On November 1, 2018 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2018. Net loss for the third quarter was $22.8 million, or $0.40 per share, compared to a net loss for the third quarter of 2017 of $32.4 million, or $0.60 per share. Cash, cash equivalents and investments totaled $210.3 million at September 30, 2018 (Press release, Cytokinetics, NOV 1, 2018, View Source [SID1234530581]).

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"With five programs advancing in development, we were pleased to report progress of our expanded pipeline of muscle biology directed potential medicines as recently outlined at our R&D Day," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "We look forward to beginning multiple trials across our cardiac muscle programs before year-end as well as soon completing enrollment in FORTITUDE-ALS, our Phase 2 clinical trial of reldesemtiv in patients with ALS, with results expected next year. I believe that the company has never been better positioned programmatically, operationally and financially to potentially deliver on the promise of our pioneering leadership in muscle biology."

Recent Highlights and Upcoming Milestones

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Continued patient enrollment in GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil. Enrollment has surpassed 70 percent completion with over 5,800 patients randomized to date having the high-risk profile intended by the trial design. We expect completion of patient enrollment in GALACTIC-HF to occur during the first half of 2019. We also expect that GALACTIC-HF will have accrued a sufficient number of events to enable the Data Monitoring Committee to conduct a first interim analysis for the trial, the design of which is tied to the potential for futility, in the first half of 2019.

Conducted readiness activities in advance of the initiation of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure). METEORIC-HF is a Phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. Cytokinetics is working together with Amgen towards the objective of starting METEORIC-HF by the end of 2018.
AMG 594 (cardiac troponin activator)

Continued pre-clinical development of AMG 594 and filed an IND in collaboration with Amgen. AMG 594 is a novel, first-in-class, selective, oral, small molecule cardiac troponin activator, discovered under a joint research program with Amgen. In preclinical models, AMG 594 increases myocardial contractility by binding to cardiac troponin through an allosteric mechanism that sensitizes the cardiac sarcomere to calcium. Based on preclinical data, AMG 594 may offer differentiated efficacy and dose-related convenience relative to omecamtiv mecarbil.

We expect that Amgen will initiate a Phase 1 program for AMG 594 before the end of the year to assess its safety, tolerability, pharmacokinetics and its potential to increase cardiac function in healthy volunteers.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Continued pre-clinical development and filed an IND for CK-274. CK-274 is a novel, oral, small molecule cardiac myosin inhibitor that company scientists discovered independent of its collaborations. CK-274 arose from an extensive next-generation chemical optimization program conducted with careful attention to therapeutic index and pharmacokinetic properties and as may translate into best-in-class potential in clinical development. In preclinical models, CK-274 reduces myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site preventing myosin from entering a force producing state.

We expect to initiate a Phase 1 program for CK-274 before the end of the year to assess its safety, tolerability, pharmacokinetics and its effect on cardiac function in healthy volunteers.
Skeletal Muscle Program

reldesemtiv (next-generation FSTA)

Announced that additional results from the Phase 2 clinical study of reldesemtiv in patients with spinal muscular atrophy (SMA) were presented by John W. Day, M.D., Ph.D., Professor of Neurology and Pediatrics (Genetics), Stanford University at the 2018 Muscle Study Group Scientific Meeting in Oxford, UK, showing sustained increases in 6MWD and MEP four weeks after discontinuation of study drug.

Continued site activation and patient enrollment in FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv which is designed to assess the change from baseline in percent predicted slow vital capacity and other measures of skeletal muscle function after 12 weeks of treatment with reldesemtiv in patients with ALS. FORTITUDE-ALS has enrolled over 400 patients toward the objective of 445 patients in the trial and is being conducted by Cytokinetics in collaboration with Astellas. We expect to complete enrollment in FORTITUDE-ALS in Q4 2018 with results from this clinical trial expected in the first half of 2019.

With Astellas, announced the Phase 2 clinical trial of reldesemtiv in patients with chronic obstructive pulmonary disease (COPD), which was designed to assess its effect on physical function, did not meet the primary endpoint and did not demonstrate a statistically significant treatment difference in any of the secondary endpoints. Adverse events were similar between groups receiving reldesemtiv and placebo.

With Astellas, announced that an interim analysis of the Phase 1b clinical trial of reldesemtiv in elderly subjects with limited mobility, which was designed to assess its effect on measures of physical function, was recently conducted. The Data Monitoring Committee determined that the pre-defined criteria for lack of efficacy of reldesemtiv had been met; Astellas has proceeded to notify investigators to halt further enrollment in the trial.
Pre-Clinical Development and Ongoing Research

Continued pre-clinical development of CK-3762601 (CK-601), a next-generation fast skeletal muscle troponin activator (FSTA) into IND-enabling studies under our collaboration with Astellas.

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators. The companies are continuing their joint research program with Astellas providing sponsorship of Cytokinetics’ activities through 2019.

Continued independent research activities directed to our other muscle biology research programs.
Corporate

Announced that The ALS Association Golden West Chapter is the inaugural recipient of the Cytokinetics Communications Fellowship, an annual grant from the company intended to support increased capacity and community engagement for nonprofit organizations.
Financials

Revenues for the three and nine months ended September 30, 2018 were $10.6 million and $22.1 million, respectively, compared to $6.2 million and $13.4 million for the corresponding periods in 2017. Revenues for the first nine months of 2018 stemmed from our strategic alliance with Astellas.

Research and development expenses for the third quarter of 2018 decreased to $21.4 million from $24.9 million for the third quarter of 2017, primarily due to cessation of development of tirasemtiv in late 2017, offset in part by increased spending in clinical trials of reldesemtiv and preclinical activities for CK-274 and other potential drug candidates. Research and development expenses for the first nine months of 2018 increased to $65.9 million from $64.0 million for the first nine months of 2017, primarily due to increased spending in clinical trials of reldesemtiv and preclinical activities for CK-274 as well as other potential drug candidates, offset in part by suspension of development of tirasemtiv in late 2017.

General and administrative expenses for the three and nine months ended September 30, 2018 decreased to $7.2 million and $23.7 million, respectively, from $9.7 million and $26.2 million for the same periods in 2017, respectively, primarily due to reduced pre-commercial activities for tirasemtiv and reduced other corporate activities.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s third quarter results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 9785146.

An archived replay of the webcast will be available via Cytokinetics’ website until November 8, 2018. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 9785146 from November 1, 2018 at 7:30 PM Eastern Time until November 8, 2018.

On November 1, 2018 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results and provided a business update for the three months ended September 30, 2018 (Press release, Lexicon Pharmaceuticals, NOV 1, 2018, View Source;2018.htm [SID1234530613]).

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"In the third quarter, we and our collaborator, Sanofi, have been working diligently with regulatory agencies to make sotagliflozin available for patients with type 1 diabetes as quickly as possible and we continue to make progress in growing XERMELO for its current indication," said Lonnel Coats, Lexicon’s president and chief executive officer. "Our collaborator, Ipsen, continues to gain approvals and market authorizations for XERMELO in Europe. We are making good progress on our pipeline. By end of year, we expect to start a clinical trial for telotristat ethyl, the investigational form of XERMELO, in biliary tract cancer as well as announce data for LX2761 in diabetes and LX9211, a neuropathic pain candidate, in healthy volunteers."

Third Quarter Product and Pipeline Highlights

XERMELO (telotristat ethyl) 250 mg

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XERMELO was approved in Australia in September for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by somatostatin analog (SSA) therapy.
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In the third quarter, Ipsen launched XERMELO in several European countries including Sweden and Switzerland.

Sotagliflozin

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In September, clinical data for sotagliflozin were presented at the European Association for the Study of Diabetes (EASD) 54th annual meeting. Data from patient exit interviews from a sotagliflozin Phase 3 study were also presented, reporting meaningful improvements in patient reported outcomes.

Third Quarter 2018 Financial Highlights

Revenues: Revenues for the three months ended September 30, 2018 decreased to $6.9 million from $26.9 million for the corresponding period in 2017, primarily due to lower revenues recognized from the collaboration and license agreement with Sanofi, partially offset by an increase in net product revenues. Net product revenues for the three months ended September 30, 2018 included $6.3 million from net sales of XERMELO in the U.S., up 19% from the prior year quarter and 5% from the second quarter of 2018.

Cost of Sales: Cost of sales related to sales of XERMELO for each of the three months ended September 30, 2018 and 2017 was $0.6 million.

Research and Development (R&D) Expenses: Research and development expenses for the three months ended September 30, 2018 decreased to $13.8 million from $39.1 million for the corresponding period in 2017, primarily due to lower external clinical development costs relating to sotagliflozin.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended September 30, 2018 decreased to $15.6 million from $16.7 million for the corresponding period in 2017, primarily due to decreased marketing costs.

Net Loss: Net loss for the three months ended September 30, 2018 was $27.5 million, or $0.26 per share, compared to a net loss of $30.7 million, or $0.29 per share, in the corresponding period in 2017. For the three months ended

September 30, 2018 and 2017, net loss included non-cash, stock-based compensation expense of $2.9 million and $2.6 million, respectively.

Cash and Investments: As of September 30, 2018, Lexicon had $187.3 million in cash and investments, as compared to $310.8 million as of December 31, 2017.

Anticipated Near-Term Milestones

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4Q 2018 – Phase 1b data for LX2761 in type 2 diabetes
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4Q 2018 – Phase 1a data for LX9211 (neuropathic pain candidate) in healthy volunteers
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4Q 2018 – Initiation of clinical development of telotristat ethyl in biliary tract cancer
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March 22, 2019 – PDUFA date for sotagliflozin in type 1 diabetes

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 8:00 am EDT / 7:00 am CDT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 6394419. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

About XERMELO (telotristat ethyl)

Discovered using Lexicon’s unique approach to gene science, XERMELO (telotristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSAs. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. Lexicon has built the in-house capability and infrastructure to launch and market XERMELO in the U.S., where it retains all commercialization rights. Lexicon also retains rights to market XERMELO in Japan. Lexicon has established a license and collaboration agreement with Ipsen to commercialize XERMELO in Europe and other countries outside of U.S. and Japan.

XERMELO was approved by the U.S. Food and Drug Administration on February 28, 2017 and by the European Commission on September 19, 2017 for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with metastatic NETs (mNETs) and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

XERMELO (telotristat ethyl) Important Safety Information

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Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
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Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
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Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

About Sotagliflozin

Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney.

Lexicon entered into a collaboration and license agreement with Sanofi in November 2015 under which Lexicon granted Sanofi an exclusive, worldwide (excluding Japan), royalty-bearing right and license to develop, manufacture and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes and has exercised an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the U.S. Sanofi is responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide (excluding Japan) and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the U.S. (excluding Japan). A New Drug Application and a Marketing Authorization Application for sotagliflozin are currently under review at the U.S. Food and Drug Administration and the European Medicines Agency, respectively, and the product has not yet been approved for use in the U.S. or in Europe.

On November 1, 2018 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported updated data from the ongoing Phase 1 dose-escalation part of its Phase 1/2 clinical trial of cusatuzumab (ARGX-110) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) (Press release, argenx, NOV 1, 2018, View Source [SID1234530646]). As of the data cut-off on July 16, 2018, a 92% (11/12 patients) overall response rate (ORR) was observed, with 42% of patients achieving minimal residual disease (MRD) negativity. The median response duration was 6.9 months as of the data cut-off date.

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Data from this ongoing AML trial are expected to be further updated, including ORR and duration of response, during a company workshop to be held around the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

"The clinical data published today are encouraging and underscore our decision to move forward into a Phase 2 clinical trial of cusatuzumab in AML, which we launched earlier this year. These data also support the deep understanding of the disease biology of CD70 as demonstrated by the preclinical work of our collaborators at the University of Bern, highlighting cusatuzumab’s potential to offer a novel mechanism of action in AML against leukemic blasts and leukemic stem cell compartments," commented Nicolas Leupin, MD, Chief Medical Officer of argenx. "We look forward to providing an update on key metrics from the Phase 1 dose-escalation of the Phase 1/2 trial, including response rate and duration of response, at our annual workshop around ASH (Free ASH Whitepaper)."

Phase 1/2 Results for Cusatuzumab in AML

In this trial, argenx evaluated the safety, tolerability and efficacy of cusatuzumab in combination with azacytidine (AZA) in an open-label, Phase 1/2 clinical trial in 12 newly diagnosed AML patients unfit for intensive chemotherapy. The data published today are from all 12 patients across four dose cohorts (1 mg/kg, 3 mg/kg, 10 mg/kg and 20 mg/kg) from the Phase 1/2 dose-escalation trial.

As of the data cut-off on July 16, 2018, the ORR across the 12 patients was 92% (11/12 patients), including 9 patients (82%) with a complete response with or without hematologic recovery (CR/CRi), 1 patient (9%) who reached morphologic leukemia-free status, and 1 (9%) partial response (PR). The median duration on study as of data cut-off was 6.9 months, ranging from 2 to 14.4 months, with 7 patients still on study. Five patients (42%) achieved MRD negativity as measured by flow cytometry. Translational data demonstrated that cusatuzumab monotherapy and in combination with AZA

significantly reduced leukemic stem cells in the bone marrow of AML patients. Cusatuzumab continued to be well-tolerated in AML patients across the different doses. More details can be found here.

Cusatuzumab in Cutaneous T-cell Lymphoma

argenx also announced today updated results from its non-randomized, open-label, multicenter Phase 1/2 trial of cusatuzumab in 27 patients with cutaneous T-cell lymphoma (CTCL). More details can be found here.

argenx announced in May 2018 that it is no longer devoting resources to the development of cusatuzumab in CTCL in order to focus on the drug candidate’s potential in AML.

About Cusatuzumab

Cusatuzumab (ARGX-110) is an investigational SIMPLE Antibody targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors and severe autoimmune diseases. Cusatuzumab is designed to: block CD70, kill cancer cells expressing CD70 through complement dependent cytotoxicity, enhanced antibody-dependent cell-mediated phagocytosis and enhanced antibody-dependent cell-mediated cytotoxicity, and restore immune surveillance against solid tumors (Silence K. et al. mAbs 2014; 6 (2):523-532). Cusatuzumab is currently being evaluated in patients with hematological malignancies, including a Phase 1/2 trial in combination with azacitidine in patients with newly diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) and the Phase 2 part of a Phase 1/2 trial in patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL). Preclinical work on cusatuzumab in AML was performed in collaboration with the Tumor Immunology Lab of Prof. A. F. Ochsenbein at the University of Bern, who won, together with Prof. Manz at the University Hospital of Zürich, the prestigious 2016 Otto Naegeli Prize for his breakthrough research on CD70/CD27 signaling with therapeutic potential for cancer patients.

On November 1, 2018 In conjunction with DURECT Corporation’s (Nasdaq: DRRX) reported third quarter 2018 financial results press release, you are invited to listen to a conference call that will be broadcast live over the internet on Wednesday, November 7, 2018 at 4:30 pm Eastern Time (1:30 pm Pacific Time) (Press release, DURECT, NOV 1, 2018, http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-newsArticle&ID=2374981 [SID1234530663]).

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A live audio webcast of the presentation will be available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section.

On November 1, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that updated data for umbralisib (TGR-1202), the Company’s once-daily PI3K delta inhibitor, and ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, have been selected for presentation at the upcoming 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition, to be held December 1-4, 2018, at the San Diego Convention Center in California (Press release, TG Therapeutics, NOV 1, 2018, View Source [SID1234532243]). Abstracts are now available online and can be accessed on the ASH (Free ASH Whitepaper) meeting website at www.hematology.org. Abstract highlights and presentation details are outlined below.

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Abstract Highlights:

Umbralisib + Ublituximab + Pembrolizumab Triple Therapy Oral Presentation:
89% ORR (8 of 9) observed in relapsed or refractory Chronic Lymphocytic Leukemia (CLL) patients with 75% ORR (3 of 4) in BTK refractory CLL patients
Notably 2 of 4 BTK-refractory CLL patients achieved a response to umbralisib plus ublituximab ("U2") alone, prior to the addition of pembrolizumab
50% ORR (2 of 4) observed in patients with Richter’s Transformation (RT)
Both responders were ibrutinib refractory and achieved durable Complete Responses (CRs) (time on therapy 15+ months and 7+ months)

Umbralisib + Ublituximab + Bendamustine Triple Therapy Poster Presentation:
85% ORR (11 of 13) observed in relapsed or refractory Follicular Lymphoma (FL) patients, including 54% CRs
48% ORR (12 of 25) observed in relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) patients, including 32% CRs
Oral Presentation Details:

Title: Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Relapsed/Refractory CLL and Richter’s Transformation
Publication Number: 297
Oral Session: 642. CLL: Therapy, excluding Transplantation: Cellular Therapy and Immunomodulation in CLL
Session Date and Time: Sunday, December 2, 2018; 7:30 AM – 9:00 AM PT
Presentation Time: 8:00 AM PT
Location: Marriott Marquis San Diego Marina, Pacific Ballroom 20
Presenter: Anthony R. Mato, MD, Memorial Sloan-Kettering Cancer Center, New York, NY
Poster Presentation Details:

Title: Combination of Umbralisib, Ublituximab, and Bendamustine Is Safe and Highly Active in Patients with Advanced Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Abstract Number: 4197
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III
Date and Time: Monday, December 3, 2018; 6:00 PM – 8:00 PM PT
Location: San Diego Convention Center, Hall GH
Presenter: Matthew A. Lunning, DO, University of Nebraska Medical Center, Omaha, NE
Following each presentation, the data presented will be available on the Publications page of the Company’s website at View Source

TG THERAPEUTICS INVESTOR & ANALYST EVENT

TG Therapeutics will also host a reception on Sunday, December 2, 2018 beginning at 7:30 PM PT with featured presentations beginning promptly at 8:00 PM PT. The event will take place at the Marriott Gaslamp in San Diego California. The event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at View Source, as well as archived for future review. This event will also be broadcast via conference call. To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG TherapeuticsDecember 2018 Investor & Analyst Event.