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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On May 12, 2021 Keros Therapeutics, Inc. ("Keros") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, reported that four abstracts will be presented from the KER-050 and ALK2 hematology programs at the 26th Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) ("EHA"), to be held as a virtual event from June 9-17, 2021 (Press release, Keros Therapeutics, MAY 12, 2021, View Source [SID1234580477]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are pleased to present additional mechanistic preclinical data for KER-050, which further demonstrate that KER-050 potentially promotes differentiation of both early- and terminal-stage progenitor cells, at this year’s virtual Congress. These data further support our belief that KER-050 can potentially treat diseases that exhibit defects in different stages of erythropoiesis, such as myelodysplastic syndromes and myelofibrosis. Additionally, new preclinical data from our ALK2 program provide further evidence of the effects of ALK2 inhibition on hepcidin and iron metabolism to potentially resolve anemias," said Jasbir S. Seehra, Ph.D., Chief Executive Officer of Keros. "Separately, we remain on track to provide a program update on KER-050 with initial data from Part 1 of our Phase 2 clinical trial of KER-050 in patients with myelodysplastic syndromes to be announced by the end of June 2021."

Details of the presentations are as follows:

"KER-050, an inhibitor of TGF-β superfamily signaling, observed to have a rapid, dynamic, and durable effect on erythropoiesis"

Abstract Number: EP758
Date and Time: Virtual poster presentation available June 11-17, 2021
"ALK2 is a potential therapeutic target in anemia resulting from chronic inflammation"

Abstract Number: EP839
Date and Time: Virtual poster presentation available June 11-17, 2021
"ALK2 inhibition, a novel therapeutic approach to iron overload"

Abstract Number: EP842
Date and Time: Virtual poster presentation available June 11-17, 2021
"Administration of ALK2 neutralizing antibodies to cynomolgus monkeys led to a sustained decrease in hepcidin, increase in circulating iron and increase in erythrocyte hemoglobin"

Abstract Number: EP840
Date and Time: Virtual poster presentation available June 11-17, 2021
About KER-050

Keros’ lead protein therapeutic product candidate, KER-050, is an engineered ligand trap comprised of a modified ligand-binding domain of the Transforming Growth Factor-Beta, or TGF-ß, receptor known as activin receptor type IIA that is fused to the portion of the human antibody known as the Fc domain. KER-050 is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes, or MDS, and in patients with myelofibrosis. In October 2020, Keros announced the dosing of the first two participants in its Phase 2 clinical trial evaluating KER-050 for the treatment of anemia and thrombocytopenia in very low-, low-, or intermediate-risk MDS. Keros expects to report initial data from Part 1 of this trial by the end of June 2021. Additionally, Keros plans to commence an open-label Phase 2 clinical trial evaluating KER-050 for the treatment of patients with myelofibrosis-associated cytopenias in the third quarter of 2021 and expects to report initial data from this trial in 2022.

On May 12, 2021 Sysmex reported that (Press release, Sysmex, MAY 12, 2021, View Source [SID1234580139])

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1. Consolidated Results for the Year Ended March 31, 2021
(2) Financial condition
(3) Cash flows

2. Dividend

3. Financial Forecast for the Year Ending March 31, 2022

4. Other Information

(1) Changes in significant consolidated subsidiaries (which resulted in changes in scope of consolidation):
No (2) Changes in accounting policies and accounting estimates

1) Changes in accounting policies required by IFRS:

No 2) Other changes in accounting policies:

No 3) Changes in accounting estimates:

No (3) Number of outstanding stock (common stock)

1) Number of outstanding stock at the end of each fiscal period (including treasury stock): 209,443,232 shares as of Mar. 31, 2021; 209,266,432 shares as of Mar. 31, 2020 2) Number of treasury stock at the end of each fiscal period: 446,876 shares as of Mar. 31, 2021; 446,680 shares as of Mar. 31, 2020 3) Average number of outstanding stock for each period (cumulative): 208,905,283 shares for the year ended Mar. 31, 2021 208,755,623 shares for the year ended Mar. 31, 2020

1. Overview of operating performance

1) Operating performance during the year Future-related information contained in the text below is based on the judgement as of the end of the fiscal period under review. During the fiscal year ended March 31, 2021, economic activity in Japan was in dire straits as a result of the COVID-19 pandemic, which sharply reduced personal consumption and caused corporate earnings to deteriorate. Thereafter, the situation began to improve due to gradual increases in the level of socioeconomic activity and the results of various government policies.

However, this was followed by a resurgence in infections and state of emergency declarations, and the outlook remains unclear. Overseas, increasingly serious COVID-19 outbreaks have prompted major cities to impose lockdowns and regulations against going out, substantially hampering economic activity. Thereafter, various government-imposed financial measures are leading to gradual recovery. That said, with no end to the pandemic in sight, the outlook remains opaque. On the healthcare front, Japan’s medical and healthcare field is expected to remain robust due to an aging society and increasingly diverse health and medical needs, which will drive up demand. Also, the Japanese government is positioning this field as part of an economic growth strategy.

Looking overseas, in developed countries efforts are underway to raise the efficiency of healthcare as populations age. Meanwhile, in emerging markets economic development is prompting an increase in demand for healthcare and the need for healthcare quality and service enhancement. Furthermore, the rapid application of artificial intelligence (AI), information communication technology (ICT) and other leading-edge technologies to the healthcare field are expected to sustain future growth.

The global COVID-19 pandemic has also prompted considerations about healthcare systems and the potential for major changes in the healthcare environment itself. As a result, further opportunities for growth is anticipated. Against this backdrop, Sysmex continued to develop its product portfolio in the hematology field. We launched two automated hematology analyzers in Japan, the XR Series (a next-generation flagship model) and the XQ series (a compact three-part WBC differential model). We will continue with a global sales rollout after receiving regulatory approval in individual countries.

We aim to continue expanding our product portfolio in the hematology field to help optimize operations at testing laboratories based on the regional characteristics and facilities’ needs. In the hemostasis field, we launched CN-6500/CN-3500 automated blood coagulation analyzers in Japan, which offer enhanced efficiency and quality. We renewed our global alliance in hemostasis products with Siemens Healthcare Diagnostics Inc. including review of products and territories, to step up sales of our CN Series automated blood coagulation analyzer and we will continue to offer extensive solutions to customers in regions throughout the world. In the life science field, Sysmex had received health insurance coverage for its gene mutation analysis set for cancer genome profiling (OncoGuide NCC Oncopanel System), becoming the first such system in Japan to receive this coverage. We received approval for partial changes to our manufacturing and marketing approval for this system. it has become possible to detect mutations and copy number alterations of 124 genes, fusions of 13 genes, and microsatellite instability (MSI).

The system will thus provide more detailed genetic information to help doctors decide treatment strategies, including diagnosis and selection of anti-cancer drugs. Medicaroid Corporation, a joint venture between Sysmex and Kawasaki Heavy Industry, Ltd., received manufacturing and marketing approval for hinotori Surgical Robot System, the first made-in-Japan robotic-assisted surgery system. As the global general distributor, Sysmex commenced sales of hinotori to medical institutions in Japan, starting with urology departments. We are working with Medicaroid to obtain regulatory approval overseas, and will begin introducing the system in overseas markets, as well. To help stem the increase in COVID-19 infections, we introduced reagent that can be used in conjunction with HISCL-5000/HISCL-800 automated immunoassay systems to detect the presence of coronavirus antigens that cause COVID-19, as well as reagent that can help in detecting the risk of COVID-19 cases worsening. Sysmex remains committed to contributing toward the research and establishment of diagnosis/treatment methods for COVID-19 by way of diverse testing, including PCR tests, antigen tests, antibody tests and cytokine tests, as well as existing hematology-3-and coagulation tests.