APGE 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• Zumilokibart is a subcutaneous (“SQ”) extended half-life monoclonal antibody (“mAb”) targeting IL-13.

• In August 2023, we initiated a Phase 1 trial of zumilokibart in healthy volunteers. The zumilokibart Phase 1 trial was a double-blind, placebo-controlled study in healthy volunteers and consisted of a single-ascending dose (“SAD”) component and a multiple ascending dose component. Eight healthy volu…

• In March 2024, we announced positive interim safety and pharmacokinetic (“PK”) data from this trial with zumilokibart demonstrating a potential best-in-class PK profile, including a half-life of 77 days, supporting the potential for every three- to six- month maintenance dosing in AD. Single doses o…

• In May 2024, we announced dosing of our first patient in the APEX Phase 2 clinical trial, which is a randomized, placebo-controlled study evaluating zumilokibart in patients with moderate-to-severe AD.

• In July 2025, we announced positive 16-week data from the Part A portion of the APEX Phase 2 clinical trial. Part A of the trial enrolled 123 adult patients who were randomized 2:1 to zumilokibart versus placebo and received an induction regimen dosing of 720mg at Weeks 0 and 2, followed by 360mg at…

相对上期删除的文字 · 来源:10-Q · 2025-11-10

• APG777 – anti-IL13 antibody, same mechanism of action as EBGLYSS (lebrikizumab)

• APG777 is a subcutaneous (“SQ”) extended half-life monoclonal antibody (“mAb”) targeting IL-13. In August 2023, we announced the dosing of our first participant in our first clinical trial for APG777. In 2024, we announced positive interim safety and pharmacokinetic (“PK”) data from this trial with …

• The APEX trial is a randomized, placebo-controlled study evaluating APG777 in patients with moderate-to-severe AD. Part A of the trial enrolled 123 adult patients who were randomized 2:1 to APG777 versus placebo and received an induction regimen dosing of 720mg at Weeks 0 and 2, followed by 360mg at…

• The trial met its primary endpoint, with APG777 showing significantly greater least squares mean percent change from baseline at Week 16 with an EASI reduction of 71.0% compared to placebo of 33.8% (p < 0.001). APG777 showed the highest absolute and placebo-adjusted EASI-75 of any biologic in a 16-w…

• EASI-90 of 33.9% compared to placebo of 14.7% (p < 0.05). Treatment of patients with APG777 led to rapid onset of itch relief and achieved a statistically significant reduction by Week 1, with a 50.7% reduction of Itch NRS from baseline compared to placebo of 23.2% (p < 0.01) at Week 16. APG777 was …

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• the continuation of our existing collaborations and licensing and other arrangements and entry into new collaborations and licensing and other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;

• We anticipate developing certain product candidates for use in combination with one or more of our other product candidates, and regulatory issues, safety issues and efficacy results of the monotherapy product candidate may delay or prevent the development, approval and successful commercialization …

• We anticipate developing certain product candidates for use in combination with one or more of our other product candidates, which may subject us to additional risks that are not faced for product candidates being administered as monotherapy. Obtaining approval for one or both monotherapies would no…

• The benefit risk profile of the combination therapy may be impacted by the efficacy and safety profile of the monotherapy. The adverse side effects of our monotherapy product candidates may be enhanced when combined with other product candidates. If such adverse side effects are experienced, we coul…

• Any preliminary or topline data should be viewed with caution until the final data are available. From time to time, we may also disclose interim data from our preclinical studies and clinical trials. Interim data are subject to the risk that one or more of the clinical outcomes may materially chang…

相对上期删除的文字 · 来源:10-Q · 2025-11-10

• Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises, political crises, geopolitical events, such as the conflict between Russia and Ukraine, and Israel and Hamas or other macroeconomic conditions, which could…

• Disruptions at the FDA and other government agencies could negatively affect the review and approval of our regulatory submissions, which could negatively impact our business.

• expenses could increase beyond expectations if we are required by the FDA or other regulatory agencies to perform preclinical studies or clinical trials in addition to those that we are currently conducting or anticipate.

• the continuation of our existing licensing arrangements and entry into new collaborations and licensing arrangements;

• required IRB approval at each clinical trial site; delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of our programs for use in clinical trials or the inability to do any of the foregoing; failure by our CROs, other third parties or us to adh…

相对上期删除的文字 · 来源:10-Q · 2025-11-10

• On August 13, 2025, Dr. Michael Henderson, the Company's Chief Executive Officer, adopted a trading plan intended to satisfy Rule 10b5-1(c) to sell up to 340,000 shares of our common stock over a period ending July 9, 2026, subject to certain conditions.

• On September 22, 2025, Dr. Carl Dambkowski, the Company's Chief Medical Officer, adopted a trading plan intended to satisfy Rule 10b5-1(c) to sell up to 132,000 shares of our common stock over a period ending January 7, 2027, subject to certain conditions.

• On September 2, 2025, Jane Pritchett Henderson, the Company's Chief Financial Officer, adopted a trading plan intended to satisfy Rule 10b5-1(c) to sell up to 20,000 shares of our common stock over a period ending December 31, 2026, subject to certain conditions.