Company: KROS
Filing Date: 2025-08-06
Form Type: 10-Q
Source: 0001664710-25-000070
Chunk: 311

Company: Keros Therapeutics, Inc.
Filing Date: 2025-08-06
Form: 10-Q
Item: Item 8
Chunk 311
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 inception and anticipate that we will continue to incur net losses in the future. 

We are a clinical-stage biopharmaceutical company with a limited operating history. Since our inception in 2015, we have invested most of our resources in developing our product candidates, building our intellectual property portfolio, developing our supply chain, conducting business planning, raising capital and providing general and administrative support for these operations. Consequently, we have no meaningful operations upon which to evaluate our business and predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing drug products. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable. We have not yet 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 fiscal year since our inception. For the three months ended June 30, 2025, we reported a net loss of $30.7 million. However, for the six months ended June 30, 2025, we reported a net income of $117.8 million. As of June 30, 2025, we had an accumulated deficit of $451.0 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, KER-065, elritercept (KER-050) and any future product candidates we may develop. 

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

■commence a Phase 2 clinical trial of KER-065 in patients with Duchenne muscular dystrophy, or DMD;

■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,