifying cures for patients with B-cell diseases.

Our approach is enabled by our clinical development platform which includes:

●

An internal team with a deep understanding of B-cell diseases and the treatment of patients; and

●

An external clinical trials network composed of over 200 community and academic clinical trial sites globally, specializing in B-cell diseases.

B-CELL DISEASES OVERVIEW

B-cell mediated diseases comprise a constellation of disorders that result from cancerous B-cells or aberrant B-cells. In the case of cancerous B-cells, the most common forms of B-cell cancers or B-cell malignancies are non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). In the case of aberrant B-cells, many autoimmune diseases are believed to result from aberrant B-cell activity, including, Multiple Sclerosis (MS), Rheumatoid Arthritis (RA), and Lupus.

The Company’s current clinical programs are focused on CLL, MZL, FL, and RMS.

Marginal Zone Lymphoma Overview

MZL comprises a group of indolent (slow growing) B-cell non-Hodgkin lymphomas (NHLs) that begin forming in the marginal zone of lymphoid tissue. With an annual incidence of approximately 7,500 newly diagnosed patients in the United States, MZL is the third most common B-cell NHL, accounting for approximately eight percent of all NHL cases. MZL consists of three different subtypes: extranodal MZL of the mucosal-associated lymphoid tissue (MALT), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL).

Follicular Lymphoma Overview

FL is typically a slow-growing or indolent form of NHL which accounts for 20 to 30 percent of all NHL cases, with a prevalence of approximately 245,000 and an incidence of approximately 31,000 in the US, Japan, and 5 major EU markets. FL is usually not considered to be curable, but more of a chronic disease, with patients living for many years.

~~PRODUCTS UNDER DEVELOPMENT~~

~~TG-1101 (ublituximab)~~

Chronic Lymphocytic Leukemia Overview

~~TG-1101 (ublituximab)~~CLL is the most common type of adult leukemia, and in 2019, it is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of cancerous cells.

Relapsing Forms of Multiple Sclerosis Overview

Relapsing forms of multiple sclerosis (RMS), a chronic demyelinating disease of the central nervous system (CNS) include people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1,000,000 people are living with MS in the United States and approximately 85 percent are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time.

OUR PRODUCTS UNDER DEVELOPMENT

We have leveraged our B-cell platform to develop a robust drug pipeline of both targeted orally available, potent and selective small molecule kinase inhibitors and intravenously delivered “off-the-shelf” immunotherapies that leverage the patient’s own immune system to fight cancer. We currently own worldwide development and commercial rights, subject to certain limited geographical restrictions, to all of our pre-clinical and clinical programs. The following table summarizes our most advanced drug candidates as of February 28, 2019.

Clinical Drug Candidate (molecular target)	Initial Target Disease	Stage of Development (pivotal study)
Ublituximab (anti-CD20/mAb)	Chronic Lymphocytic Leukemia	Phase 3 trial (UNITY-CLL)
	Multiple Sclerosis	Phase 3 trials (ULTIMATE I and II)

Umbralisib (PI3K delta inhibitor)	Chronic Lymphocytic Leukemia	Phase 3 trial (UNITY-CLL)
	Marginal Zone Lymphoma	Phase 2b trial (UNITY-NHL)
	Follicular Lymphoma	Phase 2b trial (UNITY-NHL)
TG-1501 (anti-PDL1)	B-cell Cancers	Phase 1 trial
TG-1701 (BTK inhibitor)	B-cell Cancers	Phase 1 trial
TG-1801 (anti-CD47/CD19)	B-cell Cancers	Phase 1 trial

Ublituximab Overview

Ublituximab (also referred to as TG-1101) is a ~~chimeric,~~ glycoengineered anti-CD20 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.~~B-lymphocytes. We hold exclusive worldwide rights to develop and commercialize ~~TG-1101~~ublituximab for all indications, except for the territories of France and Belgium for which ~~have~~an option to commercialize has been retained by LFB Biotechnologies, ~~(“LFB”),~~ and South Korea and Southeast Asia which 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-mediated cytotoxicity ~~(“ADCC”)~~(ADCC), complement dependent cytotoxicity ~~(“CDC”)~~(CDC), and direct or programmed cell death ~~(“DCD”~~(DCD or ~~“PCD”)~~PCD). ~~TG-1101~~Ublituximab has been specifically glycoengineered to enhance ADCC activity, which should enhance its ability to deplete B-cells and may improve its anti-cancer effects when compared to ~~Rituxan®,~~rituximab the leading anti-CD20 monoclonal antibody, which had worldwide sales in ~~2016~~2018 of ~~more than~~approximately $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~~ ~~was evaluated in relapsed or refractory CLL. Subsequently, a single-agent Phase I study was undertaken in the US enrolling patients with both NHL and CLL.~~ ~~In both studies, single agent therapy with TG-1101 was deemed well tolerated by treating investigators and displayed promising clinical activity in relapsed and refractory patients.~~

In oncology settings, anti-CD20 therapy is generally used in combination with other anti-cancer agents where it demonstrates maximum activity as opposed to single agent usage. As a result, subsequent clinical development for TG-1101 has focused on combination therapy. Currently, our priority combination trials for TG-1101 are:

●

~~The GENUINE Trial – a randomized controlled Phase 3 trial evaluating TG-1101 in combination with ibrutinib, for previously treated CLL patients with high risk cytogenetics;~~

●

The UNITY-CLL Trial – a randomized controlled Phase 3 trial under Special Protocol Assessment (SPA) evaluating TG-1101 in combination with TGR-1202, the Company’s development stage PI3K delta inhibitor, for patients with front line and previously treated CLL;

●

The UNITY-NHL Trial – registration-directed Phase 2b clinical study evaluating TGR-1202 alone and in combination with TG-1101 with or without bendamustine, in patients with previously treated Non-Hodgkin’s Lymphoma (NHL); and

●

~~TG-1101 + TGR-1202 + Pembrolizumab for patients with CLL.~~

In non-oncology settings, anti-CD20 therapy has generally been used as monotherapy. In addition to the above oncology studies, TG-1101 is being evaluated in 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. On August 1, 2017, we announced we had reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of two global Phase 3 clinical trials for TG-1101, referred to as the ULTIMATE I and ULTIMATE II Phase 3 clinical trials~~, both of which are currently open to enrollment~~.

~~Manufacturing of TG-1101 is currently performed by~~ ~~a contract manufacturer based in the US and~~ ~~our partner, LFB Biotechnologies.~~

~~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 clinical studies. 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 FccR receptors on immune system effector cells, most notably the ~~FccRIIIA~~Fc−gammaR (CD16) receptor found on NK cells. These interactions trigger cells to release cytotoxic molecules and proteases resulting in B-cell death. ~~TG-1101~~Ublituximab is a ~~third~~next generation, type I chimeric IgG1 monoclonal antibody with a glycoengineered Fc region designed specifically to induce higher ADCC activity in comparison to rituximab. In pre-clinical (non-human) experiments, ublituximab has demonstrated an ability to enhance ADCC by >50x over rituximab, ~~which has been demonstrated~~resulting in ~~pre-clinical models.~~enhanced potency.

Umbralisib Overview

Umbralisib (also referred to as TGR-1202) is an oral, once daily inhibitor of PI3K delta inhibitor with nanomolar potency to the delta isoform and high selectivity over the alpha, beta, and gamma isoforms. Umbralisib also uniquely inhibits CK1-epsilon, which may allow it to overcome certain tolerability issues associated with first generation PI3K-delta inhibitors. Umbralisib has demonstrated activity in preclinical models of hematologic malignancies and in vitro on primary cells from patients with hematologic malignancies. The phosphoinositide-3-kinases (“PI3Ks”) are a family of enzymes involved in various cellular functions, including cell proliferation and survival, cell differentiation, intracellular trafficking, and immunity. There are four isoforms of PI3K (alpha, beta, delta, and gamma), of which the delta isoform is strongly expressed in cells of hematopoietic origin, and often implicated in B-cell related lymphomas.

Additionally, in October 2016, a manuscript titled, "Silencing c-Myc Translation as a Therapeutic Strategy through Targeting PI3K Delta and CK1 Epsilon in Hematological Malignancies," was published online in the First Edition section of Blood, the Journal of the American Society of Hematology. The publication presents preclinical data describing the synergy of umbralisib with the proteasome inhibitor carfilzomib and the unique effects of the combination to silence c-Myc in various preclinical lymphoma and myeloma models. Importantly, the manuscript for the first time reports on umbralisib’s unique complimentary mechanism of inhibiting the protein kinase casein kinase-1 epsilon (CK1e), which may contribute to what we believe is a differentiated safety profile of umbralisib over first generation PI3K delta inhibitors by supporting T regulatory cells, a part of the immune system necessary to protect against autoimmune mediated toxicities.

Early Clinical ~~Data Overview~~Development of Ublituximab and ~~Recent Developments~~

*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 of development. In the cases where the requirements for clinical trials and development programs have not been fully defined, or are dependent on the success of other trials, 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 therefore direct 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 to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our product candidates, proprietary information and proprietary technology 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 other contractors. This knowledge, trade secrets, proprietary information and experience we call “know-how.” To help protect our proprietary know-how which is not patentable, and for inventions for which patents 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 from unauthorized use by third parties only to the extent that our proprietary rights are covered by valid and enforceable patents, supported by regulatory exclusivity or are effectively maintained as trade secrets. We have a number of patents and patent applications related to our compounds and other technology, but we cannot guarantee 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 patent applications 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 or patent 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 patent applications or that we were the first to file those patent applications. The patent positions of biotechnology and pharmaceutical companies are highly uncertain and involve complex legal and factual questions. Therefore, we cannot predict the breadth of claims allowed in biotechnology and pharmaceutical patents, or their enforceability. To date, there has been no consistent policy regarding the breadth of claims allowed in biotechnology patents. Third parties or competitors may challenge or circumvent our patents or patent applications, if issued. If our competitors prepare and file patent applications in the U.S. that claim technology also claimed by us, we may have to participate in interference proceedings declared by the U.S. Patent and Trademark Office to determine priority of invention, which could result in substantial cost, even if the eventual outcome is favorable to us. Because of the extensive time required for development, testing and regulatory review 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 short period following commercialization, thus reducing any advantage of the patent. However, the life of a patent covering a product that has been subject to regulatory approval may have the ability to be extended through the patent restoration program, although any such extension could still be minimal.

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 and enforceable, 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 party claim, 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 such third 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 to commercialize our products may seriously harm our business. We also may need to commence litigation to enforce any patents issued to us or to determine the scope and validity of third-party proprietary rights. Litigation would involve substantial costs.

~~TG-1101~~We file patent applications directed to our drug candidates in an effort to establish intellectual property positions regarding these new chemical entities as well as uses of these new chemical entities in the treatment of diseases. We also file patent applications directed to novel combinations of our drugs together and with drugs developed by others. The intellectual property portfolios for our most advanced drug candidates as of February 28, 2018 are summarized below. Each of these portfolios contain pending patent applications covering our drug candidates and uses and combinations of the drug candidates, prosecution has just begun or is in progress. Prosecution is a lengthy process, during which the scope of the claims initially submitted for examination by the USPTO often significantly narrowed by the time they issue, if they issue at all. We expect this to be the case with respect to our pending patent applications referred to below.

Additionally, 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 these patents following regulatory approval could be minimal.

Ublituximab

Pursuant to our license for ~~TG-1101 (ublituximab)~~ublituximab with LFB Biotechnologies, GTC Biotherapeutics, and LFB/GTC LLC, we have the exclusive commercial 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 to additional background patent rights. These patents and patent protections include composition of matter patents relating to the structure and mechanism of action for ~~TG-1101~~ublituximab as well as method of use patents which cover use of ~~TG-1101~~ublituximab in combination with various agents and for various therapeutic indications.

The composition of matter patent for ~~TG-1101~~ublituximab has been issued in the ~~United States~~U.S. and Europe, which affords patent protection until 2029 in the USU.S. and 2025 in Europe, exclusive of patent term extensions. We also have a method of use patent on the combination of ~~TGR-1202~~umbralisib and ~~TG-1101~~ublituximab which has been issued in the ~~United States~~U.S., EU, and Japan, and is pending in other territories globally. Additionally, we have numerous granted patents and ~~pedning~~pending patent applications outside the USU.S. which include claims directed to the composition of matter and methods of treatment with ~~TG-1101~~ublituximab in various settings.

~~TGR-1202~~Umbralisib

Pursuant to our license for ~~TGR-1202~~umbralisib with Rhizen, we have the exclusive commercial rights to a series of patent applications in the U.S. and abroad. The patent applications include composition of matter patents relating to the structure, mechanism of action, and formulation for ~~TGR-1202~~umbralisib as well as method of use patents which cover use of ~~TGR-1202~~umbralisib in combination with various agents and for various therapeutic indications. Our composition of matter patent for ~~TGR-1202~~umbralisib has been issued in the ~~United States~~U.S. and Europe, which affords patent protection until 2033, exclusive of patent term extensions. We also have a method of use patent on the combination of ~~TGR-1202~~umbralisib and ~~TG-1101~~ublituximab which has been issued in the ~~United States~~U.S., EU, and Japan, and is pending in other territories globally. All other patent applications currently filed for ~~TG-1202~~umbralisib are currently pending. Because the dates for any potential regulatory approval are currently unknown we cannot predict the expected expiration date, and it 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 of matter 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 these patents following regulatory approval could be minimal.

~~PD-L1 and GITR~~TG-1501 (anti-PDL1 monoclonal antibody)

Pursuant to our Global Collaboration with Checkpoint Therapeutics, we have the ~~intellectual property includes issued patents~~exclusive commercial rights in the treatment of hematological cancers and autoimmune diseases to a ~~number~~series of ~~countries, including the United States and Europe, as well as pending patent applications in several countries elsewhere. The PD-L1 segment of the portfolio includes~~ patent applications pending in 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, which are 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 (WO 2016/157221) and September 2016, respectively, claiming the benefit of two earlier-filed Indian provisional applications. Any patents maturing from this patent estate are expected to expire no sooner than March 2036.

~~BTK~~TG-1701 (BTK inhibitor)

Pursuant to our ~~BTK Agreement~~license agreement with Jiangsu Hengrui, we have the exclusive commercial rights to a patent family which covers the composition of matter and proposed methods of use for various therapeutic indications. All patent applications currently filed for the BTK program are currently pending. ~~Because~~Any patents maturing from these pending applications will expire no sooner than October 2034.

TG-1801 (anti-CD47/anti-CD19 bispecific antibody)

Pursuant to our joint venture and license option agreement with Novimmune, we have the ~~date for any potential regulatory approval is~~exclusive commercial rights to a series of global patent applications, all of which are currently ~~unknown we cannot predict the expected expiration date,~~pending. Any patents maturing from these pending applications will expire no sooner than December 2032.

Limitations on Patent Rights and ~~it is possible that the life of these patents following regulatory approval could be minimal~~.Trade Secrets

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 parties from competing against us if we obtain regulatory approval to market these product candidates. See “Item 1A – Risk Factors -- Risks Related to the Company’s Intellectual Property.” In addition, the limited patent protection may adversely affect the value of our product candidates and may inhibit our ability to obtain a corporate partner at terms acceptable to us, if at all.

Proof of direct infringement by a competitor for method of use patents can prove difficult because the competitors making and marketing a product typically 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 can also prove difficult because an off-label use of a product could prohibit a finding of contributory infringement and inducement of infringement requires proof of intent 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, or off-label indications, that are covered by the applicable patents. Although such off-label prescriptions may directly infringe or contribute to or induce infringement of 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~~while we have and plan to continue to enter into confidentiality agreements designed to protect our ~~product candidates and may inhibit our ability to obtain a corporate 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. To maintain the confidentiality of trade secrets and proprietary information, we require our employees, scientific advisors, consultants and collaborators, upon commencement of a relationship with us, to execute confidentiality agreements and, in the case of parties other than our research and development collaborators, to agree to assign their inventions to us. These agreements are designed to protect our proprietary information and to grant us ownership of ~~technologies~~inventions that are developed by individuals in connection with their relationship with ~~us. These~~us, these agreements may not, however, provide protection for our trade secrets, know-how and proprietary information in the event of unauthorized disclosure of such information.

Orphan Drug Designation

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, or FDCA, to provide market exclusivity for certain of our drug candidates. Orphan drug regulations provide incentives to pharmaceutical and biotechnology companies 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 these provisions, 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 be granted a seven-year period of marketing exclusivity for such FDA-approved orphan product.

Pursuant to these regulations, ~~TG-1101 (ublituximab)~~ublituximab has received ~~Orphan-Drug designation~~Orphan Drug Designation from the FDA for the treatment of ~~Marginal Zone Lymphoma~~MZL (Nodal and Extranodal) in September 2013, for the treatment of CLL in August of 2010, and ~~Orphan-Drug designation~~Orphan Drug Designation by the European Medicines Agency (“EMA”) for the treatment of CLL in November of 2009.

We also obtained Orphan Drug ~~designation~~Designation for ~~TGR-1202~~umbralisib as monotherapy for the treatment of CLL in August 2016, and in January 2017, we announced that the FDA granted Orphan Drug ~~designation~~Designation covering the combination of ~~TG-1101~~ublituximab and ~~TGR-1202~~umbralisib for the treatment of patients with CLL and DLBCL. We believe that ~~TG-1101~~ ublituximab and ~~TGR-1202,~~umbralisib, as well as our other pipeline productsmay be eligible for additional Orphan Drug ~~designations;~~Designations; however, we cannot assure you that ~~TG-1101, TGR-1202,~~ublituximab, umbralisib, or any other drug candidates we may acquire or in-license, will obtain such ~~orphan~~Orphan Drug Designations or that we will be the first to receive FDA approval for any drug ~~designations. Additionally,~~candidates that do obtain Orphan Drug Designation so as to be eligible for market exclusivity protection.

U.S. Patent Term Restoration and Marketing Exclusivity

Depending upon the timing, duration and specifics of the FDA approval of our drug candidates, some of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of an NDA plus the time between the submission date of an NDA and the approval of that application. Only one patent applicable to an approved drug is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, we intend to apply for restoration of patent term for one of our currently owned or licensed patents to add patent life beyond its current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant NDA.

Marketing exclusivity provisions under the FDCA can also delay the submission or the approval of certain marketing applications. The FDCA provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to obtain approval of an NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept for review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA submitted by another company for another drug based on the same active moiety, regardless of whether the drug is intended for the same indication as the original innovator drug or for another indication, where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement to one of the patents listed with the FDA by the innovator NDA holder. The FDCA also provides three years of marketing exclusivity for an NDA, or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the modification for which the drug received approval on the basis of the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs containing the active agent for the original indication or condition of use. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA. However, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all of the pre-clinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness. Orphan drug exclusivity, as described below, may offer a seven-year period of marketing exclusivity, except in certain circumstances. Pediatric exclusivity is another type of regulatory market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric trial in accordance with an FDA-issued “Written Request” for such a trial.

Upon FDA approval, we believe that ~~TG-1101~~ublituximab and ~~TGR-1202~~umbralisib each would qualify as a New Chemical Entity, or NCE, which provides for five years of exclusivity following ~~approval.~~approval as discussed above.

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 to receive 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 strategic alliances are discussed below.

~~TG-1101~~Ublituximab

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-owned subsidiaries of LFB Group, relating to the development of ~~TG-1101.~~ublituximab. Under the license agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ~~TG-1101 (ublituximab).~~ublituximab. To date, we have made no payments to LFB Group ~~and~~under the license agreement, excluding an upfront equity payment. LFB Group is eligible to receive payments of up to an aggregate of approximately $31.0 million upon our successful achievement of certain clinical development, regulatory and sales milestones, in addition to royalty payments on net sales of ~~TG-1101~~ublituximab at a royalty rate that escalates from mid-single digits to high-single digits. The license will terminate 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 the agreement, or (iii) by either party in the event of the insolvency of the other party.

Ildong Pharmaceutical Co. Ltd.

In November 2012, we entered into an exclusive (within the territory) sublicense agreement with Ildong relating to the development and commercialization of ~~TG-1101~~ublituximab in South Korea and Southeast Asia. Under the terms of the sublicense agreement, Ildong has been granted a royalty bearing, exclusive right, including the right to grant sublicenses, to develop and commercialize ~~TG-1101~~ublituximab 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 based~~sales-based milestone payments up to an aggregate of $5 million and royalty payments on net sales of ~~TG-1101~~ublituximab at a royalty rate that escalates from mid-teens to high-teens upon 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 or 15 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 the licensed 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~~Umbralisib

In September 2014, we exercised our option to license the global rights to ~~TGR-1202,~~umbralisib, thereby entering into an exclusive licensing agreement (the ~~“TGR-1202~~“Umbralisib License”) with Rhizen Pharmaceuticals, S A (“Rhizen”) for the development and commercialization of ~~TGR-1202.~~umbralisib. Prior to this, we had been jointly developing ~~TGR-1202~~umbralisib in a 50:50 joint venture with Rhizen.

Under the terms of the ~~TGR-1202~~Umbralisib License, Rhizen received a $4.0 million cash payment and 371,530 shares of our common stock as an upfront license fee. With respect to ~~TGR-1202,~~umbralisib, Rhizen will be eligible to receive regulatory filing, approval and sales based milestone payments in the aggregate of approximately $175 million, a small portion of which will be payable on the first New Drug Application (NDA) filing and the remainder on approval in multiple jurisdictions for up to two oncology indications and one non-oncology indication and attaining certain sales milestones. In addition, if ~~TGR-1202~~umbralisib is co-formulated with another drug to create a new product (a "New Product"), Rhizen will be eligible to receive similar regulatory approval and ~~sales based~~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~~umbralisib and any New Product. In lieu of sales milestones and royalties on net sales, Rhizen shall also be eligible to participate in sublicensing revenue, if any, based on a percentage that decreases as a function of the number of patients treated in clinical trials following the exercise of the license option. Rhizen will retain global manufacturing rights to ~~TGR-1202,~~umbralisib, provided that they are price competitive with alternative manufacturers. The license will terminate on a country by country basis upon the expiration of 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 party due to a breach of the agreement.

TG-1501 (anti-PD-L1 monoclonal antibody)

In March 2015, we entered into a Global Collaboration (the “Collaboration”) with Checkpoint Therapeutics, Inc. (“Checkpoint”) for the development and commercialization of Checkpoint’s anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies with an option to acquire rights in autoimmune diseases. These antibodies were generated at Dana-Farber Cancer Institute (Dana-Farber). 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 an aggregate of $164 million, and will pay a tiered single digit royalty on net sales. The royalty term will terminate on a country by country basis upon the later of (i) ten years after the first commercial sale of any applicable licensed product in such country, or (ii) the expiration of the last-to-expire patent held by Dana Farber containing a valid claim to any licensed product in such country. We are currently renegotiating certain terms of the Collaboration agreement with Checkpoint and may incur additional upfront payments when a definitive agreement is reached.

TG-1701 (BTK inhibitor)

In January 2018, we entered into a global exclusive license agreement with Jiangsu Hengrui Medicine Co., (Hengrui), to acquire worldwide intellectual property rights, excluding Asia but including Japan, and for the research, development, manufacturing, and commercialization of products containing or comprising of any of Hengrui’s Bruton’s Tyrosine Kinase inhibitors containing the compounds of either TG-1701 (SHR-1459 or EBI-1459) or TG-1702 (SHR-1266 or EBI-1266) for hematologic malignancies. Pursuant to the agreement, we paid Hengrui an upfront fee of $1.0 million in our common stock. Hengrui is eligible to receive milestone payments totaling approximately $350 million upon and subject to the achievement of certain milestones. Various provisions allow for payments in conjunction with the agreement to be made in cash or our common stock, while others limit the form of payment. Royalty payments in the low double digits are due on net sales of licensed products and revenue from sublicenses. Additionally, before we can license, sell, develop, or commercialize ublituximab within China, we must notify Hengrui, giving Hengrui the right of first offer. The agreement allows combinations of TG-1701 or TG-1702 with umbralisib, ublituximab, or U2. Additional combinations may be undertaken under the agreement subject to additional pre-specified payments to Hengrui.

The term of the agreement expires after the expiration of the last royalty term to expire with respect to any of the patent rights under the agreement. We or Hengrui may terminate the agreement upon notice to the other upon breach without remedy or upon insolvency. In addition, either party may terminate the agreement upon a material breach, after providing the other party with adequate notice and allowing 45 days to cure.

TG-1801 (anti-CD47/anti-CD19 bispecific antibody)

In June 2018, we entered into a Joint Venture and License Option Agreement with Novimmune SA (Novimmune) to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701). The companies will jointly develop the product on a worldwide basis, focusing on indications in the area of hematologic B-cell malignancies. We serve as the primary responsible party for the development, manufacturing and commercialization of the product. Pursuant to the agreement, in June 2018 we paid Novimmune an upfront payment of $3.0 million in our common stock. Further milestone payments will be paid based on early clinical development, and the Company will be responsible for the costs of clinical development of the product through the end of the Phase 2 clinical trials, after which the Company and Novimmune will be jointly responsible for all development and commercialization costs. The Company and Novimmune will each maintain an exclusive option, exercisable at specific times during development, for the Company to license the rights to TG-1801, in which case Novimmune is eligible to receive additional milestone payments totaling approximately $185 million as well as tiered royalties on net sales in the high single to low double digits upon and subject to the achievement of certain milestones.

IRAK4

In June 2014, we entered into an exclusive licensing agreement with Ligand Pharmaceuticals Incorporated ~~("Ligand")~~(Ligand) for the development and commercialization of Ligand's interleukin-1 receptor associated kinase-4 ~~("IRAK4")~~(IRAK4) inhibitor technology, which currently is in preclinical development for potential use against certain cancers and autoimmune diseases. IRAK4 is a serine/threonine protein kinase that is a key downstream signaling component of the interleukin-1 receptor and multiple toll-like receptors.

Under the terms of the license agreement, Ligand received 125,000 shares of our common stock as an upfront license fee. Ligand will also be eligible to receive maximum potential milestone payments of approximately $207 million upon the achievement of specific clinical, regulatory and commercial milestone events. Additionally, Ligand will be entitled to royalties on our future net sales of licensed products containing IRAK4 inhibitors. The basic royalty rate for licensed products covered by Ligand's issued patents will be 6% for annual sales of up to $1 billion and 9.5% for annual sales in excess of that threshold. The license will terminate 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 for the development and commercialization of Checkpoint’s anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies.

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 an aggregate of $164 million, and will pay a tiered single digit royalty on net sales. The royalty term will terminate on a country by country basis upon the later of (i) ten years after the first commercial sale of any applicable licensed product in such country, or (ii) the expiration of the last-to-expire patent held by Dana Farber containing a valid claim to any licensed product in such country.

~~BET~~TG-1601 (BET inhibitor)

In May 2016, as part of a broader agreement with Jubilant Biosys ~~(“Jubilant”)~~(Jubilant), an India-based biotechnology company, we entered into a sub-license agreement ~~(“JBET Agreement”)~~(JBET Agreement) with Checkpoint for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological 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 certain preclinical, clinical, and regulatory milestones, including commercial milestones totaling up to approximately $177 million and a single-digit royalty on net sales. TG will also provide funding to support certain targeted research efforts at Jubilant.

~~BTK~~

~~In January 2018, we entered into a global exclusive license agreement with Jiangsu Hengrui Medicine Co., or Jiangsu, to acquire worldwide intellectual property rights, excluding Asia but including Japan,~~ and for the research, development, manufacturing, and commercialization of products containing or comprising of any of Jiangsu’s Bruton’s Tyrosine Kinase inhibitors containing the compounds of either TG-1701 (SHR-1459 or EBI-1459) or TG-1702 (SHR-1266 or EBI-1266). Pursuant to the agreement, we paid Jiangsu an upfront fee of $1.0 million in our common stock. Jiangsu is eligible to receive milestone payments totaling approximately $350 million upon and subject to the achievement of certain milestones. Various provisions allow for payments in conjunction with the agreement to be made in cash or our common stock, while others limit the form of payment. Royalty payments in the low double digits are due on net sales of licensed products and revenue from sublicenses. Additionally, before we can license, sell, develop, or commercialize ublituximab (TG-1101) within China, we must notify Jiangsu, giving Jiangsu the right of first offer.

The term of the agreement expires after the expiration of the last royalty term to expire with respect to any of the patent rights under the agreement. We or Jiangsu may terminate the agreement upon notice to the other upon breach without remedy or upon insolvency. In addition, either party may terminate the agreement upon a material breach, after providing the other party with adequate notice and allowing 45 days to cure.

COMPETITION

Competition in the pharmaceutical and biotechnology industries is intense. Our competitors include pharmaceutical companies and biotechnology companies, as well as universities and public and private research institutions. In addition, companies that are active in different but related fields represent substantial competition for us. Many of our competitors have significantly greater capital resources, larger research and development staffs and facilities and greater experience 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 must identify 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 the development of pharmaceuticals that target the same diseases and conditions that we are targeting. Other companies have products or drug candidates in various stages of pre-clinical or clinical development to treat diseases for which we are also seeking to discover and develop drug candidates. Some of these potential competing drugs are further advanced in development than our drug candidates and may be commercialized earlier. The resulting changes in standard of care can impact the likelihood of regulatory accelerated approval opportunities for our drug candidates.

IfFor the cancer indications for which we are developing our products there are a number of established therapies with which we will compete:

●

For the treatment of Chronic Lymphocytic Leukemia, if U2 is approved, we expect ~~TG-1101~~U2 to compete ~~directly~~ with ~~Roche Group’s Rituxan® (rituximab)~~recently approved drugs such as ibrutinib (AbbVie and ~~Gazyva® (obinutuzumab or GA-101)~~Janssen), venetoclax (AbbVie and Roche), obinutuzumab (Roche), idelalisib (Gilead) and duvelisib (Verastem), and ~~Novartis’ Arzerra® (ofatumumab) among others, each~~established treatments such as rituximab (Roche), and several generically available chemotherapies. Additionally, there are two second generation BTK inhibitors similar to ibrutinib in late-stage clinical testing for CLL that could enter the market in the next 12-36 months. Each of ~~which is currently approved for~~these agents can be used as monotherapy or in combination with one or more of the other agents.

●

For the treatment of ~~various diseases including NHL~~Marginal Zone Lymphoma, if approved, we expect umbralisib to compete with ibrutinib (AbbVie and ~~CLL.~~ Janssen) and established treatments such as rituximab and several generically available chemotherapies. Additionally, the combination of rituximab and lenalidomide (Celgene) has been studied in MZL and may be approved.

●

For the treatment of Follicular Lymphoma, if approved, we expect umbralisib to compete with recently approved drugs such as obinutuzumab (Roche), idelalisib (Gilead), copanlisib (Bayer), and duvelisib (Verastem), and established treatments such as rituximab (Roche), and several generically available chemotherapies. Each of these agents can be used as monotherapy or in combination with one or more of the other agents. The combination of rituximab and lenalidomide (Celgene) has also been studied in FL and may be approved. There are also several PI3K delta inhibitors in earlier stages of development.

●

In addition, a number of pharmaceutical companies are developing antibodies and bispecific antibodies targeting CD20, CD19, CD47 and other B-cell associated targets, chimeric antigen receptor T-cell ~~(CAR-T)~~(“CAR-T”) immunotherapy, and other B-cell ablative therapy which, if approved, would potentially compete with ~~TG-1101 both~~U2 and umbralisib.

For Multiple Sclerosis for which we are developing ublituximab there are a number of established therapies with which we will compete:

●

If ublituximab is approved, we expect ublituximab will primarily compete against other CD20 targeted agents, while the group of CD20 targeted agents will also compete broadly against a number of already approved MS therapies. Currently, there is one anti-CD20 monoclonal antibody approved, ocrelizumab (Roche), and another in ~~oncology settings as well as in autoimmune disorders. Earlier this year,~~Phase 3 development, ofatumumab (Novartis), which is expected to enter the Roche Group’s anti-CD20 antibody ocrelizumab was approved for the treatment of MS. Genmab and GSK’s (ofatumumab) is also under clinical development for patients with MS. New developments, including the development of other pharmaceutical technologies and methods of treating disease, occurmarket in the ~~pharmaceutical and life sciences industries at a rapid pace.~~ next 12-24 months.

~~With respect to TGR-1202, there are several PI3K delta targeted compounds both approved, such as Gilead’s Zydelig~~® ~~(idelalisib)~~TG-1501, TG-1701 and ~~Bayer’s Aliqopa™ (copanlisib), and in development, including, but not limited to, Verastem’s duvelisib which~~TG-1801 if approved ~~we would expect to compete directly with TGR-1202. In addition, there are numerous other novel therapies targeting similar pathways to TGR-1202 both approved~~will also face competition from drugs on the market and inunder development ~~which could also compete with TGR-1202 in similar indications, such~~that have the same mechanism of action as the BTK inhibitor, ibrutinib (FDA approved for MCL, CLL, Marginal Zone Lymphoma and WM and marketed by AbbVie and Janssen), the BTK inhibitor acalabrutinib (FDA approved for MCL and marketed by AstraZeneca), or the BCL-2 inhibitor venetoclax (FDA approved for CLL and marketed by AbbVie and Roche).each of those drugs.

Additional information can be found under Item “1A - Risk Factors – Other Risks Related to Our Business” within this report.

SUPPLY AND MANUFACTURING

We have limited experience in manufacturing products for clinical or commercial purposes. We currently do not have any manufacturing ~~capabilities.~~capabilities of our own. We have established contract manufacturing relationships for the supply of ~~TG-1101 as part of our license agreement with LFB Biotechnologies and also with a U.S. based contract manufacturer.~~ublituximab. We have also established contract manufacturing relationships for the supply of ~~TGR-1202~~umbralisib as part of our licensing agreement with Rhizen. As with any supply program, obtaining pre-clinical and clinical materials of sufficient quality and quantity 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~~move closer to commercialization for ublituximab and umbralisib we will need to scale-up production to ensure adequate commercial supply, complete validation batches and complete pre-approval inspection batches. We are currently in the process of ~~development. There~~scaling up ublituximab and completing validation and pre-approval inspection batches for both ublituximab and umbralisib. This is an expensive process which will require significant investment on our part over the next 24 months and there can be no assurance given that such scale-up and process validation will be successful in providing pharmaceutical product that is of sufficient quantity, or of a quality that is consistent with our previously established specifications, or that meets the requirements set by regulatory agencies under which we may seek approval of our product candidates.

Process improvements are common during clinical development to accommodate raw material and component variability, enhance productivity and/or accommodate different or larger equipment utilized during the scale-up process required for commercial manufacture. These types of incremental process changes have been made during clinical development for both TG’s small and large molecule programs. For example, our UNITY-CLL Phase 3 clinical trial contains ublituximab produced from both a pre-commercial process and the current commercial process. While there are some analytical differences between the two materials, we do not expect those differences to have an effect on the clinical performance of ublituximab. The primary difference is that the commercial process has resulted in further enhancement to the ADCC effect, potentially enhancing potency. We will analyze the Phase 3 data to ensure that the materials are substantially similar in performance. If there are material differences in safety or efficacy, we may need to adjust our statistical analysis of the Phase 3 study, which could impact the approvability of the U2 combination in CLL.

At the time of commercial sale, to the extent possible and commercially practicable, we would seek to engage a back-up ~~supplier~~suppliers for raw materials, manufacturing and testing services for each of our product candidates. Until such time, we expect that we will rely on a single contract manufacturer to produce each of our product candidates under current Good Manufacturing Practice, or cGMP, regulations. Our third-party manufacturers have a limited number of facilities in which our product candidates can be produced and will have limited experience in manufacturing our product candidates in quantities sufficient for commercialization. Our third-party manufacturers will have other 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 would be 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 be no 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 and corresponding state agencies to ensure strict compliance with cGMP and other state and federal regulations. Our contractors outside of the United States face similar challenges from the numerous local and regional agencies and authorized bodies. We do not have control over third-party manufacturers’ compliance with these 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 new manufacturers in advance, which will involve testing and additional inspections to ensure compliance with FDA regulations and standards and may require significant lead times and delay. Furthermore, switching manufacturers may be difficult because the number of potential manufacturers is limited. It may be difficult 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 the clinical development, manufacture and marketing of our drug candidates, as well as our ongoing research and development activities. None of our drug candidates have 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.

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-license agreement (“JBET Agreement”) with Checkpoint Therapeutics, Inc. (“Checkpoint”) (see Note 9), for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies.

~~TG Therapeutics, Inc. and Subsidiaries~~

~~Notes to Consolidated Financial Statements~~

~~Anti-PD-L1 and anti-GITR~~

On March 3, 2015, we entered into a Global Collaboration Agreement (the “Collaboration”) with Checkpoint, a subsidiary of Fortress Biotech, Inc. (“FBIO”), a related party, for the development and commercialization of Checkpoint’s anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies. Checkpoint retains the rights to develop and commercialize these antibodies in solid tumors.

Under the terms of the Collaboration, we made an up-front payment of $0.5 million, will make development and sales-based milestone payments up to an aggregate of $164 million, and will pay a tiered single digit royalty on net sales. The royalty term will terminate on a country by country basis upon the later of (i) ten years after the first commercial sale of any applicable licensed product in such country, or (ii) the expiration of the last-to-expire patent held by the Dana Farber Cancer Institute containing a valid claim to any licensed product in such country.

~~Michael Weiss, our Executive Chairman, CEO and President is also the Executive Vice Chairman of FBIO and the Executive Chairman of Checkpoint (see Note 9).~~

TGR-1202 (Umbralisib)

On September 22, 2014, we exercised our option to license the global rights to ~~TGR-1202,~~umbralisib, thereby entering into an exclusive licensing agreement (the “TGR-1202 License”) with Rhizen Pharmaceuticals, SA (“Rhizen”) for the development and commercialization of ~~TGR-1202.~~umbralisib. Prior to this, we had been jointly developing ~~TGR-1202~~umbralisib in a 50:50 joint venture with Rhizen.

Under the terms of the TGR-1202 License, Rhizen received a $4.0 million cash payment and 371,530 shares of our common stock as an upfront license fee. With respect to ~~TGR-1202,~~umbralisib, Rhizen will be eligible to receive regulatory filing, approval and sales-based milestone payments in the aggregate of approximately $175 million, a small portion of which will be payable on the first New Drug Application (NDA) filing and the remainder on approval in multiple jurisdictions for up to two oncology indications and one non-oncology indication and attaining certain sales milestones. In addition, if ~~TGR-1202~~umbralisib is co-formulated with another drug to create a new product (a "New Product"), Rhizen will be eligible to receive similar regulatory approval and sales-based milestone payments for such New Product. Additionally, Rhizen will be entitled to tiered royalties on our future net sales of ~~TGR-1202~~umbralisib and any New Product. In lieu of sales milestones and royalties on net sales, Rhizen shall also be eligible to participate in sublicensing revenue, if any, based on a percentage that decreases as a function of the number of patients treated in clinical trials following the exercise of the license option. Rhizen will retain global manufacturing rights to ~~TGR-1202,~~umbralisib, provided that they are price competitive with alternative manufacturers.

~~IRAK4~~

On June 23, 2014, we entered into an exclusive licensing agreement with Ligand Pharmaceuticals Incorporated ("Ligand") for the development and commercialization of Ligand's interleukin-1 receptor associated kinase-4 ("IRAK4") inhibitor technology, which currently is in preclinical development for potential use against certain cancers and autoimmune diseases. IRAK4 is a serine/threonine protein kinase that is a key downstream signaling component of the interleukin-1 receptor and multiple toll-like receptors.

~~TG Therapeutics, Inc. and Subsidiaries~~

~~Notes to Consolidated Financial Statements~~

Additionally, Opus Point Partners, LLC, who identified the opportunity and advised us on the transaction, will also be entitled to receive a 1% royalty for annual sales of up to $1 billion. Michael S. Weiss, our Executive Chairman and Chief Executive Officer, is a Managing Member of Opus Point Partners, LLC.

TG-1101 (Ublituximab)

An upfront payment of $2.0 million, which was received in December 2012, net of $0.3 million of income tax withholdings, is being recognized as license revenue on a straight-line basis over the life of the agreement, which is through the expiration of the last licensed patent right or 15 years after the first commercial sale of a product in such country, unless the agreement is earlier terminated, and represents the estimated period over which we will have certain ongoing responsibilities under the sublicense agreement. We recorded license revenue of approximately $152,000 for each of the years ended December 31, 2018, 2017 ~~2016~~ and ~~2015,~~2016, and, at December 31, 2018, 2017 ~~2016~~ and ~~2015,~~2016, have deferred revenue of approximately ~~$1,219,000, $1,371,000~~$1.1 million, $1.2 million and ~~$1,524,000,~~$1.4 million, respectively, associated with this ~~$2,000,000~~$2 million payment (approximately $152,000 of which has been classified in current liabilities at December 31, ~~2017)~~2018).

We may receive up to an additional $5.0 million in payments upon the achievement of pre-specified milestones. In addition, upon commercialization, Ildong will make royalty payments to us on net sales of ~~TG-1101~~ublituximab in the sublicense territory.

TG-1701: BTK

In January 2018, we entered into a global exclusive license agreement with Jiangsu Hengrui Medicine Co. (“Hengrui”), to acquire worldwide intellectual property rights, excluding Asia but including Japan, and for the research, development, manufacturing, and commercialization of products containing or comprising of any of Hengrui’s Bruton’s Tyrosine Kinase inhibitors containing the compounds of either TG-1701 (SHR1459 or EBI1459) or TG1702 (SHR1266 or EBI1266). Pursuant to the agreement, in April 2018, we paid Jiangsu an upfront fee of $1.0 million in our common stock recorded to non-cash stock expense associated with in-licensing agreements in our consolidated statement of operations. Jiangsu is eligible to receive milestone payments totaling approximately $350 million upon and subject to the achievement of certain milestones. Various provisions allow for payments in conjunction with the agreement to be made in cash or our common stock, while others limit the form of payment. Royalty payments in the low double digits are due on net sales of licensed products and revenue from sublicenses.

TG Therapeutics, Inc. and Subsidiaries

Notes to Consolidated Financial Statements

TG-1801: anti-CD47/anti-CD19

In June 2018, we entered into a Joint Venture and License Option Agreement with Novimmune SA (“Novimmune”) to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701). The companies will jointly develop the product on a worldwide basis, focusing on indications in the area of hematologic B-cell malignancies. We serve as the primary responsible party for the development, manufacturing and commercialization of the product. Pursuant to the agreement, in June 2018 we paid Novimmune an upfront payment of $3.0 million in our common stock recorded to non-cash stock expense associated with in-licensing agreements in our consolidated statement of operations. Further milestone payments will be paid based on early clinical development, and the Company will be responsible for the costs of clinical development of the product through the end of the Phase 2 clinical trials, after which the Company and Novimmune will be jointly responsible for all development and commercialization costs. The Company and Novimmune will each maintain an exclusive option, exercisable at specific times during development, for the Company to license the rights to TG-1801, in which case Novimmune is eligible to receive additional milestone payments totaling approximately $185 million as well as tiered royalties on net sales in the high single to low double digits upon and subject to the achievement of certain milestones.

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. In addition, ~~on November 9, 2012, we nominated Dr. Yann Echelard to our Board of Directors as LFB Group’s nominee.~~ LFB Group ~~maintains~~maintained the right to nominate a board member until such time as LFB Group owns less than 10% of the outstanding common stock.

~~In connection with the~~ As of April 2018, LFB ~~License Agreement, LFB Group maintained~~no longer has the right to ~~purchase at least $750,000 in additional~~nominate a board member as LFB’s ownership had fallen below 10% of the outstanding shares of common stock at a purchase price per share as defined in a November 2012 securities exchange agreement. Accordingly, in February 2015, LFB Group purchased 114,855 shares of our common stock at a price of $6.53 per share for net proceeds of $750,000. In May 2015, LFB Group exercised its warrant to purchase 2,500,000 shares of common stock at a purchase price of $0.001 per share.the Company’s Common Stock.

~~TG Therapeutics, Inc. and Subsidiaries~~

~~Notes 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 $0.2 million, $2.3 million ~~$8.1 million~~ and ~~$9.3~~$8.1 million in expenses for such services during the years ended December 31, 2018, 2017 ~~2016~~ and ~~2015,~~2016, respectively, which have been included in other research and development expenses in the accompanying consolidated statements of operations. ~~As of~~ ~~December 31~~, 2017, and 2016, we had zero and approximately $0.4 million, respectively, recorded in accounts payable related to the LFB License Agreement. In conjunction with the development and manufacturing services discussed above, certain agreements between us and LFB Group require payments in advance of services performed or goods delivered. Accordingly, as of December 31, 2017 and 2016, we recorded zero and approximately $1.3 million, respectively, in prepaid research and development for such advance payments.

Other Parties

In March 2014, we entered into a shared services agreement (the “Opus Shared Services Agreement”) with Opus Point Partners Management, LLC (“Opus”) in which the parties agreed to share a rented facility and costs for certain other services. Michael S. Weiss, our Executive Chairman and CEO, is a Managing Member of Opus. During the years ended ~~December 31, 2017 and 2016, we incurred expenses of zero and approximately $0.3 million, respectively, principally for rent, related to this Opus Shared Services Agreement. As of~~ ~~December 31, 2017 and 2016, we had zero accounts payable related to this Opus Shared Services Agreement. The Opus Shared Services Agreement is no longer in effect as we began occupying new space in April 2016.~~

In October 2014, we entered into an agreement (the “Office Agreement”) with FBIO to occupy approximately 45% (which shall be adjusted based on utilization as discussed below) of the 24,000 square feet of New York City office space leased by FBIO, which is now our corporate headquarters. The Office Agreement requires us to pay our respective share of the average annual rent and other costs of the 15-year lease. We approximate an average annual rental obligation of $1.1 million under the Office Agreement. We began to occupy this new space in April 2016, with rental payments beginning in the third quarter of 2016. During the years ended December 31, ~~2017~~2018 and ~~2016,~~2017, we recorded rent expense of approximately ~~$1.2~~$1.3 million and ~~$1.4~~$1.2 million, and at December 31, ~~2017,~~2018, have deferred rent of approximately ~~$1.4~~$1.5 million. Mr. Weiss, our Executive Chairman and ~~CEO,~~Chief Executive Officer, is also Executive Vice Chairman of FBIO.

During the year ended December 31, ~~2017,~~2018, we ~~agreed to pay~~paid FBIO ~~$2.8~~$0.1 million for our portion of the build-out costs (as required under the Desk Agreement), which have been allocated to us at the 45% rate mentioned above. The allocated build-out costs have been recorded in Leasehold Interest, net on the Company’s consolidated balance ~~sheet~~sheets and will be amortized over the 15-year term of the Office Agreement. After an initial commitment period of the 45% rate for a period of three (3) years, we and FBIO will determine actual office space utilization annually and if our utilization differs from the amount we have been billed, we will either receive credits or be assessed incremental utilization charges. Also in connection with this lease, in October 2014 we pledged $0.6 million to secure a line of credit as a security deposit for the Office Agreement, which has been recorded as restricted cash in the accompanying consolidated balance sheets. Additional collateral of $0.6 million was pledged in April 2018 to increase the letter of credit for the office space.

In July 2015, we entered into a Shared Services Agreement (the “Shared Services Agreement”) with FBIO to share the cost of certain services such as facilities use, personnel costs and other overhead and administrative costs. This Shared Services Agreement requires us to pay our respective share of services utilized. In connection with the Shared Services Agreement, we incurred expenses of approximately $1.6 million, $1.2 million and $0.8 million for shared services for the years ended December 31, 2018, 2017 and 2016, primarily related to shared personnel.

TG Therapeutics, Inc. and Subsidiaries

Notes to Consolidated Financial Statements

In May 2016, as part of a broader agreement with Jubilant, an India-based biotechnology company, we entered into ~~the JBET Agreement~~a sublicense agreement with Checkpoint, a subsidiary of FBIO, for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies. We paid Checkpoint an up-front licensing fee of $1.0 million in July 2016 and incurred expenses of $0.2 million in March 2017 for the first milestone achievement as part of the JBET Agreement which is recorded in other research and development in the accompanying consolidated statement of operations. As

In March 2015, we entered into a Global Collaboration Agreement (“Collaboration Agreement”) with Checkpoint for the development and commercialization of anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies. We incurred expenses of approximately $0.6 million for the year ended December 31, 2018 related mainly to manufacturing costs of PD-L1, while no costs were incurred during the years ended December 31, 2017 and ~~2016, we had approximately $0.3 million and $0.8 million, respectively,~~2016. The relevant expenses are recorded in ~~accounts payable, related mostly to~~other research and development in the ~~JBET Agreement. Mr. Weiss is also the Executive Chairman~~accompanying consolidated statement of ~~Checkpoint.~~operations.

~~TG Therapeutics, Inc. and Subsidiaries~~

~~Notes to Consolidated Financial Statements~~

NOTE 10 – COMMITMENTS AND CONTINGENCIES

As of December 31, ~~2017,~~2018, we have known contractual ~~obligations,~~obligations; commitments and contingencies of ~~approximately $15.6~~$35.4 million related to our long term liabilities and operating lease obligations.

Payment due by period (in thousands)
	Payment due by period					Total	Less than 1 year	1-3 years	3-5 years	More than 5 years
	Total	Less than 1 year	1-3 years	3-5 years	More than 5 years
Contractual obligations
ontractual obligations
Operating leases	$15,592,733	$1,081,927	$2,084,258	$2,154,566	$10,271,981	$16,996	$1,362	$2,701	$2,742	$10,191
Contract manufacturer						18,350	--	18,350	--
Total	$15,592,733	$1,081,927	$2,084,258	$2,154,566	$10,271,981	$35,346	$1,362	$21,051	$2,742	$10,191

Delaware (State or other jurisdiction of incorporation or organization)	36-3898269 (I.R.S. Employer Identification No.)

2 Gansevoort St. 9th, 9th Floor New York, New York (Address of principal executive offices)	10014 (Zip Code)

Large accelerated filer ☐ ☒	Accelerated filer ☒ ☐
Non-accelerated filer ☐ ~~(Do not check if smaller reporting company)~~	Smaller reporting company ☐

		Page

SPECIAL CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS		1

PART I
ITEM 1	Business	2
ITEM 1A	Risk Factors	24 23
ITEM 2	Properties	52 58
ITEM 3	Legal Proceedings	52 58
ITEM 4	Mine Safety Disclosures	5258

PART II

ITEM 5	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	53 58
ITEM 6	Selected Financial Data	5660
ITEM 7	Management’s Discussion and Analysis of Financial Condition and Results of Operations	5761
ITEM 7A	Quantitative and Qualitative Disclosure About Market Risk	6970
ITEM 8	Financial Statements and Supplementary Data	6970
ITEM 9	Changes in and Disagreements With Accountants on Accounting and Financial Disclosures	6970
ITEM 9A	Controls and Procedures	6970
ITEM 9B	Other Information	72

PART III

ITEM 10	Directors, Executive Officers and Corporate Governance	72
ITEM 11	Executive Compensation	72
ITEM 12	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	72
ITEM 13	Certain Relationships and Related Transactions, and Director Independence	72
ITEM 14	Principal ~~Accountant~~Accounting Fees and Services	72

PART IV

ITEM 15	Exhibits and Financial Statement Schedules	73

	TG-1101 plus Ibrutinib	Ibrutinib	P-value
Treated Population (n)	n=59	n=58
Overall Response Rate (ORR)	78%	45%	P<0.001
Complete Response (CR)	7%	0%	NS
MRD-Negative	19% (n=53) *	2% (n=53) *	P<0.01

Product ~~candidate~~Candidate		Target ~~indication~~Indication	Development ~~status~~Status	Completion of ~~phase~~ Phase		Estimated ~~cost~~Cost to ~~complete phase~~Complete Phase
~~TG-1101~~Ublituximab & ~~TGR-1202~~ Umbralisib		~~In combination in~~ CLL patients	Phase III	2018* 2019	~~Approximately $7 million~~
~~TGR-1202 +/- TG-1101~~	Approximately $5 million
Umbralisib +/-Ublituximab	~~In combination in relapsed/~~	Relapsed/refractory NHL patients	Phase IIb	2019*	~~Approximately $10 million~~
~~TG-1101~~	Approximately $5 million
Ublituximab		In ~~relapsing~~Relapsing forms of Multiple Sclerosis (RMS)	Phase III	~~2021~~ 2020	~~Approximately $50 million~~	Approximately $35 million

Fiscal Year Ended December 31, 2017	High	Low
Fourth Quarter	$12.30	$7.35
Third Quarter	$12.70	$10.00
Second Quarter	$13.85	$9.90
First Quarter	$14.45	$4.20

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

~~Equity Compensation Plan Information~~

~~Plan Category~~	~~Number of securities to be issued upon exercise of outstanding options~~	~~Weighted-average exercise price of outstanding options~~	~~Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column 1)~~

~~Equity compensation plans approved by security holders~~	--	$--	~~504,128~~
~~Equity compensation plans not approved by security holders~~	--	--	--
~~Total~~	--	$--	~~504,128~~


Plan Category	Number of securities to be issued upon exercise of outstanding options	Weighted-average exercise price of outstanding options	Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column 1)

Equity compensation plans approved by security holders	1,916,900	$6.50	3,216,213
Equity compensation plans not approved by security holders	--	--	--
Total	1,916,900	$6.50	3,216,213

(in thousands)
	Years ended December 31,					Years ended December 31,
	2017	2016	2015	2014	2013	2018	2017	2016	2015	2014

License revenue	$152,381					$152

Costs and expenses:
Research and development:
Noncash stock expense associated with in-licensing agreements	--			5,350,094	--	4,000	--			5,350
Noncash compensation	5,646,716	2,742,354	4,261,406	8,731,566	1,041,519	5,598	5,647	2,742	4,261	8,731
Other research and development	96,886,134	66,489,820	43,445,817	26,004,687	12,621,161	149,793	96,886	66,490	43,446	26,005
Total research and development	102,532,850	69,232,174	47,707,223	40,086,347	13,662,680	159,391	102,533	69,232	47,707	40,086

General and administrative:
Noncash compensation	10,298,568	4,767,645	11,435,686	12,373,726	4,161,629	7,288	10,298	4,767	11,436	12,374
Other general and administrative	6,032,714	5,121,690	4,189,488	3,413,400	2,496,461	7,873	6,033	5,122	4,189	3,413
Total general and administrative	16,331,282	9,889,335	15,625,174	15,787,126	6,658,090	15,161	16,331	9,889	15,625	15,787

Impairment of in-process research and development	--				2,797,600

Total costs and expenses	118,864,132	79,121,509	63,332,397	55,873,473	23,118,370	174,552	118,864	79,121	63,332	55,873

Operating loss	(118,711,751)	(78,969,128)	(63,180,016)	(55,721,092)	(22,965,989)	(174,400)	(118,712)	(78,969)	(63,180)	(55,721)

Other (income) expense:
Interest income	(294,478)	(323,032)	(174,653)	(55,049)	(30,822)	(857)	(295)	(323)	(174)	(55)
Other (income) expense	58,739	(393,202)	(56,717)	115,234	(2,456,957)	(61)	59	(393)	(57)	115
Total other (income) expense, net	(235,739)	(716,234)	(231,370)	60,185	(2,487,779)	(918)	(236)	(716)	(231)	60

Net loss	$(118,476,012)	$(78,252,894)	$(62,948,646)	$(55,781,277)	$(20,478,210)	$(173,482)	$(118,476)	$(78,253)	$(62,949)	$(55,781)

Basic and diluted net loss per common share	$(1.91)	$(1.60)	$(1.38)	$(1.64)	$(0.81)	$(2.30)	$(1.91)	$(1.60)	$(1.38)	$(1.64)

	December 31,
(in thousands)	2018	2017	2016	2015	2014
Cash, cash equivalents, investment securities and interest receivable	$68,901	$84,825	$44,969	$102,417	$78,861
Total assets	83,616	97,381	54,782	113,473	86,747
Accumulated deficit	(528,345)	(354,863)	(236,387)	(158,134)	(95,185)
Total equity	24,036	66,993	35,868	101,573	80,102

Contents	Page
Report of Independent Registered Public Accounting Firm	F-1

Consolidated Balance Sheets as of December 31, ~~2017~~2018 and ~~2016~~2017	F-2

Consolidated Statements of Operations for the years ended December 31, 2018, 2017 ~~2016~~ and ~~2015~~2016	F-3

Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2018, 2017 ~~2016~~ and ~~2015~~2016	F-4

Consolidated Statements of Cash Flows for the years ended December 31, 2018, 2017 ~~2016~~ and ~~2015~~2016	F-5

Notes to Consolidated Financial Statements	F-6

Exhibit
Number	Exhibit Description

3.1	Amended and Restated Certificate of Incorporation of TG Therapeutics, Inc. dated April 26, 2012 (incorporated by reference to Exhibit 3.2 to the Registrant’s Form 10-Q for the quarter ended June 30, 2012).

3.2	Certificate of Amendment to Amended and Restated Certificate of Incorporation of TG Therapeutics, Inc. dated June 9, 2014 (incorporated by reference to Exhibit 3.2 to the Registrant’s Form 10-Q for the quarter ended June 30, 2014).

3.3	Amended and Restated Bylaws of TG Therapeutics, Inc. dated July 18, 2014 (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on July 21, 2014).

4.1	Specimen common stock certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Form 10-K for the year ended December 31, 2011).

~~4.2~~	~~Form of warrant to purchase common stock of TG Therapeutics, Inc. (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on November 13, 2012).~~

~~4.3~~	~~Form of Warrant issued to stockholders (incorporated by reference to Exhibit 10.34 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011).~~

4.4	Stockholder 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).

10.1	Amended and Restated Convertible Promissory Note, dated March 1, 2011 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on March 7, 2011).

10.2	Employment Agreement, effective December 29, 2011, between the Registrant and Michael Weiss (incorporated by reference to Exhibit 10.30 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). †

10.3	Restricted Stock Subscription Agreement, effective December 29, 2011, between the Registrant and Michael Weiss (incorporated by reference to Exhibit 10.31 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). †

10.4	Amendment to Restricted Stock Agreement, dated July 12, 2013, 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 July 16, 2013). †

10.5	Amendment 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). †

10.6	Employment Agreement, effective December 29, 2011, between the Registrant and Sean Power (incorporated by reference to Exhibit 10.32 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). †

10.7	Restricted Stock Subscription Agreement, effective December 29, 2011 between the Registrant and Sean Power (incorporated by reference to Exhibit 10.33 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). †

10.8	Amendment to Restricted Stock Agreement, dated July 12, 2013, 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 July 16, 2013). †

10.9	Amendment 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). †

10.10	License Agreement, dated January 30, 2012, by and among the Registrant, GTC Biotherapeutics, Inc., LFB Biotechnologies S.A.S. and LFB/GTC LLC (incorporated by reference to Exhibit 10.35 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). *

10.11	TG Therapeutics, Inc. Amended and Restated 2012 Incentive Plan, dated May 14, 2012 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q/A for the quarter ended March 31, 2012).

10.12	First Amendment to TG Therapeutics, Inc. Amended and Restated 2012 Incentive Plan, filed with the Registrant’s Definitive Proxy Statement for the Annual Meeting of Stockholders on June 4, 2015, filed on April 24, 2015, and incorporated herein by reference.

10.13	Sublicense Agreement between TG Therapeutics, Inc. and Ildong Pharmaceutical Co. Ltd., dated November 13, 2012 (incorporated by reference to Exhibit 10.37 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2012). *

10.14	License Agreement between TG Therapeutics, Inc. and Ligand Pharmaceuticals Incorporated, dated June 23, 2014 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2014).*

10.15	Licensing Agreement between TG Therapeutics, Inc. and Rhizen Pharmaceuticals SA, dated September 22, 2014 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 20, 2015). *

10.16	Collaboration Agreement between TG Therapeutics, Inc. and Checkpoint Therapeutics, Inc., dated March 3, 2015 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended March 31, 2015). *

10.17	Sublicense Agreement between TG Therapeutics, Inc. and Checkpoint Therapeutics, Inc., dated May 27, 2016, (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2016). *

10.18	Amendment to Employment Agreement, effective January 1, 2017, between TG Therapeutics, Inc. and Michael S. Weiss (incorporated by reference to Exhibit 10.18 to the Registrant’s Form 10-K/A for the year ended December 31, 2016). †

10.19	Advisory Agreement, effective January 1, 2017, between TG Therapeutics, Inc. and Caribe BioAdvisors, LLC (incorporated by reference to Exhibit 10.19 to the Registrant’s Form 10-K/A for the year ended December 31, 2016).

10.20	License Agreement between TG Therapeutics, Inc. and Jiangsu Hengrui Medicine Co., dated January 8, 2018 (incorporated by reference to Exhibit 10.20 to the Registrant’s Form 10-K for the year ended December 31, 2017). *

10.21	Joint Venture and License Option Agreement by and between TG Therapeutics, Inc. and Novimmune S.A., dated June 18, 2018 (incorporated by reference to Exhibit 10.20 to the Registrant’s Form 10-Q for the quarter ended June 30, 2018). *

10.22	Master Services Agreement, effective February 21, 2018. # * #

21.1	Subsidiaries of TG Therapeutics, Inc.

23.1	Consent of Independent Registered Public Accounting Firm

31.1	Certification of Principal Executive Officer

31.2	Certification of Principal Financial Officer

32.1	Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2	Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101	The following financial information from TG Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, ~~2017,~~2018, 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 Financial Statements.

	2017	2016	2015
TG-1101	$62,441,133	$40,839,899	$29,816,042
TGR-1202	31,963,775	21,394,427	11,671,889
Pre-clinical assets / Other	2,481,226	4,255,494	1,957,886
Total	$96,886,134	$66,489,820	$43,445,817

(in thousands)	2018	2017	2016
Ublituximab	$105,429	$62,441	$40,840
Umbralisib	42,852	31,964	21,394
Early Clinical Pipeline & Pre-Clinical	5,512	2,481	4,256
Total	$153,793	$96,886	$66,490

	Common Stock		Contingently issuable	Additional Paid-in	Treasury Stock		Accumulated		Common Stock		Contingently issuable	Additional Paid-in	Treasury Stock		Accumulated
	Shares	Amount	Shares	Capital	Shares	Amount	Deficit	Total	Shares	Amount	Shares	Capital	Shares	Amount	Deficit	Total
Balance at January 1, 2015	44,974,248	$44,974	$6	$175,476,521	41,309	$(234,337)	$(95,185,280)	$80,101,884
Issuance of common stock in connection with exercise of warrants	2,946,703	2,946		1,064,393				1,067,339
Issuance of common stock in connection with cashless exercise of warrants	2,915	3		(3)				--
Issuance of common stock in connection with conversion of notes payable	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 related party for cash (See Note 9)	114,855	115		749,890				750,005
Issuance of common stock in At-the-Market offering (net of offering costs of $1,310,591)	4,094,498	4,094		66,894,609				66,898,703
Compensation in respect of restricted stock granted to employees, directors and consultants				15,697,092				15,697,092
Net loss							(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
Balance at January 1, 2016									54,095,110	54	6	259,887	41,309	(234)	(158,134)	101,573
Issuance of common stock in connection with exercise of warrants	273,370	273		617,969				618,242	273,370	*		618				618
Issuance of common stock in connection with conversion of notes payable	3,710	4		33,013				33,017	3,710	*		33				33
Issuance of restricted stock	1,924,639	1,925		(1,925)				--	1,924,639	2		(2)				--
Forfeiture of restricted stock	(46,773)	(47)		47				--	(46,773)	*		*				--
Issuance of common stock in At-the-Market offering (net of offering costs of $108,185)	570,366	570		4,385,566				4,386,136
Issuance of common stock in At-the-Market offering (net of offering costs of $0.1 million)									570,366	*		4,386				4,386
Compensation in respect of restricted stock granted to employees, directors and consultants				7,509,999				7,509,999				7,510				7,510
Adjustment to contingently issuable shares			(6)	6				--			(6)	*				--
Net loss							(78,252,894)								(78,253)
Balance at December 31, 2016	56,820,422	56,820	--	272,432,139	41,309	(234,337)	(236,386,820)	35,867,802	56,820,422	57	--	272,432	41,309	(234)	(236,387)	35,868
Issuance of common stock in connection with exercise of warrants	887,585	888		2,142,197				2,143,085	887,585	*		2,142				2,143
Issuance of restricted stock	1,836,511	1,837		(1,837)				--	1,836,511	2		(2)				--
Forfeiture of restricted stock	(53,875)	(54)		54				--	(53,875)			*				--
Issuance of common stock in public offering (net of offering costs of $3.6 million)	5,897,436	5,897		53,634,115				53,640,012	5,897,436	6		53,634				53,640
Issuance of common stock in At-the-Market offering (net of offering costs of $1.1 million)	7,793,671	7,794		77,865,090				77,872,884	7,793,671	8		77,865				77,873
Compensation in respect of restricted stock granted to employees, directors and consultants				15,945,284				15,945,284				15,945				15,945
Net loss							(118,476,012)								(118,476)
Balance at December 31, 2017	73,181,750	$73,182	$--	$422,017,042	41,309	$(234,337)	$(354,862,832)	$66,993,055	73,181,750	73	--	422,017	41,309	(234)	(354,863)	66,993
Issuance of restricted stock									1,562,211	2		(2)				--
Forfeiture of restricted stock									(191,196)	*		*				--
Issuance of common stock in At-the-Market offerings (net of offering costs of $2.0 million)									9,025,222	9		113,630				113,639
Compensation in respect of restricted stock granted to employees, directors and consultants												12,886				12,886
Shares issued in connection with in-licensing agreements									333,868	*		4,000				4,000
Net loss															(173,482)
Balance at December 31, 2018									83,911,855	$84	$--	$552,531	41,309	$(234)	$(528,345)	$24,036

	2017	2016	2015
CASH FLOWS FROM OPERATING ACTIVITIES

Consolidated net loss	$(118,476,012)	$(78,252,894)	$(62,948,646)
Adjustments to reconcile consolidated net loss to net cash used in operating activities:
Gain on sale of long-term securities	--	(33,042)	--
Noncash stock compensation expense	15,945,284	7,509,999	15,697,092
Depreciation and amortization	82,355	62,960	15,452
Amortization of premium on investment securities	61,320	459,429	536,142
Change in fair value of notes payable and accrued interest	58,739	(109,657)	(56,717)
Changes in assets and liabilities:
Increase in restricted cash	(4,083)	(4,065)	(4,131)
(Increase) decrease in other current assets	(2,665,222)	3,564,316	(3,105,771)
Decrease (increase) in leasehold interest	124,947	(2,042,281)	--
(Increase) decrease in accrued interest receivable	(24,616)	102,169	(100,505)
Decrease (increase) in other assets	161,730	(4,784)	(41,722)
Increase in accounts payable and accrued expenses	11,020,034	6,492,644	5,470,915
Increase in deferred rent	104,343	816,257	--
Decrease in deferred revenue	(152,381)	(152,381)	(152,381)
Net cash used in operating activities	(93,763,562)	(61,591,330)	(44,690,272)

CASH FLOWS FROM INVESTING ACTIVITIES

Purchases of equipment	(2,227)	(343,985)	(42,217)
Investment in held-to-maturity securities	(28,006,270)	(15,199,922)	(48,993,652)
Proceeds from maturity of short-term securities	19,800,000	29,500,000	24,350,000
Proceeds from the sale of long-term securities	--	12,589,219	--
Net cash (used in) provided by investing activities	(8,208,497)	26,545,312	(24,685,869)

CASH FLOWS FROM FINANCING ACTIVITIES

Proceeds from the exercise of warrants	2,143,085	618,242	1,067,339
Proceeds from sale of common stock, net	131,515,541	4,411,233	67,760,517
Deferred financing costs paid	-	(13,506)	(104,170)
Net cash provided by financing activities	133,658,626	5,015,969	68,723,686

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	31,686,567	(30,030,049)	(652,455)

Cash and cash equivalents at beginning of year	25,031,280	55,061,329	55,713,784

	December 31, 2017	December 31, 2016
(in thousands)			December 31, 2018	December 31, 2017

Checking and bank deposits	$55,681,820	$4,052,333	$39,268	$55,682
Money market funds	1,036,027	20,978,947	2,690	1,036
Total	$56,717,847	$25,031,280	$41,958	$56,718

(in thousands)	December 31, 2018
	Amortized cost, as adjusted	Gross unrealized holding gains	Gross unrealized holding losses	Estimated fair value
Short-term investments:
Obligations of domestic governmental agencies (maturing between January 2019 and November 2019) (held-to-maturity)	$26,848	$2	$10	$26,840
Total short-term investment securities	$26,848	$2	$10	$26,840

	Financial liabilities at fair value as of December 31, 2017
(in thousands)					Financial liabilities at fair value as of December 31, 2018
	Level 1	Level 2	Level 3	Total	Level 1	Level 2	Level 3	Total

5% Notes	$--		$127,614		$--		$67
Totals	$--		$127,614
Total					$--		$67

Balance at January 1, ~~2016~~2017	$~~211,549~~69
Interest accrued on face value of 5% Notes	~~886,084~~845
Conversion of 5% Notes	~~(33,017~~--)
Change in fair value of Level 3 liabilities	(~~995,741~~786)
Balance at December 31, ~~2016~~2017	~~68,875~~128
Interest accrued on face value of 5% Notes	~~844,797~~878
Conversion of 5% Notes	--
Change in fair value of Level 3 liabilities	(~~786,058~~939)
Balance at December 31, ~~2017~~2018	$~~127,614~~67

	Number of shares	Weighted- average exercise price	Weighted- average contractual term	Aggregate intrinsic value	Number of shares	Weighted- average exercise price	Weighted- average Contractual Term (in years)	Aggregate intrinsic value
			(in years)
Outstanding at January 1, 2015	194	971.70	3.50	$--
Outstanding at December 31, 2017					--			$--
Granted	--				1,916,900	6.50
Exercised	--				--
Forfeited	(152)	463.32			--
Expired	(42)	2,811.53			--
Outstanding at December 31, 2015	--			$--
Granted	--
Exercised	--
Forfeited	--
Expired	--	--
Outstanding at December 31, 2016	--			$--
Granted	--
Exercised	--
Forfeited	--
Expired	--
Outstanding at December 31, 2017	--	$--	--	$--
Outstanding at December 31, 2018					1,916,900	6.50	9.75	--

Exercisable at December 31, 2017	--	$--	--	$--
Exercisable at December 31, 2018					--			$--

	Year Ended December 31, 2018
Volatility		192.76-296.71
Expected term (in years)		5.0-6.25
Risk-free rate		2.49-2.56%
Expected dividend yield		--%

	Number of Shares	Weighted Average Grant Date Fair Value	Number of Shares	Weighted Average Grant Date Fair Value
Outstanding at January 1, 2015	6,400,001	5.86
Granted	1,992,535	12.89
Vested	(1,001,455)	5.04
Forfeited	(31,166)	16.76
Outstanding at December 31, 2015	7,359,915	7.83
Outstanding at January 1, 2016			7,359,915	$7.83
Granted	1,924,639	4.99	1,924,639	4.99
Vested	(595,726)	7.38	(595,726)	7.38
Forfeited	(46,773)	10.34	(46,773)	10.34
Outstanding at December 31, 2016	8,642,055	$7.20	8,642,055	7.20
Granted	1,836,511	6.40	1,836,511	6.40
Vested	(4,103,048)	5.24	(4,103,048)	5.24
Forfeited	(53,875)	8.47	(53,875)	8.47
Outstanding at December 31, 2017	6,321,643	$7.17	6,321,643	7.17
Granted			1,562,211	13.07
Vested			(1,596,966)	9.38
Forfeited			(191,196)	8.13
Outstanding at December 31, 2018			6,095,692	$8.07

	Warrants	Weighted- average exercise price	Aggregate intrinsic value	Warrants	Weighted- average exercise price	Aggregate intrinsic value
Outstanding at January 1, 2015	4,148,228	0.94	$61,792,184
Issued	--
Exercised	(2,950,115)	0.36
Expired	(11,364)	2.25
Outstanding at December 31, 2015	1,186,749	2.37	$11,341,452
Outstanding at January 1, 2016				1,186,749	$2.37	$11,341,452
Issued	--			--
Exercised	(273,370)	2.26		(273,370)	2.26
Expired	--	2.25		--	2.25
Outstanding at December 31, 2016	913,379	$2.41	$1,961,403	913,379	2.41	1,961,403
Issued	--			--
Exercised	(887,585)	2.41		(887,585)	2.41
Expired	(25,794)	--		(25,794)	--
Outstanding at December 31, 2017	--	$--		--	$--	$--

	December 31, 2017			December 31, 2016
	Current portion, net	Non-current portion, net	Total	Current portion, net	Non-current portion, net	Total
Convertible 5% Notes Payable	$127,614	$--	$127,614	$68,875	$--	$68,875
Totals	$127,614	$--	$127,614	$68,875	$--	$68,875

	For the year ended December 31,			For the year ended December 31,
	2017	2016	2015
(in thousands)				2018	2017	2016

Loss before income taxes, as reported in the consolidated statements of operations	$(118,476,012)	$(78,252,894)	$(62,948,646)	$(173,482)	$(118,476)	$(78,253)

Computed “expected” tax benefit	$(40,281,844)	$(26,605,984)	$(21,402,540)	$(36,431)	$(40,282)	$(26,606)

Increase (decrease) in income taxes resulting from:
Expected benefit from state and local taxes	(1,105,708)	(835,072)	(672,306)	(2,243)	(1,106)	(835)
Research and development credits	(3,697,258)	(2,364,417)	(1,603,364)	(4,726)	(3,697)	(2,364)
Other	1,563,114	(7,506)	566,310	639	1,563	(8)
Impact of change in state tax rates on deferred taxes	--		5,836,819
Stock awards	8,213,188			(473)	8,213	--
Effects of federal tax reform rate changes	51,767,584
Enactment of federal tax reform				--	51,768	--
Change in the balance of the valuation allowance for deferred tax assets	(16,459,076)	29,812,979	17,275,081	43,234	(16,459)	29,813
	$--			$--

	3 Months Ended
(in thousands)					3 Months Ended
	March 31, 2017	June 30, 2017	September 30, 2017	December 31, 2017	March 31, 2018	June 30, 2018	September 30, 2018	December 31, 2018

License revenue	$38,095		$38,096	$38,095	$38

Total costs and expenses	27,704,517	28,463,466	31,623,323	31,072,826	40,615	44,383	34,366	54,188

Net loss	$(27,727,509)	$(28,353,084)	$(31,535,652)	$(30,859,767)	$(41,529)	$(44,142)	$(33,951)	$(53,861)

Basic and diluted net loss per common share	$(0.52)	$(0.45)	$(0.48)	$(0.46)	$(0.59)		$(0.43)	$(0.68)

	TG THERAPEUTICS, INC.

Date: March ~~15, 2018~~1, 2019	By:	/s/ Michael S. Weiss
		Michael S. Weiss
		Executive Chairman, Chief Executive Officer and President

Signatures		Title
/s/ Michael S. Weiss Michael S. Weiss		Executive Chairman, Chief Executive Officer and President (principal executive officer)
/s/ Sean A. Power Sean A. Power		Chief Financial Officer (principal financial and accounting officer)
/s/ Laurence N. Charney Laurence N. Charney		Director
/s/ Yann Echelard Yann Echelard		Director
/s/ Kenneth Hoberman Kenneth Hoberman		Director
/s/ Daniel Hume Daniel Hume		Director
/s/ William J. Kennedy William J. Kennedy		Director
/s/ Mark Schoenebaum, M.D. Mark Schoenebaum, M.D.		Director