ELVN 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-05

• Agreement (as defined below) and received gross proceeds of $40.0 million. As of June 30, 2026, we had cash, cash equivalents and marketable securities of $895.2 million. Based on our current operating plan, which includes the continued advancement of ELVN-001 and preparations for our planned pivota…

• Research and development expenses were $29.0 million for the three months ended June 30, 2026 compared to $21.5 million for the three months ended June 30, 2025, an increase of $7.5 million. The increase was due to higher internal research and development costs, consisting of $5.5 million in stock-b…

• General and administrative expenses were $8.2 million for the three months ended June 30, 2026 compared to $7.1 million for the three months ended June 30, 2025, an increase of $1.1 million. The increase was driven by higher stock-based compensation of $0.7 million and salaries and benefits of $0.5 …

• The following table summarizes our results of operations for the periods indicated:

• The following table summarizes our research and development expenses for the periods indicated:

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• equivalents and marketable securities will be sufficient to fund our planned operating expenses and capital expenditure requirements for at least the next 12 months from the date of the filing of this Form 10-Q.

• incur costs related to our decision not to develop the HER2 program beyond 2025;

• Comparison of the three months ended March 31, 2026 and 2025

• Research and development expenses were $20.7 million for the three months ended March 31, 2026 compared to $24.9 million for the three months ended March 31, 2025, a decrease of $4.2 million. The decrease was due to lower external research and development costs, driven by a decrease of $7.0 million …

• General and administrative expenses were $7.1 million for the three months ended March 31, 2026 compared to $6.8 million for the three months ended March 31, 2025, an increase of $0.3 million. The increase was driven by higher salaries and benefits of $0.8 million, partially offset by lower consulti…

相对上期新增的文字 · 来源:10-Q · 2026-08-05

• The design and implementation of clinical trials is a complex process. We have limited experience as a company in designing and conducting clinical trials. We are currently evaluating ELVN-001 in a Phase 1 clinical trial in adults with CML. However, we have not initiated clinical trials for any othe…

• requirements or the implementation of new requirements can increase the costs of compliance and expose us to great liabilities. Amendments may require us to resubmit our clinical trial protocols to IRBs or ethics committees for reexamination, which may impact the costs, timing or successful completi…

• We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate, recruit and enroll a sufficient number of eligible patients to participate in these trials to such trials' conclusion as required by the FDA, EMA or other comparable foreign regulatory a…

• recruitment and enrollment. Because there are effective, approved drugs and/or ongoing clinical trials being conducted for CML, it may make it difficult for us to recruit and enroll patients in our trials for the same indications. For example, CML patient recruitment and enrollment could have been a…

• Our belief in and estimates of the market opportunity for any product candidates that we develop is based on projections of both the number of people living with the disease, as well as the subset of people in a position to receive a particular line of therapy and who have the potential to benefit f…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• to have an adverse effect on our working capital, our ability to fund the development of our product candidates and our ability to achieve and maintain profitability and the performance of our stock.

• human trials, due to the inherent biologic differences in species, the differences between testing conditions in animal studies and human trials, and the particular goals, purposes, and designs of the relevant studies and trials.

• The design and implementation of clinical trials is a complex process. We have limited experience as a company in designing and conducting clinical trials. We are currently evaluating ELVN-001 in a Phase 1 clinical trial in adults with CML. To prioritize the

• advancement of ELVN-001 and its upcoming pivotal trial, we are exploring strategic alternatives for the ELVN-002 program and are no longer pursuing its development. However, we have not initiated clinical trials for any other product candidate and we may experience unexpected or adverse results in t…

• consultants who receive compensation from us. Under certain circumstances, we may be required to report some of these relationships to the FDA.

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• On January 3, 2026, Anish Patel, Pharm.D., our Chief Operating Officer and, until February 12, 2026, an officer as defined in Rule 16a-1(f), as trustee for The Patel/Dong Family Trust, dated August 24, 2017, terminated the “Rule 10b5-1 trading arrangement” as defined in Regulation S-K Item 408 that …

• On March 6, 2026, Lori Kunkel, M.D., a director, adopted a “Rule 10b5-1 trading arrangement” as defined in Regulation S-K Item 408 providing for the sale from time to time of an aggregate of up to 20,000 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defen…

• On March 18, 2026, Benjamin Hohl, our Chief Financial Officer and an officer as defined in Rule 16a-1(f), adopted a “Rule 10b5-1 trading arrangement” as defined in Regulation S-K Item 408 providing for the sale from time to time of an aggregate of up to 43,090 shares of our common stock. The trading…

• No other officers or directors, as defined in Rule 16a-1(f), adopted and/or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as defined in Regulation S-K Item 408, during the last fiscal quarter.