AnaptysBio, Inc. (NASDAQ:ANAB) announced on Tuesday that it plans to explore separating its business into two independent, publicly traded companies.Referred to as “Royalty Management Co” and “Biopharma Co,” the two companies’ different business models enable investors to align their investment philosophies and portfolio allocation with each company’s strategic opportunities and financial objectives.“Anaptys is strategically positioned with multiple attractive, high-potential assets…,” said Daniel Faga, pre ...

SAN DIEGO, Sept. 29, 2025 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced it will host a virtual investor event on ANB033, its CD122 antagonist, at 4:30pm ET / 1:30pm PT on Tuesday, Oct. 14. The event will include Joseph A. Murray, M.D., professor of medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, and Department of Immunology at the Mayo Clinic, along ...

Designed to unlock potential value by creating two independent, publicly traded companies with different business objectives and opportunitiesUpon completion, the royalty management company will manage royalties and milestone payments from financial collaborations, including Jemperli with GSK and imsidolimab with Vanda, with a focus on protecting and returning their valueUpon completion, the biopharma operations company will focus on development and potential commercialization of innovative immunology thera ...

AnaptysBio Conference Call Summary Company Overview - **Company**: AnaptysBio (NasdaqGS:ANAB) - **Focus**: Development of antibodies targeting disease-driving immune cells, specifically in autoimmune and inflammatory diseases [2][3] Key Programs 1. **Rosnilimab**: - **Type**: Selective depletor of pathogenic T cells - **Phase IIb Trial**: Completed in August 2025 with high impact and durable responses observed over nine months [2][3][4] - **Safety Profile**: Safe and tolerable with less than 2% of patients discontinuing due to adverse events [10] - **Efficacy**: High ACR20 rates, with deepening responses over time [10][12] - **Comparison with Competitors**: Demonstrated superior efficacy compared to Eli Lilly's parasolumab, which showed declining efficacy over time [12][14] 2. **ANB033**: - **Type**: CD122 receptor antagonist - **Phase IA Trial**: Nearing initiation for celiac disease, with an upcoming investor relations event [3][52] 3. **ANB101**: - **Type**: BDCA2 modulator - **Phase IA Trial**: Initiated in healthy volunteers earlier in the year [3] Financial Position - **Capital**: Almost $300 million available as of summer 2025 [3] - **Royalties**: Substantial royalty interest in dostarlimab (Jemperli) from GSK, projected to generate over $1 billion in revenue, triggering a $75 million milestone for AnaptysBio [4] Competitive Landscape - **Eli Lilly's Parasolumab**: Recent phase IIb study revealed safety concerns with malignancies reported, contrasting with AnaptysBio's safety profile [5][11][17] - **Johnson & Johnson and Gilead**: Different programs with less potency and effectiveness compared to AnaptysBio's offerings [24] Upcoming Milestones - **Ulcerative Colitis Trial**: Initial data readout expected in Q4 2025, with a focus on achieving clinical remission [27][32] - **Long-term Data**: Six-month data will be critical for strategic decisions regarding the future of rosnilimab [46][50] Market Opportunity - **Autoimmune Disease Market**: Significant potential for a biologic that can drive deeper remission and stable outcomes over time, addressing the high patient turnover in existing treatments [38][40] Safety and Regulatory Insights - **FDA Communication**: No concerns raised by the FDA regarding the class of drugs being developed [21][23] - **Ongoing Safety Monitoring**: No severe infections or malignancies reported in blinded data from ongoing trials [20] Conclusion AnaptysBio is positioned strongly within the autoimmune disease market with promising clinical data for its lead program, rosnilimab, and a robust pipeline. The company is focused on maintaining a competitive edge through targeted therapies and is preparing for significant upcoming data releases that could influence its strategic direction.

Summary of AnaptysBio Conference Call Company Overview - AnaptysBio is focused on developing antibodies that modulate overexpressed or disease-driving immune cells to restore immune homeostasis in patients with autoimmune inflammatory diseases [4][6] - The company has three development-stage antibodies: rosnilimab, ANB033, and ANB101 [4][5] Key Programs and Developments Rosnilimab - Rosnilimab is a selective and potent depleter of pathogenic T cells, with recent Phase IIb arthritis study results showing remission rates surpassing best-in-class medicines [4][5][9] - The drug demonstrated over 90% depletion of specific T cells in both the periphery and synovium, with a tolerability profile showing less than 2% dropout due to adverse events [9][10] - Initial data from an ulcerative colitis trial is expected in Q4 of this year [5][11] ANB033 - ANB033 is a CD122 antagonist targeting celiac disease, with the Phase Ib trial starting imminently [5][39] - The drug is designed to block both IL-15 and IL-2, providing a dual mechanism of action [41][42] ANB101 - ANB101 is a BDCA2 modulator currently in Phase IA trials with healthy volunteers [5] Financial Position - AnaptysBio has over $300 million in capital, sufficient to fund operations through year-end 2027 [6][50] Market Dynamics - The ulcerative colitis market is seen as an attractive opportunity, with a potential $6 billion market size in the U.S. [25][26] - The company anticipates a different market uptake in ulcerative colitis compared to rheumatoid arthritis, which is more mature and competitive [24][25] Competitive Landscape - AnaptysBio believes its rosnilimab has a differentiated mechanism compared to competitors like J&J, which faced challenges in dosing and efficacy [33][34][35] - The company is optimistic about the potential for class cycling in ulcerative colitis, similar to trends seen in rheumatoid arthritis [25][26] Future Expectations - The company is focused on achieving maximum remission rates in ulcerative colitis, with a significant readout expected in six months [27][29] - The royalty stream from Jemperli, a drug discovered by AnaptysBio, is projected to be a significant asset, with potential revenues exceeding the company's current market cap [49][50] Conclusion - AnaptysBio is positioned for growth with multiple promising drug candidates and a strong financial foundation, targeting significant unmet needs in autoimmune diseases [6][50]

Core Insights - AnaptysBio reported positive Phase 2b data for rosnilimab in rheumatoid arthritis, demonstrating a favorable safety profile and JAK-like efficacy, with durable responses observed for at least 12-14 weeks off-drug [2][5] - The company completed enrollment for a Phase 2 trial of rosnilimab in ulcerative colitis, with top-line data expected in Q4 2025 [4][9] - AnaptysBio plans to initiate a Phase 1b trial for ANB033, a CD122 antagonist targeting celiac disease, by Q4 2025 [2][4] Financial Updates - As of June 30, 2025, AnaptysBio reported cash and investments totaling $293.7 million, down from $420.8 million at the end of 2024, primarily due to operating activities and share repurchases [13] - Collaboration revenue for Q2 2025 was $22.3 million, compared to $11.0 million in Q2 2024, driven by increased royalties from Jemperli [13] - The net loss for Q2 2025 was $38.6 million, an improvement from a net loss of $46.7 million in Q2 2024, with a net loss per share of $1.34 compared to $1.71 in the prior year [13][19] Pipeline Developments - Rosnilimab's Phase 2b trial for rheumatoid arthritis involved 424 patients and showed a best-in-disease profile with monthly dosing [5] - The company is assessing different dosing levels for rosnilimab in the ulcerative colitis trial, with a primary endpoint focused on the modified Mayo score [9] - Ongoing Phase 1 trials for ANB033 and ANB101 are in healthy volunteers, with plans for further updates on ANB033 at a dedicated R&D event later this year [4][6] Collaboration and Milestones - AnaptysBio anticipates a $75 million milestone payment from GSK in 2025 once Jemperli achieves $1 billion in worldwide net sales [4][10] - GSK reported strong sales performance for Jemperli, with Q2 2025 sales of $262 million, reflecting over 19% quarter-over-quarter growth [10]

Core Insights - AnaptysBio, Inc. has released updated data from the Phase 2b trial of rosnilimab, demonstrating significant efficacy in treating rheumatoid arthritis [1][2] - The drug showed durable responses and was well tolerated compared to standard biologics and JAK inhibitors [2][4] - Analyst Emily Bodnar upgraded AnaptysBio's rating from Neutral to Buy, raising the price target from $22 to $38 based on positive trial data [4] Efficacy and Safety - In a 424-patient trial, rosnilimab achieved JAK-like efficacy on multiple measures, including low disease activity (LDA) and remission on the Clinical Disease Activity Index (CDAI) [1] - At Week 12, all three doses of rosnilimab (100mg Q4W, 400mg Q4W, 600mg Q2W) showed statistically significant reductions in DAS-28 CRP and ACR20 compared to placebo [2] - By Week 12, 45% of patients achieved CDAI LDA, increasing to 69% by Week 14 across all doses [2] Patient Outcomes - Rosnilimab demonstrated clinically meaningful improvements in patient-reported outcomes, including pain visual analog scale (VAS) and HAQ-Disability Index [4] - As of the March 11, 2025 data cutoff, 83% of patients remained in LDA at Week 34, with a median CDAI of 13 for those not sustaining LDA [3] Competitive Landscape - Data from the SELECT-CHOICE trial indicated similar efficacy results for AbbVie’s Rinvoq and Bristol Myers Squibb’s Orencia, aligning with rosnilimab's outcomes [5] - In contrast, Eli Lilly's discontinued PD-1 agonist peresolimab showed a decline in CDAI LDA rates, highlighting rosnilimab's stronger performance [6] - Johnson & Johnson is expected to present early data for its PD-1 agonist at the upcoming EULAR conference, although its study is smaller than AnaptysBio's [6]

Rosnilimab Phase 2b RA Trial Key Findings - Rosnilimab demonstrates a best-in-disease profile in RA through 6 months[8, 95] - Max response rates have not yet been observed, indicating potential for further improvement[9, 96] - Responses are durable after 6 months, suggesting potential for extended dosing intervals[10, 97] - The trial included 424 randomized patients in a placebo-controlled Phase 2b study[7, 17] - 95% of trial participants had high disease activity at baseline[18] - 95% completed the 6-month all-active treatment period, supporting favorable efficacy and tolerability[20] Efficacy and Safety Comparisons - Rosnilimab shows JAK-like efficacy in naïve patients[11] - ACR20 response rates are comparable to Rinvoq[23] - Rosnilimab surpassed the Target Product Profile (TPP) in experienced patients and is comparable to JAKs in all-active head-to-head studies[14, 58] - Rosnilimab is well-tolerated with a low dropout rate due to adverse events[81]

Core Insights - AnaptysBio's investigational drug rosnilimab shows a best-in-disease profile for treating moderate-to-severe rheumatoid arthritis (RA), demonstrating JAK-like efficacy and durable responses [1][2][3] Efficacy and Clinical Outcomes - In a Phase 2b trial with 424 patients, rosnilimab achieved significant clinical improvements, including low disease activity (LDA) and remission on the Clinical Disease Activity Index (CDAI) [1][2][3] - By Week 12, 45% of patients achieved CDAI LDA, increasing to 69% by Week 14, indicating a strong response to treatment [3][4] - Rosnilimab demonstrated a rapid onset of ACR20 response, comparable to upadacitinib, with a substantial decrease in C-reactive protein (CRP) levels [2][3] Safety and Tolerability - Rosnilimab exhibited a favorable safety profile, with no treatment-related serious adverse events (SAEs) reported and a low incidence of injection site reactions [10][11] - Less than 2% of patients discontinued treatment due to adverse events, indicating good tolerability [10][11] Market Potential - The findings suggest rosnilimab could capture a significant share of the ~$20 billion U.S. RA market, with potential for extended dosing intervals [2][3] - The company aims to complete ongoing studies for rosnilimab in ulcerative colitis, with initial data expected in Q4 2025 [2][14] Mechanism of Action - Rosnilimab targets PD-1+ T cells, aiming to restore immune homeostasis and reduce inflammation associated with RA [19][21] - The drug demonstrated a ~90% reduction in PD-1 T cells and a ~50% reduction in PD-1+ T cells, indicating robust pharmacological activity [8][19] Future Developments - AnaptysBio plans to advance rosnilimab's clinical development and explore its application in other autoimmune diseases [21][22] - The company is committed to developing innovative treatments that address the long-term needs of patients with chronic inflammatory conditions [21][22]

Core Insights - AnaptysBio reported strong Phase 2b efficacy data for its lead program, rosnilimab, in rheumatoid arthritis, with plans to present updated data in June 2025 and initial ulcerative colitis data in Q4 2025 [2][7][8] - The company is advancing its autoimmune portfolio with multiple catalysts expected in the coming years, including ongoing Phase 1 trials for ANB033 and ANB101 [2][4][5] - AnaptysBio remains well-capitalized with a cash runway extending through the end of 2027, supported by a $75 million stock repurchase program and anticipated royalties from collaborations [2][11][12] Financial Updates - For Q1 2025, AnaptysBio reported collaboration revenue of $27.8 million, a significant increase from $7.2 million in Q1 2024, driven by royalties from Jemperli and revenue from the Vanda license agreement [11][19] - Research and development expenses rose to $41.2 million in Q1 2025 from $37.0 million in Q1 2024, primarily due to costs associated with Phase 2 trials for rosnilimab and Phase 1 trials for ANB033 and ANB101 [11][19] - The net loss for Q1 2025 was $39.3 million, or $1.28 per share, compared to a net loss of $43.9 million, or $1.64 per share, in the same period of 2024 [11][16][19] Portfolio Updates - Rosnilimab is in a Phase 2b trial for rheumatoid arthritis and a Phase 2 trial for ulcerative colitis, with positive results reported in a 424-patient Phase 2b RA trial [3][8][14] - ANB033, a CD122 antagonist, and ANB101, a BDCA2 modulator, are both in Phase 1 trials, with enrollment ongoing for healthy volunteers [4][5][7] - The company has a collaboration with GSK, which includes anticipated milestone payments and royalties from the sales of Jemperli [9][12][14]