ANAB 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• In September 2025, we announced that our board of directors (“Board of Directors”) approved plans to explore separating our business into two independent, publicly traded companies. We would hold and continue to manage the financial collaboration for Jemperli with GSK and for imsidolimab with Vanda,…

• In connection with the separation, we entered into a separation and distribution agreement (the “Separation and Distribution Agreement”) with First Tracks Biotherapeutics, Inc. (“First Tracks Biotherapeutics”). The Separation and Distribution Agreement identifies the assets transferred to (including…

• endometrial cancer. In August 2024, the FDA approved Jemperli plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer. In January 2025, the EMA approved Jemperli plus chemotherapy for this same indication.

• In December 2025, Vanda announced the submission of a BLA to the FDA for imsidolimab in GPP. The FDA accepted the BLA filing for imsidolimab in GPP in February 2026 with a target action date of December 12, 2026.

• Pursuant to the terms of the Vanda License Agreement, we received an upfront payment of $10.0 million and a $5.0 million payment for existing drug supply. We are also eligible to receive a 10% royalty on net sales under the Vanda License Agreement:

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• In September 2025, we announced that our Board of Directors approved plans to explore separating our business into two independent, publicly traded companies. One company is expected to hold and continue to manage the Jemperli milestones and royalties from GSK and the milestones and royalties from V…

• Our immune cell modulating antibodies treat inflammatory disorders by down regulating immune responses mediated by multiple immune cell types including T cells. We believe these molecules have potential applicability across a broad range of autoimmune and inflammatory diseases including dermatology,…

• Rosnilimab is an IgG1 antibody that directly targets pathogenic T cells, such as activated Tph/Tfh and T effector cells, in the periphery or inflamed tissue. These T cells, when activated, proliferate and migrate, and secrete the inflammatory cytokines that are the drivers of autoimmune and inflamma…

• demonstrated a favorable pharmacokinetic (“PK”) profile with an estimated two-week half-life for subcutaneous and IV routes of administration.

• In February 2025, we announced initial data that was updated in June 2025, from rosnilimab’s randomized, placebo-controlled, global 424-patient, Phase 2b clinical trial for moderate-to-severe rheumatoid arthritis. Patients were randomized to receive either 100mg of subcutaneous rosnilimab every four…

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• On November 20, 2025, we filed a Verified Complaint in Delaware Chancery Court (the “Court”), requesting a court declaration that TESARO, Inc. (“Tesaro”) has materially breached the parties’ Collaboration and Exclusive License Agreement (“Collaboration Agreement”) and that GSK, Tesaro’s corporate pa…

• While we had approached Tesaro to engage in good faith discussions to potentially resolve these claims, on November 20, 2025, Tesaro, without notice, initiated a lawsuit against us. Tesaro’s complaint includes a request for a declaration that it has not breached the Collaboration Agreement and for a…

• Tesaro also alleged that AnaptysBio materially breached the agreement, entitling Tesaro to exercise certain rights and remedies under the agreement. Tesaro’s claim for breach was predicated on an allegation that AnaptysBio improperly alleged that Tesaro had breached the Collaboration Agreement, whic…

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. We investigate these claims as they arise and accrue estimates for resolution of legal and other contingencies when losses are probable and estimable. We are not currently a party to any litiga…

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• We derive substantially all of our revenues from GSK’s commercialization of Jemperli. As a result, our business and financial results and prospects heavily depend on GSK’s ability to successfully develop and commercialize Jemperli.

• Our existing collaboration with GSK and other collaborations are important to our business. If we are unable to maintain the GSK collaboration, or if this collaboration is not successful, our business could be adversely affected.

• If the commercialization of Jemperli in the countries in which it has received regulatory approval encounters any delays or adverse developments, or perceived delays or adverse developments, or if sales or payor coverage does not meet investors’, analysts’, or our expectations, our business will be …

• We are heavily dependent on GSK for the successful commercialization and development of Jemperli under the GSK Agreement. If GSK does not devote sufficient resources to the commercialization or development of Jemperli, is unsuccessful in its efforts, or chooses to reprioritize its commercial program…

• Jemperli faces substantial competition for its intended uses in the targeted markets from products discovered, developed and commercialized both by GSK and by other pharmaceutical companies, which could cause the royalties payable to us pursuant to the GSK Agreement to be less than expected, which i…

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• •Our product candidates in development may fail or suffer delays that adversely affect their commercial viability. Results from our initial clinical trials may not be representative of the results we will experience in later clinical trials. If we or our collaborators are unable to complete developm…

• •Our ongoing and planned clinical trials or those of our collaborators may reveal significant adverse events, toxicities or other side effects and may result in a safety profile that could inhibit regulatory approval or market acceptance of any of our product candidates.

• •We and/or our collaborators may be unable to obtain, or may be delayed in obtaining, required regulatory approvals in the United States or in foreign jurisdictions, which would materially impair our ability to commercialize and generate revenue from our product candidates.

• •Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements.

• •We may not be successful in our efforts to expand our pipeline of product candidates and develop marketable products.

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• As disclosed below, during the three months ended March 31, 2026, certain of our directors or officers adopted, modified or terminated any “Rule 10b5-1 trading arrangements” or any “non-Rule 10b5-1 trading arrangements,” as each term is defined in Item 408 of Regulation S-K.

• On January 13, 2026, Dennis Mulroy, our former chief financial officer, entered into a written plan for the potential sale of common stock. The plan was subsequently terminated on March 25, 2026.

• On January 14, 2026, Paul Lizzul, our former chief medical officer, entered into a written plan for the potential sale of common stock. The plan was subsequently terminated on March 3, 2026. On March 3, 2026, Dr. Lizzul, also terminated a written 10b5-1 Plan dated April 14, 2025.

• On March 3, 2026, Eric Loumeau, our former chief legal officer, terminated a written 10b5-1 Plan dated April 11, 2025.

• On March 30, 2026, Hollings Renton, one of our directors, entered into a written plan for the potential sale of up to an aggregate 15,000 shares of common stock. The plan is intended to satisfy the affirmative defense condition of Rule 10b5-1(c) under the Exchange Act and is scheduled to terminate n…

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• On July 15, 2025, Daniel Faga, Chief Executive Officer of the company, terminated a Rule 10b5-1 trading plan dated April 11, 2025. The plan was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act. No shares were sold under the plan.