On February 26, 2025 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, reported a business update and announced financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Keros Therapeutics, FEB 26, 2025, View Source [SID1234650632]).
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"The efforts over the past year by the team at Keros have positioned us to continue to advance our promising pipeline of novel therapeutics," said Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer. "We are excited to report initial data from the ongoing Phase 1 clinical trial of KER-065 in healthy volunteers in the first quarter of 2025, which we believe can inform our advancement into a Phase 2 clinical trial in neuromuscular disease, with our initial focus on Duchenne muscular dystrophy. We continue to expect to report data from the Phase 2 TROPOS trial evaluating cibotercept (KER-012) in patients with pulmonary arterial hypertension, and we plan to evaluate the appropriate development strategy for cibotercept following that data readout."
Recent Corporate Highlights:
•Cash position strengthened: In February 2025, Keros received a $200.0 million upfront payment pursuant to the exclusive license agreement it entered into with Takeda Pharmaceuticals U.S.A., Inc. (the "Takeda Agreement") to further develop, manufacture and commercialize elritercept (KER-050) worldwide outside of mainland China, Hong Kong and Macau, which became effective on January 16, 2025. Based on current operating assumptions, the Company expects that its cash and cash equivalents as of December 31, 2024, together with the upfront payment received from the Takeda Agreement, will enable the Company to fund its planned operating expenses and capital expenditure requirements into 2029.
2024 Financial Results
Keros reported a net loss of $46.0 million for the fourth quarter and $187.4 million for the year ended December 31, 2024, as compared to a net loss of $40.2 million for the fourth quarter and $153.0 million for the year ended December 31, 2023. The increase in net loss for the fourth quarter and 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 $3.0 million for the fourth quarter and $3.6 million for the year ended December 31, 2024 compared to $0.1 million for the fourth quarter and $0.2 million for the year ended December 31, 2023. Revenue in 2024 was largely related to a milestone achieved under Keros’ license agreement with Hansoh (Shanghai) Healthtech Co., Ltd. ("Hansoh").
Research and development expenses were $45.6 million for the fourth quarter and $173.6 million for the year ended December 31, 2024, as compared to $37.5 million for the fourth quarter and $135.3 million for the year ended December 31, 2023. 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 TROPOS trial, the ongoing Phase 1 clinical trial of KER-065 and the progression of two Phase 2 clinical trials and the Phase 3 clinical trial of elritercept, as well as an increase in personnel costs and infrastructure to support operations and expansion of the Company’s pipeline.
General and administrative expenses were $10.7 million for the fourth quarter and $40.8 million for the year ended December 31, 2024, as compared to $9.1 million and $34.8 million for the fourth quarter and year ended December 31, 2023, respectively. 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 the growth of the Company’s organization and an increase in professional fees.
Keros’ cash and cash equivalents as of December 31, 2024 was $559.9 million compared to $331.1 million as of December 31, 2023. Based on current operating assumptions, Keros expects that its cash and cash equivalents as of December 31, 2024, together with the $200 million upfront payment from the Takeda Agreement, which the Company received in February 2025, will enable the Company to fund its planned operating expenses and capital expenditure requirements into 2029.