Company: KROS
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001664710-25-000018
Chunk: 213

Company: Keros Therapeutics, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 213
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 demonstrated the ability to progress any product candidate through late-stage clinical trials, we have no products approved for commercial sale and we have not generated any revenue from product sales to date. We continue to incur significant research and development and other expenses related to our ongoing operations. As a result, we are not profitable and have incurred losses in each period since our inception. For the years ended December 31, 2024 and 2023, we reported a net loss of $187.4 million and $153.0 million, respectively.  As of December 31, 2024, we had an accumulated deficit of $568.8 million. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, our lead product candidate, cibotercept, our second product candidate, KER-065, our most advanced product candidate, elritercept, and any future product candidates we may develop. 

We anticipate that our expenses will increase substantially if, and as, we: 

▪progress and complete our ongoing Phase 2 clinical trial of cibotercept in patients with pulmonary arterial hypertension, or PAH; 

▪progress and complete our ongoing Phase 1 clinical trial of KER-065 in healthy volunteers;

▪commence a Phase 3 clinical trial of elritercept in patients with lower-risk myelodysplastic syndrome, or MDS;

▪continue the research and development of our other clinical- and preclinical-stage product candidates and discovery-stage programs; 

▪increase the amount of research and development activities to identify and develop product candidates using our proprietary discovery approach; 

▪make milestone, royalty or other payments under in-license or collaboration agreements; 

▪maintain, expand and protect our intellectual property portfolio; 

▪expand our operational, financial and management systems and increase personnel, including personnel to support our clinical development, manufacturing and commercialization efforts and our operations as a public company; 

▪establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any products for which we may obtain marketing approval and intend to commercialize on our own or jointly with third parties; 

▪invest in or in-license other technologies; and 

▪experience any delays or encounter any issues with any of the above, including but not limited to failed studies, complex results, manufacturing challenges, safety issues or other regulatory challenges. 

To become and remain profitable, we