Topline data announced from the TROPOS trial, a Phase II clinical trial of cibotercept (KER-012) in patients with pulmonary arterial hypertension.- Keros Therapeutics

 Keros Therapeutics, Inc., announced topline data from the TROPOS trial, a Phase II clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulmonary arterial hypertension (“PAH”), and provided a corporate update.

TROPOS Trial Results; TROPOS is a randomized, double-blind, placebo-controlled, global Phase II clinical trial to evaluate cibotercept in combination with background therapy in patients with PAH. On December 12, 2024, the Company announced that it had voluntarily halted the 3.0 mg/kg and 4.5 mg/kg treatment arms based on the observation of pericardial effusions at those dose levels. Furthermore, on January 15, 2025, the Company announced that it had voluntarily halted all dosing in the trial, including the 1.5 mg/kg and placebo treatment arms, based on the ongoing safety review due to new observations of pericardial effusion adverse events. Following the early termination of the trial, patients continued to be monitored through their end-of-trial visits.

Following the analysis of all available safety and efficacy data from the TROPOS trial, the Company has decided to discontinue all development of cibotercept in PAH.

“Additional treatment options for individuals with PAH are critically needed,” said Jasbir S. Seehra, Ph.D, Chair and Chief Executive Officer. “We are immensely grateful to the patients, investigators and Keros colleagues for their dedication to seeking new treatment options for this devastating disease.”

The Company plans to further evaluate the appropriate development strategy for cibotercept, if any, in other indications following the completion of the strategic alternative review process.

Corporate Restructuring; In connection with the decision to discontinue all development of cibotercept in PAH and an assessment of its ongoing development programs, the Keros Board of Directors (the “Board”) and management team have decided to reduce the Company’s headcount by approximately 45%, after which the Company will have 85 full-time employees. The reduction in headcount will commence after the 60-day notice period required by the Worker Adjustment and Retraining Notification Act has elapsed, and as a result of these actions, Keros expects to realize average annualized cost savings of approximately $17 million.

Dr. Seehra added, “Consistent with our commitment to being data driven and taking action to best position Keros to drive sustainable stockholder value, we have identified opportunities to restructure our operations and reduce costs as we focus on our key ongoing development programs. As a result, we have made the difficult decision to reduce our workforce to better align with our strategic priorities. We appreciate the hard work and dedication of our impacted team members and we are committed to supporting them through this transition. Looking ahead, Keros maintains a robust balance sheet and we are making meaningful progress on our other development programs. Our focus remains on the execution of our strategy as we concurrently work to complete the ongoing review of strategic alternatives to maximize value for all stockholders.”

As previously announced on April 10, 2025, with the assistance of outside financial and legal advisors, the Strategic Committee of the Board, which consists of independent and disinterested directors, is continuing to evaluate a comprehensive range of strategic alternatives, including but not limited to a sale of the Company or other business combination transaction, continued investment in the Company’s pipeline, and/or return of excess capital to stockholders. Keros intends to provide a preliminary update regarding the status of the process no later than June 9, 2025.