ELDN 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• mL/min/1.73 m2 range during the first year after kidney transplant using current standard of care immunosuppression. An eGFR of 60 mL/min/1.73 m2 or below generally indicates chronic kidney disease.

• The first subject in the Phase 1b study was dosed in July 2022. We reported interim safety and efficacy results from the Phase 1b clinical trial in March 2023, and provided updated data in November 2023, June 2024 and August 2025.

• At the time of the August 2025 update, which reported data as of July 2025, 32 patients undergoing kidney transplantation were enrolled in the Phase 1b study. The updated data showed that kidney function, as assessed by eGFR, stabilized after the first month post-transplant and remained in the range…

• In January 2026, we presented 24-month data from eight patients enrolled in the Phase 1b trial long-term extension evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium held in Scottsdale, Arizona. During the reported follow-up period, no ep…

• In July 2022, we received Investigational New Drug (“IND”) application clearance from the FDA for our controlled, Phase 2 BESTOW trial of tegoprubart for the prevention of transplant rejection in persons receiving a kidney transplant. The BESTOW study is a multi-center, two-arm, active comparator, h…

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• We reported interim safety and efficacy results from the Phase 1b clinical trial in March 2023, and provided updated data in November 2023, June 2024 and August 2025.

• At the time of the August 2025 update, which reported data as of July 2025, 32 patients undergoing kidney transplantation have been enrolled in the Phase 1b study. Updated data showed that kidney function, as assessed by eGFR, stabilized after the first month post-transplant and remained in the rang…

• In July 2022, we received Investigational New Drug (“IND”) application clearance from the FDA for our controlled, Phase 2 BESTOW trial of tegoprubart for the prevention of transplant rejection in persons receiving a kidney transplant. The BESTOW study is a multi-center, two-arm, active comparator, h…

• On November 6, 2025, we announced topline efficacy and safety data from the Phase 2 BESTOW trial evaluating tegoprubart for the prevention of kidney transplant rejection. Safety and efficacy results supported the potential for tegoprubart to provide effective immunosuppression with a favorable safet…

• In January 2026, we presented 24-month follow-up data from eight patients enrolled in the Phase 1b trial long-term extension evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium held in Scottsdale, Arizona. During the reported follow-up per…

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• Our financial condition raises substantial doubt as to our ability to continue as a going concern if we are unable to raise additional financing to fund our operations.

• We have incurred significant net losses since our inception and expect to continue to incur losses for the foreseeable future. As of June 30, 2026, we had cash, cash equivalents and short-term investments of $88.8 million and an accumulated deficit of $471.9 million. We do not currently have suffici…

• Our unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2026 have been prepared assuming we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. The going concern conclusion…

• Our ability to continue as a going concern will require us to obtain additional financing to fund our operations. We may seek to raise additional capital through the sale of equity or debt securities, entering into strategic collaborations or licensing arrangements, or other financing transactions. …

• scale back, or discontinue one or more of our research and development programs or other operations, relinquish rights to our technologies or product candidates on unfavorable terms, or liquidate and cease operations altogether. Any of these events could have a material adverse effect on our busines…

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• The global economy, including the financial and credit markets, continues to experience extreme volatility and disruptions, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, elevated inflati…

• could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies or cause us to delay our clinical development plans, research and development programs or commercialization efforts, out-license intellectual property rights to our product candidat…

• and/or that subsequent studies will not match results seen in prior studies. It is impossible to predict when or if any of our product candidates will prove effective, safe and well-tolerated in humans or will receive regulatory approval.

• there may be changes in governmental regulations or administrative actions. For example, the Trump administration issued an Executive Order that paused the FDA’s rulemaking ability and could affect recently finalized FDA rules that have not yet taken effect. The extent to which such existing or futu…

• activities. In addition, our development and commercialization activities could be harmed or delayed by a shutdown of the U.S. government or reduction in funding or staffing at U.S. government agencies, including the FDA and SEC. For example, a prolonged shutdown or the reduction of funding or staff…