On May 12, 2021 Kuraray reported that Financial Results for the First Quarter of the Fiscal Year Ending December 31, 2021 (January 1, 2021 to March 31, 2021) (Press release, Kuraray, MAY 12, 2021, https://pdf.irpocket.com/C3405/eq9A/Kj61/GizM.pdf [SID1234579789])

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1. Consolidated Financial Results for the First Quarter of the Fiscal Year Ending December 31, 2021 (January 1, 2021 to March 31, 2021)

(1) Consolidated Operating Results (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)

(2) Consolidated Financial Position2. Dividends 3. Forecasts of Consolidated Financial Results for the Fiscal Year Ending December 31, 2021 (January 1, 2021 to December 31, 2021) (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)

1. Qualitative Information regarding Business Results
1) Overview of Consolidated Business Results In the first quarter of fiscal 2021 (January 1, 2021–March 31, 2021), the world economy is still feeling the effects of the COVID-19 pandemic, and the outlook remains unclear. Amid these circumstances, the Group’s business results continued to recover owing to an increase in demand for at-home consumption due to the pandemic and an increase in automotive-related demand.

Consequently, consolidated operating results for the first quarter of fiscal 2021 are as follows: net sales rose ¥7,470 million, or 5.5%, compared with the previous fiscal year to ¥144,398 million; operating income increased ¥4,814 million, or 40.2%, to ¥16,786 million; ordinary income increased ¥4,962 million, or 43.9%, to ¥16,268 million; and net income attributable to owners of the parent decreased ¥1,422 million, or 21.2%, to ¥5,282 million. Furthermore, in the first quarter, we recorded a loss on litigation of ¥3,054 million related to a fire that occurred at our U.S. subsidiary in May 2018. We also recorded a disaster loss of ¥3,016 million due mainly to the suspension of production for some equipment at our U.S. subsidiary caused by a severe cold wave in the southern United States in February.

The Group’s long-term vision for its 100th anniversary coming up in 2026, Kuraray Vision 2026, is to become a "Specialty Chemical Company, growing sustainably by incorporating new foundational platforms into its own technologies." We will continue striving to optimize our business portfolio by steadily taking specific measures based on the three basic policies of Kuraray Vision 2026: pursuing competitive superiority, expanding new business fields and enhancing comprehensive strength of the Kuraray Group. We formulated a single-year management plan for fiscal 2021 and will focus on safe and stable operations amid the pandemic as well as thoroughly implement various measures decided on during the period of the previous medium-term management plan "PROUD 2020." At the same time, we will move ahead with formulating the next medium-term management plan, which is set to start in fiscal 2022. In the Functional Materials segment, due to an organizational reform on January 1, 2021, we integrated the Calgon Carbon Division and Carbon Materials Division, whose core products are activated carbon, into the Environmental Solutions Division. Results by Business Segment Vinyl Acetate Sales in this segment increased 13.0% year on year to ¥72,175 million, and segment income rose 59.9% year on year to ¥13,415 million

(1) Sales of PVA resin increased as global demand began to recover though overall business was affected by the U.S. cold wave. Sales of optical-use poval film were brisk due to an increase in demand for LCD panels, especially large displays, from the second half of the previous fiscal year. The sales volume of PVB film rose on the back of a recovery in demand for both construction and automotive applications. Sales of water-soluble PVA film steadily expanded for use in unit dose detergent packets, including for dish detergents, as more customers stay at home due to the COVID-19 pandemic.

(2) The sales volume of EVAL ethylene vinyl alcohol copolymer (EVOH resin) increased as food packaging applications remained firm and demand for gas tank applications recovered, but overall performance was affected by the U.S. cold wave. Isoprene Sales in this segment increased 13.2% year on year to ¥14,894 million, and segment income fell 3.0% year on year to ¥3,046 million.

(1) The sales volume of isoprene chemicals and SEPTON thermoplastic elastomer increased by a demand recovery mainly in China and the rest of Asia, but performance was affected by higher raw material and fuel prices.2) Sales of GENESTAR heat-resistant polyamide resin remained brisk for electric and electronic device applications and automotive applications amid growing demand. Functional Materials Sales in this segment decreased 1.5% year on year to ¥30,294 million, and segment income fell 16.3% year on year to ¥1,061 million.

(1) In the methacrylate business, sales for sign applications were weak despite an increase in sales of spatter-blocking barrier panels and displays.
(2) In the medical business, the dental materials business saw brisk sales, mainly in Europe and the United States.
(3) In the environmental solutions business, shipments decreased, especially for industrial applications. Fibers and Textiles Sales in this segment fell 5.2% year on year to ¥13,721 million while segment income decreased 52.4% year on year to ¥435 million

1) Sales of CLARINO man-made leather remained stable amid signs of a recovery in demand, especially for shoe applications in Asia and luxury good applications in Europe
2) In fibers and industrial materials, sales of KURALON were lower than the previous year despite a recovery in demand, which had fallen in the second half of the previous year
3) In consumer goods and materials, the sales volume of KURAFLEX decreased as 5 demand for counter cloths for the restaurant industry remained weak despite an increase in sales volume for mask-related applications.Trading In fiber-related businesses, sales stagnated, especially for sports clothing. Sales of resins and chemicals remained favorable due to an increase in demand in Japan and Asia, including China. As a result, segment sales increased 10.8% year on year to ¥32,972 million, and segment income rose 11.8% to ¥1,074 million

(2) Overview of Financial Position Total assets decreased ¥2,877 million from the end of the previous fiscal year to ¥1,048,707 million mainly because of a ¥30,184 million decrease in cash and cash deposits and a ¥5,794 million decrease in short-term investment securities, despite a ¥6,845 million increase in construction in progress, a ¥5,067 million increase in notes and accounts receivable-trade, a ¥4,615 million increase in inventories, a ¥4,608 million increase in machinery, equipment and vehicles, a ¥3,314 million in other current assets accompanying mainly an increase in other accounts receivable, and a ¥2,410 million increase in goodwill due to the effects of foreign exchange rates. Total liabilities decreased ¥25,709 million to ¥510,394 million due to factors that included the redemption of commercial paper totaling ¥20,000 million and a ¥11,684 million decrease in other current liabilities accompanying mainly a decrease in otheraccounts payable, despite a ¥3,626 million increase in notes and accounts payable–trade. Net assets rose ¥22,831 million to ¥538,312 million. Equity attributable to owners of the parent amounted to ¥520,151 million, for an equity ratio of 49.6%.

(3) Basis for the Revision in Forecasts, Including Consolidated Operating Results Forecasts In the consolidated first quarter, shipments in many of Kuraray’s businesses increased due to growth in demand, including for mainstay applications for automobiles, displays, and electronic and electric devices. We assume that demand will remain firm in the second quarter as well. Based on these circumstances, the forecast of consolidated operating results for the second quarter of fiscal 2021 (January 1, 2021 to June 30, 2021) is as shown below. The revised cumulative consolidated operating results forecast for the second quarter of the fiscal year ending December 31, 2021 (January 1, 2021 to June 30, 2021) is as follows.

Furthermore, although we recorded an extraordinary loss in the consolidated first quarter related to the litigation over the fire at the U.S. subsidiary, the litigation is still ongoing.

On May 12, 2021 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported its first quarter 2021 financial results and corporate highlights (Press release, Kezar Life Sciences, MAY 12, 2021, View Source [SID1234579788]).

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"Last quarter saw excellent execution by the Kezar team across both of our programs. We look forward to sharing data this June from the completed Phase 1b portion of the MISSION study of KZR-616 in SLE patients, followed by an interim review of the Phase 2 portion of MISSION in LN patients in the fourth quarter. Our conviction continues to deepen that immunoproteasome inhibition has the potential to be a powerful, differentiated treatment approach for patients with autoimmune diseases," said John Fowler, Kezar’s Co-founder and Chief Executive Officer. "In addition, we are on track to submit an IND for KZR-261, our first-in-class protein secretion inhibitor, in mid-2021 and commence a Phase 1 study in solid tumors shortly thereafter."

Clinical Highlights & Updates

KZR-616: Selective Immunoproteasome Inhibitor

MISSION – Phase 1b/2 clinical trial in patients with systemic lupus erythematous (SLE) and lupus nephritis (LN), respectively (NCT03393013)

The last patient from the MISSION Phase 1b completed treatment in February 2021, and final clinical data from this 25-week safety and tolerability study of up to 75 mg weekly of KZR-616 in 47 patients with SLE will be presented during the European Congress of Rheumatology (EULAR 2021) in June.
The amended Phase 2 open-label portion of the MISSION trial in patients with active, proliferative lupus nephritis opened for enrollment in August 2020 and is actively recruiting. The primary efficacy endpoint for the trial is the proportion of patients achieving a renal response measured by a 50% or greater reduction in urine protein to creatinine ratio (UPCR) at six months.
Interim data are expected in late 2021, and topline data are expected in the first half of 2022.
PRESIDIO – Phase 2 clinical trial in patients with dermatomyositis (DM) and polymyositis (PM) (NCT04033926)

The PRESIDIO Phase 2, placebo controlled cross-over trial of KZR-616 in DM and PM is actively enrolling. Additionally, a 12-month open-label extension study is open to patients completing the 32-week placebo-controlled trial (NCT04628936).
Topline data are expected in the first half of 2022.
Protein Secretion Program

KZR-261 is a first-in-class protein secretion inhibitor which targets the Sec61 translocon and has demonstrated broad anti-tumor activity in preclinical models of both solid and hematologic malignancies.
Pending successful completion of drug product manufacturing, submission of an Investigational New Drug (IND) application for KZR-261 is anticipated in mid-2021. The Phase 1 clinical trial will evaluate pharmacokinetics, safety, and tolerability in patients with solid tumors as well as preliminary signs of efficacy in tumor-specific expansion cohorts. The trial is expected to commence shortly after the IND becomes effective.
Two abstracts featuring Kezar’s small molecule inhibitors of the Sec61 translocon were presented in April during the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2021 Virtual Annual Meeting.
Corporate Update

In May 2021, Kezar was recognized as a winner of the 2021 Bay Area Best Places to Work, an awards program presented by the San Francisco Business Times and the Silicon Valley Business Journal.
Financial Results

Cash, cash equivalents and marketable securities totaled $142.3 million as of March 31, 2021, compared to $140.4 million as of December 31, 2020. The increase in cash, cash equivalents and marketable securities was primarily attributable to the net proceeds from the issuance of common stock under the "at-the-market" Sales Agreement with Cowen and Company, LLC, offset by cash used by the company in operations to advance its clinical-stage programs and preclinical research and development.
Research and development expenses for the first quarter of 2021 increased by $1.8 million to $9.3 million compared to $7.5 million in the first quarter of 2020. This increase was primarily related to advancing the KZR-616 clinical program in multiple indications and the protein secretion preclinical program.
General and administrative expenses for the first quarter of 2021 increased by $0.8 million to $3.8 million compared to $3.0 million in the first quarter of 2020. The increase was primarily due to an increase in personnel expenses and stock-based compensation as a result of an increase in headcount and salaries and an increase in the cost of directors’ and officers’ liability insurance.
Net loss for the first quarter of 2021 was $13.0 million, or $0.25 per basic and diluted common share, compared to a net loss of $10.0 million, or $0.30 per basic and diluted common share, for the first quarter of 2020.
Total shares of common stock outstanding were 48.1 million shares as of March 31, 2021. Additionally, there were outstanding pre-funded warrants to purchase 3.8 million shares of common stock at an exercise price of $0.001 per share and outstanding options to purchase 7.1 million shares of common stock at a weighted-average exercise price of $5.90 per share as of March 31, 2021.
About KZR-616

KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1a and 1b clinical trials provide evidence that KZR-616 exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases. Phase 2 trials are underway in severe autoimmune diseases.

About KZR-261

KZR-261, a novel, first-in-class protein secretion inhibitor, is the first clinical candidate to be nominated from Kezar’s research and discovery efforts targeting protein secretion pathway. KZR-261 is a broad-spectrum anti-tumor agent that acts through direct interaction and inhibition of Sec61 activity. The compound was discovered by Kezar through a robust medicinal chemistry campaign in which several scaffolds were progressed through the company’s proprietary platform evaluating Sec61 modulation. As a result, Kezar has established a broad library of protein secretion inhibitors. KZR-261 has demonstrated several encouraging properties that lead to its potential to be an anti-cancer agent for the treatment of solid and hematologic malignancies. An IND submission in solid tumors is expected to be filed in mid-2021.

About Lupus Nephritis

Lupus nephritis is one of the most serious complications of systemic lupus erythematosus. LN is a disease comprising a spectrum of vascular, glomerular and tubulointerstitial lesions and develops in approximately 50% of SLE patients within 10 years of their initial diagnosis. LN is associated with considerable morbidity, including an increased risk of end-stage renal disease requiring dialysis or renal transplantation and an increased risk of death. There are limited approved therapies for the treatment of LN. Management typically consists of induction therapy to achieve remission and long-term maintenance therapy to prevent relapse.

About Dermatomyositis and Polymyositis

Dermatomyositis and Polymyositis are two of the five types of autoimmune myositis diseases. Both are chronic, debilitating, inflammatory autoimmune myopathies that are distinguished by inflammation of the muscles as well as the skin (in DM). Approximately 30,000 to 120,000 people in the United States are living with these severe and progressive inflammatory myopathies that are characterized by marked morbidity and associated mortality. While debilitating muscle weakness is the hallmark of these myopathies, including compromised muscles of respiration, other internal organ system dysfunctions can be equally disabling. The aim of treatment for these diseases is to suppress inflammation, increase muscle strength and prevent long-term damage to muscles and extramuscular organs; however, treatment options are limited for DM, and there are currently no approved treatments for PM.

On May 12, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), reported that the Journal of Clinical Oncology has published a manuscript of clinical data for Cohort 2 in the C-144-01 study of lifileucel TIL therapy in metastatic melanoma (Press release, Iovance Biotherapeutics, MAY 12, 2021, View Source [SID1234579787]). Online open access to the publication is available at View Source

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Amod Sarnaik, Associate Professor of Cutaneous Oncology and Immunology at H. Lee Moffitt Cancer Center stated, "Effective treatment options are limited for patients with advanced melanoma who progress after immune checkpoint inhibitors and targeted therapies. Lifileucel represents a significant improvement in the treatment of advanced melanoma, particularly in the expanding post-immune checkpoint inhibitor patient population. The results from the C-144-01 clinical study, as well as the advancement of lifileucel using a centralized TIL manufacturing process, offer a new opportunity for accessible treatment for the most challenging to treat patients with metastatic melanoma."

"With this publication we have summarized several years of our clinical development and TIL manufacturing as we strive to make TIL a broadly accessible cell therapy for patients with advanced melanoma," said Maria Fardis, PhD, MBA, President and Chief Executive Officer of Iovance. "At the time of the data extract for publication, the overall response rate (ORR) was 36%, median duration of response (DOR) had not been reached at 18.7 months of median study follow up and median overall survival (OS) was 17.4 months. As a reference, patients treated with chemotherapy are expected to have an OS of approximately 7 months. I believe these results demonstrate the durability of one-time treatment with lifileucel. Importantly, durable responses were seen across all patient subgroups regardless of prior treatment or mutation status, including patients who were primary refractory to anti−PD-1 therapy. I would like to thank the investigators who contributed to this manuscript as well as the patients who participated in Cohort 2 of the C-144-01 clinical study."

Publication Summary
In Cohort 2 of the C-144-01 clinical study, 66 patients received a mean of 3.3 prior therapies. As of the data extract for the publication (April 23, 2020), the ORR was 36% (2 complete responses and 22 partial responses), meeting the study primary endpoint in a patient population that had failed frontline anti−PD-1 therapy, the current standard of care. The median DOR was not reached after a median of 18.7 months of study follow-up (range 0.2 to 34.1 months) and 69% of patients had DOR of at least one-year. The median OS was 17.4 months, and one-year survival was 38% in patients with stable disease and 92% in patients with a partial or complete response.

Lifileucel also demonstrated similar ORR across Cohort 2 subgroups, including patients who were primary refractory to anti−PD-1 or anti−PD-L1 therapy (41%); patients who received anti−PD-1 or anti−PD-L1 combination as a frontline therapy (33%) or after failing frontline therapy (32%); and patients with primary resistance or acquired resistance to anti−PD-1 plus anti−CTLA-4 combination therapy (35% and 27%, respectively).

Responses to lifileucel were agnostic of PD-L1 status, BRAF mutation status, or prior anti−CTLA-4 therapy. Safety profile was consistent with known adverse events associated with advanced disease, non-myeloablative lymphodepletion, and IL-2

On May 12, 2021 Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, reported its cash position as of March 31, 2021 and its revenues for the first quarter of 2021, and provided an update on its collaboration with AbbVie in auto-immune diseases (Press release, Inventiva Pharma, MAY 12, 2021, View Source [SID1234579786]).

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Cash Position

As of March 31, 2021, Inventiva’s cash and cash equivalents stood at €107.8 million compared to €113.0 million as of December 31, 2020.

Net cash used in operating activities amounted to €7.8 million in the first quarter of 2021 compared to €3.6 million for the same period in 2020. R&D expenses for the first quarter, mainly driven by the development of lanifibranor in NASH, were up 22% compared to the first quarter of 2020. This increase in cash used is due to the preparation for the initiation of NATIV3, a Phase III clinical trial evaluating lanifibranor in NASH, while the first quarter of 2020 had been positively impacted by the receipt of a €4.2 million non-recurrent late payment of the 2018 research tax credit.

Net cash from investing activities for the first quarter of 2021 amounted to €1.1 million, as compared to no net cash from investing activities generated in the first quarter of 2020.

No net cash from financing activities was generated over the first quarter of 2021 while Inventiva recorded €14.6 million of net cash from financing activities for the same period in 2020, notably related to the issuance of €15 million (gross proceeds) of ordinary shares in February 2020.

Over the first quarter of 2021, the Company recorded a positive exchange rate effect on cash and cash equivalent of €3.7 million.

Considering its current R&D and clinical development programs, and excluding additional financial resources, Inventiva has adjusted its projected cash runway by one quarter, allowing the Company to finance its operating activities through the third quarter of 2022 compared to the fourth quarter of 2022 as previously communicated.

Revenues

The Company’s revenues for the first quarter of 2021 amounted to €0.1 million, similar to the amounts received in the first quarter of 2020.

Update on the collaboration with AbbVie in auto-immune diseases2

Cedirogant, a clinical stage RORγ inverse agonist co-discovered by Inventiva with potential in several auto-immune diseases, demonstrated promising activity as an oral psoriasis agent during a Phase Ib clinical trial3 led by AbbVie. Following these results, AbbVie has decided to move the drug candidate into a Phase IIb dose-ranging study, planned to be initiated in the second half of 2021.

As part of this collaboration, Inventiva is eligible to receive development, regulatory and commercial milestone payments as well as royalty payments. As such, the Company expects to receive another milestone payment upon the initiation by AbbVie of the Phase IIb clinical trial with cedirogant.

Next key milestones expected

Initiation of NATIV3 Phase III clinical trial evaluating lanifibranor in NASH – planned for the first half of 2021
Initiation by AbbVie of a Phase IIb clinical trial with cedirogant – expected in the second half of 2021
Strategy update on the development of odiparcil – planned for 2021
Publication of the results of the Phase II clinical trial evaluating lanifibranor for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with type 2 diabetes (T2DM) – planned for the first half of 2022

Upcoming investor conference participation

Jefferies Virtual Healthcare Conference, June 1-4, 2021
SVB Leerink CybeRx Series: Liver Disease Day, June 17, 2021
Citi’s 16th Annual BioPharma Conference 2021, September 8-9, 2021
H.C. Wainwright 23rd Annual Global Investment Conference, September 13-15, 2021
Portzampac Health Biotech Seminar 2021, October 6, 2021
Stifel Healthcare Conference 2021, November 16-17, 2021
Jefferies 2021 London Healthcare Conference, November 16-18, 2021

Upcoming scientific conference participation

International Liver Congress 2021, June 23-26, 2021
Paris NASH Meeting, October 22-23, 2021
AASLD The Liver Meeting, November 12-15, 2021

Next financial results publication

Revenues and cash position for the first half of 2021: Wednesday, July 28, 2021 (after U.S. market close)

On May 12, 2021 Incyte (Nasdaq:INCY) reported that multiple abstracts highlighting data from its oncology portfolio will be presented during the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress, held virtually from June 9-17, 2021 (Press release, Incyte, MAY 12, 2021, View Source [SID1234579785]).

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"We are pleased that data highlighting the strength of Incyte’s oncology portfolio and partner-sponsored programs will be presented at this year’s EHA (Free EHA Whitepaper) Virtual Congress," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. "In particular, data being presented at the congress – including the first presentation of data from our Phase 2 study of parsaclisib, our PI3kδ inhibitor, in autoimmune hemolytic anemia; an oral presentation on real-world data for ruxolitinib, our JAK1/JAK2 inhibitor; and an ePoster from our Phase 2 combination study of ruxolitinib and parsaclisib in patients with myelofibrosis – reinforce our commitment to finding solutions for patients with significant unmet medical needs."

Key abstracts accepted by EHA (Free EHA Whitepaper) include:

Oral Presentations

Ponatinib

OPTIC Primary Analysis: A Dose-Optimization Study of 3 Starting Doses of Ponatinib (PON)1(Abstract #S153. Session: Response, Resistance and Treatment-Free Remission in CML.)

Ruxolitinib

Efficacy and Safety of Ruxolitinib in Patients with Steroid-Refractory Acute Graft-Vs-Host Disease After Crossover in the Phase 3 REACH2 Study2(Abstract #S236. Session: Stem cell transplantation – GvHD.)

Impact of Ruxolitinib on Survival of Patients with Myelofibrosis in Real World – Update of ERNEST (European Registry for Myeloproliferative Neoplasms) Study2(Abstract #S158. Session: Population based studies in myeloid disorders.)

ePosters

Parsaclisib

Efficacy and Safety Results from an Open-Label Phase 2 Study of Parsaclisib for the Treatment of Autoimmune Hemolytic Anemia (AIHA) (Abstract #EP685. Session: Enzymopathies, Membranopathies and Other Anemias.)

Pharmacologic Inhibition of PI3kδ Reduces Autoantibody Formation and is Efficacious in a Preclinical Model of Autoimmune Hemolytic Anemia (Abstract #EP693. Session: Enzymopathies, Membranopathies and Other Anemias.)

FACIT-Fatigue Subscale Outcomes from an Ongoing Phase 2, Open-Label Study of the Phosphatidylinositol 3-Kinase Delta (PI3Kδ) Inhibitor Parsaclisib in Patients with Autoimmune Hemolytic Anemia (AIHA) (Abstract #EP706. Session: Enzymopathies, Membranopathies and Other Anemias.)

Ponatinib

French Real-Life Observational Study "TOPASE" Evaluating Safety and Efficacy of Ponatinib Confirms Induction of Deep Molecular Responses in 110 Resistant or Intolerant CML Patients (Abstract #EP679. Session: Chronic Myeloid Leukemia – Clinical.)

Ruxolitinib

An Epidemiological Study of the Cardiovascular Health and Thrombotic Risk Profiles of Patients with Myeloproliferative Neoplasms in Primary Care Across the United Kingdom2 (Abstract #EP1090. Session: Myeloproliferative Neoplasms – Clinical.)

Impact of Bone Marrow Fibrosis Grade on Response and Outcome in Patients with Primary Myelofibrosis Treated with Ruxolitinib: A Post-Hoc Analysis of the JUMP Study2 (Abstract #EP1092. Session: Myeloproliferative Neoplasms – Clinical.)

Healthcare Resource Utilization in Patients with Myeloproliferative Neoplasms: A Nationwide Matched Cohort Study2 (Abstract #EP1107. Session: Myeloproliferative Neoplasms – Clinical.)

Ruxolitinib-Parsaclisib Combination Studies

Add-On Parsaclisib (a PI3kδ inhibitor) in Patients with Myelofibrosis and Suboptimal Response to Ruxolitinib: Interim Analysis from a Phase 2 Study (Abstract #EP1075. Session: Myeloproliferative Neoplasms – Clinical.)

Tafasitamab

Estimation of Long-Term Survival with Tafasitamab + Lenalidomide in Relapsed/Refractory Diffuse Large B-Cell Lymphoma3(Abstract #EP553. Session: Aggressive Non-Hodgkin Lymphoma – Clinical.)

First-MIND: A Phase 1b, Open-Label, Randomized Study to Assess Safety of Tafasitamab or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed DLBCL3(Abstract #EP496. Session: Aggressive Non-Hodgkin Lymphoma – Clinical.)

Lenalidomide-Induced Effects on Cell Surface Expression of CD19 and CD20 in DLBCL Cell Lines and Functional Impact on Antibody-Mediated Cytotoxicity3(Abstract #EP879 . Session: Lymphoma Biology & Translational Research.)

In addition to the presentations noted above, more than 10 publications highlighting data from Incyte’s portfolio will be made available by EHA (Free EHA Whitepaper) as publications. Notably, these publications include bioequivalence and bioavailability data for ruxolitinib’s once-daily extended release (XR) formulation – Bioequivalence of 50 mg Once-Daily Ruxolitinib Extended Release (XR) Tablets Compared to 25 mg Twice-Daily Ruxolitinib Immediate Release (IR) Tablets (Abstract #PB1706) and Relative Bioavailability and Dose Linearity of Five Strengths of Ruxolitinib Extended Release (XR) Tablets (Abstract #PB1717).

Full listings for oral presentations and ePoster sessions are available on the EHA (Free EHA Whitepaper) website: View Source Oral, poster discussion and poster sessions, as well as track-based clinical science symposia, accepted for presentation at EHA (Free EHA Whitepaper) will be available on demand for registered attendees beginning Friday, June 11, 2021, through Sunday, August 15, 2021.