CRIS 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• In January 2026, we announced that we are focusing our operations on our ongoing combination Phase 1/2 study in relapsed/refractory, or R/R, PCNSL with ibrutinib and our recently initiated Phase 2 combination study of emavusertib in CLL with zanubrutinib. Our monotherapy and combination studies of e…

• In August 2025, we announced a Phase 2 open label clinical study of emavusertib in combination with zanubrutinib in frontline CLL (CA-4948-203, NCT07271667), also known as the TakeAim CLL study. We expect to announce the dosing of our fifth patient by mid-2026, with initial data expected in December…

• Emavusertib is currently undergoing testing in combination with ibrutinib in a Phase 1/2 open-label, single arm expansion trial in patients with R/R PCNSL (CA-4948-101, NCT03328078), also known as the TakeAim Lymphoma Phase 1/2 study. In June 2022 and December 2023, we provided preliminary clinical …

• For submission in Europe, we engaged CHMP for scientific advice on the potential for CMA submission, with the following feedback:

• •Primary endpoint of Overall Response Rate, or ORR, for a single-arm study is supported;

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• Emavusertib is currently undergoing testing in combination with ibrutinib, a BTK inhibitor, in a Phase 1/2 open-label, single arm expansion trial in patients with R/R PCNSL (NCT03328078), also known as the TakeAim Lymphoma Phase 1/2 study. In June 2022 and December 2023, we provided preliminary clin…

• In August 2025, we announced a new clinical study of emavusertib in combination with a commercially approved BTK inhibitor in frontline CLL. We expect to begin activating sites later this year and will initiate dosing later this year or early next year, with data expected in the fourth quarter of 20…

• In addition to the TakeAim Lymphoma Phase 1/2 study, emavusertib is currently undergoing testing in a Phase 1/2 open-label, single arm expansion trial in patients with R/R AML and hrMDS (NCT04278768), also known as the TakeAim Leukemia Phase 1/2 study. In January and December 2022, July and December…

• We have initiated a Phase 1 clinical study of emavusertib as an add-on agent to the combination of venetoclax and azacitidine in AML (2023-505828-58), which we refer to as the AML Triplet study. The AML Triplet study is currently being conducted in Spain, Germany, and Italy. The study is assessing t…

• We are party to a collaboration agreement with Genentech, a member of the Roche Group, under which Genentech and F. Hoffmann-La Roche Ltd, or Roche, are commercializing Erivedge® (vismodegib), a first-in-class orally administered small molecule Hedgehog signaling pathway antagonist. Erivedge is appr…

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act) as of March 31, 2026.

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Secu…

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• We are required to meet specified requirements to maintain our listing on the Nasdaq Capital Market, including a minimum bid price of $1.00 per share for our common stock and standards relative to minimum stockholders’ equity, minimum market value of publicly held shares and various additional requi…

• In the past we have, from time to time, received deficiency letters from Nasdaq as a consequence of our failure to satisfy such requirements. On February 3, 2026, we received written notice from Nasdaq indicating that we regained compliance with Nasdaq Listing Rule 5550(b)(2), or MVLS Rule, and was …

• On April 27, 2026, we received a Delist Determination Letter from the Staff notifying us that the bid price for our common stock had closed for the last 30 consecutive business days below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market pursuant to Nasdaq …

• However, there can be no assurance that any Hearings Panel will grant us additional time to regain compliance with the Bid Price Rule or if we will be able to suspend or delay our delisting from Nasdaq. If we are delisted from Nasdaq, we may transfer to and commence trading on the OTC Markets or ano…

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• Our common stock is currently listed on the Nasdaq Capital Market. We are required to meet specified requirements to maintain our listing on the Nasdaq Capital Market, including a minimum bid price of $1.00 per share for our common stock and standards relative to minimum stockholders’ equity, minimu…

• If we fail to satisfy the Nasdaq Capital Market’s continued listing requirements and we are delisted from Nasdaq, we may transfer to and commence trading on the OTC Markets or another quotation medium. As a result, an investor would likely find it more difficult to trade or obtain accurate price quo…

• Changes in and uncertainty surrounding U.S. trade policy and international trade policies, particularly with respect to China, could have a material adverse impact on our business, financial condition and results of operations.

• We rely on third party contract manufacturing organizations, or CMOs, to produce our product candidate. One of our CMOs has a Chinese subcontractor that produces regulatory starting materials. Another CMO operates in Canada and produces our drug product. This past spring, the U.S. government initiat…

• Separately, in April 2025, the Department of Commerce initiated an investigation under Section 232 of the Trade Expansion Act of 1962 into the impact on U.S. national security of the imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures,…