Cibotercept

LEXINGTON, Mass., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced that the Company has closed screening for the TROPOS trial, a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulmonary arterial hypertension (“PAH”). As a result, Keros expects to complete enrollment by the end of September and present topline data in the second quarter of 2025. “We are very pleased to announce the closing of screening in the TROPOS trial,” said Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer. “The tremendous demand and speed we have observed in enrolling this trial will enable us to present topline data earlier than anticipated, now expected in the second quarter of 2025.” “We want to thank the TROPOS investigators, research staff and their patients for their participation in this important clinical research,” said Chris Rovaldi, President and Chief Operating Officer. “This milestone, which could not have been achieved without their commitment, brings us one step closer to bringing a potentially differentiated treatment option to patients living with PAH.” About TROPOS (NCT05975905) TROPOS is a randomized, double-blind, placebo-controlled, global Phase 2 clinical trial to evaluate cibotercept in combination with background therapy in patients with PAH. The primary objective of this trial is to evaluate the effect of cibotercept on pulmonary hemodynamics compared to placebo in participants on background PAH therapy. The key secondary objective of this trial is to evaluate the effect of cibotercept on exercise capacity compared to placebo on participants on background PAH therapy. About Cibotercept Cibotercept is designed to bind to and inhibit the signaling of TGF-β ligands that stimulate smooth muscle hypertrophy and fibrosis, including activin A, activin B and myostatin. Keros believes that cibotercept 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. Cibotercept is being developed for the treatment of PAH and for the treatment of cardiovascular disorders. About Keros Therapeutics, Inc. Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the TGF-ß family of proteins. The Company is a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of a number of tissues, including blood, bone, skeletal muscle, adipose and heart tissue. By leveraging this understanding, Keros has discovered and is developing protein therapeutics that have the potential to provide meaningful and potentially disease-modifying benefit to patients. Keros’ lead product candidate, elritercept (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’ second product candidate, cibotercept, is being developed for the treatment of PAH and for the treatment of cardiovascular disorders. Keros’ third product candidate, KER-065, is being developed for the treatment of obesity and for the treatment of neuromuscular diseases. 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 “expects,” “enable,” “potential,” “will” 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 cibotercept (including expected timing for enrollment completion and data readout for the TROPOS trial). 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 product candidates, elritercept, cibotercept and KER-065; 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; and Keros’ dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. 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 7, 2024, 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:Justin Frantzjfrantz@kerostx.com 617-221-6042

LEXINGTON, Mass., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today reported financial results for the quarter ended June 30, 2024. “Keros continued to build upon the progress of all programs across our pipeline in the second quarter of 2024, as evidenced by our recent positive regulatory and data updates from the elritercept (KER-050) program,” said Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer. “We continue to be excited by the strong enrollment activity we have seen to date in our Phase 2 clinical trial of cibotercept (KER-012) in patients with pulmonary arterial hypertension and look forward to completing enrollment of that trial in the fourth quarter of this year.” Second Quarter 2024 Financial Results Keros reported a net loss of $45.3 million in the second quarter of 2024 as compared to a net loss of $37.5 million in the second quarter of 2023. The increase of $7.8 million for the second quarter was largely due to increased research and development efforts as well as additional investments to support the achievement of Keros’ clinical and corporate goals. Research and development expenses were $40.5 million for the second quarter of 2024 as compared to $32.5 million for the same period in 2023. The increase of $8.0 million was primarily due to additional research and development efforts, manufacturing activities and personnel expenses to support the advancement of Keros’ pipeline. General and administrative expenses were $10.0 million for the second quarter of 2024 as compared to $8.8 million for the same period in 2023. The increase of $1.2 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, 2024 was $405.9 million compared to $331.1 million as of December 31, 2023. Keros expects that the cash and cash equivalents it had on hand at June 30, 2024 will enable Keros to fund its operating expenses and capital expenditure requirements into 2027. About Keros Therapeutics, Inc. Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the TGF-ß family of proteins. We are a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of a number of tissues, including blood, bone, skeletal muscle, adipose and heart tissue. By leveraging this understanding, we have discovered and are developing protein therapeutics that have the potential to provide meaningful and potentially disease-modifying benefit to patients. Keros’ lead product candidate, elritercept (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’ second product candidate, cibotercept (KER-012), is being developed for the treatment of pulmonary arterial hypertension and for the treatment of cardiovascular disorders. Keros’ third product candidate, KER-065, is being developed for the treatment of obesity and for the treatment of neuromuscular diseases. 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 “enable,” “expects,” “look forward,” “progress” and “will” 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 elritercept and cibotercept, including its regulatory plans; 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 product candidates, elritercept, cibotercept and KER-065; 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; and Keros’ dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. 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 8, 2024, 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: Justin Frantzjfrantz@kerostx.com 617-221-6042 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, 2024 2023 2024 2023 REVENUE: Service and other revenue 37 — 120 — Total revenue 37 — 120 — OPERATING EXPENSES: Research and development (40,515) (32,534) (78,773) (63,625)General and administrative (9,961) (8,803) (20,269) (16,581)Total operating expenses (50,476) (41,337) (99,042) (80,206)LOSS FROM OPERATIONS (50,439) (41,337) (98,922) (80,206)OTHER INCOME (EXPENSE), NET Dividend income 5,378 3,987 11,184 7,093 Other expense, net (196) (155) (633) (196)Total other income, net 5,182 3,832 10,551 6,897 Net loss$(45,257) $(37,505) $(88,371) $(73,309)Net loss attributable to common stockholders—basic and diluted$(45,257) $(37,505) $(88,371) $(73,309)Net loss per share attributable to common stockholders—basic and diluted$(1.25) $(1.27) $(2.46) $(2.53)Weighted-average common stock outstanding—basic and diluted 36,103,187 29,602,458 35,894,305 28,989,361 KEROS THERAPEUTICS, INC.Condensed Consolidated Balance Sheets(In thousands, except share and per share data)(Unaudited) JUNE 30,2024 DECEMBER 31,2023ASSETS CURRENT ASSETS: Cash and cash equivalents405,863 331,147 Accounts receivable4 143 Prepaid expenses and other current assets26,847 16,003 Total current assets432,714 347,293 Operating lease right-of-use assets14,649 15,334 Property and equipment, net4,292 4,134 Restricted cash1,212 1,212 Other long-term assets2,155 2,052 TOTAL ASSETS455,022 370,025 LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable6,535 5,450 Current portion of operating lease liabilities1,096 1,005 Accrued expenses and other current liabilities13,614 17,918 Total current liabilities21,245 24,373 Operating lease liabilities, net of current portion12,861 13,439 Total liabilities34,106 37,812 STOCKHOLDERS' EQUITY: Preferred stock, par value of $0.0001 per share; 10,000,000 shares authorized as of June 30, 2024 and December 31, 2023; no shares issued and outstanding— — Common stock, par value of $0.0001 per share; 200,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 36,169,558 and 31,841,084 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively3 3 Additional paid-in capital890,710 713,636 Accumulated deficit(469,797) (381,426)Total stockholders' equity420,916 332,213 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY455,022 370,025