KROS Keros Therapeutics Inc.

53.11
-1.24  -2%
Previous Close 54.35
Open 55.2
52 Week Low 25.6
52 Week High 88.8
Market Cap $1,236,602,299
Shares 23,283,794
Float 12,809,391
Enterprise Value $1,001,661,393
Volume 129,939
Av. Daily Volume 141,816
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Upcoming Catalysts

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

Drug Stage Notes
KER-047
Anemia
Phase 2
Phase 2
Phase 2 trials to commence 2H 2021.
KER-012
Osteoporosis
Phase 1
Phase 1
Phase 1 trial to be initiated 2H 2021.

Latest News

  1. 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



    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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  2. 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



    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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  3. 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



    646-378-2936



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  4. 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



    646-378-2936

     



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  5. 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



    646-378-2936



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    View Full Article Hide Full Article
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