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Keros Therapeutics Reports Recent Business Highlights and Fourth Quarter and Full Year 2023 Financial ResultsLEXINGTON, Mass., Feb. 28, 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 provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2023. “In 2023, Keros made continued clinical progress across our pipeline, including commencing our Phase 2 clinical trial evaluating KER-012 in patients with pulmonary arterial hypertension (“PAH”) and presenting exciting data from our two ongoing Phase 2 clinical trials of KER-050, one in patients with myelodysplastic syndromes (“MDS”) and one in patients with myelofibrosis,” said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. “We continue to build on that momentum in 2024, as highlighted by the advancement of our third clinical asset, KER-065, into a Phase 1 healthy volunteer clinical trial at the beginning of this year. We look forward to providing updates from the KER-050 and KER-012 programs in the first half of this year.” Recent Corporate Highlights:
Selected Anticipated Program Milestones:
2023 Financial Results Keros reported a net loss of $40.2 million for the fourth quarter and $153.0 million for the year ended December 31, 2023, as compared to a net loss of $29.7 million for the fourth quarter and $104.7 million for the year ended December 31, 2022. The increase in net loss for the fourth quarter and the increase in net loss for the year was largely due to increased research and development efforts as well as additional investments to support the achievement of Keros' clinical and corporate goals. Keros generated revenue of $0.2 million for the year ended December 31, 2023, related to a manufacturing technology transfer agreement Keros entered into with Hansoh (Shanghai) Healthtech Co., Ltd. (“Hansoh”) effective June 2023, in connection with the license agreement Keros entered into with Hansoh in December 2021. Keros did not generate any revenue for the year ended December 31, 2022. Research and development expenses were $37.5 million for the fourth quarter and $135.3 million for the year ended December 31, 2023, as compared to $24.9 million for the fourth quarter and $87.3 million for the year ended December 31, 2022. The increase in research and development expenses for the fourth quarter and the year was driven by the continued advancement of the Company's pipeline, notably the progression of its two Phase 2 clinical trials of KER-050, the advancement of KER-012 into the TROPOS trial, as well as an increase in personnel costs and infrastructure to support operations and expansion of its pipeline. General and administrative expenses were $9.1 million for the fourth quarter and $34.8 million for the year ended December 31, 2023, as compared to $7.1 million and $27.5 million for the fourth quarter and year ended December 31, 2022. The increase was primarily due to an increase in personnel expenses to support the Company's organizational growth and achievement of its corporate goals, an increase in facilities, supplies and other office expenses due to growth of the Company's organization, and an increase in professional fees and director and officer insurance premiums. Keros’ cash and cash equivalents as of December 31, 2023 was $331.1 million compared to $279.0 million as of December 31, 2022. Keros expects that its cash and cash equivalents as of December 31, 2023, together with the net proceeds from the January 2024 Offering, will enable the Company to fund its planned 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, KER-050 (elritercept), 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, KER-012, 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 “anticipates,” “believes,” “continue,” “expects,” “enable,” “potential” 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 KER-050, KER-012 and KER-065, 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, KER-050, KER-012 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 November 6, 2023, 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:
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