KROS 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-03

• trial of rinvatercept in healthy adult male volunteers. We have initiated a Phase 2 clinical trial of rinvatercept in patients with DMD, and expect to announce initial data from this trial in the first half of 2027. We also plan to engage regulators on the design of a Phase 2 clinical trial of rinva…

• Our most advanced product candidate, elritercept (KER-050), is an engineered ligand trap comprised of a modified ligand-binding domain of the TGF-ß receptor known as activin receptor type IIA, or ActRIIA, that is fused to the portion of the human antibody known as the Fc domain. Elritercept is being…

• Since our inception in 2015, we have devoted the majority of our efforts to business planning, research and development of our product candidates, including by conducting clinical trials and preclinical studies, raising capital and recruiting management and technical staff to support these operation…

• execution of the Pontifax Repurchase Agreement, each of Tomer Kariv and Ran Nussbaum resigned from our board of directors and all committees thereof.

• Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase for the foreseeable future, with the exception of elritercept-related expenses which are

相对上期删除的文字 · 来源:10-Q · 2026-05-14

• Our most advanced product candidate, elritercept (KER-050), is an engineered ligand trap comprised of a modified ligand-binding domain of the TGF-ß receptor known as activin receptor type IIA, or ActRIIA, that is fused to the portion of the human antibody known as the Fc domain. Elritercept is being…

• Since our inception in 2015, we have devoted the majority of our efforts into business planning, research and development of our product candidates, including by conducting clinical trials and preclinical studies, raising capital and recruiting management and technical staff to support these operati…

• as none of our product candidates have been approved for commercialization. We have historically financed our operations primarily through the sale of convertible preferred stock, common stock and cash received from licensing agreements.

• in the Hansoh Territory, we will be entitled to receive royalty payments based on a tiered percentage of annual net sales in each region within the Hansoh Territory, with such percentage ranging from the low double digit to high teens, subject to specified potential royalty reductions. We did not re…

• Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase for the foreseeable future, with the exception of elritercept-related expenses which are expected to decrease once transitioned to Takeda, as we conti…

相对上期新增的文字 · 来源:10-Q · 2026-08-03

• We maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarize…

• Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2026. Based on the evaluation of our disclosure controls and procedures as of June 30, 2026, our Chief Executive…

相对上期删除的文字 · 来源:10-Q · 2026-05-14

• We maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarize…

• forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our pri…

• Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2026. Based on the evaluation of our disclosure controls and procedures as of March 31, 2026, our Chief Executi…

相对上期新增的文字 · 来源:10-Q · 2026-08-03

• profitable in the year ended December 31, 2025, this was primarily driven by the one-time upfront payment from our license agreement with Takeda Pharmaceuticals U.S.A., Inc., or Takeda. We continue to incur significant research and development and other expenses related to our ongoing operations. As…

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

• candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. Furthermore, we expect to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional fundin…

• receiving the investigational product candidate or either an existing approved product or placebo. Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. For example, in our ongoing Phase 2 clinical trial for rinva…

• In addition, on December 11, 2025, the European Commission, the European Parliament and the European Council reached a political agreement on a comprehensive overhaul of EU pharmaceutical legislation, or the Pharma Package. The reform has been under negotiation since the European Commission submitte…

相对上期删除的文字 · 来源:10-Q · 2026-05-14

• year ended December 31, 2025. For the three months ended March 31, 2026, we reported a net loss of $23.7 million and as of March 31, 2026, we had an accumulated deficit of $505.5 million. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to incr…

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

• terms, we could be forced to delay, reduce or eliminate our product development programs or any future commercialization efforts.

• Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. For example, in our ongoing Phase 2 clinical trial for elritercept in patients with lower-risk MDS, the dose levels for Cohorts 1, 2, 3, 4 and 5 of Part 1 of t…

• In addition, on December 11, 2025, the European Commission, the Parliament and the European Council reached a political agreement on a comprehensive overhaul of EU pharmaceutical legislation, or the Pharma Package. The reform has been under negotiation since the European Commission submitted its pro…

相对上期新增的文字 · 来源:10-Q · 2026-08-03

• During the three months ended June 30, 2026, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement,” or "non-rule 10b5-1 trading arrangement," as each term is defined in Item 408(a) of Regulation S-K.

相对上期删除的文字 · 来源:10-Q · 2026-05-14

• During the three months ended March 31, 2026, the following director of the Company adopted a “Rule 10b5-1 trading arrangement,” as that term is defined in Item 408(a) of Regulation S-K, which was entered into during an open trading window in accordance with the Company’s Insider Trading Policy and …

• •On March 12, 2026, Charles Newton, a member of our board of directors, adopted a Rule 10b5-1 trading plan that provides for the sale of up to 2,201 shares of our common stock to be acquired upon the settlement of RSUs. The plan will expire on February 28, 2027, subject to early termination for cert…