0001664710-22-000057.txt : 20221103 0001664710-22-000057.hdr.sgml : 20221103 20221103090236 ACCESSION NUMBER: 0001664710-22-000057 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20221103 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20221103 DATE AS OF CHANGE: 20221103 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Keros Therapeutics, Inc. CENTRAL INDEX KEY: 0001664710 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39264 FILM NUMBER: 221356454 BUSINESS ADDRESS: STREET 1: 99 HAYDEN AVENUE, SUITE 120 (BLD E) STREET 2: LEDGEMONT TECHNOLOGY CENTER CITY: LEXINGTON STATE: MA ZIP: 02421 BUSINESS PHONE: 617-513-8774 MAIL ADDRESS: STREET 1: 99 HAYDEN AVENUE, SUITE 120 (BLD E) STREET 2: LEDGEMONT TECHNOLOGY CENTER CITY: LEXINGTON STATE: MA ZIP: 02421 8-K 1 kros-20221103.htm 8-K kros-20221103
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM 8-K 
 
 
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 3, 2022
 
 
Keros Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
 
 
 
Delaware 001-39264 81-1173868
(state or other jurisdiction
of incorporation)
 
(Commission
File Number)
 
(I.R.S. Employer
Identification No.)
99 Hayden Avenue, Suite 120, Building E
Lexington, Massachusetts
 02421
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (617) 314-6297
 
Not applicable
(Former name or former address, if changed since last report.)
 
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 



 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class 
Trading
Symbol
 
Name of each exchange
on which registered
Common Stock, $0.0001 par value per share KROS The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
 
 



Item 8.01 Other Events.

On November 3, 2022, Keros Therapeutics, Inc. (the “Company”) issued a press release announcing that five of the Company's abstracts will be presented from the KER-050 and KER-047 hematology programs at the 64th American Society of Hematology ("ASH") Annual Meeting and Exposition, to be held in person and virtually from December 10 through 13, 2022. The Company also announced that it remains on track to release additional efficacy data from its ongoing Phase 2 clinical trial of KER-050 in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes by mid-December 2022.

A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the Company’s expectations regarding its growth, strategy, progress and timing of its clinical trials for KER-050 and the Company's presentation plans for the upcoming ASH Annual Meeting and Exposition. 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 the Company's 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 3, 2022, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Item 9.01     Financial Statements and Exhibits.
(d) Exhibits

Exhibit No.Description
99.1
104Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document)





SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
KEROS THERAPEUTICS, INC.
By: /s/ Jasbir Seehra
 
Jasbir Seehra, Ph.D.
Chief Executive Officer
Dated: November 3, 2022

EX-99.1 2 exhibit991ashabstracts.htm EX-99.1 Document

Exhibit 99.1
Keros Therapeutics to Present at the 64th American Society of Hematology Annual Meeting and Exposition, Including Presenting Data from its Phase 2 Clinical Trials Evaluating KER-050 and KER-047

November 3, 2022 at 9:00 AM ET

LEXINGTON, Mass., Nov. 03, 2022 (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, pulmonary and cardiovascular disorders with high unmet medical need, today announced that five abstracts will be presented from the KER-050 and KER-047 hematology programs at the 64th American Society of Hematology (“ASH”) Annual Meeting and Exposition, to be held in person and virtually from December 10 through 13, 2022. Keros will be presenting additional and initial preliminary results, respectively, from its two Phase 2 clinical trials of KER-050, one in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes (“MDS”) and one in patients with myelofibrosis. In addition, Keros will be presenting preliminary results from its Phase 2 clinical trial of KER-047 in patients with iron-refractory iron deficiency anemia.

“We are excited to have multiple abstracts accepted for presentation at ASH, which provides us with the opportunity to share updates from our preclinical and Phase 2 clinical programs, including biomarker data from our ongoing Phase 2 clinical trial of KER-050 in patients with MDS,” said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. “We remain on track to release additional efficacy data from our KER-050 Phase 2 MDS trial by mid-December 2022.”

The following abstracts were posted to the ASH website on November 3, 2022, 9:00 a.m. Eastern time.

Clinical Presentations

“Preliminary Results of a Phase-2 Clinical Trial of the ALK-2 Inhibitor KER-047 for Treatment of Iron-Refractory Iron Deficiency Anemia”

Publication Number: 1028
Session Name: 102. Iron Homeostasis and Biology: Poster I
Date: Saturday, December 10, 2022
Presentation Time: 5:30 p.m. – 7:30 p.m. Central time

“Effects of KER-050 on Iron Metabolism: Exploratory Analyses from an Ongoing Phase 2 Study in Patients with Myelodysplastic Syndromes”

Publication Number: 3656
Session Name: 102. Iron Homeostasis and Biology: Poster III
Date: Monday, December 12, 2022
Presentation Time: 6:00 p.m. - 8:00 p.m. Central time

“Modulation of TGF-β Superfamily Signaling to Treat Myelofibrosis and Mitigate JAK Inhibitor Toxicity: A Report on the Phase 2 Study of KER-050 in Participants with Myelofibrosis”

Publication Number: 4361
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Date: Monday, December 12, 2022
Presentation Time: 6:00 p.m. - 8:00 p.m. Central time

Preclinical Presentations



“ALK2 Inhibition and a Modified Activin Receptor Type IIA Ligand Trap Cotherapy Maximized Hematologic Improvements in a Mouse Model of Anemia of Inflammation”

Publication Number: 2338
Session Name: 102. Iron Homeostasis and Biology: Poster II
Date: Sunday, December 11, 2022
Presentation Time: 6:00 p.m. - 8:00 p.m. Central time

“RKER-050, a Novel Activin Receptor Type II Ligand Trap, Rescued Anemia and Reduced Bone Loss in a Mouse Model of Myelodysplastic Syndromes”

Publication Number: 4387
Session Name: 636. Myelodysplastic Syndromes - Basic and Translational: Poster III
Date: Monday, December 12, 2022
Presentation Time: 6:00 p.m. – 8:00 p.m. Central time

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”) superfamily 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.

About KER-047

Keros’ lead small molecule product candidate, KER-047, is designed to selectively and potently inhibit activin receptor-like kinase-2, a TGF-β superfamily receptor. KER-047 is being developed for the treatment of functional iron deficiency which is a consequence of elevated ALK2 signaling.

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 hematological, pulmonary and cardiovascular 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 a number of tissues, including blood vessels and heart tissue. 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 MDS and in patients with myelofibrosis. Keros’ lead small molecule product candidate, KER-047, is being developed for the treatment of functional iron deficiency. Keros’ third product candidate, KER-012, is being developed for the treatment of pulmonary arterial hypertension and for the treatment of cardiovascular disorders associated with cardiac hypertrophy.

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 ASH Annual Meeting & Exposition. 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, KER-012 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 3, 2022, 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:

Deepankar Roy
droy@kerostx.com
213-268-1878

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