Core Insights - AnaptysBio, Inc. reported quarterly earnings of $0.52 per share, significantly beating the Zacks Consensus Estimate of a loss of $1.06 per share, marking an earnings surprise of +149.06% [1] - The company achieved revenues of $76.32 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 145.36% and showing a substantial increase from $30.02 million in the same quarter last year [2] - AnaptysBio shares have increased approximately 172.2% year-to-date, outperforming the S&P 500's gain of 16.5% [3] Earnings Outlook - The future performance of AnaptysBio's stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4] - The current consensus EPS estimate for the upcoming quarter is $0.24 on revenues of $82.95 million, while for the current fiscal year, the estimate is -$3.57 on revenues of $146.17 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which AnaptysBio belongs, is currently ranked in the top 39% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Ovid Therapeutics, another company in the same industry, is expected to report a quarterly loss of $0.15 per share, reflecting a year-over-year change of +25%, with revenues anticipated to be $0.34 million, up 100% from the previous year [9]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2025 OR ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . Commission File Number: 001-37985 ANAPTYSBIO, INC. (Exact name of registrant as specified in its charter) Delaware 20-3828755 (State or other jurisdiction of in ...

Anaptys Announces Third Quarter 2025 Financial Results and Provides Business Update SAN DIEGO, Nov. 4, 2025 — AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today reported financial results for the third quarter ended September 30, 2025, and provided a business update. "Our intent to separate our wholly owned biopharma programs from our royalty assets provides investors with the opportunity to realize and enhance the potentia ...

Company Overview - AnaptysBio, Inc. is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [2] - The lead program, rosnilimab, has completed a Phase 2b trial for rheumatoid arthritis and is currently in a Phase 2 trial for ulcerative colitis [2] - The pipeline includes ANB033, a CD122 antagonist in a Phase 1b trial for celiac disease, and ANB101, a BDCA2 modulator in a Phase 1a trial [2] - Anaptys has out-licensed multiple therapeutic antibodies, including a PD-1 antagonist to GSK and an IL-36R antagonist to Vanda Pharmaceuticals [2] Upcoming Events - Daniel Faga, CEO, and other executives will participate in several investor conferences, including the TD Cowen Immunology & Inflammation Summit and the Jefferies Global Healthcare Conference [1] - Live webcasts of the events will be available on the investor section of the Anaptys website, with replays accessible for at least 30 days [1] Strategic Developments - Anaptys plans to separate its biopharma operations from its royalty assets by the end of 2026, allowing investors to align their investment strategies with the distinct opportunities of each entity [3]

Core Insights - AnaptysBio, Inc. reported strong financial results for Q3 2025, with a net income of $15.1 million for the quarter, marking a significant improvement compared to a net loss of $32.9 million in Q3 2024 [14][23]. - The company announced its intent to separate its biopharma operations from its royalty assets by the end of 2026, aiming to unlock potential value for investors [5][16]. Financial Performance - Collaboration revenue for Q3 2025 was $76.3 million, up from $30.0 million in Q3 2024, driven primarily by Jemperli sales exceeding $750 million [17][23]. - Research and development expenses decreased to $31.4 million in Q3 2025 from $42.2 million in Q3 2024, while general and administrative expenses remained relatively stable [17][23]. - Cash and investments totaled $256.7 million as of September 30, 2025, down from $420.8 million at the end of 2024, primarily due to operating activities and share repurchases [17][20]. Business Updates - Jemperli sales grew to $785 million year-to-date in 2025, with a quarter-over-quarter growth of over 16% [5][6]. - Anaptys anticipates a one-time $75 million commercial sales milestone in Q4 2025 from GSK once Jemperli achieves $1 billion in worldwide net sales [5][6]. - The company is on track to report top-line Phase 2 data for rosnilimab in ulcerative colitis in November or December 2025 [5][13]. Strategic Initiatives - The planned separation will create two independent publicly traded companies, allowing investors to align their portfolios with distinct business objectives [6][16]. - The biopharma operations will focus on innovative immunology therapeutics, including rosnilimab, ANB033, and ANB101, while the royalty management company will handle royalties and milestone payments [6][16]. Clinical Development - Rosnilimab's Phase 2b data in rheumatoid arthritis was presented at ACR Convergence 2025, showing promising response rates [13]. - A Phase 1b trial for ANB033 in celiac disease has been initiated, with top-line data expected in Q4 2026 [5][13].

Core Insights - AnaptysBio, Inc. announced positive late-breaking data from a Phase 2b trial of rosnilimab for rheumatoid arthritis, showing durable clinical benefits and a favorable safety profile [1][4][5] Group 1: Trial Overview - The Phase 2b RENOIR trial involved 424 patients with moderate-to-severe rheumatoid arthritis, assessing the efficacy, safety, and tolerability of rosnilimab [3][4] - Patients were either naïve to biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) or had prior treatment experience [3][6] Group 2: Efficacy Results - Positive results were observed at Week 12, with significant efficacy on primary endpoints such as DAS28-CRP and ACR20 across all doses [5] - By Week 28, clinical responses continued to improve, including CDAI remission and ACR50/70 rates, regardless of prior treatments [4][5] - Durable clinical benefits were confirmed for at least three months off drug, with significant reductions in Tph cells by over 90% [4][5] Group 3: Safety Profile - Rosnilimab was well-tolerated throughout the trial, with no treatment-related serious adverse events or malignancies reported [1][4][5] - The trial demonstrated a low dropout rate and no safety trends similar to those seen with JAK inhibitors or other biologics [2][4] Group 4: Mechanism of Action - Rosnilimab targets pathogenic T cells, effectively depleting them while sparing nonpathogenic T cells, which helps maintain overall immune function [8][9] - The drug's mechanism was validated by significant reductions in T cell and B cell activation in synovial biopsies [5]

Group 1 - The article does not provide any specific content or key points related to a company or industry [1]

Summary of AnaptysBio Investor Event on ANB033 Company Overview - **Company**: AnaptysBio (NasdaqGS:ANAB) - **Focus**: Development of ANB033, a CD123 antagonist for autoimmune and inflammatory diseases, particularly celiac disease and eosinophilic esophagitis (EoE) [2][3][61] Key Points on ANB033 and Its Development - **Separation of Operations**: In 2026, AnaptysBio plans to separate its biopharma operations from its royalty assets to create two independent publicly traded companies [2] - **Clinical Trials**: - A Phase 1b trial for celiac disease has been initiated, with plans for a second indication trial in 2026 [3][26] - The trial design includes two cohorts: one for patients with minimal mucosal damage and another for those with significant damage [55][56] Mechanism of Action - **Targeting CD123**: ANB033 is designed to inhibit IL-15 and IL-2 signaling pathways, which are crucial in the activation and proliferation of pathogenic immune cells [4][12][20] - **Therapeutic Potential**: The drug has broad therapeutic potential across various areas, including gastrointestinal and dermatological diseases [5][26] Market Opportunity - **Celiac Disease**: - Approximately 2 million celiac patients in the U.S., with a projected 250,000 diagnosed non-responsive patients by early 2030s [8][61] - The market for celiac disease treatments is estimated to exceed $4 billion, with no approved therapies currently available [8][62] - **EoE Market**: - EoE is characterized by inflammation of the esophagus, with limited treatment options available [63] - Dupilumab, the only approved therapy, is expected to generate $2 billion in sales by 2025, indicating a significant market opportunity for ANB033 [63] Clinical Data and Safety Profile - **Phase 1a Trial Results**: - ANB033 demonstrated a favorable safety profile with no severe adverse events reported [36] - The drug maintained full receptor occupancy for over 30 days, with a dose-response observed on relevant pharmacodynamic biomarkers [36] - **Impact on Immune Cells**: - ANB033 significantly reduced CD123 expressing CD8 T cells and NK cells without compromising overall immune competency [37][39] Unmet Medical Need - **Celiac Disease Treatment**: Current treatment options are limited to a gluten-free diet, which is often poorly tolerated [41][62] - **Patient Population**: Many patients continue to suffer from symptoms such as anemia and fatigue despite adherence to a gluten-free diet [41][62] Future Directions - **Additional Indications**: AnaptysBio is exploring other potential indications for ANB033, including EoE, with plans to advance one additional proof of concept trial in 2026 [26][61] - **Regulatory Engagement**: The FDA has shown enthusiasm for new treatments for celiac disease, emphasizing the need for therapies that can prevent symptoms and improve histological injury [51] Conclusion - **Strategic Positioning**: AnaptysBio is well-positioned to address significant unmet needs in the treatment of celiac disease and EoE with ANB033, leveraging its unique mechanism of action and favorable safety profile to capture a substantial market opportunity [62][63]

Core Insights - AnaptysBio, Inc. announced that complete data from the Phase 2b trial of rosnilimab for rheumatoid arthritis has been accepted for a late-breaking oral presentation at the ACR Convergence 2025 [1][2] Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [6] - The lead program, rosnilimab, is a pathogenic T cell depleter that has completed a Phase 2b trial for rheumatoid arthritis and is currently in a Phase 2 trial for ulcerative colitis [6] - The company also has a pipeline that includes ANB033, a CD122 antagonist for celiac disease, and ANB101, a BDCA2 modulator, both in Phase 1 trials [6] Product Details - Rosnilimab is designed to selectively deplete pathogenic T cells while sparing nonpathogenic T cells, aiming to preserve overall immune function [5] - The therapeutic targets activated Tph/Tfh and T effector cells, which are involved in autoimmune and inflammatory diseases [4] Presentation Information - The presentation will be made by Professor Paul Emery from the University of Leeds, highlighting the safety, tolerability, and efficacy of rosnilimab [2][8] - The session is scheduled for October 29, 2025, from 8:00 am to 9:30 am CT [8] Strategic Developments - AnaptysBio plans to separate its biopharma operations from its royalty assets by the end of 2026, allowing investors to align their investment strategies with the distinct objectives of each entity [7]

Core Viewpoint - AnaptysBio, Inc. plans to separate its business into two independent, publicly traded companies: Royalty Management Co and Biopharma Co, allowing investors to align their investment strategies with each company's objectives [1][2] Royalty Management Co Profile - Royalty Management Co will manage rights to significant royalties from GSK's Jemperli and milestones from Vanda Pharmaceuticals, focusing on maximizing shareholder value [3] - GSK reported Jemperli sales of $262 million in Q2 2025 and $482 million in the first half of 2025, with peak sales guidance of approximately $2.7 billion for Jemperli in monotherapy indications [4] - For imsidolimab, Royalty Management Co could receive up to $35 million in future sales milestones and a 10% royalty on net sales, with Vanda planning FDA BLA submission for generalized pustular psoriasis in the second half of 2025 [5] Biopharma Co Profile - Biopharma Co will focus on developing therapeutics for autoimmune and inflammatory diseases, including rosnilimab, ANB033, and ANB101, with rosnilimab having completed a Phase 2b trial in rheumatoid arthritis [6] - Anaptys is exploring strategic options for rosnilimab, which may influence its economic value allocation between the two companies [7] - Biopharma Co is expected to have a new name and sufficient capital for at least two years of operations, with the separation anticipated to be completed by year-end 2026 [7] Leadership and Market Reaction - Daniel Faga, the current president and CEO of Anaptys, is expected to lead Biopharma Co post-separation [8] - Following the announcement, ANAB stock increased by 28.95%, reaching $30.01 [8]