KROS Keros Therapeutics Inc.

38.26
+0.01  (+0%)
Previous Close 38.25
Open 37.94
52 Week Low 28.5
52 Week High 88.8
Market Cap $892,906,600
Shares 23,337,862
Float 12,863,459
Enterprise Value $653,684,056
Volume 26,013
Av. Daily Volume 185,063
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Upcoming Catalysts

Drug Stage Catalyst Date
KER-050
Myelodysplastic syndromes
Phase 2
Phase 2
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KER-047
Anemia
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
KER-012
Osteoporosis
Phase 1
Phase 1
Phase 1 trial to be initiated 2H 2021.

Latest News

  1. LEXINGTON, Mass., Oct. 04, 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 it presented results from a preclinical study of KER-012 at the American Society for Bone and Mineral Research (ASBMR) 2021 Annual Meeting held October 1 through 4, 2021.

    RKER-012 prevented loss of bone volume, bone volume fraction and trabecular number, and reduced trabecular separation in a rodent PAH model.

    • RKER-012, a Novel Activin Receptor Type II Ligand Trap, Protected Rats from Pulmonary Arterial

    LEXINGTON, Mass., Oct. 04, 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 it presented results from a preclinical study of KER-012 at the American Society for Bone and Mineral Research (ASBMR) 2021 Annual Meeting held October 1 through 4, 2021.

    RKER-012 prevented loss of bone volume, bone volume fraction and trabecular number, and reduced trabecular separation in a rodent PAH model.

    • RKER-012, a Novel Activin Receptor Type II Ligand Trap, Protected Rats from Pulmonary Arterial Hypertension-Associated Bone Loss in a SUGEN/Hypoxia Model

    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 of pulmonary arterial hypertension ("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 20 mg/kg RKER-012 twice weekly for four weeks. Rats maintained under normal oxygen conditions ("normoxic controls") received only vehicle. Relative to normoxic controls, vehicle-treated SH rats had reduced bone volume (-30.9%; p≤0.05), lower bone volume fraction (-27.1%; p≤0.05), reduced trabecular number (-27.6%; p≤0.01) and increased trabecular separation (50.0%; p≤0.0001). In contrast to the reduced parameters observed in vehicle-treated SH rats, treatment with RKER-012 increased bone volume, led to a higher bone volume fraction, increased trabecular number and decreased trabecular separation. Bone volume, bone volume fraction, trabecular number and trabecular separation remained equivalent to normoxic controls, which suggests that RKER-012 protected rats from PAH-induced bone loss.

    "We are excited to announce additional preclinical data from our KER-012 program, which we presented at the ASBMR 2021 Annual Meeting. The results of this study suggest that RKER-012 prevented bone loss in this PAH model, which we believe supports that KER-012 has the potential to treat bone loss resulting from secondary osteoporosis, such as in PAH," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros.

    About KER-012

    KER-012 is designed to bind to and inhibit the transforming growth factor-Beta ligands that suppress bone growth, including activin A and activin B, in order to promote bone growth to potentially treat diseases such as osteogenesis imperfecta and osteoporosis. 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 PAH.

    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 bone loss resulting from secondary osteoporosis, such as PAH. 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 August 5, 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) 221-9660



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  2. 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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  3. 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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  4. 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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  5. 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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