ANNX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• The currently ongoing open-label U.S./Europe FORWARD study is designed to broaden Western experience with tanruprubart. We recently announced that the initial cohort of U.S. and European patients in the FORWARD study showed clinically meaningful and rapid improvement in strength and reduced disabili…

• Vonaprument is an investigational neuroprotective inhibitor of C1q and the classical complement cascade delivered intravitreally for GA, a leading cause of blindness affecting more than eight million people worldwide. There are no approved therapies for GA targeting the preservation of vision. Vonap…

• acuity. In the Phase 2 ARCHER trial, vonaprument also reduced risk of 15-letter vision loss by more than 70%.

• In the ongoing global, sham-controlled, double-masked Phase 3 ARCHER II trial of 659 patients with GA, all eligible patients have received at least 12 months of vonaprument treatment, with masked event accrual in line with projections. ARCHER II retains strong statistical power and continues to be w…

• ANX1502 is a novel oral small molecule inhibiting the activated form of C1s, an enzyme carried by C1q to initiate the classical cascade, which we believe is first-in-kind and has the potential to offer the advantages of selective upstream classical complement inhibition with the convenience and flex…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• Vonaprument is an investigational neuroprotective inhibitor of C1q and the classical complement cascade delivered intravitreally for GA, a leading cause of blindness affecting more than eight million people worldwide. There are no approved therapies for GA targeting the preservation of vision. Vonap…

• In July 2025, we completed enrollment of 659 patients in ARCHER II, a global, sham-controlled, double-masked Phase 3 trial. The primary endpoint of ARCHER II is the gold standard for visual acuity, measuring proportion of patients with confirmed BCVA

• ≥15-letter loss at any two consecutive visits through month 15. A secondary endpoint is EZ loss, which is a key anatomic measure of photoreceptor health and function. We plan to report topline data in the fourth quarter of 2026. We have established a global registration path with the FDA and EMA, wh…

• ANX1502 is a novel oral small molecule inhibiting the activated form of C1s, an enzyme carried by C1q to initiate the classical cascade, which we believe is first-in-kind and has the potential to offer the advantages of selective upstream classical complement inhibition with the convenience and flex…

• We were incorporated in March 2011 and commenced operations later that year. To date, we have focused primarily on performing research and development activities, hiring personnel and raising capital to support and expand these activities. We do not have any products approved for sale, and we have n…

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• Adverse events or undesirable side effects caused by, or other unexpected properties of, any of our product candidates could halt their clinical development, delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.

• Our debt obligations under the Loan and Security Agreement place restrictions on our operating and financial flexibility and could adversely affect our financial condition.

• On July 30, 2026, we entered into a Loan and Security Agreement, or Loan Agreement, with Oxford Finance LLC, as collateral agent, or Collateral Agent, and certain lenders from time to time party thereto, or Lenders, providing for term loans in an aggregate principal amount of up to $200.0 million, o…

• Our debt obligations under the Loan Agreement could adversely impact us as follows:

• require us to use a large portion of our cash flow to repay the outstanding principal balance, accrued and unpaid interest, prepayment fees, a final payment fee and other fees, if applicable, which will reduce the amount of cash flow available to fund working capital, capital expenditures, product c…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• Adverse events or undesirable side effects caused by, or other unexpected properties of, any of our product candidates could halt their clinical development, delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.

• candidates, either on our own or through arrangements with one or more third parties, we may not be able to generate any future product revenue and we would incur significant additional losses.

• severely disrupt our operations, and could materially and adversely affect our business, financial condition, results of operations and prospects.

• Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair our research, product development and manufacturing efforts. In addition, we cannot entirely eliminate the risk of accidental injury or contamination fr…

• In addition, patent applications in the United States and many other jurisdictions are typically not published until 18 months after the filing of certain priority documents (or, in some cases, are not published until they issue as patents), and publications in the scientific literature often lag be…

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• During the three months ended June 30, 2026, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted, amended or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Item 408 of Regulation S-K.

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• As previously disclosed, on March 26, 2024, we entered into a Sales Agreement, or Sales Agreement, with TD Cowen, pursuant to which we from time to time could offer and sell shares of its common stock through or to TD Cowen having an aggregate offering price of up to $100.0 million. On May 6, 2026, …

• The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the copy of the Sales Agreement filed as Exhibit 1.2 to the Company’s Registration Statement on Form S-3 filed on March 26, 2024.

• During the three months ended March 31, 2026, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Item 408 of Regulation S-K.