1. LEXINGTON, Mass., Sept. 02, 2021 (GLOBE NEWSWIRE) -- 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, today announced that Keros' President and Chief Executive Officer Jasbir S. Seehra, Ph.D., will participate in two upcoming healthcare conferences.

    Presentation Details:

    Event: Morgan Stanley 19th Annual Global Healthcare Conference
    Date/Time: Friday, September 10 at 11:00 AM ET
    Format: Fireside Chat

    Event: H.C. Wainwright 23rd Annual Global Investment Conference
    Date/Time: Available on Monday, September 13 starting at…

    LEXINGTON, Mass., Sept. 02, 2021 (GLOBE NEWSWIRE) -- 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, today announced that Keros' President and Chief Executive Officer Jasbir S. Seehra, Ph.D., will participate in two upcoming healthcare conferences.

    Presentation Details:

    Event: Morgan Stanley 19th Annual Global Healthcare Conference

    Date/Time: Friday, September 10 at 11:00 AM ET

    Format: Fireside Chat

    Event: H.C. Wainwright 23rd Annual Global Investment Conference

    Date/Time: Available on Monday, September 13 starting at 7:00 AM ET

    Format: Corporate Presentation

    The Morgan Stanley fireside chat presentation will be webcast live at https://morganstanley.webcasts.com/starthere.jsp?ei=1488923&tp_key=f6a26a9322 and the H.C. Wainwright presentation will be available at https://journey.ct.events/view/2af63db8-a98e-40f7-bb4e-4fc6d4b18ba0. Both will be archived in the Investors section of the Keros website at https://ir.kerostx.com/. A replay will be available for 90 days following the conclusion of the event.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Investor Contact:

    Mike Biega

    mbiega@soleburytrout.com 

    (617) 221-9660



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  2. LEXINGTON, Mass., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today provided a business update and reported financial results for the quarter ended June 30, 2021.

    "We have made substantial progress over the past quarter, including announcing our preliminary results from our Phase 2 clinical trial of KER-050," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "We continue to make notable progress advancing our pipeline, and remain focused on the…

    LEXINGTON, Mass., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today provided a business update and reported financial results for the quarter ended June 30, 2021.

    "We have made substantial progress over the past quarter, including announcing our preliminary results from our Phase 2 clinical trial of KER-050," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "We continue to make notable progress advancing our pipeline, and remain focused on the execution of our near-term development plans. In that regard, we remain on track to initiate several clinical trials for KER-050, KER-047 and KER-012 over the balance of 2021."

    Recent Corporate Highlights:

    • Executive leadership changes: In August 2021, the Company announced that Simon Cooper, M.B.B.S., has been appointed to serve as the Company's Chief Medical Officer, effective as of August 2, 2021. Dr. Cooper succeeded Claudia Ordonez, M.D., who departed from the Chief Medical Officer position effective July 30, 2021. Dr. Ordonez will provide consulting services to the Company until September 15, 2021.
    • Issuance of Keros foundational U.S. patent: In May 2021, the United States Patent and Trademark Office issued U.S. Patent No. 11,013,785, which is a composition of matter patent directed to novel therapeutic proteins, including KER-050, that contains 20 claims and expires in November 2037.

    Recent Program Highlights:

    • KER-050 for the treatment of ineffective hematopoiesis to address cytopenias
      • In June 2021, Keros announced preliminary results from Cohorts 1 and 2 (0.75 mg/kg and 1.5 mg/kg) of Part 1 of its Phase 2 clinical trial evaluating KER-050 in patients with myelodysplastic syndromes. Following Safety Review Committee recommendation, dosing for Cohort 3 of the trial was initiated at 2.5 mg/kg of KER-050, to be administered once every four weeks for 12 weeks.
      • The Company expects to report additional Part 1 data and initiate Part 2 of the trial by the end of 2021.

    Second Quarter 2021 Financial Results

    Keros reported a net loss of $15.6 million in the second quarter of 2021 as compared to a net loss of $10.8 million in the second quarter of 2020. The increase in net loss for the second quarter was largely due to increased research and development efforts as well as additional infrastructure expenses

    to support our operations as a publicly traded company.

    Research and development expenses were $10.0 million for the second quarter of 2021 as compared to $7.3 million for the same period in 2020. The increase of $2.7 million was primarily due to additional research and development efforts, manufacturing activities, and personnel expenses to support the advancement of our pipeline.

    General and administrative expenses were $5.7 million for the second quarter of 2021 as compared to $3.7 million for the same period in 2020. The increase of $2.0 million was primarily due to increase in personnel expenses and other external expenses to support Keros' organizational growth.

    Keros' cash and cash equivalents as of June 30, 2021 was $237.1 million compared to $265.9 million as of December 31, 2020. Keros expects that the cash and cash equivalents it had on hand at June 30, 2021 will fund its operating expenses and capital expenditure requirements into the fourth quarter of 2023.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and timing of its preclinical studies and clinical trials for KER-050, KER-047 and KER-012; the potential impact of COVID-19 on Keros' ongoing and planned preclinical studies, clinical trials, business and operations; and Keros' expected cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and risks relating to the impact on Keros' business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 6, 2021, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Mike Biega

    mbiega@soleburytrout.com

    617-921-966



    KEROS THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except share and per share data)

    (Unaudited)

     THREE MONTHS ENDED

    JUNE 30,
     SIX MONTHS ENDED

    JUNE 30,
    2021 2020 2021 2020
    REVENUE:       
    License revenue$100   $   $100   $  
    Total revenue100      100     
    OPERATING EXPENSES:       
    Research and development(9,983)  (7,264)  (21,478)  (15,791) 
    General and administrative(5,658)  (3,650)  (9,932)  (5,627) 
    Total operating expenses(15,641)  (10,914)  (31,410)  (21,418) 
    LOSS FROM OPERATIONS(15,541)  (10,914)  (31,310)  (21,418) 
    OTHER INCOME (EXPENSE), NET       
    Interest expense, net(1)  (1)  (2)  (3) 
    Change in fair value of preferred stock tranche obligation         (1,490) 
    Other income (expense), net(80)  158   (145)  90  
    Total other income (expense), net(81)  157   (147)  (1,403) 
    Loss before income taxes(15,622)  (10,757)  (31,457)  (22,821) 
    Income tax (provision) benefit      (50)  172  
    Net loss$(15,622)  $(10,757)  $(31,507)  $(22,649) 
    Net loss attributable to common stockholders—basic and diluted$(15,622)  $(10,963)  $(31,507)  $(23,661) 
    Net loss per share attributable to common stockholders—basic and diluted$(0.67)  $(0.62)  $(1.35)  $(2.35) 
    Weighted-average common stock outstanding—basic and diluted23,305,673   17,623,994   23,267,943   10,054,026  
                    

    KEROS THERAPEUTICS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands, except share and per share data)

    (Unaudited)

     JUNE 30,

    2021
     DECEMBER 31,

    2020
    ASSETS   
    CURRENT ASSETS:   
    Cash and cash equivalents237,113   265,876  
    Accounts receivable100     
    Prepaid expenses and other current assets4,204   1,850  
    Total current assets241,417   267,726  
    Operating lease right-of-use assets676   878  
    Property and equipment, net1,253   724  
    Restricted cash115   115  
    TOTAL ASSETS243,461   269,443  
    LIABILITIES AND STOCKHOLDERS' EQUITY    
    CURRENT LIABILITIES:   
    Accounts payable1,372   2,149  
    Current portion of operating lease liabilities449   423  
    Accrued expenses and other current liabilities5,710   4,612  
    Total current liabilities7,531   7,184  
    Operating lease liabilities, net of current portion242   476  
    Other liabilities32   62  
    Total liabilities7,805   7,722  
    STOCKHOLDERS' EQUITY:   
    Common stock, par value of $0.0001 per share; 200,000,000 authorized as of June 30, 2021 and December 31, 2020, respectively; 23,328,771 and 23,192,866 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively2   2  
    Additional paid-in capital332,172   326,730  
    Accumulated deficit(96,518)  (65,011) 
    Total stockholders' equity235,656   261,721  
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY243,461   269,443  



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  3. LEXINGTON, Mass., Aug. 02, 2021 (GLOBE NEWSWIRE) -- 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, today announced the appointment of Simon Cooper, M.B.B.S, as Keros' Chief Medical Officer, effective as of August 2, 2021.

    "We are pleased to welcome Dr. Cooper to Keros as Chief Medical Officer," said Jasbir S. Seehra, Ph.D., Chief Executive Officer of Keros. "As we continue to advance our clinical pipeline, we will benefit tremendously from his clinical and development experience, as well as his deep understanding…

    LEXINGTON, Mass., Aug. 02, 2021 (GLOBE NEWSWIRE) -- 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, today announced the appointment of Simon Cooper, M.B.B.S, as Keros' Chief Medical Officer, effective as of August 2, 2021.

    "We are pleased to welcome Dr. Cooper to Keros as Chief Medical Officer," said Jasbir S. Seehra, Ph.D., Chief Executive Officer of Keros. "As we continue to advance our clinical pipeline, we will benefit tremendously from his clinical and development experience, as well as his deep understanding of the regulatory landscape."

    Dr. Cooper joins Keros Therapeutics after most recently serving as the Senior Vice President, Chief Medical Officer of Kadmon Holdings, Inc. Prior to that, Dr. Cooper served as Chief Medical Officer of Anokion SA, a private biopharmaceutical company, from January 2019 to February 2021. From May 2016 to December 2018, Dr. Cooper served as Asset Strategy Leader at AbbVie Inc. From July 2014 to May 2016, Dr. Cooper served as Vice President, Global Project Head, Immunology and Inflammation, at Sanofi S.A. From November 2012 to July 2014, Dr. Cooper served as Global Program Medical Director at Novartis International AG. Prior to that, Dr. Cooper served as Executive Director, Clinical Research at Human Genome Sciences. Earlier in his career, Dr. Cooper worked in various clinical research positions at MedIumme Ltd., Roche, Napp Pharmaceutical Research Limited, Wyeth Research and Medeval Limited. Dr. Cooper received an M.B.B.S. from University of Newcastle upon Tyne in the United Kingdom before undertaking his higher medical training in Oxford, UK.

    "Keros has made meaningful progress toward advancing its pipeline of novel therapeutics that target the Transforming Growth Factor-Beta superfamily for the treatment of patients in significant areas of unmet need," said Dr. Cooper. "I'm excited for the potential of KER-050, particularly given the Company's preclinical data demonstrating its ability to potentially target early through terminal stages of erythropoiesis. I look forward to guiding KER-050, KER-047, KER-012 and future programs through and into the clinic and making an important contribution to Keros' future success."

    Dr. Cooper is succeeding Claudia Ordonez, M.D., who will be pursuing other opportunities. Dr. Ordonez will provide consulting services to Keros until September 15, 2021. "We extend our gratitude to Dr. Ordonez for the pivotal role she played in advancing KER-050 into a Phase 2 clinical trial and helping transform Keros Therapeutics into a publicly-traded biopharmaceutical company with a promising clinical pipeline," continued Dr. Seehra.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Investor Contact:

    Mike Biega

    mbiega@soleburytrout.com

    617-921-9660



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  4. LEXINGTON, Mass., June 22, 2021 (GLOBE NEWSWIRE) -- 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, today announced preliminary results from Cohorts 1 and 2 of its Phase 2 clinical trial evaluating KER-050 for the treatment of anemia and thrombocytopenia in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes ("MDS") who either have ring sideroblasts ("RS positive") or do not have ring sideroblasts ("non-RS") and who either have or have not previously received treatment with an erythroid stimulating…

    LEXINGTON, Mass., June 22, 2021 (GLOBE NEWSWIRE) -- 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, today announced preliminary results from Cohorts 1 and 2 of its Phase 2 clinical trial evaluating KER-050 for the treatment of anemia and thrombocytopenia in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes ("MDS") who either have ring sideroblasts ("RS positive") or do not have ring sideroblasts ("non-RS") and who either have or have not previously received treatment with an erythroid stimulating agent.

    The ongoing trial is designed as an open-label, two-part, multiple ascending dose trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of KER-050 in patients with MDS. As of May 14, 2021 (the "data cut-off date"), 12 patients had received at least one dose of KER-050, nine of whom had completed eight weeks of treatment. Patients in Cohort 1 and 2 received 0.75 mg/kg and 1.5 mg/kg doses of KER-050, respectively, once every four weeks for 12 weeks. Preliminary results from Cohorts 1 and 2 of the trial, as of the data cut-off date, include:

    • Five patients that completed eight weeks of treatment with KER-050 as of the data cut-off date met at least one of the following endpoints:
      • Increase in hemoglobin ≥ 1.5 g/dL for eight weeks, or
      • 50% reduction in transfusion requirements over eight weeks, or
      • Transfusion independence for at least eight weeks.
    • Observed increases in reticulocytes, hemoglobin and platelets.
    • Observed clinically meaningful reductions in transfusion burden in both RS positive and non-RS patients that required transfusions at baseline (≥2 red blood cell units over eight weeks).
    • Three patients that completed eight weeks of treatment with KER-050 as of the data cut-off date achieved transfusion independence for at least eight weeks.

    As of the data cut-off date, KER-050 was well tolerated in Cohorts 1 and 2 of this trial. No drug-related serious adverse events ("SAEs") were reported. There were four treatment-emergent SAEs reported, all of which were deemed unrelated to study drug, including anemia, febrile illness, pneumonia and death. Two patients withdrew from the trial prior to completing eight weeks of treatment with KER-050, one due to death deemed unrelated to study drug and one patient withdrew consent. There was one observed treatment-related adverse event of maculopapular rash that was moderate in severity.

    "These preliminary results are encouraging, as we observed increases in hematological parameters in the two lowest Part 1 dose cohorts, dosed monthly, in both RS positive and non-RS patients with MDS," said Jasbir S. Seehra, Ph.D., Chief Executive Officer of Keros. "We believe these initial results demonstrate proof-of-concept of KER-050 in patients with very low-, low- to intermediate-risk MDS, and support the potential of KER-050 as a treatment for diseases associated with ineffective hematopoiesis."

    Following Safety Review Committee recommendation, dosing for Cohort 3 of the trial was initiated at 2.5 mg/kg of KER-050, to be administered once every four weeks for 12 weeks. Keros expects to report additional Part 1 data and initiate Part 2 of the trial by the end of 2021.

    Additionally, based on these preliminary results as of the data cut-off date, Keros plans to extend the treatment duration of the trial from 12 weeks to up to two years to define response rate following six months of treatment with KER-050 and to confirm durability of response. Keros also intends to update the protocol to increase the size of Part 2 of the trial to confirm response rates and to help guide the design of the expected registration program. Keros expects to share the Part 2 trial design by the end of 2021.

    Conference Call and Webcast

    Keros will host a conference call and webcast on Wednesday, June 23, 2021 at 8:00 AM EDT to review the preliminary results from the KER-050 Phase 2 clinical trial. The conference call will be webcast live at https://edge.media-server.com/mmc/p/pnjzf86g. The live teleconference may be accessed by dialing (833) 528-0563 (domestic) or (830) 221-9673 (international) and entering conference ID: 1889520. An archived version of the call will be available in the Investors section of the Keros website at https://ir.kerostx.com/ for 90 days following the conclusion of the call.  

    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 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.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and the design, objectives and timing of its clinical trials for KER-050; and the potential of KER-050 to treat patients with MDS and diseases associated with ineffective hematopoiesis. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 6, 2021, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Mike Biega

    mbiega@soleburytrout.com

    617-921-966



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    • Multiple poster presentations demonstrate that ALK2 inhibition lowered hepcidin levels and improved iron homeostasis in preclinical models of anemia and iron overload.
    • Poster presentation demonstrates that KER-050 had effects on multiple stages of erythroblast maturation (both early- and late-stage) and increased circulating erythropoietin in preclinical models. The observed rapid and durable effects on erythropoiesis provide continued support for KER-050 as a potential treatment for ineffective hematopoiesis in myelodysplastic syndromes ("MDS") and myelofibrosis.

    LEXINGTON, Mass., June 11, 2021 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros") (NASDAQ:KROS), a clinical-stage biopharmaceutical company focused on the discovery, development…

    • Multiple poster presentations demonstrate that ALK2 inhibition lowered hepcidin levels and improved iron homeostasis in preclinical models of anemia and iron overload.

    • Poster presentation demonstrates that KER-050 had effects on multiple stages of erythroblast maturation (both early- and late-stage) and increased circulating erythropoietin in preclinical models. The observed rapid and durable effects on erythropoiesis provide continued support for KER-050 as a potential treatment for ineffective hematopoiesis in myelodysplastic syndromes ("MDS") and myelofibrosis.

    LEXINGTON, Mass., June 11, 2021 (GLOBE NEWSWIRE) -- 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, today presented data from the ALK2 and KER-050 hematology programs at the European Hematology Association EHA2021 Virtual Congress held from June 9 through June 17, 2021.

    "We are pleased to be able to present multiple posters at this year's EHA2021 Virtual Congress. Our preclinical studies continue to elucidate the relationship between ALK2 inhibition, hepcidin and serum iron. These data support that ALK2 inhibition may be a potential treatment option for indications associated with high hepcidin, including anemia of inflammation ("AI") and iron refractory iron-deficiency anemia ("IRIDA"). In addition, the data suggests that ALK2 inhibition has the potential to mobilize and reduce tissue iron in diseases of iron overload," said Jasbir S. Seehra, Ph.D., Chief Executive Officer of Keros. "We also presented new preclinical data for KER-050 that demonstrated its rapid and durable effects on erythropoiesis and increases in circulating erythropoietin, which we believe provides a strong rationale for investigating KER-050 as a treatment for ineffective hematopoiesis in MDS and myelofibrosis."

    Details of the presentations are as follows:

    Inhibition of ALK2 Through Administration of a Small Molecule Inhibitor Decreased Hepcidin, Increased Serum Iron and Ameliorated Anemia in an Induced Model of Anemia of Inflammation

    • ALK2 is a potential therapeutic target in anemia resulting from chronic inflammation - Abstract Number: EP839

    To induce a model of chronic kidney disease ("CKD"), mice were dosed daily for six weeks with 50 mg/kg of adenine, leading to iron deficiency anemia (37.6% decrease in serum iron; p<0.0001), associated with increased circulating interleukin-6 ("IL6") (2.42-fold; p<0.05) and hepcidin (3.49-fold; p<0.01). After completing the six weeks of adenine-administration, we administered 5 mg/kg of either a selective small molecule ALK2 kinase inhibitor ("KTI-2338"), or vehicle daily for 10 days in the CKD mice, and observed a reversal of the CKD-related changes in the KTI-2338-treated mice. We observed an increase in serum iron (108.2%; p<0.0001), decrease in hepcidin (85.4%; p<0.0001) and improvements in red blood cell ("RBC") count (7.2%; ns), hemoglobin ("HGB") (10.9%; p<0.0001) and hematocrit (10.3%; p<0.05) compared to vehicle. Reticulocyte hemoglobin ("RET-HGB") content, a measure of the incorporation of iron into hemoglobin, increased 9.9% (p<0.01) with KTI-2338 compared to vehicle-treated CKD mice, normalizing to baseline levels.

    These data demonstrate that inhibition of ALK2 improved hematological markers of anemia, serum hepcidin and serum iron levels in a mouse model of AI resulting from chronic kidney disease characterized by elevated IL6, suggesting that targeting ALK2 inhibition could potentially treat anemia arising from high hepcidin.

    Administration of an ALK2 Inhibitor in a Mouse Model of Iron Overload Resulted in Significant Reductions in Liver Non-Heme Iron

    • ALK2 inhibition, a novel therapeutic approach to iron overload - Abstract Number: EP842

    Administration of KTI-2338 reduced circulating hepcidin levels and increased serum iron in wild-type mice after three days of daily dosing. Specifically, we observed a reduction in hepcidin as soon as four hours post the third administration of KTI-2338, which was sustained through 12 hours post-administration, as well as an increase in serum iron eight hours post-administration, which peaked at 16 hours post-administration.

    Mice were dosed daily with 100 mg/kg of iron dextran to induce iron overload and subsequently dosed with either KTI-2338 (5 mg/kg) or vehicle. Mice dosed with iron dextran became iron overloaded and exhibited a substantial 47-fold increase in hepatic iron compared to mice that received vehicle (p<0.0001). Our initial results indicated that, after 63 hours of dosing with KTI-2338, there were significant reductions in liver non-heme iron content (62%). Subsequent analysis using a more selective iron assay confirmed that treatment with KTI-2338 reduced non-heme iron (13.4%) compared to vehicle treated mice (p<0.006).

    These data suggest that, in conditions with iron overload, ALK2 inhibition may potentially be used to remove excess iron from the liver, potentially improving the effectiveness of chelation therapy and excretion.

    Treatment with ALK2 Antibodies to Neutralize the ALK2 Receptor Reduced Serum Hepcidin and Increased Circulating Iron in Non-Human Primates, a Preclinical Model Highly Representative of Human Biology

    • 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

    Keros has developed two fully human antibodies, KTI-016 and KTI-018, that are designed to specifically bind to and neutralize the ALK2 receptor. To determine the pharmacokinetic and pharmacodynamic properties of these antibodies, female cynomolgus monkeys received a single subcutaneous dose (3 mg/kg) of either antibody. Serum drug concentrations and indices of iron and hematology were assessed intermittently over an 8-week period. KTI-016 and KTI-018 were both rapidly absorbed, reached Cmax within 48 hours and had half-lives of 49.1 hours and 33.9 hours, respectively.

    Six hours after administration, KTI-016 and KTI-018 reduced serum hepcidin by 50.3% and 55.6%, respectively. The reduction in hepcidin peaked starting at 48 hours post-administration, at 77.8% in the KTI-016-treated group and 77.2% in the KTI-018-treated group. These decreases remained through day 10 before returning to baseline by day 14. A corresponding increase in circulating iron occurred starting at 24 hours following administration, peaking at 63.9% (p<0.01) and 72.4% (p<0.001) in the KTI-016- and KTI-018-treated groups, respectively. This response was also sustained through day 10, returning to baseline by day 14.

    KTI-016 and KTI-018 were also observed to have comparable effects on increasing RET-HGB, red blood cell hemoglobin ("RBC-HGB") and mean corpuscular hemoglobin concentration ("MCHC") (data from the two antibodies were combined). RET-HGB increased by 4.9% (p<0.001) at 3 days post-dose and remained elevated for at least 10 days. Increases in RBC-HGB content were observed initially at 35 days post-dose, with a 4.2% increase (p<0.0001) at day 56. We also observed increases in MCHC starting at 42 days post-dose, with a 3.7% increase (p<0.001) at day 56.

    We believe iron mobilized by treatment with KTI-016 and KTI-018 was incorporated into hemoglobin, as evidenced by the observed increases in RET-HGB, RBC-HGB and MCHC. Accordingly, these data demonstrate that these antibodies may be a potential treatment for anemias arising from elevated hepcidin, such as IRIDA and AI.

    Preclinical Study of KER-050 Demonstrated Effects on Multiple Stages of Erythroblast Maturation and Increased Circulating Erythropoietin

    • KER-050, an inhibitor of TGF-β superfamily signaling, observed to have a rapid, dynamic, and durable effect on erythropoiesis - Abstract Number: EP758

    Mice treated with a single dose of a research form of KER-050 ("RKER-050") showed rapid and sustained increases in RBCs and HGB, observed from 12 hours (RBCs +8%; p<0.001 and HGB +9%; p<0.005) through day 51 (RBCs + 8% p<0.001), compared to vehicle-treated mice.

    Treatment with RKER-050 also resulted in a dynamic mobilization of erythroblasts from the bone marrow into circulation. At 12 hours post-administration, we observed a 20% reduction in bone marrow ("BM") proerythroblasts that corresponded to a 37% increase in erythroblasts at 24 hours post-administration, which we believe indicates that early progenitors were differentiating into erythroblasts. We also observed an increase in mature erythroblasts, which suggests the differentiation of late-stage progenitors. This maturation of erythroblasts corresponded to an increase in circulating reticulocytes ("RETs") at 12 hours post-administration (+18%; p<0.05), as well as to an increase in RBCs observed at 48 hours post-dose (+8% p<0.0001).

    The initial increase in RETs observed at 12 hours post-administration was reduced (-15%; p<0.05) at 24 hours post-administration, which we believe indicates that RETs matured to RBCs. At 48 hours post-administration, RET numbers returned to vehicle-comparable levels, which we believe indicates that the RET pool was replenished. This data potentially demonstrates that there was a continued progression of erythroblasts through maturation. This increased differentiation and maturation of erythroblast contributed to a sustained upregulation of erythropoiesis at day 14 post-dose.

    In the RKER-050-treated mice, erythropoietin upregulation was not observed until day 4. However, erythropoietin was significantly increased from day 7 (+68%, p<0.0001) through day 37 (4-fold increase, p<0.05) which potentially indicates that erythropoietin has a contributing role in sustaining the RKER-050-mediated increase in RBCs and HGB, compared to vehicle, through at least day 51.

    We believe the observed rapid and durable effect on erythropoiesis via multiple stages of erythroblast maturation (both early- and late-stage) as well as the observed increase in circulating erythropoietin provides a strong rationale for investigating KER-050 as a potential treatment for ineffective erythropoiesis in MDS and myelofibrosis.

    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 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.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and timing of its clinical trials for KER-050; the potential of KER-050 to treat diseases that exhibit defects in different stages of erythropoiesis, including MDS and myelofibrosis; the potential of ALK2 inhibition to treat a variety of indications, including iron overload and anemias that arise from elevated hepcidin, such as IRIDA and AI; and the potential of ALK2 inhibition to improve the effectiveness of chelation therapy and excretion. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 6, 2021, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936



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  5. LEXINGTON, Mass., May 27, 2021 (GLOBE NEWSWIRE) -- 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, today announced that Keros' President and Chief Executive Officer Jasbir S. Seehra, Ph.D., will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 1 at 2:00 PM EST.

    The fireside chat presentation will be webcast live at https://wsw.com/webcast/jeff174/kros/1876041 and archived in the Investors section of the Keros website at https://ir.kerostx.com/. A replay will be available for 90 days following…

    LEXINGTON, Mass., May 27, 2021 (GLOBE NEWSWIRE) -- 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, today announced that Keros' President and Chief Executive Officer Jasbir S. Seehra, Ph.D., will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 1 at 2:00 PM EST.

    The fireside chat presentation will be webcast live at https://wsw.com/webcast/jeff174/kros/1876041 and archived in the Investors section of the Keros website at https://ir.kerostx.com/. A replay will be available for 90 days following the conclusion of the event.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936



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    View Full Article Hide Full Article
  6. LEXINGTON, Mass., May 25, 2021 (GLOBE NEWSWIRE) -- 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, today announced that the United States Patent and Trademark Office ("USPTO") has issued U.S. Patent No. 11,013,785 ("the '785 patent"). The '785 patent is a composition of matter patent directed to novel therapeutic proteins, including KER-050. The '785 patent contains 20 claims and expires no earlier than November 2037.

    "We are very pleased to have this foundational patent issued, which is the first for the Company's…

    LEXINGTON, Mass., May 25, 2021 (GLOBE NEWSWIRE) -- 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, today announced that the United States Patent and Trademark Office ("USPTO") has issued U.S. Patent No. 11,013,785 ("the '785 patent"). The '785 patent is a composition of matter patent directed to novel therapeutic proteins, including KER-050. The '785 patent contains 20 claims and expires no earlier than November 2037.

    "We are very pleased to have this foundational patent issued, which is the first for the Company's wholly-owned internal programs and is a validation of the differentiated approach that we are taking to develop new product candidates," said Jasbir S. Seehra, Ph.D., Chief Executive Officer of Keros. "We will continue to strengthen our patent portfolio to support our discovery efforts and protect our expanding pipeline of wholly-owned assets for the treatment of hematological and musculoskeletal diseases."

    Keros has an extensive intellectual property portfolio covering KER-050, KER-047 and KER-012, in addition to multiple preclinical assets in the Company's pipeline.

    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 TGF-β 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.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the TGF-β family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its ability to strengthen its patent portfolio to support its discovery efforts and protect its expanding pipeline. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 6, 2021, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936



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  7. LEXINGTON, Mass., May 14, 2021 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced results from a preclinical study of KER-012 on pulmonary and cardiac dysfunction in an established rodent model of pulmonary arterial hypertension ("PAH") at the virtual American Thoracic Society International Conference held May 14 through 19, 2021. Additional data from a previously conducted nonclinical study in cynomolgus monkeys was also included in the presentation.

    KER-012 prevented

    LEXINGTON, Mass., May 14, 2021 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced results from a preclinical study of KER-012 on pulmonary and cardiac dysfunction in an established rodent model of pulmonary arterial hypertension ("PAH") at the virtual American Thoracic Society International Conference held May 14 through 19, 2021. Additional data from a previously conducted nonclinical study in cynomolgus monkeys was also included in the presentation.

    KER-012 prevented markers of inflammation and fibrosis, and vascular remodeling in a rodent PAH model and did not alter red blood cell number in rats or non-human primates.

    • RKER-012, a Novel Activin Receptor Type IIB (ActRIIB) Ligand Trap, Reduced Cardiopulmonary Pathology in a Rodent Model of Pulmonary Arterial Hypertension

    Keros combined administration of SUGEN5416, a tyrosine kinase inhibitor of vascular endothelial growth factor receptors 1/2, with exposure to chronic hypoxia to recapitulate the biology in PAH. A research form of KER-012 ("RKER-012") was tested in this SUGEN/hypoxia ("SH") rat model of PAH. Adult male rats were subjected to SH and received either vehicle or 10 mg/kg RKER-012 twice weekly for four weeks. Rats maintained under normal oxygen conditions ("normoxic controls") received only vehicle.

    Consistent with enhanced pulmonary vascular remodeling and cardiac fibrosis, vehicle-treated SH rats showed significantly greater right ventricle plasminogen activator inhibitor-1 ("PAI-1") expression (+236.7%; p<0.05), α-smooth muscle actin ("α-SMA") expression (+255.4%; p<0.05) and increased arterial wall thickness (+43.8%, p<0.001), relative to normoxic controls. Treatment with RKER-012 reduced heart PAI-1 expression and lung α-SMA to levels equivalent to normoxic controls and reduced arterial wall thickness, which Keros believes suggests that KER-012 could potentially prevent the progression of PAH.

    Additionally, vehicle-treated SH rats had significantly greater neutrophil number (+139.2%; p<0.01) relative to normoxic controls. Treatment with RKER-012 reduced neutrophils to levels of normoxic controls, indicating a reduction in PAH-associated inflammation. There was no effect of SH or RKER-012 on either white blood cells or lymphocytes.

    Finally, vehicle-treated SH rats had significantly greater Fulton index, which measures enlargement of the right ventricle (+21.7; p<0.0001), as well as trends for increased atrial natriuretic peptide ("ANP") (+172.8%; p=0.18) and B-type natriuretic peptide ("BNP") (+38.7%; p=0.057), relative to normoxic controls. Treatment with RKER-012 reduced Fulton Index to control levels, and reduced ANP and BNP expression to levels below controls, which Keros believes indicates that KER-012 could potentially reduce PAH-induced damage to the heart.

    RKER-012 did not increase red blood cell number in the SH rats, relative to either vehicle-treated SH rats or normoxic controls. Similarly, KER-012 did not increase red blood cells in healthy naïve non-human primates, a model highly translatable to humans.

    "The Keros team is presenting exciting data on our KER-012 program at ATS. PAH is associated with imbalanced signaling in the transforming growth factor-beta ("TGF-ß") pathway, and the results of this study suggest that KER-012 prevented disease progression in this PAH model, which we believe supports our hypothesis that rebalancing signaling by inhibiting certain ligands may provide benefit in PAH," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. "Additionally, treatment with KER-012 did not increase red blood cells in both rats and nonhuman primates, which can result from inhibition of this pathway. We believe that the current study supports that KER-012 has the potential to treat PAH in patients without dose-limiting increases in red blood cells."

    About KER-012

    KER-012 is designed to bind to and inhibit the signaling of TGF-ß ligands, including activin A and activin B, which are key regulators of bone remodeling that act to suppress bone growth. Keros believes that KER-012 has the potential to increase the signaling of bone morphogenic protein ("BMP") pathways through this inhibition of activin A and activin B signaling, and consequently treat diseases such as PAH that are associated with reduced BMP signaling due to inactivating mutations in the BMP receptors. KER-012 is being developed for the treatment of disorders associated with bone loss, such as osteogenesis imperfecta and osteoporosis, and for the treatment of PAH.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: the potential of KER-012 to treat diseases such as PAH without dose-limiting increases in red blood cells. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; Keros' ability to enter into new collaborations; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 6, 2021, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936



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    View Full Article Hide Full Article
  8. LEXINGTON, Mass., May 12, 2021 (GLOBE NEWSWIRE) -- 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, today announced 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"), to be held as a virtual event from June 9-17, 2021.

    "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…

    LEXINGTON, Mass., May 12, 2021 (GLOBE NEWSWIRE) -- 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, today announced 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"), to be held as a virtual event from June 9-17, 2021.

    "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.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and timing of its clinical trials for KER-050; the potential of KER-050 to treat diseases that exhibit defects in different stages of erythropoiesis; the potential of ALK2 inhibition to treat anemias; and Keros' presentation plans for the upcoming EHA virtual annual meeting. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 6, 2021, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936



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  9. LEXINGTON, Mass., May 06, 2021 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today provided a business update and reported financial results for the quarter ended March 31, 2021.

    "As we maintain hope that the world has begun to turn the corner on the ongoing COVID-19 pandemic, we look forward to the upcoming year for Keros. The first quarter of 2021 provided a strong start, both operationally and from a financial position," said Jasbir S. Seehra, Ph.D., President and Chief Executive…

    LEXINGTON, Mass., May 06, 2021 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today provided a business update and reported financial results for the quarter ended March 31, 2021.

    "As we maintain hope that the world has begun to turn the corner on the ongoing COVID-19 pandemic, we look forward to the upcoming year for Keros. The first quarter of 2021 provided a strong start, both operationally and from a financial position," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "We are continuing to enroll patients for our open-label Phase 2 clinical trial of KER-050 in patients with myelodysplastic syndromes, and we remain on track to report the initial data from Part 1 of that trial in mid-2021. We are also progressing towards the expected initiation of three additional Phase 2 clinical trials this year, one evaluating KER-050 and two evaluating KER-047, and are generating exciting preclinical data to both support our clinical efforts and expand our early pipeline."

    Recent Highlights:

    • KER-012 for the treatment of disorders associated with bone loss and for the treatment of pulmonary arterial hypertension
      • Keros will present data from a preclinical study of a research form of KER-012 on pulmonary and ventricular dysfunction in an established model of pulmonary arterial hypertension at the American Thoracic Society International Conference, to be held virtually May 14-19, 2021.

    First Quarter 2021 Financial Results

    Keros reported a net loss of $15.9 million in the first quarter of 2021 as compared to a net loss of $11.9 million in the first quarter of 2020. The increase in net loss for the first quarter was largely due to increased research and development efforts as well as the infrastructure to support operations as a publicly traded company.

    Research and development expenses were $11.5 million for the first quarter of 2021 as compared to $8.5 million for the same period in 2020. The increase of $3.0 million was primarily due to additional preclinical and manufacturing activities related to KER-012, as well as an increase in personnel expenses, including additional share-based compensation cost, to support the advancement of our pipeline.

    General and administrative expenses were $4.3 million for the first quarter of 2021 as compared to $2.0 million for the same period in 2020. The increase of $2.3 million was primarily due to increase in personnel expenses, which includes share-based compensation cost, to support Keros' organizational growth as well as expenses related to our directors and officers insurance.

    Keros' cash and cash equivalents as of March 31, 2021 was $255.2 million compared to $265.9 million as of December 31, 2020. Keros expects that the cash and cash equivalents it had on hand at March 31, 2021 will fund its operating expenses and capital expenditure requirements into the fourth quarter of 2023.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and timing of its preclinical studies and clinical trials for KER-050 and KER-047; the potential impact of COVID-19 on Keros' ongoing and planned preclinical studies, clinical trials, business and operations; Keros' plans to present preclinical data at an upcoming conference; and Keros' expected cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and risks relating to the impact on Keros' business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Annual Report on Form 10-K, filed with the SEC on March 25, 2021, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936



    KEROS THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except share and per share data)

    (Unaudited)

     THREE MONTHS ENDED

    MARCH 31,
     2021 2020
    OPERATING EXPENSES:   
    Research and development(11,495)  (8,527) 
    General and administrative(4,274)  (1,977) 
    Total operating expenses(15,769)  (10,504) 
    LOSS FROM OPERATIONS(15,769)  (10,504) 
    OTHER EXPENSE, NET   
    Interest expense, net(1)  (2) 
    Change in fair value of preferred stock tranche obligation   (1,490) 
    Other expense, net(65)  (68) 
    Total other expense, net(66)  (1,560) 
    Loss before income taxes(15,835)  (12,064) 
    Income tax (provision) benefit(50)  172  
    Net loss$(15,885)  $(11,892) 
    Net loss attributable to common stockholders—basic and diluted$(15,885)  $(12,698) 
    Net loss per share attributable to common stockholders—basic and diluted$(0.68)  $(5.11) 
    Weighted-average common stock outstanding—basic and diluted23,229,794   2,484,057  



    KEROS THERAPEUTICS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands, except share and per share data)

    (Unaudited)

     MARCH 31,

    2021
     DECEMBER 31,

    2020
    ASSETS   
    CURRENT ASSETS:   
    Cash and cash equivalents$255,203   $265,876  
    Prepaid expenses and other current assets779   1,850  
    Total current assets255,982   267,726  
    Operating lease right-of-use assets779   878  
    Property and equipment, net854   724  
    Restricted cash115   115  
    TOTAL ASSETS257,730   269,443  
    LIABILITIES AND STOCKHOLDERS' EQUITY    
    CURRENT LIABILITIES:   
    Accounts payable3,008   2,149  
    Current portion of operating lease liabilities436   423  
    Accrued expenses and other current liabilities5,506   4,612  
    Total current liabilities8,950   7,184  
    Operating lease liabilities, net of current portion361   476  
    Other liabilities47   62  
    Total liabilities9,358   7,722  
    STOCKHOLDERS' EQUITY:   
    Common stock, par value of $0.0001 per share; 200,000,000 authorized as of March 31, 2021 and December 31, 2020, respectively; 23,271,494 and 23,192,866 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively2   2  
    Additional paid-in capital329,266   326,730  
    Accumulated deficit(80,896)  (65,011) 
    Total stockholders' equity248,372   261,721  
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY257,730   269,443  


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  10. LEXINGTON, Mass., March 25, 2021 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2020.

    "2020 was a transformative year for Keros, as we continued to make important preclinical and clinical progress across our pipeline and brought the company public," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "While our open-label Phase 2 clinical…

    LEXINGTON, Mass., March 25, 2021 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2020.

    "2020 was a transformative year for Keros, as we continued to make important preclinical and clinical progress across our pipeline and brought the company public," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "While our open-label Phase 2 clinical trial of KER-050 in patients with myelodysplastic syndromes is ongoing, we are also working to initiate three more Phase 2 clinical trials this year: a KER-050 trial in patients with myelofibrosis and two KER-047 trials, one in patients with iron deficiency anemia and one in patients with iron-refractory iron deficiency anemia. Our ability to progress multiple product candidates over the last year reflects the dedication of our team and the potential reach of our discovery approach, particularly given the many challenges resulting from the ongoing COVID-19 pandemic."

    Recent Corporate Highlights:

    • Completed public offering: In November 2020, Keros completed its public offering of 2,990,000 shares of common stock, which included the exercise in full by the underwriters of their option to purchase up to 390,000 additional shares, at a public offering price of $50.00 per share, for aggregate gross proceeds to Keros of $149.5 million. Keros received approximately $140.1 million in net proceeds after deducting underwriting discounts and commissions and offering costs.

    • Strengthened leadership with board appointment: In December 2020, Keros appointed Mary Ann Gray, Ph.D., to its board of directors. Concurrent with Dr. Gray joining Keros' Board of Directors, Alon Lazarus stepped down as a director of the Company.

    Recent Program Highlights:

    • KER-050 for the treatment of ineffective hematopoiesis to address cytopenias:
      • Keros has initiated dosing of the first two cohorts (0.75 mg/kg and 1.5 mg/kg) of Part 1 of its Phase 2 clinical trial evaluating KER-050 in patients with myelodysplastic syndromes. The Company expects to report initial data from Part 1 of this trial in mid-2021.
      • Presented preclinical data at the virtual European School of Haematology ("ESH") 2nd Translational Research E-Conference in March 2021, demonstrating that a research form of KER-050 induced red blood cell production by promoting multiple stages of erythroid differentiation.

    • KER-047 for the treatment of anemia resulting from iron imbalance and for the treatment of fibrodysplasia ossificans progressiva:

      • Presented preclinical data on an ALK2 inhibitor closely related to KER-047 at the March 2021 ESH E-Conference, demonstrating targeted ALK2 inhibition as a potential therapeutic approach to reducing hepcidin and elevating serum iron.
      • Keros expects to initiate two Phase 2 clinical trials of KER-047, one in patients with iron deficiency anemia and one in patients with iron-refractory iron deficiency anemia, in the second half of 2021 and to report initial data from both trials in 2022.

    Selected Anticipated 2021 Corporate Milestones:

    • Report initial data from Part 1 of the Phase 2 clinical trial of KER-050 in patients with myelodysplastic syndromes in mid-2021
    • Initiate a Phase 2 clinical trial of KER-050 in patients with myelofibrosis in mid-2021
    • Initiate two Phase 2 clinical trials of KER-047, one in patients with iron deficiency anemia and one in patients with iron-refractory iron deficiency anemia, in the second half of 2021
    • Initiate a Phase 1 clinical trial of KER-012 in the second half of 2021

    2020 Financial Results

    Keros reported a net loss of $10.7 million for the fourth quarter and $45.4 million for the year ended December 31, 2020, as compared to a net loss of $2.8 million for the fourth quarter and $12.3 million for the year ended December 31, 2019. The increase in net loss for the fourth quarter and the year was largely due to increased research and development efforts as well as the infrastructure to support operations as a publicly traded company.

    Research and development expenses were $9.7 million for the fourth quarter and $33.9 million for the year ended December 31, 2020 as compared to $4.2 million for the fourth quarter and $17.4 million for the year ended December 31, 2019. The increase in research and development expense for the fourth quarter and the year was primarily due to additional preclinical, clinical and manufacturing activities, as well as an increase related to personnel expenses, including additional share-based compensation cost, driven primarily by increased headcount.

    General and administrative expenses were $3.6 million for the fourth quarter and $12.8 million for the year ended December 31, 2020 as compared to $1.1 million and $3.2 million for the year ended December 31, 2019. The increase was primarily due to an increase in personnel expenses to support Keros' organizational growth, additional share-based compensation costs and an increase in professional fees to support Keros' transition to a public company.

    Keros' cash and cash equivalents as of December 31, 2020 was $265.9 million compared to $7.0 million as of December 31, 2019. Keros substantially extended its cash runway, largely by raising $55.8 million in net proceeds from its March 2020 Series C preferred stock offering, $100.1 million in net proceeds from its April 2020 initial public offering and $140.1 million in net proceeds from its November 2020 public offering. Keros expects that the cash and cash equivalents it had on hand at December 31, 2020 will fund its operating expenses and capital expenditure requirements into the fourth quarter of 2023.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and timing of its preclinical studies and clinical trials for KER-050, KER-047 and KER-012, including its regulatory plans; the potential impact of COVID-19 on Keros' ongoing and planned preclinical studies, clinical trials, business and operations; and Keros' expected cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on November 10, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936

    KEROS THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except share and per share data)

    (Unaudited)

     THREE MONTHS ENDED DECEMBER 31, YEAR ENDED DECEMBER 31,
     2020 2019 2020 2019
    REVENUE:       
    Research collaboration revenue$   $2,500   $   $10,000  
    Total revenue$   $2,500   $   $10,000  
    OPERATING EXPENSES:       
    Research and development$(9,674)  $(4,161)  $(33,860)  $(17,379) 
    General and administrative$(3,617)  $(1,067)  $(12,797)  $(3,184) 
    Total operating expenses$(13,291)  $(5,228)  $(46,657)  $(20,563) 
    LOSS FROM OPERATIONS$(13,291)  $(2,728)  $(46,657)  $(10,563) 
    OTHER INCOME (EXPENSE), NET:       
    Interest expense, net$(1)  $(1)  $(6)  $(8) 
    Research and development incentive income$2,460   $   $2,460   $558  
    Change in fair value of preferred stock tranche obligation$   $(78)  $(1,490)  $(2,564) 
    Other income (expense), net$156   $56   $160   $241  
    Total other income (expense), net$2,615   $(23)  $1,124   $(1,773) 
    Loss before income taxes$(10,676)  $(2,751)  $(45,533)  $(12,336) 
    Income tax benefit$   $   $172   $  
    Net loss$(10,676)  $(2,751)  $(45,361)  $(12,336) 
    Net loss attributable to common stockholders—basic and diluted$(10,676)  $(3,201)  $(45,361)  $(14,136) 
    Net loss per share attributable to common stockholders—basic and diluted$(0.49)  $(1.32)  $(2.93)  $(6.08) 
    Weighted-average common stock outstanding—basic and diluted 21,623,123    2,416,387    15,506,397    2,326,857  
            



    KEROS THERAPEUTICS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands, except share and per share data)

    (Unaudited)

     DECEMBER 31,
     2020 2019
        
    ASSETS   
    CURRENT ASSETS:   
    Cash and cash equivalents$265,876   $7,020  
    Prepaid expenses and other current assets1,850   381  
    Deferred initial public offering costs   604  
    Research and development incentive receivable   922  
    Total current assets267,726   8,927  
    Operating lease right-of-use assets878   1,205  
    Property and equipment, net724   708  
    Restricted cash115   115  
    TOTAL ASSETS$269,443   $10,955  
    LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT   
    CURRENT LIABILITIES:   
    Accounts payable$2,149   $2,088  
    Current portion of operating lease liabilities423   376  
    Accrued expenses and other current liabilities4,612   2,022  
    Total current liabilities7,184   4,486  
    Operating lease liabilities, net of current portion476   899  
    Preferred stock tranche liability   4,956  
    Other liabilities62   119  
    Total liabilities7,722   10,460  
    COMMITMENTS AND CONTINGENCIES   
    Series A convertible preferred stock, par value of $0.0001 per share; 0 and 10,000,000 shares authorized as of December 31, 2020 and December 31, 2019, respectively; 0 and 4,607,652 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively; liquidation and redemption value of $0 as of December 31, 2020   9,891  
    Series A-1 convertible preferred stock, par value of $0.0001 per share; 0 and 800,000 shares authorized as of December 31, 2020 and December 31, 2019, respectively; 0 and 368,612 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively; liquidation and redemption value of $0 as of December 31, 2020   944  
    Series B-1 convertible preferred stock, par value of $0.0001 per share; 0 and 3,427,004 shares authorized as of December 31, 2020 and December 31, 2019, respectively; 0 and 1,579,043 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively; liquidation and redemption value of $0 as of December 31, 2020   9,106  
    STOCKHOLDERS' DEFICIT:   
    Common stock, par value of $0.0001 per share; 200,000,000 and 27,000,000 shares authorized as of December 31, 2020 and December 31, 2019, respectively; 23,192,866 and 2,429,705 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively2   1  
    Additional paid-in capital326,730   203  
    Accumulated deficit(65,011)  (19,650) 
    Total stockholders' equity (deficit)261,721   (19,446) 
    TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT$269,443   $10,955  

     



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  11. LEXINGTON, Mass., March 05, 2021 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced results from preclinical studies of KER-050 and the Company's ALK2 inhibitor program at the virtual European School of Haematology (ESH) 2nd Translational Research E-Conference held March 5 through 7, 2021.

    "We are pleased to present preclinical data from our hematology programs at the ESH Translational Research E-Conference. Data from multiple in vivo disease models continue to support…

    LEXINGTON, Mass., March 05, 2021 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced results from preclinical studies of KER-050 and the Company's ALK2 inhibitor program at the virtual European School of Haematology (ESH) 2nd Translational Research E-Conference held March 5 through 7, 2021.

    "We are pleased to present preclinical data from our hematology programs at the ESH Translational Research E-Conference. Data from multiple in vivo disease models continue to support the positive observations in our Phase 1 clinical trials," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. "For KER-050, these data support the observations from our Phase 1 clinical trial in healthy volunteers of a rapid hematological response, which we believe is indicative of effects on terminal differentiation, and a durable response, which we believe is indicative of effects on early precursors. We believe the ability to target multiple stages of erythropoiesis makes KER-050 a potential therapeutic candidate for diseases that cause anemia due to ineffective erythropoiesis, including myelodysplastic syndrome and myelofibrosis. Additionally, data from multiple anemia models recapitulated the increases in serum iron and decreases in serum hepcidin observed in our Phase 1 clinical trial of KER-047 in healthy volunteers, further highlighting the potential therapeutic benefit of ALK2 inhibition in hepcidin-mediated anemia."

    KER-050, a Novel Inhibitor of TGF-β Superfamily Signaling, Induces Red Blood Cell Production by Promoting Multiple Stages of Erythroid Differentiation

    Keros has previously shown that mice treated with a single 10 mg/kg dose of a research form of KER-050 ("RKER-050"), a novel inhibitor of Transforming Growth Factor-Beta superfamily signaling, had increased red blood cells ("RBCs", +7%), hemoglobin ("HGB", +6.7%) and reticulocytes ("RET", +20%) as soon as 12 hours after administration compared to vehicle-treated mice. Keros also observed increases in colony forming unit-erythroid progenitors as soon as Day 2, consistent with an effect on early stages of erythropoiesis, followed by changes in polychromatophilic/early orthochromatic erythroid precursors as soon as Day 4 and late orthochromatic erythroblasts/reticulocytes by Day 7, which is consistent with progression of cells through erythropoiesis.

    A single dose of RKER-050 increased RBCs and HGB through at least Day 51 (+8.5% and +3%, respectively). Concurrently, despite increased erythropoiesis, erythropoietin levels were greater than two-fold higher than controls, starting at Day 4, continuing through Day 37 and returning to baseline by Day 51.

    Keros believes that these results suggest that RKER-050 potentially elicits the combined effects of stimulating terminal maturation of late-stage erythroid precursors to rapidly increase RBCs and potentially mobilizes a prolonged supply of progenitors through expansion of early-stage precursor populations that allows for sustained upregulation of erythropoiesis.

    Targeted ALK2 Inhibition as a Therapeutic Approach to Reducing Hepcidin and Elevating Serum Iron

    Hepcidin is an endocrine regulator of iron metabolism that, when elevated, can decrease levels of iron available for erythropoiesis, resulting in anemia. Keros believes that ALK2 signaling is an integral part of hepcidin-mediated iron mobilization and has previously used an siRNA-based model of iron-refractory iron deficiency anemia ("IRIDA") to demonstrate that administration of either KTI-2338, a small molecule ALK2 kinase inhibitor, or KTI-A2.0MAb, a novel neutralizing ALK2 antibody, in mice can decrease serum hepcidin, resulting in an increase in HGB, hematocrit and serum iron compared to control cohorts receiving vehicle.

    These results have been further explored using a mouse model of anemia of inflammation via induced chronic kidney disease. In this preclinical study, mice were dosed daily for six weeks with 50 mg/kg of adenine to induce kidney damage, and developed inflammation-mediated anemia, with corresponding elevated levels of hepcidin and decreased serum iron. Thereafter, mice continued to receive either vehicle or adenine daily, but also received treatment of either vehicle or 5 mg/kg KTI-2338 daily for 10 days.

    At study termination, mice receiving adenine in combination KTI-2338 had serum iron values 108.2% higher than the vehicle-treated mice receiving adenine and vehicle. Additionally, serum hepcidin was decreased by 85.4% over vehicle-treated mice. These data substantiate the role of ALK2 signaling in anemia arising from high hepcidin and illustrate the potential therapeutic benefit of specific ALK2 inhibition in these diseases, including anemia of inflammation.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: the potential of KER-050 to treat diseases that cause anemia due to ineffective erythropoiesis, including myelodysplastic syndrome and myelofibrosis; the potential of ALK2 inhibition to treat hepcidin-mediated anemias, including anemia of inflammation; and the potential of RKER-050 to stimulate both terminal maturation of late-stage erythroid precursors and expansion of early-stage precursor populations. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on November 10, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936



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  12. LEXINGTON, Mass., March 02, 2021 (GLOBE NEWSWIRE) -- 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, today announced that Keros President and Chief Executive Officer Jasbir S. Seehra, Ph.D. will present at the H.C. Wainwright Global Life Sciences 2021 Virtual Conference.

    The presentation will be available on Tuesday, March 9 starting at 7:00 am ET at https://journey.ct.events/view/0765d266-9f83-4bfb-b12e-dadbd0da9d03 and archived in the Investors section of the Keros website at https://ir.kerostx.com/. A replay will…

    LEXINGTON, Mass., March 02, 2021 (GLOBE NEWSWIRE) -- 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, today announced that Keros President and Chief Executive Officer Jasbir S. Seehra, Ph.D. will present at the H.C. Wainwright Global Life Sciences 2021 Virtual Conference.

    The presentation will be available on Tuesday, March 9 starting at 7:00 am ET at https://journey.ct.events/view/0765d266-9f83-4bfb-b12e-dadbd0da9d03 and archived in the Investors section of the Keros website at https://ir.kerostx.com/. A replay will be available for 90 days following the conclusion of the event.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936

     



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  13. LEXINGTON, Mass., Feb. 17, 2021 (GLOBE NEWSWIRE) -- 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, today announced that Keros's President and Chief Executive Officer Jasbir S. Seehra, Ph.D. will present at the 10th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 24th at 1:40 pm ET.

    The fireside chat presentation will be webcast live at https://wsw.com/webcast/svbleerink47/kros/2684928 and archived in the Investors section of the Keros website at https://ir.kerostx.com/. A replay will be available…

    LEXINGTON, Mass., Feb. 17, 2021 (GLOBE NEWSWIRE) -- 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, today announced that Keros's President and Chief Executive Officer Jasbir S. Seehra, Ph.D. will present at the 10th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 24th at 1:40 pm ET.

    The fireside chat presentation will be webcast live at https://wsw.com/webcast/svbleerink47/kros/2684928 and archived in the Investors section of the Keros website at https://ir.kerostx.com/. A replay will be available for 90 days following the conclusion of the event.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936



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  14. LEXINGTON, Mass., Dec. 21, 2020 (GLOBE NEWSWIRE) -- 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, today announced that is has been selected for addition to the NASDAQ Biotechnology Index® (NASDAQ:NBI). Keros' addition to the NBI will become effective prior to market open on Monday, December 21, 2020.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® that are classified as either biotechnology or pharmaceutical according to the Industry Classification…

    LEXINGTON, Mass., Dec. 21, 2020 (GLOBE NEWSWIRE) -- 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, today announced that is has been selected for addition to the NASDAQ Biotechnology Index® (NASDAQ:NBI). Keros' addition to the NBI will become effective prior to market open on Monday, December 21, 2020.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. All securities in the index are listed on the Nasdaq Global Market or the Nasdaq Global Select Market. The NBI is re-ranked each year and is calculated under a modified capitalization-weighted methodology. More information about the NBI, including eligibility criteria, can be found at www.nasdaq.com.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: the Company's anticipated addition to the NASDAQ Biotechnology Index® and the timing of such inclusion. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Many factors could cause the actual results, performance or achievements that may be expressed or implied by such forward-looking statements to vary from those described herein should one or more of these risks or uncertainties materialize, including those risk factors discussed or referred to in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on November 10, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com 

    646-378-2936



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  15. LEXINGTON, Mass., Dec. 17, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced that it appointed Mary Ann Gray, Ph.D., to its Board of Directors.

    "We are delighted to welcome Dr. Gray to Keros' Board of Directors," said President and Chief Executive Officer Jasbir Seehra, Ph.D. "Her deep experience guiding both growing and commercial-stage companies as a board member, coupled with her scientific and financial acumen, will be a tremendous asset as we continue…

    LEXINGTON, Mass., Dec. 17, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced that it appointed Mary Ann Gray, Ph.D., to its Board of Directors.

    "We are delighted to welcome Dr. Gray to Keros' Board of Directors," said President and Chief Executive Officer Jasbir Seehra, Ph.D. "Her deep experience guiding both growing and commercial-stage companies as a board member, coupled with her scientific and financial acumen, will be a tremendous asset as we continue to further advance multiple assets in the clinic."

    Dr. Gray is President of Gray Strategic Advisors, LLC, a biotechnology strategic planning and advisory firm. Previously, she served as Senior Analyst and Portfolio Manager of Federated Kaufmann Fund, where she focused on both public and private healthcare investments. Prior to Federated Kaufmann Fund, she served as a biotechnology equity research analyst at multiple firms. Earlier in her career, she worked as a senior scientist both at Schering Plough Research and NeoRx Corporation. Dr. Gray currently serves on the boards of BioAtla, Inc., Sarepta Therapeutics, Inc., Seneca Biopharmaceuticals, Inc. and Rapt Therapeutics, Inc. and previously served on the board of many public and private biotechnology companies.

    Dr. Gray holds a B.S. from the University of South Carolina, a Ph.D. in pharmacology from the University of Vermont, and completed her post-doctoral work at Northwestern University Medical School and at the Yale University School of Medicine.

    Concurrent with Dr. Gray joining Keros' Board of Directors, the Company also announced that Alon Lazarus will be stepping down as a director of the Company. Dr. Lazarus has served on Keros' Board of Directors since April 2016. Dr. Seehra commented, "On behalf of the Board and Keros' executive team, I would like to thank Alon for the service he has provided to the company and wish him well in any and all future endeavors."

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Investor Contact:

    Julia Balanova 

    jbalanova@soleburytrout.com

    646-378-2936



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    • Presentation highlights data from Keros' Phase 1 clinical trial of KER-047, which demonstrated robust and sustained dose-related increases in serum iron and transferrin saturation that were associated with decreases in ferritin and hepcidin.
    • Preclinical presentation demonstrates that inhibition of activin receptor-like kinase-2 ("ALK2") signaling through both small molecule and biologic approaches has potentially positive effects on hepcidin-mediated iron deficiency.
    • Additional preclinical presentations demonstrate that KER-050 potentially works at multiple stages of erythroid differentiation and resolved anemia in multiple preclinical models.

    LEXINGTON, Mass., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros") (NASDAQ:KROS

    • Presentation highlights data from Keros' Phase 1 clinical trial of KER-047, which demonstrated robust and sustained dose-related increases in serum iron and transferrin saturation that were associated with decreases in ferritin and hepcidin.
    • Preclinical presentation demonstrates that inhibition of activin receptor-like kinase-2 ("ALK2") signaling through both small molecule and biologic approaches has potentially positive effects on hepcidin-mediated iron deficiency.
    • Additional preclinical presentations demonstrate that KER-050 potentially works at multiple stages of erythroid differentiation and resolved anemia in multiple preclinical models.

    LEXINGTON, Mass., Dec. 07, 2020 (GLOBE NEWSWIRE) -- 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, today announced that it presented data from its Phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effects of ascending dose levels of KER-047 in healthy volunteers and preclinical data evaluating the role of ALK2 inhibition in regulating hepcidin and serum iron at the virtual 62nd American Society of Hematology Annual Meeting and Exposition ("ASH") held December 5 through 8, 2020. In addition, Keros announced preclinical data on the differentiated mechanism of action of KER-050 and its activity in multiple anemia models.

    "We were pleased to present complete data from all cohorts of our Phase 1 first-in-human clinical trial of KER-047, following our initial data announcement on August 4, 2020.   In addition to characterizing the tolerability profile of KER-047 in healthy volunteers across increasing doses and after multiple administrations, we observed rapid, robust and sustained dose-related increases in serum iron and transferrin saturation that were associated with decreases in ferritin and hepcidin. Reticulocyte hemoglobin was also observed to increase, which we believe suggests that the iron mobilized with treatment was incorporated into hemoglobin. Based on these findings, we believe that the differentiated pharmacologic effect of KER-047 on hepcidin and iron mobilization has the potential to treat diseases arising from iron imbalance," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. "In addition, the data from our preclinical studies of KER-050 further elucidate its differentiated mechanism of action and ability to potentially target multiple stages along the spectrum of erythropoiesis and resolve anemia due to multiple causes. These data further support our belief that KER-050 can potentially treat diseases that cause cytopenias due to ineffective hematopoiesis, including myelodysplastic syndromes ("MDS") and myelofibrosis."

    Clinical Data Highlight the Effects of KER-047 on Iron Mobilization

    • Administration of KER-047, a Novel ALK2 Inhibitor, Elicited Robust and Sustained Increases in Serum Iron in Healthy Participants - Publication Number: 769.

    In Part 1 of the Phase 1 first-in-human clinical trial, two formulations of KER-047 were evaluated in single ascending oral doses, ranging from 1 mg to 300 mg of a capsule formulation, and 30 mg to 450 mg of a liquid formulation or placebo. In Part 2 of this trial, the liquid formulation was evaluated in multiple ascending doses (50 mg, 100 mg, 200 mg and 350 mg) of KER-047 or placebo, administered daily for 7 to 14 days.

    In healthy participants, administration of KER-047 elicited rapid, robust and sustained dose-related increases in serum iron and transferrin saturation that were associated with decreases in ferritin, an effect which is consistent with mobilization of iron stores [Figures 1, 2 and 3].Keros also observed decreases in serum hepcidin in Cohorts 1 through 3 of Part 2 of this trial (50 mg, 100 mg and 200 mg dose groups) [Figure 4]. These data were not collected in Part 1 of this trial or in Cohort 4 of Part 2 of this trial (350 mg dose group).

    Additionally, Keros observed a decrease in hepcidin as early as four hours after administration of the first dose in Cohort 5 of Part 2 of this trial (100 mg dose group).

    Keros also observed an increase in reticulocyte hemoglobin in Cohorts 1 through 4 of Part 2 of this trial, starting on Day 4 of treatment [Figure 5].

    We believe the observed decrease in ferritin and hepcidin coupled with the observed increases in reticulocyte hemoglobin content are indicative of increased iron mobilization, resulting in increased iron incorporation into hemoglobin.

    The tolerability profile of KER-047 in healthy participants was characterized in this Phase 1 trial. There were no serious adverse events ("SAEs") in either part of the trial, and the majority of adverse events ("AEs") observed were mild or moderate in severity.  

    In Part 2 of this trial, 10 of 40 (25%) participants administered KER-047 and 1 of 11 (9.1%) participants administered placebo discontinued study drug due to AEs. AEs that led to study drug discontinuation in three or more participants in the KER-047 groups included lymphopenia and chills.   Details on AEs were as follows:

    • Severe AEs were reported in 1 of 8 (12.5%) participants in the 350 mg and 100 mg (Cohort 5) dose groups.
    • AEs reported in two or more participants and more common in the KER-047 groups than placebo were: abdominal discomfort, abdominal pain (upper), chills, decreased appetite, diarrhea, dizziness, fatigue, gastroenteritis, headache, lymphopenia, myalgia, nausea, neutropenia, pyrexia, rhinorrhea, tonsilitis, vomiting.
    • Lymphopenia, which Keros believes is consistent with KER-047's mechanism of action, was observed after multiple doses that was reversible after discontinuation of study drug.

    Photos accompanying this announcement are available at

    https://www.globenewswire.com/NewsRoom/AttachmentNg/030e90e0-609b-4ec7-988c-759ce3ae4486

    https://www.globenewswire.com/NewsRoom/AttachmentNg/1d3af6eb-127a-40f7-b894-f93ec20e39b3

    https://www.globenewswire.com/NewsRoom/AttachmentNg/126f6ad1-d11c-438d-a7b2-ee39a8d3b0c8

    https://www.globenewswire.com/NewsRoom/AttachmentNg/a7d6cde6-40f5-4820-97ea-84780e65f8f3

    https://www.globenewswire.com/NewsRoom/AttachmentNg/fd4f5f2d-36f8-4776-ba5b-84619dfd6772

    Multiple Modalities of ALK2 Inhibition Reduced Hepcidin and Resolved Anemia in IRIDA Model

    • Selective Inhibition of ALK2 Signaling Suppresses Serum Hepcidin and Increases Serum Iron Publication Number: 771

    In an siRNA-based model of iron-refractory iron deficiency anemia ("IRIDA"), administration of either KTI-2338, a small molecule ALK2 kinase inhibitor, or KTI-A2.0MAb, a novel neutralizing ALK2 antibody, resulted in the rescue of hemoglobin ("HGB"), hematocrit ("HCT"), serum hepcidin and serum iron from the disease state. Following treatment, HGB, HCT and serum iron were increased and serum hepcidin was decreased in treated groups compared to control cohorts receiving vehicle.

    These data further show that inhibition of ALK2 signaling via either modality in anemic mice potentially contributes to a decrease in serum hepcidin and an increase in serum iron levels, which we believe suggests that ALK2 signaling is an integral part of hepcidin-mediated iron mobilization, and illustrate the potential therapeutic benefit of ALK2 inhibition (with a small molecule inhibitor or a neutralizing monoclonal antibody) in anemia of high hepcidin, including IRIDA and anemia of inflammation.

    Preclinical Studies of KER-050 Demonstrated Effects on Multiple Stages in the Erythropoiesis Cascade and in Multiple Models of Anemia

    • KER-050, a Modified ActRIIA Ligand Trap, Alleviates Cytopenia Arising from Multiple Etiologies Presentation Number: 2582.

    Administration of a research form of KER-050 ("RKER-050") was shown to alleviate cytopenias caused by multiple conditions:

    • Aged (2-year-old), vehicle-treated mice had significantly lower red blood cells ("RBCs"), HGB and HCT (-14.0%, -13.5%, -10.9%, respectively) relative to 11-week-old young vehicle-treated mice after six weeks of twice weekly treatment. However, aged mice treated with RKER-050 had higher RBCs, HGB and HCT (+12.3%, +10.0%, +9.1%, respectively) compared to aged mice receiving vehicle, with levels indistinguishable from those of young controls.
    • Anemic NUP98-HOXD13 mice (a murine model of MDS) dosed twice weekly with RKER-050 for six weeks had increases in RBCs, HGB and HCT (+10.9%, +11.2%, + 9.8%, respectively), achieving values comparable to the wild-type control animal of the same age, while vehicle-treated MDS mice continued to have significantly reduced RBCs, HGB and HCT.
    • In Sprague-Dawley rats, where anemia was induced by bleeding 20% of total blood volume, treatment with RKER-050 twice weekly showed early and robust increases in both RBCs and HGB that exceeded baseline levels, whereas decreased RBCs and HGB in the vehicle-treated group persisted longer. RKER-050 treatment also resulted in an increase in platelet count at Day 3 post-phlebotomy, which remained elevated at Day 6. 



    • KER-050, a Novel Inhibitor of TGF-β Superfamily Signaling, Induces Red Blood Cell Production by Promoting Multiple Stages of Erythroid Differentiation Presentation Number: 2736. 

    Mice treated with a single 10 mg/kg dose of RKER-050 had increased RBCs, HGB and HCT (+8%, +9%, +7%, respectively) 12 hours after administration compared to vehicle-treated mice. This effect was further increased on Day 7 and persisted to at least Day 14. The following was also observed:

    • A reduction in the number of enucleated erythroid cells in the bone marrow and a parallel increase in the percent of immature reticulocytes ("RET") in peripheral blood, suggesting an increased outflux of RET into circulation.
    • Increases in colony forming unit-erythroid progenitors, which is consistent with an effect on early stages of erythropoiesis.
    • Changes in polyerythrochromatic/early orthochromatic erythroid precursors and late orthochromatic erythroblasts/RETs, which is consistent with progression of cells through erythropoiesis.
    • A greater than two-fold increase in serum levels of erythropoietin ("Epo") at Days 4, 7 and 14.

    Overall, we believe these data demonstrate that KER-050 stimulates terminal maturation of late-stage

    erythroid precursors, expands the early-stage precursor population and progresses precursors

    through erythropoiesis. Additionally, KER-050 was observed to increase Epo concurrent with elevated RBCs.

    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 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 MDS and in patients with myelofibrosis. Keros has initiated a Phase 2 clinical trial in patients with MDS evaluating KER-050 for the treatment of cytopenias, including anemia and thrombocytopenia, and expects to report initial data from Part 1 of this trial in mid-2021. Keros also plans to initiate a Phase 2 clinical trial evaluating KER-050 for the treatment of patients with myelofibrosis-associated cytopenias in 2021.

    About KER-047

    Keros' lead small molecule product candidate, KER-047, is designed to selectively and potently inhibit ALK2, a Transforming Growth Factor-Beta receptor. KER-047 is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva, a rare musculoskeletal disorder. Keros expects to commence two Phase 2 clinical trials of KER-047, one in patients with iron deficiency anemia and one in patients with IRIDA, in 2021.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and timing of its clinical trials for KER-050 and KER-047; the potential of KER-050 to treat multiple cytopenias in diseases of ineffective hematopoiesis; the potential of KER-047 to treat diseases arising from iron imbalance; and the potential of ALK2 inhibition to treat IRIDA and other hepcidin-mediated anemias. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on November 10, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936 



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  16. LEXINGTON, Mass., Nov. 17, 2020 (GLOBE NEWSWIRE) -- 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, today announced the closing of its public offering of 2,990,000 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase up to 390,000 additional shares, at a price to the public of $50.00 per share. The gross proceeds to Keros from the offering, before deducting underwriting discounts and commissions and offering expenses, were $149.5 million. All securities in the offering…

    LEXINGTON, Mass., Nov. 17, 2020 (GLOBE NEWSWIRE) -- 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, today announced the closing of its public offering of 2,990,000 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase up to 390,000 additional shares, at a price to the public of $50.00 per share. The gross proceeds to Keros from the offering, before deducting underwriting discounts and commissions and offering expenses, were $149.5 million. All securities in the offering were sold by Keros.

    Jefferies LLC, SVB Leerink LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. H.C. Wainwright & Co., LLC is acting as co-manager for the offering.

    Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on November 12, 2020. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained by visiting www.sec.gov or from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at Prospectus_Department@Jefferies.com; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at 1-800-808-7525, ext. 6132, or by email at syndicate@svbleerink.com; and Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by e-mail at prospectus@psc.com.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936



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  17. LEXINGTON, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Keros' President and Chief Executive Officer Jasbir S. Seehra, Ph.D. will present at the Jefferies Virtual London Healthcare Conference on Wednesday, November 18th at 9:05 am ET.

    The presentation will be webcast live and archived in the Investors section of the Keros website at https://ir.kerostx.com/. A replay will be available for 90 days following the conclusion of the event.

    About Keros Therapeutics,

    LEXINGTON, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Keros' President and Chief Executive Officer Jasbir S. Seehra, Ph.D. will present at the Jefferies Virtual London Healthcare Conference on Wednesday, November 18th at 9:05 am ET.

    The presentation will be webcast live and archived in the Investors section of the Keros website at https://ir.kerostx.com/. A replay will be available for 90 days following the conclusion of the event.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936



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  18. LEXINGTON, Mass., Nov. 12, 2020 (GLOBE NEWSWIRE) -- 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, today announced the pricing of its public offering of 2,600,000 shares of common stock at a price to the public of $50.00 per share. The gross proceeds to Keros from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $130.0 million. All securities in the offering are being offered by Keros. In addition, Keros has granted the underwriters a 30-day option to purchase…

    LEXINGTON, Mass., Nov. 12, 2020 (GLOBE NEWSWIRE) -- 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, today announced the pricing of its public offering of 2,600,000 shares of common stock at a price to the public of $50.00 per share. The gross proceeds to Keros from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $130.0 million. All securities in the offering are being offered by Keros. In addition, Keros has granted the underwriters a 30-day option to purchase up to an additional 390,000 shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on November 17, 2020, subject to satisfaction of customary closing conditions.

    Jefferies LLC, SVB Leerink LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. H.C. Wainwright & Co., LLC is acting as co-manager for the offering.

    Registration statements relating to these securities have been filed with the Securities and Exchange Commission ("SEC") and became effective on November 12, 2020. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering, when available, may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at Prospectus_Department@Jefferies.com; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at 1-800-808-7525, ext. 6132, or by email at syndicate@svbleerink.com; and Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by e-mail at prospectus@psc.com.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: the completion, timing and size of the proposed offering. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and risks relating to the impact on Keros' business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of Keros' Quarterly Report on Form 10-Q, filed with the SEC on November 10, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936

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  19. LEXINGTON, Mass., Nov. 10, 2020 (GLOBE NEWSWIRE) -- 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, today announced it has filed a registration statement on Form S-1 with the Securities and Exchange Commission ("SEC") relating to a proposed underwritten public offering of 2,250,000 shares of common stock. Keros also intends to grant the underwriters a 30-day option to purchase up to an additional 337,500 shares of common stock at the public offering price, less the underwriting discounts and commissions. The public offering…

    LEXINGTON, Mass., Nov. 10, 2020 (GLOBE NEWSWIRE) -- 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, today announced it has filed a registration statement on Form S-1 with the Securities and Exchange Commission ("SEC") relating to a proposed underwritten public offering of 2,250,000 shares of common stock. Keros also intends to grant the underwriters a 30-day option to purchase up to an additional 337,500 shares of common stock at the public offering price, less the underwriting discounts and commissions. The public offering price has not yet been determined. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Jefferies LLC, SVB Leerink LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. H.C. Wainwright & Co., LLC is acting as co-manager for the offering.

    A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the proposed offering, when available, may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at Prospectus_Department@Jefferies.com; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at 1-800-808-7525, ext. 6132, or by email at syndicate@svbleerink.com; and Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by e-mail at prospectus@psc.com.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: the completion, timing, terms and size of the proposed offering and Keros' expectations with respect to granting the underwriters a 30-day option to purchase additional shares. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and risks relating to the impact on Keros' business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of Keros' Quarterly Report on Form 10-Q, filed with the SEC on November 10, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com 

    646-378-2936

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  20. LEXINGTON, Mass., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today provided a business update and reported financial results for the third quarter of 2020.

    "We are very pleased to reach the significant milestone of dosing the first patients in our Phase 2 clinical trial of KER-050. The initiation of this trial is a tremendous accomplishment for Keros and moves us closer to proof-of-concept by potentially demonstrating therapeutic benefit for patients with…

    LEXINGTON, Mass., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today provided a business update and reported financial results for the third quarter of 2020.

    "We are very pleased to reach the significant milestone of dosing the first patients in our Phase 2 clinical trial of KER-050. The initiation of this trial is a tremendous accomplishment for Keros and moves us closer to proof-of-concept by potentially demonstrating therapeutic benefit for patients with myelodysplastic syndromes ("MDS")," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "This Phase 2 clinical trial, along with the completion of our expanded Phase 1 clinical trial of KER-047, positions us to potentially have multiple ongoing Phase 2 clinical trials in 2021. Additionally, by regaining the rights to development programs in metabolic diseases and continuing rapid development of KER-012, Keros continues to further expand its already deep pipeline.

    Recent Corporate Highlights:

    Return of worldwide rights to development programs in metabolic diseases: On October 26, 2020, Keros announced that it received notice from Novo Nordisk A/S ("Novo Nordisk") that Novo Nordisk had elected to terminate the Research Collaboration and Exclusive License Agreement, dated December 14, 2017 (the "Collaboration Agreement"), between Novo Nordisk and the Company, for strategic and business reasons. As a result of the termination of the Collaboration Agreement, the Company will regain worldwide rights to all ligand traps selected under the Collaboration Agreement, along with all rights to develop Keros molecules in diabetes, obesity, nonalcoholic steatohepatitis and cachexia. The termination of the Collaboration Agreement will be effective on April 26, 2021.

    Recent Program Highlights:

    KER-050 for the treatment of ineffective hematopoiesis to address cytopenias:
      ºOn October 20, 2020, Keros announced the dosing of the first two participants in its open-label, 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 in mid-2021, subject to any delays related to the COVID-19 pandemic.
      ºKeros will present two preclinical abstracts on a mouse version of KER-050 highlighting the differentiated mechanism of action and potential of KER-050 to address multiple types of cytopenias at the 62nd American Society of Hematology ("ASH") Annual Meeting and Exposition, to be held virtually December 5-8, 2020.
          
    KER-047 for the treatment of anemia arising from iron imbalance and for the treatment of fibrodysplasia ossificans progressiva ("FOP"):
      ºIn August 2020, Keros announced the completion of its planned single and multiple ascending dose cohorts in a Phase 1 clinical trial of KER-047 in healthy volunteers, as well as the expansion of this trial to evaluate additional cohorts of healthy volunteers.
        In this expanded Phase 1 clinical trial, Keros observed rapid and dose-related increases in serum iron and transferrin saturation in the volunteers who received KER-047. Keros also observed a reduction in hepcidin at each dose level tested in Part 2 of this expanded trial.
        Keros terminated the trial after determining that the data from the additional cohort, in addition to the data from the planned cohorts, was sufficient to inform the design of the expected Phase 2 clinical trials of KER-047, and expects to report topline data at a scientific conference by the end of 2020.
        Keros also expects to commence separate Phase 2 clinical trials in patients with iron deficiency anemia ("IDA") and patients with iron-refractory iron deficiency anemia in 2021. Following the completion of the expected Phase 2 clinical trial of KER-047 in patients with IDA, Keros plans to commence a Phase 2 clinical trial in patients with FOP.
      ºKeros will present final data from the KER-047 Phase 1 clinical trial at the 62nd ASH Annual Meeting, along with a preclinical abstract highlighting the observed effects of activin receptor-like kinase-2 inhibition on hepcidin levels and iron metabolism.

    Third Quarter 2020 Financial Results

    Keros reported a net loss of $12.0 million in the third quarter of 2020 as compared to a net loss of $3.5 million in the third quarter of 2019. The increase in net loss for the second quarter was largely due to increased research and development efforts as well as the infrastructure needed as a publicly traded company. 

    Research and development expenses were $8.4 million for the third quarter of 2020 as compared to $3.9 million for the same period in 2019. The increase of $4.5 million was primarily due to additional toxicology studies and manufacturing activities, as well as an increase related to personnel expenses, including additional share-based compensation cost, driven by increased headcount to support the advancement of Keros' pipeline.

    General and administrative expenses were $3.6 million for the third quarter of 2020 as compared to $1.0 million for the same period in 2019. The increase of $2.6 million was primarily due to an increase in personnel expenses to support Keros' organizational growth and achievement of Keros' corporate goals, additional share-based compensation costs and an increase in professional fees to support Keros' transition to a public company. 

    Keros' cash and cash equivalents as of September 30, 2020 was $133.8 million compared to $144.7 million as of June 30, 2020. Keros expects that the cash and cash equivalents it had on hand at September 30, 2020 will fund its operating expenses and capital expenditure requirements into the second half of 2022.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and timing of its preclinical studies and clinical trials for KER- KER-047, including its regulatory plans; the potential impact of COVID-19 on Keros' ongoing and planned preclinical studies, clinical trials, business and operations; Keros' plans to present preclinical and clinical data at an upcoming conference; and Keros' expected cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and risks relating to the impact on Keros' business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on August 13, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936





    KEROS THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except share and per share data)

    (Unaudited)

     THREE MONTHS ENDED

    SEPTEMBER 30,
     NINE MONTHS ENDED

    SEPTEMBER 30,
     2020   2019   2020   2019 
    REVENUE:       
    Research collaboration revenue$  $2,500  $  $7,500 
    Total revenue  2,500    7,500 
    OPERATING EXPENSES:       
    Research and development(8,395) (3,854) (24,186) (13,218)
    General and administrative(3,553) (972) (9,180) (2,117)
    Total operating expenses(11,948) (4,826) (33,366) (15,335)
    LOSS FROM OPERATIONS(11,948) (2,326) (33,366) (7,835)
    OTHER INCOME (EXPENSE), NET       
    Interest expense, net(2) (3) (5) (7)
    Research and development incentive income      558 
    Change in fair value of preferred stock tranche obligation  (1,235) (1,490) (2,486)
    Other income (expense), net(86) 15  4  185 
    Total other income (expense), net(88) (1,223) (1,491) (1,750)
    Loss before income taxes(12,036) (3,549) (34,857) (9,585)
    Income tax benefit    172   
    Net loss$(12,036) $(3,549) $(34,685) $(9,585)
    Net loss attributable to common stockholders—basic and diluted (Note 10)$(12,036) $(3,999) $(35,697) $(10,935)
    Net loss per share attributable to common stockholders—basic and diluted$(0.60) $(1.71) $(2.65) $(4.76)
    Weighted-average common stock outstanding—basic and diluted20,175,883  2,342,782  13,452,606  2,296,701 





    KEROS THERAPEUTICS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands, except share and per share data)

    (Unaudited)

     SEPTEMBER 30,

    2020
     DECEMBER 31,

    2019
    ASSETS   
    CURRENT ASSETS:   
    Cash and cash equivalents$133,810  $7,020 
    Prepaid expenses and other current assets2,606  381 
    Deferred IPO costs  604 
    Research and development incentive receivable  922 
    Total current assets136,416  8,927 
    Operating lease right-of-use assets976  1,205 
    Property and equipment, net739  708 
    Restricted cash115  115 
    TOTAL ASSETS138,246  10,955 
    LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)   
    CURRENT LIABILITIES:   
    Accounts payable1,716  2,088 
    Current portion of operating lease liabilities412  376 
    Accrued expenses and other current liabilities4,697  2,022 
        Total current liabilities6,825  4,486 
    Operating lease liabilities, net of current portion586  899 
    Preferred stock tranche liability  4,956 
    Other liabilities77  119 
        Total liabilities7,488  10,460 
    Series A convertible preferred stock, par value of $0.0001 per share; 0 and 10,000,000 shares authorized as of September 30, 2020 and December 31, 2019, respectively; 0 and 4,607,652 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively; liquidation and redemption value of $0 as of September 30, 2020  9,891 
    Series A-1 convertible preferred stock, par value of $0.0001 per share; 0 and 800,000 shares authorized as of September 30, 2020 and December 31, 2019, respectively; 0 and 368,612 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively; liquidation and redemption value of $0 as of September 30, 2020  944 
    Series B-1 convertible preferred stock, par value of $0.0001 per share; 0 and 3,427,004 shares authorized as of September 30, 2020 and December 31, 2019, respectively; 0 and 1,579,043 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively; liquidation and redemption value of $0 as of September 30, 2020  9,106 
    STOCKHOLDERS' EQUITY (DEFICIT):   
    Common stock, par value of $0.0001 per share; 200,000,000 and 27,000,000 shares authorized as of September 30, 2020 and December 31, 2019, respectively; 20,185,730 and 2,429,705 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively2  1 
    Additional paid-in capital185,091  203 
    Accumulated deficit(54,335) (19,650)
    Total stockholders' equity (deficit)130,758  (19,446)
    TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)138,246  10,955 

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  21. VANCOUVER, British Columbia, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Quark Venture LP (Quark) and GF Securities are pleased to announce the successful listing of portfolio company, SQZ Biotechnologies (NYSE:SQZ) ("SQZ") on the New York Stock Exchange (NYSE) as of October 30, 2020. This announcement marks Global Health Sciences (GHS) Fund's third portfolio company to successfully go public after Eloxx Pharmaceuticals, Inc., (NASDAQ:ELOX) in April 2018 and Keros Therapeutics, Inc. (NASDAQ:KROS) in April 2020.

    As one of the early investors in SQZ in 2016, alongside Polaris Partners, NanoDimension and GV (formerly Google Ventures), Quark has continued to support the growth of the company to advance its proprietary CellSqueeze® technology and its application…

    VANCOUVER, British Columbia, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Quark Venture LP (Quark) and GF Securities are pleased to announce the successful listing of portfolio company, SQZ Biotechnologies (NYSE:SQZ) ("SQZ") on the New York Stock Exchange (NYSE) as of October 30, 2020. This announcement marks Global Health Sciences (GHS) Fund's third portfolio company to successfully go public after Eloxx Pharmaceuticals, Inc., (NASDAQ:ELOX) in April 2018 and Keros Therapeutics, Inc. (NASDAQ:KROS) in April 2020.

    As one of the early investors in SQZ in 2016, alongside Polaris Partners, NanoDimension and GV (formerly Google Ventures), Quark has continued to support the growth of the company to advance its proprietary CellSqueeze® technology and its application in developing impactful cell therapies for patients. The SQZ technology was invented by company founder and CEO Armon Sharei based on the research of his team in the laboratories of Klavs Jensen and Robert Langer at the Massachusetts Institute of Technology (MIT) in Boston. The company focuses on developing transformative cell therapies for patients with cancer, infectious diseases, and other serious conditions. Using its proprietary technology, SQZ has the unique ability to engineer almost any cell type and deliver multiple materials, potentially resulting in powerful, multifunctional cell therapies for a range of diseases. In 2018 Roche expanded on its existing partnership with SQZ to develop SQZ APC in oncology and SQZ is currently enrolling patients in their Phase I trial for SQZ-PBMC-HPV for patients with HPV16+ tumors.

    "We were always confident about the company's ground-breaking work to enable the development of innovative cell therapies. By physically squeezing cells, effectively opening the cell membrane and allowing desired cargo to diffuse inside, SQZ's proprietary technology overcomes the limitations of current cell therapies. SQZ's news coupled with our portfolio company Keros Therapeutics' recent IPO, marks another milestone for our GHS Fund this year, especially during this challenging time of pandemic and economic volatility," said Karimah Es Sabar, CEO & Partner, Quark Venture and Director of the GHS Fund.

    About Quark Venture LP

    Quark Venture LP is a global venture capital company, headquartered in Vancouver, British Columbia, Canada, with a health investment portfolio. Focused on equity financing of innovative life science companies with breakthrough discovery and innovation, led by outstanding scientific and business teams, our strategic goal is to identify early stage companies and support their growth and development of innovative health solutions.

    For information about Quark Venture and its innovative health enterprise portfolio, please visit www.quarkventure.com.

    About Global Health Sciences Fund 

    Global Health Sciences [GHS] Fund is a joint venture between Quark Venture LP and GF Securities established in 2016. The Fund is a diversified health sciences focused fund investing globally in innovative biotechnology and health technology companies addressing unmet medical needs through innovations in drug development, medical devices, digital health, big data/AI in health and emerging convergent technologies.

    For Media Interest Please Contact:

    Kamran Shaikh, 778-846-5406

    kshaikh@prassociates.com

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  22. LEXINGTON, Mass., Nov. 04, 2020 (GLOBE NEWSWIRE) -- 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, today announced that four abstracts will be presented from the KER-050 and ALK2 hematology programs, including topline data from Keros' Phase 1 clinical trial of KER-047, at the 62nd American Society of Hematology ("ASH") Annual Meeting and Exposition, to be held as a virtual event from December 5-8, 2020.

    The following abstracts were posted to the ASH website on November 4, 2020, 9:00 a.m. Eastern time.

    "KER-050, a

    LEXINGTON, Mass., Nov. 04, 2020 (GLOBE NEWSWIRE) -- 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, today announced that four abstracts will be presented from the KER-050 and ALK2 hematology programs, including topline data from Keros' Phase 1 clinical trial of KER-047, at the 62nd American Society of Hematology ("ASH") Annual Meeting and Exposition, to be held as a virtual event from December 5-8, 2020.

    The following abstracts were posted to the ASH website on November 4, 2020, 9:00 a.m. Eastern time.

    "KER-050, a Novel Inhibitor of TGF-β Superfamily Signaling, Induces Red Blood Cell Production by Promoting Multiple Stages of Erythroid Differentiation"

    • Publication Number: 2736
    • Session Name: 501. Hematopoietic Stem and Progenitor Biology: Poster III
    • Date: Monday, December 7, 2020

    "KER-050, a Modified ActRIIA Ligand Trap, Alleviates Cytopenia Arising from Multiple Etiologies"

    • Publication Number: 2582
    • Session Name: 101L. Red Cells and Erythropoiesis, structure and function, metabolism, and survival, excluding Iron: Poster III
    • Date: Monday, December 7, 2020

    "Administration of KER-047, a Novel ALK2 Inhibitor, Elicited Robust and Sustained Increases in Serum Iron in Healthy Participants"

    • Publication Number: 769
    • Session Name: 102. Regulation of Iron Metabolism: Poster I
    • Date: Saturday, December 5, 2020

    "Selective Inhibition of ALK2 Signaling Suppresses Serum Hepcidin and Increases Serum Iron"

    • Publication Number: 771
    • Session Name: 102. Regulation of Iron Metabolism: Poster I
    • Date: Saturday, December 5, 2020

    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 ("TGF-β") receptor known as activin receptor type IIA ("ALK2") 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 MDS and in patients with myelofibrosis.

    About KER-047

    Keros' lead small molecule product candidate, KER-047, is designed to selectively and potently inhibit ALK2. KER-047 is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva, a rare musculoskeletal disorder.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' presentation plans for the upcoming ASH virtual annual meeting. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Many factors could cause the actual results, performance or achievements that may be expressed or implied by such forward-looking statements to vary from those described herein should one or more of these risks or uncertainties materialize, including those risk factors discussed or referred to in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on August 13, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com 

    646-378-2936

    Primary Logo

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    • First two participants dosed in a Phase 2 clinical trial of KER-050 in MDS
    • Initial data expected by mid-2021

    LEXINGTON, Mass., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced that it has dosed the first two participants in a Phase 2 clinical trial evaluating KER-050 for the treatment of anemia and thrombocytopenia in myelodysplastic syndromes ("MDS").   Keros expects to report initial data from Part 1 of this trial in mid-2021.

    The Phase 2 clinical…

    • First two participants dosed in a Phase 2 clinical trial of KER-050 in MDS
    • Initial data expected by mid-2021

    LEXINGTON, Mass., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced that it has dosed the first two participants in a Phase 2 clinical trial evaluating KER-050 for the treatment of anemia and thrombocytopenia in myelodysplastic syndromes ("MDS").   Keros expects to report initial data from Part 1 of this trial in mid-2021.

    The Phase 2 clinical trial is an open-label, multiple ascending dose trial to evaluate KER-050 in participants with very low-, low-, or intermediate-risk MDS who either have previously received treatment with an erythropoiesis-stimulating agent or have not received such treatment.   Keros presented data from its Phase 1 clinical trial of KER-050 in healthy post-menopausal women, which demonstrated a robust, dose-dependent response of multiple hematological parameters, at the 25th Annual Congress of European Hematology Association in June 2020.

    "We are pleased to announce the initiation of our open-label Phase 2 clinical trial of KER-050 in MDS. The results from our Phase 1 clinical trial demonstrated robust hematological effects in healthy volunteers that we are excited to potentially explore further in patients with MDS." said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. "The majority of patients with MDS develop anemias and other cytopenias and we believe that the differentiated mechanism of action of KER-050 provides a potential benefit not only in addressing ineffective erythropoiesis, but also in increasing platelet counts."

    The Phase 2 clinical trial will be conducted in 2 parts. In Part 1, approximately six participants will be enrolled in each of up to four cohorts of ascending doses of KER-050 to be administered by subcutaneous injection every four weeks for up to four cycles. In Part 2, the dose selected from Part 1 will be evaluated in up to 30 participants. The primary objective of the trial is to confirm the safety and tolerability of KER-050 in MDS participants with ring sideroblasts (RS+) as well as in participants without ring sideroblasts (non-RS).

    About Myelodysplastic Syndromes (MDS)

    Myelodysplastic syndromes ("MDS") is a collection of bone marrow disorders characterized by ineffective hematopoiesis, often with a dramatic expansion of progenitor cells that are unable to mature into functioning blood cells. In the United States, there are 60,000 to 170,000 patients with MDS and 15,000 to 20,000 new cases of MDS reported each year. MDS predominantly affects older adults, with approximately 75% of patients aged 60 years or older at diagnosis. Median survival ranges from approximately nine years for very low-risk patients to less than a year for high-risk patients.

    Cytopenias in MDS are caused by defects occurring across the various stages of hematopoiesis, from the self-renewal of progenitor cells to differentiation in early through terminal stages. Anemia is the most frequent consequence of ineffective hematopoiesis in patients with MDS due to low red blood cell production, and impacts 90% of MDS patients, with approximately 40% becoming transfusion dependent. Another consequence is thrombocytopenia, a deficiency of platelets in the blood, which can lead to impaired blood clotting and higher risk of bleeding. The prevalence of thrombocytopenia in patients with MDS has been reported at 40% to 65%. A deficiency of neutrophils in the blood, or neutropenia, also increases the risk of serious infections in patients with MDS and has been reported to affect approximately 20% of patients with MDS.

    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 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 MDS and in patients with myelofibrosis. Keros recently completed a Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of KER-050 in healthy post-menopausal women, and has commenced a Phase 2 clinical trial in patients with MDS evaluating KER-050 for the treatment of cytopenias, including anemia and thrombocytopenia.   Keros also plans to commence a Phase 2 clinical trial evaluating KER-050 for the treatment of patients with myelofibrosis-associated cytopenias in 2021.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and the design, objectives and timing of its clinical trials for KER-050; and the potential of KER-050 to treat patients with MDS. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Many factors could cause the actual results, performance or achievements that may be expressed or implied by such forward-looking statements to vary from those described herein should one or more of these risks or uncertainties materialize, including those risk factors discussed or referred to in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on August 13, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936

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  23. LEXINGTON, Mass., Sept. 14, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Jasbir S. Seehra, Ph.D., President and Chief Executive Officer, is scheduled to present at the H.C. Wainwright 22nd Annual Global Investment Conference on Monday, September 14, 2020 at 10:30 am ET.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic…

    LEXINGTON, Mass., Sept. 14, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Jasbir S. Seehra, Ph.D., President and Chief Executive Officer, is scheduled to present at the H.C. Wainwright 22nd Annual Global Investment Conference on Monday, September 14, 2020 at 10:30 am ET.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936

    Primary Logo

    View Full Article Hide Full Article
  24. LEXINGTON, Mass., Sept. 11, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced results from preclinical studies of KER-012 at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting Virtual Event held September 11-15, 2020.

    In Preclinical Studies, KER-012 Increased Trabecular Bone by Reducing Bone Catabolism and Enhancing Anabolism

    • KER-012, A Novel Activin Receptor Type II Ligand Trap, Increases Bone in Mice Via a Unique Mechanism of Action

    LEXINGTON, Mass., Sept. 11, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced results from preclinical studies of KER-012 at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting Virtual Event held September 11-15, 2020.

    In Preclinical Studies, KER-012 Increased Trabecular Bone by Reducing Bone Catabolism and Enhancing Anabolism

    • KER-012, A Novel Activin Receptor Type II Ligand Trap, Increases Bone in Mice Via a Unique Mechanism of Action - Presentation Number: P-656

    TGF-β superfamily ligands, including activin A and B, are negative regulators of bone remodeling, suppressing bone growth. KER-012 is a modified activin receptor type II ligand trap designed to bind to and inhibit activins and SMAD 2/3 signaling. In adult male mice, administration of KER-012 (20 mg/kg twice weekly for 5 weeks) resulted in the following statistically significant changes relative to vehicle treatment:

    • Increased trabecular bone volume (82.0%; p<0.001), higher trabecular bone volume fraction (78.3%; <0.001) and increased trabecular number (33.5%; p<0.01).
    • Increased trabecular thickness (28.8%; p<0.01) and reduced trabecular separation (-27.2%; p<0.001).

    Enhanced bone anabolism was demonstrated through:

    • Increased (i) trabecular mineralizing surface (+63.4%; p<0.01), (ii) trabecular mineral apposition rate (+29.9%; p<0.05) and (iii) trabecular bone formation rate (+107.7%; p<0.01), as well as a trend towards increased osteoblast number (+29.0%; NS).

    Reductions in bone catabolism were evidenced by:

    • Reduced (i) trabecular eroded surface (-42.2%; p<0.001) and (ii) trabecular osteoclast number (-45.8%; p<0.01).

    The observed increase in osteoblast/osteoclast ratio (+125.0%; p<0.01) is potentially indicative of the dual mechanism of increased anabolism and decreased catabolism.

    "Taken together, we believe the results from these preclinical studies provide further support of our hypothesis that KER-012 acts through a differentiated mechanism to increase trabecular bone by reducing bone resorption and enhancing formation," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. "We believe that the mechanism of action of KER-012 represents a unique opportunity to potentially treat a number of conditions where bone loss is an issue, such as osteoporosis and cancer-induced bone loss."

    About KER-012

    KER-012 is designed to bind to and inhibit the signaling of transforming growth factor-beta ligands, including activin A and activin B, which are key regulators of bone remodeling that act to suppress bone growth. KER-012 is being developed for the treatment of disorders associated with bone loss, such as osteogenesis imperfecta and osteoporosis, and for the treatment of pulmonary arterial hypertension.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: the potential of KER-012 to act through a differentiated mechanism and the potential of KER-012 to treat bone loss conditions, such as osteogenesis imperfect, osteoporosis and cancer-induced bone loss. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on Keros' business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on August 13, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936

    Primary Logo

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  25. LEXINGTON, Mass., Aug. 13, 2020 (GLOBE NEWSWIRE) -- 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, today provided a business update and reported financial results for the second quarter of 2020.

    "By closing our initial public offering in the second quarter of 2020, Keros completed the transition to a public company," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "With the net proceeds from the offering and our earlier Series C financing, we believe Keros is well capitalized to allow us to…

    LEXINGTON, Mass., Aug. 13, 2020 (GLOBE NEWSWIRE) -- 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, today provided a business update and reported financial results for the second quarter of 2020.

    "By closing our initial public offering in the second quarter of 2020, Keros completed the transition to a public company," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "With the net proceeds from the offering and our earlier Series C financing, we believe Keros is well capitalized to allow us to continue to aggressively drive the development of our lead programs through multiple Phase 2 clinical trials planned for the near term."

    Recent Program Highlights:

    • KER-047 for the treatment of anemia arising from high hepcidin levels and for the treatment of fibrodysplasia ossificans progressiva
      • On August 4, 2020, Keros announced the completion of the planned cohorts for the Phase 1 clinical trial of KER-047, and reported the topline findings from those cohorts. Based upon its preliminary analysis, Keros expects to expand its Phase 1 clinical trial to evaluate an additional two cohorts of healthy volunteers, which will help to further define dosing regimens to inform the design of upcoming Phase 2 clinical trials.
      • Keros continues to expect commencement of a Phase 2 clinical trial in patients with iron-refractory iron deficiency anemia and other anemias with elevated levels of hepcidin, including myelofibrosis, and a Phase 2 clinical trial in patients with FOP, both in the first half of 2021.

         
    • KER-012 for the treatment of disorders associated with bone loss and for the treatment of pulmonary arterial hypertension
      • An abstract outlining preclinical data on the differentiated mechanism of action of KER-012 has been selected to be presented as an e-Poster at the American Society for Bone and Mineral Research 2020 Annual Meeting, to be held virtually September 11-15, 2020.

    Second Quarter 2020 Financial Results

    Keros reported a net loss of $10.8 million in the second quarter of 2020 as compared to a net loss of $2.9 million in the second quarter of 2019. The increase in net loss for the second quarter was largely due to increased research and development efforts and increased expenses associated with being a public company.

    Research and development expenses were $7.3 million for the second quarter of 2020 as compared to $4.5 million for the same period in 2019. The increase of $2.8 million was primarily due to a $2.0 million increase in manufacturing activities for KER-050 to support Keros' ongoing clinical trial activities and a $0.7 million increase related to personnel expenses, including additional share-based compensation cost, driven by increased headcount to support the advancement of Keros' pipeline.

    General and administrative expenses were $3.7 million for the second quarter of 2020 as compared to $0.7 million for the same period in 2019. The increase of $3.0 million was primarily due to a $1.4 million increase in personnel expenses, which includes additional share-based compensation costs, to support Keros' organizational growth and achievement of its corporate goals and a $1.5 million increase in professional fees to support Keros' transition to a public company.

    Keros' cash and cash equivalents as of June 30, 2020 was $144.7 million compared to $54.5 million as of March 31, 2020. Keros expects that the cash and cash equivalents it had on hand at June 30, 2020 will fund its operating expenses and capital expenditure requirements into the second half of 2022.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and timing of its preclinical studies and clinical trials for KER-047, including its regulatory plans; the potential impact of COVID-19 on Keros' ongoing and planned preclinical studies, clinical trials, business and operations; Keros' plans to present preclinical data at an upcoming conference; and Keros' expected cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 22, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936



    KEROS THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except share and per share data)

    (Unaudited)

     THREE MONTHS ENDED JUNE 30, SIX MONTHS ENDED JUNE 30,
    2020 2019 2020 2019 
    REVENUE:        
    Research collaboration revenue$   $2,500   $   $5,000  
    Total revenue   2,500      5,000  
    OPERATING EXPENSES: 
    Research and development(7,264)  (4,497)  (15,791)  (9,364) 
    General and administrative(3,650)  (654)  (5,627)  (1,145) 
    Total operating expenses(10,914)  (5,151)  (21,418)  (10,509) 
    LOSS FROM OPERATIONS(10,914)  (2,651)  (21,418)  (5,509) 
    OTHER INCOME (EXPENSE), NET 
    Interest expense, net(1)  (2)  (3)  (4) 
    Research and development incentive income   378      558  
    Change in fair value of preferred stock tranche obligation   (647)  (1,490)  (1,251) 
    Other income, net158   69   90   170  
    Total other income (expense), net157   (202)  (1,403)  (527) 
    Loss before income taxes(10,757)  (2,853)  (22,821)  (6,036) 
    Income tax benefit      172     
    Net loss$(10,757)  $(2,853)  $(22,649)  $(6,036) 
    Net loss attributable to common stockholders—basic and diluted$(10,963)  $(3,303)  $(23,661)  $(6,936) 
    Net loss per share attributable to common stockholders—basic and diluted$(0.62)  $(1.44)  $(2.35)  $(3.05) 
    Weighted-average common stock outstanding—basic and diluted17,623,994   2,288,058   10,054,026   2,273,278  
                    
                    

    KEROS THERAPEUTICS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands, except share and per share data)

    (Unaudited)

     JUNE 30,

     2020
     DECEMBER 31,

     2019
    ASSETS   
    CURRENT ASSETS:   
    Cash and cash equivalents$144,687   $7,020  
    Prepaid expenses and other current assets3,830   381  
    Deferred IPO costs   604  
    Research and development incentive receivable   922  
    Total current assets148,517   8,927  
    Operating lease right-of-use assets1,025   1,205  
    Property and equipment, net781   708  
    Restricted cash115   115  
    TOTAL ASSETS$150,438   $10,955  
        
    LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)   
    CURRENT LIABILITIES:   
    Accounts payable$4,852   $2,088  
    Current portion of operating lease liabilities400   376  
    Accrued expenses and other current liabilities3,042   2,022  
    Total current liabilities8,294   4,486  
    Operating lease liabilities, net of current portion692   899  
    Preferred stock tranche liability   4,956  
    Other liabilities91   119  
    Total liabilities9,077   10,460  
    Series A convertible preferred stock, par value of $0.0001 per share; 0 and 10,000,000 shares authorized as of June 30, 2020 and December 31, 2019, respectively; 0 and 4,607,652 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively; liquidation and redemption value of $0 as of June 30, 2020   9,891  
    Series A-1 convertible preferred stock, par value of $0.0001 per share; 0 and 800,000 shares authorized as of June 30, 2020 and December 31, 2019, respectively; 0 and 368,612 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively; liquidation and redemption value of $0 as of June 30, 2020   944  
    Series B-1 convertible preferred stock, par value of $0.0001 per share; 0 and 3,427,004 shares authorized as of June 30, 2020 and December 31, 2019, respectively; 0 and 1,579,043 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively; liquidation and redemption value of $0 as of June 30, 2020   9,106  
    STOCKHOLDERS' EQUITY (DEFICIT):   
    Common stock, par value of $0.0001 per share; 200,000,000 and 27,000,000 shares authorized as of June 30, 2020 and December 31, 2019, respectively; 20,158,080 and 2,429,705 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively2   1  
    Additional paid-in capital183,658   203  
    Accumulated deficit(42,299)  (19,650) 
    Total stockholders' equity (deficit)141,361   (19,446) 
    TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)$150,438   $10,955  

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  26. LEXINGTON, Mass., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced that the Company will be featured on Behind the Mystery, a recurring series highlighting rare diseases, to raise awareness of the devastating condition, fibrodysplasia ossificans progressiva ("FOP").

    The segment, sponsored by Keros, will feature Nancy Sando, patient and one of the founding members and board member of the International FOP Association ("IFOPA"), along with Dr. Richard Keen…

    LEXINGTON, Mass., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced that the Company will be featured on Behind the Mystery, a recurring series highlighting rare diseases, to raise awareness of the devastating condition, fibrodysplasia ossificans progressiva ("FOP").

    The segment, sponsored by Keros, will feature Nancy Sando, patient and one of the founding members and board member of the International FOP Association ("IFOPA"), along with Dr. Richard Keen, treating physician and researcher. The segment will cover scientific and medical aspects of this rare disorder and the daily challenges faced by patients with this debilitating disease through the life story of one patient living with FOP and from those providing medical care.

    "Keros is honored to have the opportunity to bring awareness of FOP to a wider audience. The Company was founded with a mission to develop treatments for rare diseases and developing a therapy for patients with FOP underscores the importance of our mission," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. "We sincerely thank both Nancy and Professor Keen for participating in the segment and bringing a voice to the challenges that all patients with FOP face daily."

    The segment is expected to air on The Balancing Act on Lifetime® Thursday, August 13, 2020 (at 7:30 AM, ET/PT) and again on Tuesday, September 1, 2020 (at 7:30 AM ET/PT), after which it will be shown in syndication. 

    Keros collaborated with the IFOPA on the production of the segment. 

    "As a voice of the FOP community, IFOPA has a mission to educate and raise awareness of FOP, and a segment such as this with a wide audience is invaluable in doing that," said Adam Sherman, Research Development and Partnerships Director of IFOPA. "We were pleased to have this opportunity to work with Keros and are grateful for the participation of one of our early members, Nancy Sando, along with a key member of the clinical community."

    For the past eight years, Behind the Mystery has spotlighted undiagnosed, misdiagnosed and complex medical disorders by partnering with pharmaceutical and biotechnology companies who are on a mission to educate the public in an effort to bring earlier diagnosis and treatment and provide a community for people suffering from these disorders.

    "We were happy to have Keros and IFOPA involved in bringing about this important segment on FOP," says Carri Levy, Creator - Behind the Mystery: Rare and Genetic Series. "The show has aired more than 125 segments over the last eight years and we continue to be amazed at the power of these stories."

    About Fibrodysplasia Ossificans Progressiva

    Fibrodysplasia ossificans progressiva ("FOP") is a rare connective tissue disease. In FOP, muscle and connective tissues, such as tendons and ligaments, gradually become replaced by bone (ossified), forming bone outside the skeleton, and constraining movement. This process generally becomes noticeable in early childhood, starting with the neck and shoulders and proceeding down the body and into the limbs. The median age of survival is 40 years, with proper management.

    The IFOPA estimates that there are 3,500 people worldwide with FOP, with approximately 800 patients identified. There are 285 known cases in the United States. There are no therapies approved to treat FOP.

    About The Balancing Act

    The Balancing Act is a weekday morning show created and produced by BrandStar that brings fresh ideas to today's modern woman to help balance and enrich her life every day. Now in its ninth season, The Balancing Act features everything from recipes, style makeovers and dream getaways to parenting tips and the latest news in health and wealth.

    About the International FOP Association (IFOPA)

    IFOPA is a 501(c)3 nonprofit organization that provides hope to individuals with FOP and their families through education and support programs, while funding research to find a cure for FOP. The IFOPA was founded in 1988 by Jeannie Peeper. Today, the IFOPA is the umbrella organization for people with FOP worldwide and is a place for FOP families to come for education and support. The IFOPA is one of the largest funders of FOP research in the world, with nearly two-thirds of the annual budget dedicated to funding research grants; providing research infrastructure, including the world's only patient registry; hosting scientific meetings; and engaging the FOP community in clinical studies and trials.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: the air dates of the Keros-sponsored Behind the Mystery segment. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Many factors could cause the actual results, performance or achievements that may be expressed or implied by such forward-looking statements to vary from those described herein should one or more of these risks or uncertainties materialize, including those risk factors discussed or referred to in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 22, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936

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  27. LEXINGTON, Mass., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced the completion of the planned cohorts in a randomized, double-blind, placebo-controlled, two-part Phase 1 clinical trial to evaluate single and multiple ascending doses of its lead small molecule product candidate, KER-047, in healthy volunteers.

    "We are pleased to report the topline findings from the completed cohorts in our Phase 1 clinical trial demonstrating target engagement and further…

    LEXINGTON, Mass., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced the completion of the planned cohorts in a randomized, double-blind, placebo-controlled, two-part Phase 1 clinical trial to evaluate single and multiple ascending doses of its lead small molecule product candidate, KER-047, in healthy volunteers.

    "We are pleased to report the topline findings from the completed cohorts in our Phase 1 clinical trial demonstrating target engagement and further delineating the relationship of activin receptor-like kinase-2 ("ALK2") inhibition and hepcidin suppression. We believe the translation of biology from rodents to humans provides a strong rationale to evaluate KER-047 in anemias due to elevated levels of hepcidin and in fibrodysplasia ossificans progressiva ("FOP"), a rare musculoskeletal disorder resulting from aberrant ALK2 signaling," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros.

    Keros has performed a preliminary analysis of single ascending and multiple ascending dose cohorts completed to date and plans to present the results from this Phase 1 clinical trial at a major medical conference later in 2020.

    • The objectives of the Phase 1 clinical trial were to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single and multiple ascending dose levels of KER-047 in healthy volunteers. In the multiple ascending dose cohorts, KER-047 was administered as daily doses ranging from 50-350 mg for up to 7 days. The tolerability profile in healthy volunteers has been characterized in this Phase 1 clinical trial.
    • There were no serious adverse events reported in either part of the trial. The most common adverse events observed in healthy volunteers in this trial were headache, nausea, vomiting, diarrhea, gastroenteritis, chills, pyrexia, myalgia, decreased appetite, lymphopenia, neutropenia, and liver enzyme increases. Dose-related decreases in lymphocytes were observed following peak increases in serum iron at the highest doses, which we believe is consistent with KER-047's mechanism of action and suggestive of excessive mobilization and subsequent depletion of iron.
    • Multiple pharmacodynamic biomarkers were included to assess KER-047's inhibition of ALK2. A reduction in hepcidin was observed following 7 days of dosing in the multiple ascending dose cohorts. Additionally, the reduction in hepcidin, increases in serum iron and increases in reticulocyte hemoglobin observed in healthy volunteers administered KER-047 is supportive of iron mobilization from tissue stores.

    Based upon its preliminary analysis, Keros expects to expand its Phase 1 clinical trial to evaluate an additional two cohorts of healthy volunteers, which will help to further define dosing regimens to inform the design of upcoming Phase 2 clinical trials. Keros continues to expect commencement of a Phase 2 clinical trial in patients with iron-refractory iron deficiency anemia and other anemias with elevated hepcidin, including myelofibrosis, and a Phase 2 clinical trial in patients with FOP, both in the first half of 2021.

    "Based on the tolerability and pharmacodynamic effects observed after 7 days of dosing in healthy volunteers, we believe there is a potential to develop several different dosing regimens for KER-047 for use in different indications, which we plan to further refine by evaluating two additional cohorts of healthy volunteers. We believe this will facilitate a more rapid exploration of safety and efficacy of relevant dosing regimen in the patient population," added Dr. Seehra.

    KER-047 has been developed by Keros under an exclusive patent license agreement with The General Hospital Corporation through Mass General Brigham Inc. and in collaboration with scientists at Massachusetts General Hospital, Brigham and Women's Hospital and the National Center for Advancing Translational Sciences ("NCATS") at the National Institutes of Health.

    "At NCATS, we aim to reduce costly and time-consuming bottlenecks in the translational research pipeline in order to potentially speed the delivery of new products to patients," said Christopher P. Austin, M.D., Director of NCATS. "A goal of the NCATS collaboration with Keros is to accelerate the development of a potential novel treatment for conditions with high unmet clinical needs."

    About KER-047

    Keros' lead small molecule product candidate, KER-047, is designed to selectively and potently inhibit activin receptor-like kinase-2, a Transforming Growth Factor-Beta receptor. KER-047 is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva, a rare musculoskeletal disorder.

    About Mass General Brigham Inc.

    Mass General Brigham Inc. is an integrated health care system, founded by Brigham and Women's Hospital and Massachusetts General Hospital, that offers patients a continuum of coordinated and high-quality care. In addition to its two academic medical centers, the system includes community and specialty hospitals, a health insurance plan, a physician network, community health centers, home health and long-term care services, and other health care entities. Mass General Brigham Inc. is a non-profit organization that is committed to patient care, research, teaching, and service to the community. In addition, Mass General Brigham Inc. is one of the nation's leading biomedical research organizations and is a principal teaching affiliate of Harvard Medical School.

    About Massachusetts General Hospital

    Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH Research Institute conducts the largest hospital-based research program in the nation, with an annual research budget of more than $1 billion and comprises more than 8,500 researchers working across more than 30 institutes, centers and departments.

    About Brigham Health

    Brigham Health, a global leader in creating a healthier world, consists of Brigham and Women's Hospital, Brigham and Women's Faulkner Hospital, the Brigham and Women's Physicians Organization and many related facilities and programs. With more than 1,000 inpatient beds, approximately 60,000 inpatient stays and 1.7 million outpatient encounters annually, Brigham Health's 1,200 physicians provide expert care in virtually every medical and surgical specialty to patients locally, regionally and around the world. An international leader in basic, clinical and translational research, Brigham Health has nearly 5,000 scientists, including physician-investigators, renowned biomedical researchers and faculty supported by over $700 million in funding. Boston-based Brigham and Women's Hospital is a teaching affiliate of Harvard Medical School and dedicated to educating and training the next generation of health care professionals.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and timing of its clinical trials for KER-047; the potential of KER-047 to treat anemias with elevated hepcidin and fibrodysplasia ossificans progressiva; and Keros' plans to present clinical data at an upcoming conference. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Many factors could cause the actual results, performance or achievements that may be expressed or implied by such forward-looking statements to vary from those described herein should one or more of these risks or uncertainties materialize, including those risk factors discussed or referred to in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 22, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936

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  28. LEXINGTON, Mass, June 26, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced that the Company is set to join the Russell 2000® Index, effective after the close of the U.S. markets on June 26, 2020.

    The Russell 2000® Index measures the performance of the small-cap segment of the U.S. equity universe. The index is a subset of the Russell 3000® Index and includes approximately 2,000 securities based on a combination of their market cap and current index membership…

    LEXINGTON, Mass, June 26, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros" or the "Company") (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, today announced that the Company is set to join the Russell 2000® Index, effective after the close of the U.S. markets on June 26, 2020.

    The Russell 2000® Index measures the performance of the small-cap segment of the U.S. equity universe. The index is a subset of the Russell 3000® Index and includes approximately 2,000 securities based on a combination of their market cap and current index membership.

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's U.S. indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: the Company's anticipated inclusion in the Russell 2000® Index and the timing of such inclusion. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Many factors could cause the actual results, performance or achievements that may be expressed or implied by such forward-looking statements to vary from those described herein should one or more of these risks or uncertainties materialize, including those risk factors discussed or referred to in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 22, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936

    Primary Logo

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    • Poster presentation highlights Phase 1 clinical trial data demonstrating tolerability, pharmacokinetics and pharmacodynamics of KER-050 in healthy postmenopausal women.
    • Poster presentations introduce data demonstrating KER-050 robustly promoted hematopoiesis in multiple animal species in preclinical studies and support a potentially novel mechanism of action.
    • Oral presentation on a novel ALK2 kinase inhibitor that suppressed hepcidin production and subsequently ameliorated anemia in a mouse model of iron-refractory iron deficiency anemia.

    LEXINGTON, Mass., June 12, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros") (NASDAQ:KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of…

    • Poster presentation highlights Phase 1 clinical trial data demonstrating tolerability, pharmacokinetics and pharmacodynamics of KER-050 in healthy postmenopausal women.
    • Poster presentations introduce data demonstrating KER-050 robustly promoted hematopoiesis in multiple animal species in preclinical studies and support a potentially novel mechanism of action.
    • Oral presentation on a novel ALK2 kinase inhibitor that suppressed hepcidin production and subsequently ameliorated anemia in a mouse model of iron-refractory iron deficiency anemia.

    LEXINGTON, Mass., June 12, 2020 (GLOBE NEWSWIRE) -- 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, today announced updated data from its Phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effects of ascending dose levels of KER-050 in healthy post-menopausal women, along with preclinical data on KER-050 from multiple animal models and additional preclinical data evaluating the role of ALK2 inhibition in regulating hepcidin and serum iron.

    These data were presented at the 25th Annual Congress of European Hematology Association (EHA), held as a virtual event from June 11-21, 2020. 

    "The presentations by Keros at the 25th Congress of EHA showcase the breadth and depth of the Keros franchise in hematological disorders," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. "KER-050 was well tolerated in healthy volunteers in our Phase 1 clinical trial across increasing doses and after multiple administrations. Importantly, we also observed a robust, dose-dependent response of multiple hematological parameters.  Based on these findings and the results from preclinical studies, we believe KER-050 has a differentiated pharmacologic effect on red blood cells and platelets and has the potential to treat multiple cytopenias in diseases of ineffective hematopoiesis such as myelodysplastic syndromes and myelofibrosis.  In addition, our preclinical data from our ALK2 program demonstrated that ALK2 inhibition was able to reverse elevated hepcidin and anemia in a mouse model of iron-refractory iron deficiency anemia.  We believe these findings support that ALK2 inhibition is a potentially promising therapeutic for improving iron levels and anemia in IRIDA patients and could potentially provide benefit in other hepcidin-mediated anemias such as chronic kidney disease or anemia of inflammation."

    Clinical Data Highlight Potential of KER-050 to Address Multiple Cytopenias

    • Administration of KER-050, a Novel ActRIIA Ligand Trap, to Healthy Participants Elicited Robust and Sustained Increases in Hemoglobin and Platelets - Abstract Number: EP806. 

    Administration of KER-050 in healthy subjects was observed to elicit rapid, robust, sustained and dose-dependent increases in hemoglobin, reticulocytes and red blood cells, in addition to clinically meaningful increases in platelets.  In Part 1 of the Phase 1 first-in-human clinical trial, 38 subjects received either a single dose of KER-050 (0.05, 0.5, 1.5 or 4.5 mg/kg) or placebo, and in Part 2 of the trial, 10 subjects received either two doses, 28 days apart, of KER-050 (0.75 mg/kg) or placebo. KER-050 was well tolerated at dose levels up to 4.5 mg/kg as a single dose, and 0.75 mg/kg after two doses. No treatment-related serious adverse events were reported.  There were no discontinuations due to adverse events, which in KER-050-treated subjects were all mild or moderate in severity; as expected with the KER-050 mechanism of action, reversible mild hypertension events were observed in subjects with approximately 3g/dL increase in hemoglobin.

    A dose-dependent increase in the proportion of subjects with a hemoglobin increase of ≥1.5 g/dL was observed. The proportion of subjects treated with KER-050 that demonstrated this hemoglobin increase in Part 1 of the trial was 12.5% (0.05 mg/kg dose), 12.5% (0.5 mg/kg dose), 50% (1.5 mg/kg dose), 66.7% (4.5 mg/kg dose) and 0% (placebo group), and in Part 2 of the trial was 25% (0.75 mg/kg dose) and 0% (placebo group).  Overall, there was a dose-dependent increase in hemoglobin observed in Part 1 of this trial, with the highest dose of 4.5 mg/kg eliciting a mean change from baseline in hemoglobin of 2.1 g/dL on Day 29. In addition, clinically relevant increases in platelet counts were observed, with a mean change from baseline of 39.2 x 109 cells/L in the 4.5 mg/kg group on Day 7.

    Additionally, in the Phase 1 clinical trial of KER-050:

    • The mean half-life of KER-050 observed in the 0.5, 1.5 and 4.5 mg/kg doses in Part 1 and after the first 0.75 mg/kg dose was administered in Part 2 ranged from 9.7 to 11.9 days.
    • In the 4.5 mg/kg group, the mean percent change (decrease) from baseline in follicle-stimulating hormone, a biomarker of activin inhibition, on Day 11 was 18.6%.  
    • In Part 1, the maximum percentage change from baseline observed in bone specific alkaline phosphatase, a biomarker of bone remodeling, was 9.6% (0.05 mg/kg dose), 21.8% (0.5 mg/kg dose), 21.8% (1.5 mg/kg dose), 34.1% (4.5 mg/kg dose) and 13.3% (placebo group).

    Preclinical Studies of KER-050 Demonstrated Robust Effects on Hematopoiesis and Differentiated Mechanism of Action

    • KER-050, a Novel Modified ActRIIA Ligand Trap, Increases Red Blood Cell Production in Cynomolgus Monkeys - Abstract Number: EP782.

    Treatment with KER-050 resulted in robust and dose-dependent increases in red blood cell ("RBC") number, hemoglobin ("Hgb"), hematocrit ("Hct") and reticulocyte ("RET") number in male and female cynomolgus monkeys dosed subcutaneously with KER-050 at doses of 3, 10 or 50 mg/kg for three months compared to vehicle-treated cohorts:

    • RBC number and Hct both showed statistically significant increases in treated animals compared to vehicle at all doses in females and at 10 mg/kg and 50 mg/kg in males.
    • Hgb increases from baseline were all statistically significant in treated animals compared to vehicle at all doses in both females and males.
    • RET number increase was statistically significant in both female and male treated animals compared to vehicle at the 50 mg/kg dose.

    KER-050 increased RBC number, Hct, Hgb and RET number in both male and female monkeys across multiple doses, demonstrating the effect of KER-050 on erythropoiesis in higher order species.

    • KER-050, a Novel Inhibitor of TGF-b Superfamily Signaling, Induces Red Blood Cell Production and is a Potential Candidate for the Treatment of Ineffective Erythropoiesis - Abstract Number: EP786. 

    In healthy mice dosed with 10 mg/kg of RKER-050 (a research form of KER-050), rapid increases in circulating reticulocytes, RBCs, hemoglobin and hematocrit were observed compared to vehicle-treated mice, supporting an effect on maturation of late-stage erythroid precursors.  Additionally, bone marrow from mice harvested four days after treatment with RKER-050 had an increased proerythroblast population, with a concomitant reduction in  burst-forming unit-erythroids (BFU-Es) and colony-forming unit-erythroids (CFU-Es), which is consistent with RKER-050 affecting early stages of erythropoiesis.

    In a subsequent study evaluating the involvement of erythropoietin in the RKER-050 mechanism of action, groups of mice received vehicle, 10 mg/kg of RKER-050, 5.5 mg/kg of neutralizing erythropoietin ("EPO") antibody ("mEpo Ab"), or a combination of both RKER-050 and mEPO Ab.  While treatment with mEpo Ab significantly reduced hematologic parameters, RKER-050 administered in combination with mEpo Ab resulted in RBC numbers comparable to vehicle.

    Keros believes these data support that KER-050 has the potential to stimulate terminal maturation of late-stage erythroid precursors, increase the early stage precursor population and acts via a mechanism of action that is distinct from EPO.

    Administration of ALK2 Inhibitor Reduced Hepcidin and Resolved Anemia in Preclinical IRIDA Model

    • Selective Inhibition of ALK2 Signaling Ameliorates Disease in a Novel Model of Iron Refractory Iron Deficiency Anemia (IRIDA) - Abstract Number: S308

    An ALK2 inhibitor ("KTI-2338") was used to test the effect of suppressing ALK2 signaling on regulation of hepcidin, serum iron and hematological parameters in a mouse model of IRIDA.

    IRIDA is a disease that arises from mutations in the TMPRSS6 gene, resulting in excessive signaling of the ALK2 receptor and subsequent hepcidin-mediated anemia. Keros developed a mouse model of IRIDA using an siRNA to knock down TMPRSS6 expression. Mice receiving the TMPRSS6 siRNA replicated the anemia in IRIDA patients, including having elevated hepcidin levels and anemia. In the preclinical study, mice received TMPRSS6 siRNA and were confirmed to have high hepcidin and anemia prior to receiving treatment with the ALK2 inhibitor KTI-2338. Daily treatment of KTI-2338 in mice with established disease resulted in increases in hemoglobin, hematocrit, RBCs and serum iron with a concomitant decrease in hepcidin.     

    These data demonstrate ALK2 inhibition can overcome changes in hepcidin, serum iron and anemia resulting from TMPRSS6-deficiency and therefore, Keros believes ALK2 inhibition has the potential to treat patients with IRIDA.

    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 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. Keros recently completed a Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of KER-050 in healthy post-menopausal women. Keros plans to commence a Phase 2 clinical trial in patients with MDS evaluating KER-050 for the treatment of cytopenias, including anemia and thrombocytopenia, in the second half of 2020. Keros also plans to commence a Phase 2 clinical trial evaluating KER-050 for the treatment of patients with myelofibrosis-associated cytopenias in 2021.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and timing of its clinical trials for KER-050; the potential of KER-050 to treat multiple cytopenias in diseases of ineffective hematopoiesis; and the potential of ALK2 inhibition to treat IRIDA and other hepcidin-mediated anemias. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 22, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Julia Balanova

    jbalanova@soleburytrout.com

    646-378-2936

    Primary Logo

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  29. LEXINGTON, Mass., May 28, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Keros' President and Chief Executive Officer Jasbir S. Seehra, Ph.D. is scheduled to present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 9:00 am ET.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal…

    LEXINGTON, Mass., May 28, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Keros' President and Chief Executive Officer Jasbir S. Seehra, Ph.D. is scheduled to present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 9:00 am ET.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Investor Contact:
    Julia Balanova
    jbalanova@soleburytrout.com
    646-378-2936

    Primary Logo

    View Full Article Hide Full Article
  30. LEXINGTON, Mass., May 22, 2020 (GLOBE NEWSWIRE) -- 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, today provided a business update and reported financial results for the first quarter of 2020.

    "Keros continued to make meaningful strides in the first quarter of 2020 as we continued our transition from a private company to a public company," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "In addition to our continued progress in the clinic with KER-047 and KER-050, we have strengthened our balance…

    LEXINGTON, Mass., May 22, 2020 (GLOBE NEWSWIRE) -- 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, today provided a business update and reported financial results for the first quarter of 2020.

    "Keros continued to make meaningful strides in the first quarter of 2020 as we continued our transition from a private company to a public company," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "In addition to our continued progress in the clinic with KER-047 and KER-050, we have strengthened our balance sheet with the successful completion of our Series C financing in March 2020 and our initial public offering in April 2020.  Our team continues to execute on our development plan with the aim of meeting our milestones in 2020.  We are well positioned to build on our Phase 1 clinical trials with multiple planned Phase 2 clinical trials in each of our two lead programs in patients who are underserved by current therapies."

    Recent Corporate Highlights:

    • Completed Series C financing: In March 2020, Keros closed a Series C financing for total gross proceeds of $56.0 million, bringing the total venture funding for the company to approximately $78.5 million in gross proceeds.
       
    • Completed upsized initial public offering: In April 2020, Keros completed its initial public offering of 6,900,000 shares of common stock, which included the exercise in full by the underwriters of their option to purchase up to 900,000 additional shares at a public offering price of $16.00 per share, for aggregate gross proceeds to Keros of $110.4 million. Keros received approximately $99.8 million in net proceeds after deducting underwriting discounts and commissions and offering costs.
       
    • Leadership team strengthened and board of directors expanded to support growth: In February 2020, Keros appointed Keith Regnante as its Chief Financial Officer. Mr. Regnante will lead the finance and information technology functions, together with overseeing investor relations and fundraising efforts. Additionally, in March 2020, Keros appointed Nima Farzan, the Chief Executive Officer of Kinnate Biopharma Inc., and Carl Gordon, Managing Partner and Co-Head of Global Private Equity at OrbiMed Advisors LLC, to its board of directors.  

    Recent Program Highlights:

    • KER-050 for the treatment of ineffective hematopoiesis to address cytopenias:
      • In January 2020, Keros completed a randomized, double-blind, placebo-controlled, two-part, dose-escalation Phase 1 clinical trial of KER-050 in 48 healthy post-menopausal women. Keros plans to report the positive topline data from this trial at the virtual 25th Congress of the European Hematology Association (EHA) taking place June 11-14 2020.  In addition, two abstracts outlining data from preclinical studies of KER-050 in multiple animal models have been accepted for presentation at the 25th Congress of the EHA taking place from June 11 to 14, 2020.
      • Commencement of an open-label Phase 2 clinical trial of KER-050 evaluating the treatment of cytopenias, including anemia and thrombocytopenia, in patients with very low-, low- or intermediate-risk myelodysplastic syndromes is expected in the second half of 2020, subject to any delays related to the COVID-19 pandemic.
         
    • KER-047 for the treatment of anemia arising from high hepcidin levels and for the treatment of fibrodysplasia ossificans progressiva:
      • Keros expects to complete its Phase 1 clinical trial of KER-047 in mid-2020, and to subsequently report data from this trial in the second half of 2020, subject to any delays related to the COVID-19 pandemic.
         
    • KER-012 for the treatment of disorders associated with bone loss and for the treatment of pulmonary arterial hypertension
      • Keros has selected KER-012 as a product candidate for further preclinical and clinical development.

    First Quarter 2020 Financial Results

    Keros reported a net loss of $11.9 million in the first quarter of 2020 as compared to a net loss of $3.2 million in the first quarter of 2019. The increase in net loss for the first quarter was largely due to increased research and development efforts as well as investments to enable the company transition to a publicly traded company.

    Research and development expenses were $8.5 million for the first quarter of 2020 as compared to $4.9 million for the same period in 2019. The increase of $3.7 million was primarily due to an increase in KER-050 related costs associated with the advancement of its Phase 1 clinical trial and start-up costs associated with the Phase 2 MDS trial, an increase in expenses associated with the advancement of its KER-047 Phase 1 clinical trial, and increased headcount to support the advancement of its pipeline.

    General and administrative expenses were $2.0 million for the first quarter of 2020 as compared to $0.5 million for the same period in the prior year. The increase of $1.5 million was primarily due to an increase in professional fees for services related to preparing for the filing of Keros' registration statement for its initial public offering in April 2020, as well as increases in headcount to support the achievement of Keros' corporate goals, including its transition to a public company. 

    Keros' cash and cash equivalents as of March 31, 2020 was $54.5 million compared to $7.0 million as of December 31, 2019.  Total cash and cash equivalents as of March 31, 2020 did not include total net proceeds of approximately $99.8 million from the Company's initial public offering completed in April 2020.   Keros expects that the cash and cash equivalents it had on hand at March 31, 2020, together with the net proceeds from its initial public offering, will fund its operating expenses and capital expenditure requirements into the second half of 2022.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and timing of its preclinical studies and clinical trials for KER-050, KER-047 and KER-012, including its regulatory plans; the potential impact of COVID-19 on Keros' ongoing and planned preclinical studies, clinical trials, business and operations; Keros' plans to present preclinical and clinical data at upcoming conferences; and Keros' expected cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's final prospectus for its initial public offering, filed with the SEC on April 8, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:
    Julia Balanova
    jbalanova@soleburytrout.com
    646-378-2936

     
     
    KEROS THERAPEUTICS, INC.
    Condensed Consolidated Statements of Operations
    (In thousands, except share and per share data)
    (Unaudited)
       
      THREE MONTHS ENDED MARCH 31,
      2020   2019
    REVENUE:      
    Research collaboration revenue $     $ 2,500  
    Total revenue     2,500  
    OPERATING EXPENSES:              
    Research and development (8,527 )   (4,867 )
    General and administrative (1,977 )   (491 )
    Total operating expenses (10,504 )   (5,358 )
    LOSS FROM OPERATIONS (10,504 )   (2,858 )
    OTHER EXPENSE, NET:              
    Interest expense, net (2 )   (2 )
    Research and development incentive income     180  
    Change in fair value of preferred stock tranche obligation (1,490 )   (604 )
    Other (expense) income, net (68 )   101  
    Total other expense, net (1,560 )   (325 )
    Loss before income taxes (12,064 )   (3,183 )
    Income tax benefit 172      
    Net loss $ (11,892 )   $ (3,183 )
    Net loss attributable to common stockholders—basic and diluted (Note 10) $ (12,698 )   $ (3,633 )
    Net loss per share attributable to common stockholders—basic and diluted $ (5.11 )   $ (1.61 )
    Weighted-average common stock outstanding—basic and diluted 2,484,057     2,258,335  
                   


    KEROS THERAPEUTICS, INC.
    Condensed Consolidated Balance Sheets
    (In thousands, except share and per share data)
    (Unaudited)
           
      MARCH 31,
    2020
      DECEMBER 31,
    2019
    ASSETS      
    CURRENT ASSETS:      
    Cash and cash equivalents $ 54,518     $ 7,020  
    Prepaid expenses and other current assets 1,197     381  
    Deferred IPO costs 2,019     604  
    Research and development incentive receivable 805     922  
    Total current assets 58,539     8,927  
    Operating lease right-of-use assets 1,116     1,205  
    Property and equipment, net 822     708  
    Restricted cash 115     115  
    TOTAL ASSETS $ 60,592     $ 10,955  
           
    LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT      
    CURRENT LIABILITIES:      
    Accounts payable $ 2,426     $ 2,088  
    Current portion of operating lease liabilities 388     376  
    Accrued expenses and other current liabilities 6,022     2,022  
    Total current liabilities 8,836     4,486  
    Operating lease liabilities, net of current portion 797     899  
    Preferred stock tranche liability     4,956  
    Other liabilities 104     119  
    Total liabilities 9,737     10,460  
    COMMITMENTS AND CONTINGENCIES      
    Series A convertible preferred stock, par value of $0.0001 per share; 10,000,000 shares authorized          
    as of March 31, 2020 and December 31, 2019; 4,607,652 shares issued and outstanding as of
    March 31, 2020 and December 31, 2019; liquidation and redemption value of $12,471 as of
    March 31, 2020
    9,891     9,891  
    Series A-1 convertible preferred stock, par value of $0.0001 per share; 800,000 shares authorized          
    as of March 31, 2020 and December 31, 2019; 368,612 shares issued and outstanding as of
    March 31, 2020 and December 31, 2019; liquidation and redemption value of $1,191 as of
    March 31, 2020
    944     944  
    Series B-1 convertible preferred stock, par value of $0.0001 per share; 3,427,004 shares authorized          
    as of March 31, 2020 and December 31, 2019; 1,579,043 shares issued and outstanding as of
    March 31, 2020 and December 31, 2019; liquidation and redemption value of $12,826 as of
    March 31, 2020
    9,106     9,106  
    Series C convertible preferred stock, par value of $0.0001 per share; 9,049,783 and 0 shares           
    authorized as of March 31, 2020 and December 31, 2019, respectively; 4,169,822 and 0 shares
    issued and outstanding as of March 31, 2020 and December 31, 2019, respectively; liquidation
    and redemption value of $56,356 as of March 31, 2020
    55,781      
    STOCKHOLDERS' DEFICIT:      
    Common stock, par value of $0.0001 per share; 35,000,000 and 27,000,000 shares authorized as           
    of March 31, 2020 and December 31, 2019, respectively; 2,491,670 and 2,429,705 shares
    issued and outstanding as of March 31, 2020 and December 31, 2019, respectively
    1     1  
    Additional paid-in capital 6,674     203  
    Accumulated deficit (31,542 )   (19,650 )
    Total stockholders' deficit (24,867 )   (19,446 )
    TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT $ 60,592      $ 10,955   

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  31. OMER, Israel, May 19, 2020 (GLOBE NEWSWIRE) -- ScoutCam Inc. (OTC:SCTC), a company developing and manufacturing customized visual solutions for organizations by offering the world's smallest cameras and supplementary technologies, today announced it had entered into and consummated a securities purchase agreement with M. Arkin (1999) Ltd. in connection with an investment of $2,000,000.

    Founder and Chairman of Arkin Holdings, Moshe "Mori" Arkin, is one of Israel's most successful life sciences and pharmaceutical entrepreneurs. A renowned industrialist and generic drug specialist, he founded Arkin Holdings, which owns a healthcare portfolio of $1 billion through four investment arms, with holdings in some 20 Israeli companies developing pharmaceutical…

    OMER, Israel, May 19, 2020 (GLOBE NEWSWIRE) -- ScoutCam Inc. (OTC:SCTC), a company developing and manufacturing customized visual solutions for organizations by offering the world's smallest cameras and supplementary technologies, today announced it had entered into and consummated a securities purchase agreement with M. Arkin (1999) Ltd. in connection with an investment of $2,000,000.

    Founder and Chairman of Arkin Holdings, Moshe "Mori" Arkin, is one of Israel's most successful life sciences and pharmaceutical entrepreneurs. A renowned industrialist and generic drug specialist, he founded Arkin Holdings, which owns a healthcare portfolio of $1 billion through four investment arms, with holdings in some 20 Israeli companies developing pharmaceutical drugs and medical equipment, such as UroGen Pharma (NASDAQ:URGN), Keros Therapeutics (NASDAQ:KROS) and Novolog (TASE: NVLG). Mori previously grew Agis into a leading dermatological company in the U.S., which led to its acquisition by Perrigo in 2005 for $818 million.

    ScoutCam develops and manufactures customized visual solutions for organizations across a variety of industries in the form of highly resistant micro cameras and supplementary technologies. With the smallest cameras produced in the world, which are down to 1mm diameter including illumination, the high resolution technology has unique properties that have been authenticated by customers, such as NASA, in the strictest environmental conditions, including extreme temperatures, vibrations, and radiation. ScoutCam devices have been used across the medical, aerospace, industrial, research and defense industries.

    "We are proud to have received Mr. Mori Arkin's vote of confidence by having him make a substantial investment in ScoutCam Inc. Mr. Arkin's contribution will go beyond a financial investment as he requested and ScoutCam gladly accepted to appoint a director to the company's board of directors." said Professor Benad Goldwasser, chairman of ScoutCam's board of directors.

    Dr. Irit Yaniv, an experienced and accomplished senior executive in the MedTech industry, will join ScoutCam's board of directors, as Mori Arkin's representative.

    As part of the agreement and in exchange for the investment of $2,000,000, ScoutCam issued to Arkin 4,132,232 shares of common stock, 2,066,116 warrants to purchase common stock at an exercise price of $0.595 and 4,132,232 warrants to purchase common stock at an exercise price of $0.893.

    About ScoutCam

    ScoutCam is a leading provider of customized visual solutions for organizations across a variety of industries in the form of highly resistant micro cameras and supplementary technologies. ScoutCam devices are used across the medical, aerospace, industrial, research and defense industries. For more information please visit: https://www.scoutcam.com

    Cautionary Note Regarding Forward Looking Statements

    Information set forth in this news release contains forward-looking statements that are based on the Company's expectations, beliefs, assumptions and intentions regarding, among other things, its product-development efforts, business, financial condition, results of operations, strategies or prospects, as of the date of this news release. They are not guarantees of future performance. Forward-looking statements can be identified by the use of forward-looking words such as "believe," "expect," "intend," "plan," "may," "should" or "anticipate" or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. The Company cautions that all forward-looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company's control. Such factors include, among other things: risks and uncertainties relating to, inter alia, the spread of COVID-19, including any resultant restrictions on our business operations and/or its negative impact on our financial condition; the Company's reliance on third-party suppliers; market acceptance of our products by prospect markets and industries; the Company's ability to raise sufficient funding in order to meet the Company's business and financial goals; and certain other factors summarized in the Company's filings with the SEC. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

    Contact                                                                                                                                          

    Yaron Silberman
    Chief Executive Officer
    yaron.silberman@scoutcam.com

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  32. OMER, Israel, May 19, 2020 (GLOBE NEWSWIRE) -- Medigus Ltd. (NASDAQ:MDGS) (TASE:MDGS), a technology company developing minimally invasive tools and an innovator in direct visualization technology, today announced that ScoutCam Inc. (OTC:SCTC), the Company's subsidiary, entered into and consummated a securities purchase agreement with M. Arkin (1999) Ltd. in connection with an investment of $2,000,000.

    Founder and Chairman of Arkin Holdings, Moshe "Mori" Arkin, is one of Israel's most successful life sciences and pharmaceutical entrepreneurs. A renowned industrialist and generic drug specialist, he founded Arkin Holdings, which owns a healthcare portfolio of $1 billion through four investment arms, with holdings in some 20 Israeli companies…

    OMER, Israel, May 19, 2020 (GLOBE NEWSWIRE) -- Medigus Ltd. (NASDAQ:MDGS) (TASE:MDGS), a technology company developing minimally invasive tools and an innovator in direct visualization technology, today announced that ScoutCam Inc. (OTC:SCTC), the Company's subsidiary, entered into and consummated a securities purchase agreement with M. Arkin (1999) Ltd. in connection with an investment of $2,000,000.

    Founder and Chairman of Arkin Holdings, Moshe "Mori" Arkin, is one of Israel's most successful life sciences and pharmaceutical entrepreneurs. A renowned industrialist and generic drug specialist, he founded Arkin Holdings, which owns a healthcare portfolio of $1 billion through four investment arms, with holdings in some 20 Israeli companies developing pharmaceutical drugs and medical equipment, such as UroGen Pharma (NASDAQ:URGN), Keros Therapeutics (NASDAQ:KROS) and Novolog (TASE: NVLG). Mori previously grew Agis into a leading dermatological company in the U.S., which led to its acquisition by Perrigo in 2005 for $818 million.

    ScoutCam develops and manufactures customized visual solutions to organizations across a variety of industries in the form of highly resistant micro cameras and supplementary technologies. With the smallest cameras produced in the world, which are down to 1mm diameter including illumination, the high resolution technology has unique properties that have been authenticated by customers, such as NASA, in the strictest environmental conditions, including extreme temperatures, vibrations, and radiation. ScoutCam devices have been used across the medical, aerospace, industrial, research and defense industries.

    "We are proud to have received Mr. Mori Arkin's vote of confidence by having him make a substantial investment in ScoutCam Inc. Mr. Arkin's contribution will go beyond a financial investment as he requested and ScoutCam gladly accepted to appoint a director to the company's board of directors." said Professor Benad Goldwasser, chairman of ScoutCam's board of directors.

    Dr. Irit Yaniv, an experienced and accomplished senior executive in the Medtech industry, will join ScoutCam's board of directors, as Mori Arkin's representative.

    As part of the agreement and in exchange for the investment of $2,000,000, ScoutCam issued to Arkin 4,132,232 shares of common stock, 2,066,116 warrants to purchase common stock at an exercise price of $0.595 and 4,132,232 warrants to purchase common stock at an exercise price of $0.893.

    About Medigus

    Medigus is traded on the Nasdaq Capital Market and the TASE (Tel Aviv Stock Exchange). To learn more about the company's advanced technology, please visit www.medigus.com.

    Cautionary Note Regarding Forward Looking Statements

    This press release may contain statements that are "Forward-Looking Statements," which are based upon the current estimates, assumptions and expectations of the company's management and its knowledge of the relevant market. The company has tried, where possible, to identify such information and statements by using words such as "anticipate," "believe," "envision," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "contemplate" and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words. These forward-looking statements represent Medigus' expectations or beliefs concerning future events, and it is possible that the results described in this press release will not be achieved. By their nature, Forward-Looking Statements involve known and unknown risks, uncertainties and other factors which may cause future results of the company's activity to differ significantly from the content and implications of such statements. Other risk factors affecting the company are discussed in detail in the company's filings with the Securities and Exchange Commission. Forward-Looking Statements are pertinent only as of the date on which they are made, and the company undertakes no obligation to update or revise any Forward-Looking Statements, whether as a result of new information, future developments or otherwise. Neither the company nor its shareholders, officers and employees, shall be liable for any action and the results of any action taken by any person based on the information contained herein, including without limitation the purchase or sale of company securities. Nothing in this press release should be deemed to be medical or other advice of any kind.

    Contact (for media only)

    Tatiana Yosef
    Chief Financial Officer
    +972-8-6466-880
    ir@medigus.com

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  33. LEXINGTON, Mass., May 14, 2020 (GLOBE NEWSWIRE) -- 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 today announced that four abstracts will be presented from the KER-050 and ALK2 hematology programs, including topline data from the Phase 1 clinical trial of KER-050,  at the 25th Annual Congress of the European Hematology Association ("EHA"), to be held as a virtual event from June 11-14, 2020.

    "We are pleased to be given the opportunity to present at this year's virtual Congress," said Jasbir S. Seehra, Ph.D., Chief Executive…

    LEXINGTON, Mass., May 14, 2020 (GLOBE NEWSWIRE) -- 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 today announced that four abstracts will be presented from the KER-050 and ALK2 hematology programs, including topline data from the Phase 1 clinical trial of KER-050,  at the 25th Annual Congress of the European Hematology Association ("EHA"), to be held as a virtual event from June 11-14, 2020.

    "We are pleased to be given the opportunity to present at this year's virtual Congress," said Jasbir S. Seehra, Ph.D., Chief Executive Officer of Keros. "We look forward to sharing these exciting data from our two lead programs with the EHA community."

    Details of the presentations are as follows:

    "Administration of KER-050, a Novel ActRIIA Ligand Trap, to Healthy Participants Elicited Robust and Sustained Increases in Hemoglobin and Platelets"

    • Abstract Number: EP806
    • Date and Time: Virtual poster presentation available June 11-14, 2020

    "KER-050, A Novel Modified ActRIIA Ligand Trap, Increases Red Blood Cell Production in Cynomolgus Monkeys"

    • Abstract Number: EP782
    • Date and Time: Virtual poster presentation available June 11-14, 2020

    "KER-050, a Novel Inhibitor of TGFΒ Superfamily Signaling, Induces Red Blood Cell Production and is a Potential Candidate for the Treatment of Ineffective Erythropoiesis

    • Abstract Number: EP786
    • Date and Time: Virtual poster presentation available June 11-14, 2020

    "Selective Inhibition of ALK2 Signaling Ameliorates Disease in a Novel Model of Iron Refractory Iron Deficiency Anemia (IRIDA)"

    • Abstract Number: S308
    • Date and Time: Virtual oral presentation available June 11-14, 2020

    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. Keros recently completed a Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of KER-050 in healthy post-menopausal women. Keros plans to commence a Phase 2 clinical trial in patients with MDS evaluating KER-050 for the treatment of cytopenias, including anemia and thrombocytopenia, in the second half of 2020. Keros also plans to commence a Phase 2 clinical trial evaluating KER-050 for the treatment of patients with myelofibrosis-associated cytopenias in 2021.

    About Keros Therapeutics, Inc.

    Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros' lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros' lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros' third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its growth, strategy, progress and timing of its clinical trials for KER-050; and Keros' presentation plans for the upcoming EHA virtual annual meeting. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; Keros' dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's final prospectus for its initial public offering, filed with the SEC on April 8, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:
    Julia Balanova
    jbalanova@soleburytrout.com
    646-378-2936

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