On May 4, 2023 Keros Therapeutics, Inc. ("Keros" or the "Company") (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, reported a business update and announced financial results for the quarter ended March 31, 2023 (Press release, Keros Therapeutics, MAY 4, 2023, View Source [SID1234631035]).
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"We are on track to report additional data from multiple clinical trials this year, including our two 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 believe these data readouts, combined with the planned commencement of our Phase 2 clinical trial of KER-012 in patients with pulmonary arterial hypertension in the first half of this year, position Keros for a year of important clinical milestones."
Recent Corporate Highlights
•Cash position strengthened: The Company has utilized its existing at the market offering to sell additional shares of common stock, which strengthened its cash position. The Company expects that its cash and cash equivalents as of March 31, 2023 will enable the Company to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2025.
•Strengthened leadership with board appointment: In May 2023, Keros appointed Dr. Alpna Seth, Ph.D., to its board of directors.
Recent Program Highlights
•KER-012 for the treatment of pulmonary arterial hypertension and for the treatment of cardiovascular disorders
◦Keros will present three poster abstracts from its KER-012 program at the American Thoracic Society ("ATS") 2023 International Conference, to be held from May 19 through May 24, 2023. The following abstracts were posted to the ATS conference website on March 2, 2023:
▪Clinical Presentation: "Administration of KER-012, a Modified Activin Receptor IIB Ligand Trap, Led to Changes in Biomarkers of Cardiovascular Health in a Ph1 Study Conducted in Healthy Post-Menopausal Women"
•Session Name: A26: Precision-Based Approaches to Pulmonary Vascular Disease
•Date and Presentation Time: May 21, 2023; 9:00 a.m. – 11:00 a.m. Eastern time
▪Preclinical Presentation: "RKER-012, a Novel Modified ActRII Ligand Trap, Attenuated Cardiac Remodeling and Fibrosis in a Transverse Aortic Constriction Model of Heart Failure"
•Session Name: A71: Matters of the Heart: Studies on Cardiopulmonary Vascular Disease
•Date and Presentation Time: May 21, 2023; 11:30 a.m. – 1:15 p.m. Eastern time
▪Preclinical Presentation: "RKER-012, a Novel Activin Receptor Type IIB (ActRIIB) Ligand Trap, Inhibited Mediators of Dysregulated Vascular Remodeling in Pulmonary Endothelial and Smooth Muscle Cells"
•Session Name: B59: Breaking Bad: New Drugs and Formulations for Pulmonary Hypertension and RV Failure
•Date and Presentation Time: May 22, 2023; 11:30 a.m. – 1:15 p.m. Eastern time
First Quarter 2023 Financial Results
Keros reported a net loss of $35.8 million in the first quarter of 2023 as compared to a net loss of $24.2 million in the first quarter of 2022. The increase of $11.6 million for the first 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 $31.1 million for the first quarter of 2023 as compared to $18.1 million for the same period in 2022. The increase of $13.0 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 $7.8 million for the first quarter of 2023 as compared to $6.0 million for the same period in 2022. The increase of $1.7 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 March 31, 2023 was $351.4 million compared to $279.0 million as of December 31, 2022. Keros expects that the cash and cash equivalents it had on hand at March 31, 2023 will enable Keros to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2025.