Keros Therapeutics, Inc. (NASDAQ:KROS) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders linked to dysfunctional signaling of the transforming growth factor-beta (TGF-β) family of proteins. The company's pipeline includes three lead product candidates: KER-050, KER-012, and KER-065, all of which are in various stages of clinical development.

Financials

For the fiscal year ended December 31, 2023, Keros reported annual revenue of $151,000 and a net loss of $152,992,000. The company's annual operating cash flow was -$124,508,000, and its annual free cash flow was -$126,972,000. These financial results reflect Keros' continued investment in the research and development of its product candidates.

In the first quarter of 2024, Keros reported total revenue of $83,000, compared to $0 in the same period of the prior year. The company's net loss for the first quarter of 2024 was $43,114,000, compared to a net loss of $35,804,000 in the first quarter of 2023. Keros' operating cash flow for the first quarter of 2024 was -$44,560,000, and its free cash flow was -$45,506,000.

Pipeline and Clinical Development

Keros' lead product candidate, KER-050, is an engineered ligand trap comprised of a modified ligand-binding domain of the TGF-β superfamily receptor known as activin receptor type IIA (ActRIIA), that is fused to the portion of the human antibody known as the Fc domain. KER-050 is being developed for the treatment of low blood cell counts (cytopenias), including anemia and thrombocytopenia, in patients with myelodysplastic syndromes (MDS) and in patients with myelofibrosis.

In December 2023, Keros announced additional data from its ongoing Phase 2 clinical trial evaluating KER-050 for the treatment of anemia and thrombocytopenia in patients with very low-, low-, or intermediate-risk MDS. The company expects to report additional data from Part 2 of this trial in the second and fourth quarters of 2024. Additionally, Keros has engaged with the U.S. Food and Drug Administration (FDA) regarding the design of the planned Phase 3 clinical trial of KER-050 in patients with MDS and expects to provide an update on the planned trial design in mid-2024.

Keros' second product candidate, KER-012, is designed to bind to and inhibit the signaling of TGF-β ligands that stimulate the proliferation of vascular endothelial and smooth muscle cells and fibroblasts, including activin A, activin B, and myostatin (GDF8). The company is developing KER-012 for the treatment of pulmonary arterial hypertension (PAH) and for the treatment of cardiovascular disorders. Keros expects to provide an update on enrollment for its ongoing Phase 2 clinical trial evaluating KER-012 in patients with PAH, known as the TROPOS trial, in the first half of 2024. The company also expects to announce initial data from its ongoing open-label Phase 2 biomarker clinical trial of KER-012 in patients with chronic heart failure with preserved ejection fraction and in such patients with reduced ejection fraction in the second half of 2024.

Keros' third product candidate, KER-065, is designed to bind to and inhibit TGF-β ligands, including myostatin (GDF8) and activin A, which are negative regulators of muscle and bone mass and strength. The company is developing KER-065 for the treatment of obesity and for the treatment of neuromuscular disorders. Keros has commenced a Phase 1 clinical trial of KER-065 in a healthy volunteer adult population and expects to announce initial data from this trial in the first quarter of 2025.

Business Overview

Keros was incorporated in 2015 and is headquartered in Lexington, Massachusetts. The company's principal focus is on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the TGF-β family of proteins. Keros is a leader in understanding the role of the TGF-β 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.

Keros has a limited operating history, having incurred net losses in every year since its inception. As of March 31, 2024, the company had $442,443,000 in cash and cash equivalents, which it believes will be sufficient to fund its projected liquidity requirements for at least the next 12 months. However, Keros will need to raise additional capital in the future to continue the development and potential commercialization of its product candidates.

Risks and Challenges

Keros faces several risks and challenges that are common to the biopharmaceutical industry, including the need to successfully complete clinical trials, obtain regulatory approvals, and effectively commercialize its product candidates. The company's ability to generate revenue and achieve profitability is dependent on the successful development and commercialization of its product candidates, which is inherently uncertain and may be delayed or prevented by a variety of factors.

Additionally, Keros operates in a highly competitive environment, with several other companies developing therapies that target the same or similar indications as its product candidates. The company's success will depend on its ability to differentiate its products, maintain a strong intellectual property position, and effectively market and sell any approved products.

Outlook

Keros has not provided specific financial guidance for the full year 2024. However, the company has stated that it expects to continue to invest heavily in the research and development of its product candidates, which will result in ongoing operating losses and negative cash flows.

Despite the challenges, Keros remains optimistic about the potential of its pipeline and is committed to advancing its product candidates through clinical development and, if approved, to the commercialization stage. The company's strong cash position and the progress it has made with its clinical trials provide a solid foundation for its future growth and development.

Conclusion

Keros Therapeutics is a promising biopharmaceutical company with a diverse pipeline of novel therapeutic candidates targeting a range of disorders linked to dysfunctional TGF-β signaling. While the company faces the typical risks and challenges associated with drug development, its strong financial position and the progress it has made with its clinical trials suggest that Keros is well-positioned to continue advancing its pipeline and potentially bringing much-needed therapies to patients in the future.