APGE 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-10

• The APEX Part A induction regimen was designed to exceed EBGLYSS exposures by approximately 30% to 40% with potential for improved clinical outcomes and a maintenance regimen designed to equal lebrikizumab’s exposures. The results at Week 16 of the Part A study showed that patients in the highest zu…

• In May 2026, we announced positive 16-week induction dose optimization results from the Part B portion of the APEX Phase 2 clinical trial of zumilokibart in patients with moderate-to-severe AD. The Part B portion of the trial enrolled 346 adult patients who were randomized 1:1:1:1 to receive high-, …

• Anticipated Program Milestones for Zumilokibart for the Treatment of AD

• Based on results from the APEX clinical program, we plan to initiate Phase 3 trials of zumilokibart for moderate-to-severe AD (the “ADventure trials”) with the mid-dose in the second half of 2026. The ADventure 1 and ADventure 2 trials are randomized, placebo-controlled, replicate Phase 3 monotherap…

• The ADventure TCS Phase 3 trial will evaluate zumilokibart in combination with background topical corticosteroids (“TCS”) in patients with moderate-to-severe AD (EASI ≥16, vIGA ≥3, BSA ≥10%). The randomized, placebo-controlled study is expected to enroll approximately 400 patients and includes a 16-…

相对上期删除的文字 · 来源:10-Q · 2026-05-11

• In February 2025, we announced that we had commenced dosing of the Part B portion of the APEX Phase 2 trial. Part B is testing low, medium (Part A dose), and high dose regimens against placebo. In January 2026, we announced that we completed Part B enrollment ahead of schedule and exceeded target en…

• The APEX Part A induction regimen was designed to exceed EBGLYSS exposures by approximately 30% to 40% with potential for improved clinical outcomes and a maintenance regimen designed to equal lebrikizumab’s exposures. The results at Week 16 of the Part A study showed that patients in the highest zu…

• In April 2025, we initiated a Phase 1b trial of zumilokibart (APG777) in patients with mild-to-moderate asthma, and in January 2026, we announced positive interim data from the trial. The trial is a double-blind, placebo-controlled trial evaluating the safety and tolerability of zumilokibart in pati…

• In August 2024, we initiated a Phase 1 clinical trial of APG990, which was designed as a double-blind, placebo-controlled, first-in-human, SAD trial designed to evaluate the safety and PK of APG990 in 40 healthy adult participants across five cohorts. Doses of

• SQ APG990 evaluated in the study included 75mg, 150mg, 300mg, 600mg and 1,200mg. In March 2025, we announced positive interim safety and PK data from the trial. PK data showed a half-life of approximately 60 days across doses tested. APG990, in single doses up to 1,200mg, was well-tolerated and show…

相对上期新增的文字 · 来源:10-Q · 2026-08-10

• We may not complete the Merger within the time frame we anticipate or at all, which could have an adverse effect on our

• While the Merger Agreement is in effect, we are subject to restrictions on our business activities.

• We may not complete the Merger within the time frame we anticipate or at all, which could have an adverse effect on our business, financial results and/or operations.

• The completion of the pending Merger is conditioned upon (i) the adoption of the Merger Agreement and approval of the Merger by the holders of at least a majority of the outstanding shares of our voting common stock, (ii) for so long as at least 6,061,821 shares of our non-voting common stock remain…

• As previously disclosed in the Proxy Statement, we and Parent each filed a notification of the proposed Merger with the FTC and DOJ under the HSR Act on July 6, 2026. On August 5, 2026, the applicable waiting period under the HSR Act expired. The expiration of the waiting period under the HSR Act sa…

相对上期删除的文字 · 来源:10-Q · 2026-05-11

• Accordingly, we will require substantial additional funding to continue our operations. Based on our current operating plan, we estimate that our existing cash, cash equivalents, and marketable securities will be sufficient to enable us to fund our operating expenses and capital expenditure requirem…

• We do not have any committed external sources of funds and adequate additional financing may not be available to us on acceptable terms, or at all. We may be required to seek additional funds sooner than planned through public or private equity offerings, debt financings, collaborations and licensin…

• around interest rates and regulatory uncertainty have caused significant market volatility in recent months, and particularly in the biotechnology and biopharmaceutical industries, which such volatility can have an adverse effect on the ability to raise capital. Our failure to raise capital as and w…

• From time to time, we estimate the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product development goals, which we sometimes refer to as milestones. These milestones may include the commencement, receipt of interim results or completion of scientifi…

• We cannot be sure that the FDA will agree with our clinical development plan. We used the data from our Phase 1 trial of zumilokibart in healthy volunteers to support our Phase 2 trial in AD and plan to use such data to support Phase 2 trials in other I&I indications. If the FDA requires us to condu…