LEXINGTON, Mass., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, today provided a business update and reported financial results for the third quarter of 2020.
“We are very pleased to reach the significant milestone of dosing the first patients in our Phase 2 clinical trial of KER-050. The initiation of this trial is a tremendous accomplishment for Keros and moves us closer to proof-of-concept by potentially demonstrating therapeutic benefit for patients with myelodysplastic syndromes ("MDS"),” said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. “This Phase 2 clinical trial, along with the completion of our expanded Phase 1 clinical trial of KER-047, positions us to potentially have multiple ongoing Phase 2 clinical trials in 2021. Additionally, by regaining the rights to development programs in metabolic diseases and continuing rapid development of KER-012, Keros continues to further expand its already deep pipeline.
Recent Corporate Highlights:
| KER-050 for the treatment of ineffective hematopoiesis to address cytopenias: | ||||
| On October 20, 2020, Keros announced the dosing of the first two participants in its open-label, Phase 2 clinical trial evaluating KER-050 for the treatment of anemia and thrombocytopenia in very low-, low- or intermediate-risk MDS. Keros expects to report initial data from Part 1 of this trial in mid-2021, subject to any delays related to the COVID-19 pandemic. | ||||
| Keros will present two preclinical abstracts on a mouse version of KER-050 highlighting the differentiated mechanism of action and potential of KER-050 to address multiple types of cytopenias at the 62nd American Society of Hematology ("ASH") Annual Meeting and Exposition, to be held virtually December 5-8, 2020. | ||||
| KER-047 for the treatment of anemia arising from iron imbalance and for the treatment of fibrodysplasia ossificans progressiva ("FOP"): | ||||
| In August 2020, Keros announced the completion of its planned single and multiple ascending dose cohorts in a Phase 1 clinical trial of KER-047 in healthy volunteers, as well as the expansion of this trial to evaluate additional cohorts of healthy volunteers. | ||||
| Keros will present final data from the KER-047 Phase 1 clinical trial at the 62nd ASH Annual Meeting, along with a preclinical abstract highlighting the observed effects of activin receptor-like kinase-2 inhibition on hepcidin levels and iron metabolism. | ||||
Third Quarter 2020 Financial Results
Keros reported a net loss of $12.0 million in the third quarter of 2020 as compared to a net loss of $3.5 million in the third quarter of 2019. The increase in net loss for the second quarter was largely due to increased research and development efforts as well as the infrastructure needed as a publicly traded company.
Research and development expenses were $8.4 million for the third quarter of 2020 as compared to $3.9 million for the same period in 2019. The increase of $4.5 million was primarily due to additional toxicology studies and manufacturing activities, as well as an increase related to personnel expenses, including additional share-based compensation cost, driven by increased headcount to support the advancement of Keros’ pipeline.
General and administrative expenses were $3.6 million for the third quarter of 2020 as compared to $1.0 million for the same period in 2019. The increase of $2.6 million was primarily due to an increase in personnel expenses to support Keros' organizational growth and achievement of Keros' corporate goals, additional share-based compensation costs and an increase in professional fees to support Keros' transition to a public company.
Keros’ cash and cash equivalents as of September 30, 2020 was $133.8 million compared to $144.7 million as of June 30, 2020. Keros expects that the cash and cash equivalents it had on hand at September 30, 2020 will fund its operating expenses and capital expenditure requirements into the second half of 2022.
About Keros Therapeutics, Inc.
Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros’ lead protein therapeutic product candidate, KER-050, 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’ lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros’ third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.
