On February 28, 2024 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 reported financial results for the fourth quarter and full year ended December 31, 2023 (Filing, 3 mnth, DEC 31, Keros Therapeutics, 2024, FEB 28, 2024, View Source [SID1234640589]).
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"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:
•Cash position strengthened: The Company closed an underwritten public offering of 4,025,000 shares of common stock on January 8, 2024, at a public offering price of $40.00 per share, inclusive of the underwriters’ exercise in full of their option to purchase up to an additional 525,000 shares of common stock at the public offering price (the "January 2024 Offering"). The Company 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.
Selected Anticipated Program Milestones:
•KER-050 (elritercept) for the treatment of ineffective hematopoiesis to address cytopenias:
◦Engage with regulators on the design of the planned Phase 3 clinical trial of KER-050 in patients with MDS in the first half of 2024
◦Report additional data from Part 2 of the ongoing Phase 2 clinical trial of KER-050 in patients with MDS in the second and fourth quarters of 2024
◦Report additional data from the ongoing Phase 2 clinical trial of KER-050 in patients with myelofibrosis in the second and fourth quarters of 2024
•KER-012 for the treatment of PAH and for the treatment of cardiovascular disorders:
◦Provide an update on enrollment of the ongoing Phase 2 clinical trial evaluating KER-012 in patients with PAH (the "TROPOS trial") in the first half of 2024
◦Report initial data from the ongoing Phase 2 open-label biomarker trial of KER-012 in patients with chronic heart failure with preserved injection and in such patients with reduced ejection fraction in the second half of 2024
•KER-065 for the treatment of obesity and for the treatment of neuromuscular diseases:
◦Report initial data from the ongoing Phase 1 clinical trial in healthy volunteers in the first quarter of 2025
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.