What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-02-27 compared with 2025-03-03 · 88 added, 101 removed, 401 unchanged (32% of the section changed)

TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell mediated diseases.

TG has received approval from the U.S.

Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, in adults, as well as approval by the European Commission (EC) and the Medicines and Healthcare products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom (UK), respectively.

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases.

In addition to a research pipeline, TG Therapeutics has received approval from the U.S.

Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S.

for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features.

We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.

Business Highlights

Next In MS ™ Platform Launch in Collaboration with Christina Applegate

Announced collaboration with Christina Applegate to raise awareness of multiple sclerosis (MS) via a Super Bowl LX commercial

Launched, Next In MS™, a platform designed to foster honest, real-world conversations about life with MS—featuring unfiltered dialogue, including discussions with Christina Applegate—and to support people living with MS in continuing those conversations with family, friends, and healthcare professionals on their own terms.

Commercialization of BRIUMVI

BRIUMVI is an anti-CD20 monoclonal antibody that can be administered to adults with RMS in a one-hour infusion every 24 weeks, following the starting dose.

BRIUMVI received approval by the FDA on December 28, 2022 for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, based on data from the ULTIMATE I & II Phase 3 trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (ARR, the primary endpoint), the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions.

BRIUMVI received approval by the FDA in December 2022 for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, based on data from the ULTIMATE I & II Phase 3 trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (ARR, the primary endpoint), the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions.

Results from the ULTIMATE I & II trials were published in August 2022 in The New England Journal of Medicine.

We commercially launched BRIUMVI in the U.S.

on January 26, 2023, making it available to physicians and patients.

in January 2023, making it available to physicians and patients.

In August 2023, we entered into a commercialization agreement (the Commercialization Agreement) with Neuraxpharm Pharmaceuticals, S.L.

1 unchanged sentence

commercialization of BRIUMVI.

On February 26, 2024, BRIUMVI was first made available in the European market by Neuraxpharm in Germany and is now commercially available in several other countries in the European Union and the United Kingdom.

Pipeline Expansion and Development

On January 9, 2024, we entered into an agreement with Precision BioSciences, Inc.

(Precision) to acquire a worldwide license to Precision’s Azercabtagene Zapreleucel (azer-cel), an allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications.

Azer-cel is an allogeneic (off the shelf) CAR T program.

In August 2024, we announced FDA clearance of the Investigational New Drug Application (IND) for azer-cel for the treatment of progressive forms of multiple sclerosis.

In August 2024, we announced the initiation of a Phase 1 clinical trial evaluating subcutaneous ublituximab in patients with RMS and in January 2025, at the Annual J.P.

Morgan Healthcare Conference we announced our plans to commence a pivotal program in 2025 evaluating a subcutaneous ublituximab with an expected dosing frequency of at least every other month.

In February 2024, BRIUMVI was first made available in the European market by Neuraxpharm in Germany and is now commercially available in several other countries outside of the U.S.

Pipeline Development

In January 2025, we announced the first patients with myasthenia gravis (MG) have been enrolled in a clinical trial evaluating ublituximab.

In August 2025, we announced the first patient with progressive multiple sclerosis has been dosed with azer-cel in a Phase 1 trial.

In September 2025, we announced enrollment commenced in the Phase 3 pivotal program evaluating subcutaneous ublituximab.

The Phase 3 pivotal program is a randomized, open label, parallel-group, multicenter study designed to evaluate the pharmacokinetics, pharmacodynamics, safety, radiological and clinical effects of subcutaneous ublituximab compared to IV BRIUMVI in adult participants with RMS.

Participants will be randomized into one of three arms:

8-week regimen of subcutaneous ublituximab, 12-week regimen of subcutaneous ublituximab or the currently approved IV BRIUMVI dosing schedule.

The primary endpoint of the trial is non inferior exposure of subcutaneous ublituximab compared to IV BRIUMVI with respect to area under the curve (AUC) at week 24.

In February 2026, we announced that the Phase 3 trial was more than approximately 75% enrolled.

In October 2025, we announced completion of enrollment in the randomized cohort of the Phase 3 ENHANCE trial evaluating a consolidated day 1 and day 15 dosing schedule for IV BRIUMVI® in people with RMS.

The primary endpoint of this trial is non inferior exposure with respect to area under the curve (AUC) at week 16.

Share Repurchase Program

In September 2025, we announced the completion of our previously authorized $100 million share repurchase program, which was initially announced in August 2024 (the Prior Share Repurchase Program).

Under the Prior Share Repurchase Program, we repurchased a total of 3,502,334 shares of our common stock at an average price of $28.55 per share.

In September 2025, the Board authorized and approved a new share repurchase program (the 2025 Share Repurchase Program) for up to $100 million of the currently outstanding shares of our common stock.

There were no repurchases under the 2025 Share Repurchase Program during the three and twelve months ended December 31, 2025.

CORPORATE INFORMATION

2 unchanged sentences

Our telephone number is 1-877-575-TGTX(8489), and our e-mail address is info@tgtxinc.com.

We maintain a website with the address www.tgtherapeutics.com and maintain various social media accounts, including but not limited to X (formerly Twitter) and LinkedIn.

We maintain a corporate website with the address www.tgtherapeutics.com, a website with the address www.NextinMS, and various social media accounts, including but not limited to X (formerly Twitter) and LinkedIn.

We also maintain websites related to BRIUMVI, including but not limited to www.BRIUMVI.com, and www.BRIUMVIPATIENTSUPPORT.com.

6 unchanged sentences

Therefore, in light of the SEC’s guidance, we encourage investors, the media and others interested in us to also review the information we post on the social media channels listed on our website.

As a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B cell mediated diseases, our key corporate objectives include:

As a fully-integrated, commercial stage biotechnology company focused on the acquisition, development and commercialization of novel treatments for B cell mediated diseases, our key corporate objectives include:

Successfully commercializing BRIUMVI in the U.S.

for RMS and submitting for FDA approval a simplified dosing schedule for IV BRIUMVI in the U.S.;

Building upon the BRIUMVI approval to evaluate other uses for BRIUMVI in additional MS indications and/or other autoimmune diseases;

Developing and seeking FDA approval of subcutaneous form of BRIUMVI (ublituximab);

Identifying additional areas to expand the use of BRIUMVI beyond MS;

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

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

Evaluating the potential of azer-cel to treat patients with B-cell mediated diseases, including progressive forms of multiple sclerosis;

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

15 unchanged sentences

Examples of common and very debilitating autoimmune disorders for which abnormally functioning B-cells have been implicated include multiple sclerosis (MS) and rheumatoid arthritis (RA).

The Company’s current focus is on MS.

The Company’s primary focus is on MS.

Multiple Sclerosis Overview

10 unchanged sentences

Ublituximab IV (anti-CD20 mAb)

Ublituximab IV Simplified Dosing Schedule

Phase 3 completed enrollment

Ublituximab Subcutaneous (anti-CD20 mAb)

Phase 1 trial

Auto-immune disorders

Phase 3 enrolling

Progressive Forms of Multiple Sclerosis

Phase 1 enrolling

BRIUMVI (ublituximab-xiiy) Overview

BRIUMVI is an anti-CD20 monoclonal antibody that can be administered to adults with RMS in a one-hour infusion every 24 weeks, following the starting dose.

Late-Stage Clinical Development of Ublituximab-xiiy

ULTIMATE I & II Trials Evaluating Single Agent Ublituximab in RMS

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 evaluating the efficacy and safety/tolerability of ublituximab-xiiy (450mg dose administered by one hour intravenous infusion every six months, following a Day 1 infusion of 150mg over four hours, and a Day 15 infusion of 450mg over one hour) to teriflunomide (14mg oral tablets taken once daily) in subjects with RMS.

ULTIMATE I and ULTIMATE II were two independent Phase 3 trials.

Each trial was a global, randomized, multi-center, double-blinded, double-dummy, active-controlled study that evaluated the efficacy and safety/tolerability of ublituximab-xiiy (450mg dose administered by one hour intravenous infusion every six months, following a day 1 infusion of 150mg over four hours, and a day 15 infusion of 450mg over one hour) to teriflunomide (14mg oral tablets taken once daily) in subjects with RMS.

The primary endpoint for each study was ARR following 96 weeks of treatment.

3 unchanged sentences

Key secondary magnetic resonance imaging (MRI) endpoints were also met.

On August 22, 2022, the full results from the ULTIMATE I & II trials were published in the New England Journal of Medicine.

On February 27, 2024, we announced the issuance of three additional patents by the United States Patent and Trademark Office (USPTO) for BRIUMVI, which extended patent protection through 2042.

In August 2022, the full results from the ULTIMATE I & II trials were published in the New England Journal of Medicine.

In February 2024, we announced the issuance of three additional patents by the United States Patent and Trademark Office (USPTO) for BRIUMVI, which extended patent protection through 2042.

In September 2024 we presented new five-year data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with RMS, at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting.

These data demonstrate that 92% of patients with RMS were free from disability progression after five years of BRIUMVI treatment, the annualized relapse rate during year five of treatment was 0.02 (equivalent to one relapse occurring every fifty years of patient treatment), and the overall safety profile remained consistent over five years of continuous treatment, with no new safety signals emerging with prolonged treatment.

These data were published in JAMA Neurology in February of 2026.

In September 2025 we presented new six-year data from the ULTIMATE I & II Phase 3 trials in patients with RMS at the 2025 ECTRIMS annual meeting.

These data demonstrate that 89.9% of patients with RMS were free from 24-week confirmed disability progression after six years of continuous BRIUMVI treatment, the annualized relapse rate in the sixth year of BRIUMVI treatment was 0.012 (equivalent to one relapse occurring every 83 years of patients’ treatment), and the overall safety profile remained consistent over six years of continuous treatment, with no new safety signals emerging with prolonged treatment.

ENHANCE Phase 3b Trial

The ENHANCE Phase 3b trial is an ongoing, multi-center, open-label study designed to evaluate alternative dosing regimens for BRIUMVI in patients with RMS.

The first data from the ENHANCE trial were presented at the 2023 ECTRIMS annual meeting and updated data were also presented at the 2024 ECTRIMS annual meeting and most recently at the Americas Committee for Treatment and Research (ACTRIMS) annual meeting held in February of 2025.

These data showed rapid 30-minute infusions of BRIUMVI were well tolerated in patients with RMS and infusion related reactions in these patients were generally mild and resolved completely.

The data also demonstrated that RMS patients who are already B-cell depleted were able to switch from a prior anti-CD20 therapy directly to a full 450 mg dose of BRIUMVI administered in 1 hour as an initial infusion, without a 150 mg initial dose.

The first data from the non-randomized portion of the ENHANCE trial were presented at the 2023 ECTRIMS annual meeting.

These data have been updated at various medical meetings, including most recently at the 2025 ECTRIMS annual meeting, and demonstrated that consolidating day 1 (150 mg) and day 15 (450 mg) BRIUMVI infusions into a single 600 mg dose on day 1 was well-tolerated across a range of infusion durations, from 1 hour to 4 hours, and the 4 hour 600 mg BRIUMVI day 1 infusion was associated with the lowest infusion related reaction (IRR) rate and is currently being evaluated in a double-blinded, randomized, label-enabling trial design compared to standard dosing.

Commercialization of BRIUMVI (ublituximab-xiiy)

On December 28, 2022, BRIUMVI received approval by the FDA for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease based on results from the ULTIMATE I & II Phase 3 trials.

In December 2022, BRIUMVI received approval by the FDA for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease based on results from the ULTIMATE I & II Phase 3 trials.

In January 2023, we announced the U.S.

1 unchanged sentence

Commercialization of BRIUMVI

On June 1, 2023, we announced that the EC granted approval of BRIUMVI for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features.

With this approval, the centralized marketing authorization is valid in all EU member states, Iceland, Norway and Liechtenstein.

On August 1, 2023, we entered into a Commercialization Agreement with Neuraxpharm, a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, for the ex-US commercialization of BRIUMVI.

In August 2023, we entered into a Commercialization Agreement with Neuraxpharm, a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, for the ex-U.S.

commercialization of BRIUMVI.

Under the terms of the commercialization agreement, we received an upfront payment of $140 million and $12.5 million upon launch in the first EU country.

3 unchanged sentences

In exchange, Neuraxpharm will have the exclusive right to commercialize BRIUMVI in certain territories outside the United States, Canada and Mexico, the commercialization rights for which had been previously retained by TG, thus excluding certain Asian countries subject to previously existing partnerships.

We retain an option to buy back all rights under the Commercialization Agreement for a period of two years in the event of a change in control of TG.

On November 1, 2023, we announced that we also received approval by the MHRA for BRIUMVI to treat adult patients with RMS with active disease defined by clinical or imaging features in the UK.

On February 26, 2024, we announced the commercial launch of BRIUMVI in the European Union (EU).

BRIUMVI was first made available in the European market by Neuraxpharm in Germany and is now commercially available in several other countries in the European Union and the United Kingdom.

In February 2024, we announced the commercial launch of BRIUMVI in the European Union (EU).

BRIUMVI was first made available in the European market by Neuraxpharm in Germany and is now commercially available in several other countries outside the U.S.

Subcutaneous Ublituximab Overview

In August 2024, we announced the initiation of a Phase 1 clinical trial evaluating subcutaneous ublituximab in patients with RMS.

In January 2025, at the Annual J.P.

Morgan Healthcare Conference we announced our plans to commence a pivotal program in 2025 evaluating subcutaneous ublituximab with an expected dosing frequency of at least every other month.

TG-1701 (BTK inhibitor) Overview

TG-1701 is a novel, orally available and covalently-bound Bruton’s tyrosine kinase (BTK) inhibitor that exhibits strong selectivity to BTK in in vitro kinase screening.

B-cell receptor (BCR) signaling is crucial for normal B-cell development and supports the survival and growth of B-cells.

We evaluated TG-1701 in a Phase 1, multi-center, dose-escalation clinical trial in patients with B-cell malignancies, which is now closed.

Data from this trial were presented at the 2021 American Society of Hematology (ASH) annual meeting.

In September 2025, we announced enrollment had commenced in the Phase 3 pivotal program evaluating subcutaneous ublituximab.

Participants will be randomized into one of three arms:

8-week regimen of subcutaneous ublituximab, 12-week regimen of subcutaneous ublituximab or the currently approved IV BRIUMVI dosing schedule.

The primary endpoint of the trial is non inferior exposure of subcutaneous ublituximab compared to IV BRIUMVI with respect to AUC at week 24.

In February 2026, we announced the trial is more than approximately 75% enrolled.

Azercabtagene Zapreleucel (azer-cel)

3 unchanged sentences

In August 2024, we announced FDA clearance of the IND for azer-cel for the treatment of progressive forms of MS.

In August 2025, we announced the first patient with progressive multiple sclerosis had been dosed with azer-cel in a Phase 1 trial.

INTELLECTUAL PROPERTY AND PATENTS

53 unchanged sentences

Since the enactment of the BPCIA, the FDA has issued guidance on biosimilars, addressing scientific, quality and procedural issues relevant to an abbreviated application for a biosimilar product.

As of December 2024, the FDA had approved 60 biosimilar products.

Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms.

2 unchanged sentences

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 2025 are summarized below.

A summary of our intellectual property portfolios for our most advanced drug candidates is included below.

Each of these portfolios contains one or more pending patent applications covering our products and product candidates and uses and combinations thereof.

6 unchanged sentences

These patents and patent applications include composition of matter patents relating to the structure and mechanism of action for ublituximab, as well as method of use patents which cover use of ublituximab in combination with various agents and for various therapeutic indications.

Our earliest in time patent family relates to compositions of matter for ublituximab, which have issued in the U.S., Europe and other jurisdictions, including Australia, Canada, China, Japan, Korea and India.

Our earliest in time patent family relates to compositions of matter for ublituximab, which have issued in the U.S., Europe and other jurisdictions, including Australia, Brazil, Canada, China, Israel, Japan, Korea and India.

The expected expiration for the composition of matter patent in the U.S.

is 2029 and in Europe and other non-U.S.

is 2029, exclusive of patent term extension, which could result in later expiration date, and in Europe and other non-U.S.

jurisdictions, exclusive of patent term extensions which could result in later expiration dates, is 2025.

Our most recently filed patent family relates to compositions of matter comprising ublituximab, methods of manufacturing those compositions and methods for treating multiple sclerosis using those compositions.

To date, patent term extension has been applied for in the U.S., and granted in Australia, Austria, Belgium, Switzerland, Germany, Denmark, Italy, France, United Kingdom, Netherlands, Poland, Spain, and Sweden, extending expiry into 2030 in these countries.

More recently filed patent family relates to compositions of matter comprising ublituximab, methods of manufacturing those compositions and methods for treating multiple sclerosis using those compositions.

This family includes four issued U.S.

patents and two pending U.S.

applications.

applications, which extends patent protection on the composition of matter for ublituximab until 2042, not accounting for any patent term adjustment or extensions or terminal disclaimers.

We also have patent applications pending in this family in the U.S., Argentina, the EU, Taiwan, United Arab Emirates, Australia, Brazil, Canada, China, Hong Kong, Israel, India, Japan, Korea, Kuwait, Mexico, and Saudi Arabia.

Any patents issuing from this family may first begin to expire as early as 2042, not accounting for any patent term adjustment or extensions or terminal disclaimers, and assuming that all applicable annuity and/or maintenance fees are paid timely .

A further family of patents, presently in the PCT phase, relates to formulations for subcutaneous administration.

In the U.S., the Biologics Price Competition and Innovation Act provides that BRIUMVI is eligible for 12 years of market exclusivity from the date of BRIUMVI’s U.S.

During this 12-year period a biosimilar product that references our BRIUMVI product cannot be approved.

TG-1701 (BTK inhibitor)

Pursuant to our license agreement with Jiangsu Hengrui Medicine Co.

(Hengrui), we have the exclusive commercial rights in the treatment of hematologic cancers to a patent family which covers the composition of matter and proposed methods of use for various therapeutic indications in the U.S.

and certain other countries.

Patents directed to the compound have granted in the U.S., Europe, and other jurisdictions, including Australia, Canada, Japan, China, and Korea and are expected to expire no sooner than October 2034.

Applications are pending in other jurisdictions.

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

Pursuant to our joint venture and license option agreement with Novimmune SA (Novimmune), we maintain an exclusive option, exercisable at specific times during development, to license the commercial rights to a series of global patent applications and patents, and the non-exclusive right to certain technology patent applications.

Patents directed to a bispecific antibody have issued in Australia, China, Europe, Japan, and Russia and are pending in other jurisdictions including the U.S.

Any patents maturing from these pending applications are expected to expire no sooner than December 2033.

approval, which was granted in December 2022.

During this 12-year period, which extends until December 2034, a biosimilar product that references our BRIUMVI product cannot be approved.

Azer-Cel (allogeneic CD19 CAR T)

16 unchanged sentences

Under the terms of the LFB License Agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ublituximab.

As of December 31, 2024, we have incurred expenses of approximately $31.0 million related to milestones in accordance with the terms of the LFB License Agreement.

From the inception of the LFB License Agreement, we incurred expenses of approximately $31.0 million related to the achievement of certain milestones under the LFB License Agreement.

LFB Group is eligible to receive royalty payments on net sales of ublituximab at a royalty rate in the 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.

In November 2012, we entered into an exclusive (within the territory) sublicense agreement with Ildong relating to the development and commercialization of ublituximab in South Korea and Southeast Asia.

Under the terms of the sublicense agreement, Ildong has been granted a royalty bearing, exclusive right, including the right to grant sublicenses, to develop and commercialize ublituximab in South Korea, Taiwan, Singapore, Indonesia, Malaysia, Thailand, Philippines, Vietnam, and Myanmar.

To date, we have received $2 million in the form of an upfront payment from Ildong and are eligible to receive sales-based milestone payments up to an aggregate of $5 million and royalty payments on net sales of 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.

In August 2023, we entered into a Commercialization Agreement with Neuraxpharm, for the ex-U.S.

5 unchanged sentences

We retain an option to buy back all rights under the Commercialization Agreement for a period of two years in the event of a change in control of TG.

TG-1701 (BTK inhibitor)

In January 2018, we entered into a global exclusive license agreement with Jiangsu 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).

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.

In July 2020, we paid Hengrui $2.0 million as part of a milestone in accordance with the license agreement.

Royalty payments in the low double digits are due on net sales of licensed products and revenue from sublicenses.

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 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.

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.

Azer-Cel (allogeneic CD19 CAR T)

6 unchanged sentences

The Company has also agreed to make certain payments to Precision’s licensors during the term of our license agreement with Precision.

UKONIQ (umbralisib)

In September 2014, we exercised our option to license the global rights to umbralisib, thereby entering into an exclusive licensing agreement (the Umbralisib License) with Rhizen Pharmaceuticals, S A (Rhizen) for the development and commercialization of umbralisib.

Rhizen is eligible to receive approval and sales-based milestone payments in the aggregate of approximately $175 million.

Additionally, Rhizen receives tiered royalties that escalate from high single digits to low double digits on any net sales of umbralisib.

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, or (ii) by either party due to a breach of the agreement.

Competition in the pharmaceutical and biotechnology industries is intense.

8 unchanged sentences

The resulting changes in standard of care can impact the likelihood of regulatory accelerated approval opportunities for our drug candidates.

For BRIUMVI, there are a number of established therapies with which we will compete:

We expect BRIUMVI will primarily compete against other iv 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 other approved intravenously delivered anti-CD20 monoclonal antibody ocrelizumab (Roche Holdings AG).

In addition, while we believe not directly competitive, there is also a subcutaneous anti-CD20 monoclonal antibody approved for MS, ofatumumab (Novartis AG).

Azer-cel, if approved will also face competition from drugs on the market and under development in the same therapeutic class as each of those drugs.

For BRIUMVI, there are a number of established therapies with which we compete:

Currently, BRIUMVI directly competes with ocrelizumab, the only other approved intravenously administered anti-CD20 monoclonal antibody (Roche Holdings AG).

BRIUMVI also competes with a subcutaneous version of ocrelizumab administered by healthcare providers.

In addition, BRIUMVI competes with ofatumumab (Novartis AG), a patient/self-administered subcutaneous anti-CD20 monoclonal antibody approved for MS.

Ofatumumab would represent direct competition for any future self-administered subcutaneous formulation of ublituximab currently under development

There is the potential for a new class of therapies, Bruton’s tyrosine kinase (BTK) inhibitors, to be approved for the treatment of RMS.

If approved, therapies in this class may compete with existing oral therapies and could alter treatment paradigms, including treatment sequencing, which may impact the utilization of anti-CD20 therapies such as BRIUMVI.

In addition, novel mechanisms of action, including therapies targeting CD40 ligand (CD40L), are in clinical development for MS and other autoimmune diseases.

While these programs are at varying and, in many cases, early stages of development, if successful they could introduce alternative treatment approaches that may compete with or reduce the utilization of existing therapies, including anti-CD20 monoclonal antibodies.

Azer-cel, if approved, would face competition from approved therapies and product candidates in development within the same therapeutic class.

Many of these competitors may have greater resources, more extensive clinical or commercial experience, or product candidates that are further advanced in development.

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 of our own.

We have established a contract manufacturing relationship for the commercial supply of BRIUMVI with Samsung Biologics.

As with any supply program, obtaining materials of sufficient quality and quantity to meet the requirements of the market demand for BRIUMVI and our ublituximab development programs cannot be guaranteed and we cannot ensure that we will be successful in this endeavor.

We currently do not have any manufacturing capabilities of our own and we rely on third-party contract manufacturers for the clinical and commercial supply of our products.

We have established a contract manufacturing relationship with Samsung Biologics for our primary clinical and commercial supply of BRIUMVI, and a secondary contract manufacturing relationship with FUJIFILM Diosynth Biotechnologies.

As with any supply program, obtaining materials of sufficient quality and quantity to meet the requirements of the market demand for BRIUMVI and our development programs cannot be guaranteed and we cannot ensure that we will be successful in these endeavors.

To the extent possible and commercially practicable, we plan to develop back-up strategies for raw materials, manufacturing and testing services for our commercial products.

Given the long lead times and cost of establishing additional commercial manufacturing sites we expect that we will rely on single contract manufacturers to produce our commercial products under current Good Manufacturing Practice, or cGMP, regulations for many years.

Our commercial manufacturing partners 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.

However, due to the long lead times and costs associated with establishing and qualifying additional commercial manufacturing sites, we expect to rely on a limited number of contract manufacturers to produce our commercial products under current Good Manufacturing Practice, or cGMP, regulations for the foreseeable future.

Our third-party manufacturing partners operate a limited number of facilities in which our product can be produced and will have limited experience in manufacturing our product candidates in quantities sufficient for commercialization.

Additionally, 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.

All 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.

3 unchanged sentences

If our manufacturing partners are inspected and 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 may need to approve these new manufacturers in advance, which will involve testing, regulatory submissions, and additional inspections to ensure compliance with FDA regulations and standards and may require significant lead times and delay.

If we need to change or add manufacturers after commercialization, the FDA and corresponding foreign regulatory agencies will need to approve these new manufacturers in advance, which will involve testing, regulatory submissions, 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.

190 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business