Company: KROS
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0001664710-25-000046
Chunk: 138

Company: Keros Therapeutics, Inc.
Filing Date: 2025-05-06
Form: 10-Q
Item: Item 1
Chunk 138
---
 $720.5 million.

Recent Significant Developments

In March 2025, we announced initial topline results from the Phase 1 clinical trial of KER-065 in healthy volunteers, as of a data cut-off date of February 6, 2025. Topline results from this ongoing trial were through the multiple ascending dose treatment period (Day 85). KER-065 was generally well-tolerated, with no major safety signals observed to date. No serious adverse events or dose-limiting toxicities reported. Additionally, we observed evidence for activin inhibition across tissues of interest, as KER-065 elicited:

•Increases in bone specific alkaline phosphate, a biomarker of bone formation, and decreases in C-Terminal Telopeptide, a biomarker of bone resorption;

•Increases in adiponectin, a biomarker of fat mobilization, and decreases in leptin, a biomarker of fat mass; and

•Changes in body composition, as demonstrated by increases in bone mineral density and muscle mass and decreases in fat mass, which in totality were consistent with activin inhibition.

We plan on engaging with regulatory authorities, starting in the third quarter of 2025. Subject to the outcome of these regulatory interactions, we expect to initiate a Phase 2 clinical trial of KER-065 in patients with DMD in the first quarter of 2026.

In April 2025, we announced that our board of directors has determined to initiate a formal review process to evaluate strategic alternatives to enhance our stockholder value. In connection with this determination, our board of directors has authorized the formation of a committee, consisting of independent and disinterested directors, to oversee the process, or the Strategic Committee, and make a recommendation to the full board of directors. The Strategic Committee, with the assistance of outside financial and legal advisors, intends to consider a comprehensive range of strategic alternatives, including but not limited to a sale of us or other business combination transaction, continued investment in our pipeline and/or return of excess capital to stockholders. There can be no assurance that the strategic alternatives review process will result in us pursuing a transaction or any other strategic outcome. There is no deadline or definitive timetable set for completion of the strategic alternatives review process. We intend to provide a preliminary update regarding the status of the process within 60 days of the initial announcement of this process. Otherwise, we do not intend to disclose developments related to the process unless and until it is determined that further disclosure is appropriate or necessary.

In