Rosnilimab (PD-1 depleter and agonist) in Rheumatoid Arthritis (RA) - Rosnilimab is well-positioned for the ~$20 billion U S RA market, which hasn't had a new mechanism approved since 2012[14] - In b/tsDMARD-naïve patients, Rosnilimab shows JAK-like efficacy, with 64% achieving CDAI LDA, 48% achieving ACR50, and 23% achieving ACR70[28] - In b/tsDMARD-experienced patients, Rosnilimab surpassed the 6-month Target Product Profile (TPP) and is comparable at mid/high dose to JAKs in all-active H2H study[30] - 83% of Week 28 CDAI LDA responders were still in response at Week 34, demonstrating durable responses for at least 2-months off-drug[33] - Synovial biopsies show ~90% reduction of PD-1+ T cells in the target issue with 400mg/600mg doses[39, 40] Rosnilimab in Ulcerative Colitis (UC) - Initial Phase 2 data for Rosnilimab in Ulcerative Colitis is expected in Q4 2025[2, 78] - Enrollment is ongoing in the Phase 2 trial for moderate-to-severe UC, with interim 6-month data expected in Q4 2025[60] - The primary endpoint of the UC trial is the change in modified Mayo score (mMS) vs placebo at Week 12[62] ANB033 (CD122 antagonist) - Phase 1 trial of ANB033 in healthy volunteers has been initiated, with an R&D event planned for H2 2025[63, 78] - ANB033 is designed to reduce pathogenic T cells and NK Cells by potently inhibiting IL-15 and IL-2 biology[63, 65, 66] Financial Position - The company has a strong capital position with ~$383 million in cash as of Q1 2025, expected to provide a cash runway through YE 2027[7, 69, 76]

AnaptysBio (ANAB) FY Conference June 11, 2025 08:40 AM ET Speaker0 All right. Good morning. And it's my pleasure to introduce Dan Vega, President and CEO of Adaptive Bio as our next speaker. Dan, welcome. It's the time for me to host you at the Goldman Sachs Conference. Conference. So thank you for being here. Before we kick off with the Q and A, I'm going to turn it to you for a quick opening remark. Speaker1 Perfect. Well, thanks for having me here today. It's my pleasure to be here. We have a lot going o ...

Core Insights - The article emphasizes the importance of understanding the underlying science, fundamentals, and technical analysis in biotech investing, highlighting the risks of speculative investments [2]. Group 1: Investment Strategy - The focus is on innovative companies developing breakthrough therapies and pharmaceuticals, particularly those with catalysts for potential acquisitions [2]. - The article suggests that effective position management around catalysts is crucial for success in biotech investments [2]. Group 2: Analyst Background - The author has a long position in shares of major pharmaceutical companies such as ABBV, PFE, and LLY, indicating a vested interest in the sector [3]. - The author has a background in the medical field, which informs their investment strategy in biotech and life-saving therapies [2].

Group 1 - AnaptysBio, Inc. (NASDAQ: ANAB) reported positive results from its phase 2b study for a PD-1 depleter and agonist drug aimed at treating moderate-to-severe rheumatoid arthritis (RA) [2] - The study's results indicate potential for the drug to address significant unmet medical needs in the RA patient population [2] Group 2 - The Biotech Analysis Central service offers in-depth analysis of pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2]

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: Updated Phase 2b Data in RA June 3, 2025 Safe harbor statement This presentation and any accompanying oral presentation contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from the Company's clinical trials, including rosnilimab's Phase 2b clinical trial in rheumatoid arthritis at Week 38 and top-line data for rosnilimab's Phase 2 clinical t ...

Summary of AnaptysBio (ANAB) Conference Call on June 03, 2025 Company Overview - **Company**: AnaptysBio - **Product**: Rozanolimab (ozanilumab) - **Indication**: Rheumatoid Arthritis (RA) Key Points and Arguments Clinical Trial Results 1. **Efficacy of Rozanolimab**: The phase 2b trial demonstrated significant efficacy with statistical significance on primary endpoints (DAS28 CRP and ACR20) at week 12, with all doses showing positive results compared to placebo [4][8] 2. **Durability of Response**: Patients exhibited durable responses off drug for at least two months after six months of treatment, indicating potential for extended dosing intervals [8][63] 3. **Market Potential**: The RA market generates over $10 billion in annual revenue in the US alone, highlighting the commercial opportunity for rozanolimab [8] 4. **Comparison with Competitors**: Rozanolimab showed comparable or superior results to existing therapies like RINVOQ and Orencia in terms of ACR20, ACR50, and ACR70 response rates [9][14][57] Safety Profile 5. **Safety Data**: Rozanolimab exhibited a notably unremarkable safety profile with no treatment-related serious adverse events (SAEs) reported, and a low incidence of injection site reactions [78][80] 6. **Tolerability**: Less than 2% of patients discontinued due to adverse events, indicating high tolerability compared to standard care [80][84] Mechanism of Action 7. **Targeting T Cells**: Rozanolimab demonstrated a rapid and sustained reduction in PD-1 positive T cells, which are implicated in RA pathology, supporting its mechanism of action [39][41] 8. **Gene Expression Changes**: Significant downregulation of genes associated with T cell and B cell activation was observed, indicating a broad impact on immune pathways relevant to RA and ulcerative colitis [42][43] Patient Population Insights 9. **Patient Disposition**: 95% of patients completed the all-active treatment period, demonstrating high acceptance of the treatment [23] 10. **Real-World Implications**: The trial design may have capped the maximum response rates achievable, as many patients who showed improvement were ineligible to continue treatment [21][56] Expert Commentary 11. **Clinical Relevance**: Experts highlighted the importance of the trial design and the implications of excluding patients who showed improvement but did not meet the strict criteria for continuation [66][69] 12. **Long-Term Efficacy**: The consistency of clinical responses and the durability of effects post-treatment were emphasized as significant advantages of rozanolimab [72][73] Additional Important Content - **Market Context**: The RA market has not seen a new mechanism approved since 2012, making rozanolimab's introduction particularly timely [9] - **Comparative Efficacy**: Rozanolimab's performance in the naive patient population was noted to be particularly strong, suggesting a high ceiling for response rates [35] - **Future Directions**: Ongoing studies and follow-ups will provide further insights into the long-term efficacy and safety of rozanolimab [24][62] This summary encapsulates the critical insights from the conference call regarding AnaptysBio's rozanolimab, its clinical trial results, safety profile, and market potential in the context of rheumatoid arthritis treatment.

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, Inc. is hosting an investor call and live webcast to discuss updated data from the Phase 2b RENOIR clinical trial of rosnilimab for rheumatoid arthritis on June 3, 2025 [1] - The event will feature key management members and clinical trial investigators, highlighting the company's commitment to transparency and investor engagement [2] Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [4] - The lead program, rosnilimab, is currently in a Phase 2b trial for rheumatoid arthritis and a Phase 2 trial for ulcerative colitis [4] - The pipeline includes ANB033, a CD122 antagonist, and ANB101, a BDCA2 modulator, both in Phase 1 trials [4] - The company has collaborations with GSK for multiple therapeutic antibodies, including a PD-1 antagonist and a TIM-3 antagonist [4] Upcoming Events - AnaptysBio's executive leadership will participate in several investor conferences following the data release, including the Jefferies Global Healthcare Conference and the Goldman Sachs 46th Annual Global Healthcare Conference [3] - Live webcasts of the data release and subsequent presentations will be available on the company's investor website, with replays accessible for at least 30 days [3]

Financial Performance - The company reported a total revenue of $374.3 million from collaborations since inception through March 31, 2025, with no revenue generated from product sales [124]. - Royalty revenue for the three months ended March 31, 2025, was $18.1 million, up from $7.2 million in the same period of 2024, representing a 151.4% increase [135]. - Research and development expenses increased to $41.2 million for the three months ended March 31, 2025, compared to $37.0 million in 2024, reflecting an increase of $4.2 million or 11.4% [137]. - General and administrative expenses rose to $14.1 million in the three months ended March 31, 2025, from $12.3 million in 2024, marking an increase of $1.8 million or 14.6% [139]. - Non-cash interest expense for the sale of future royalties was $18.1 million for the three months ended March 31, 2025, compared to $6.3 million in 2024, an increase of $11.8 million or 187.3% [141]. - Cash, cash equivalents, and investments totaled $383.0 million as of March 31, 2025, down from $420.8 million as of December 31, 2024, a decrease of $37.8 million or 9.0% [150]. - Net cash used in operating activities was $10.7 million for the three months ended March 31, 2025, compared to $37.3 million in 2024, a reduction of $26.6 million or 71.4% [152]. - Net cash provided by investing activities was $14.8 million for the three months ended March 31, 2025, compared to $68.6 million in 2024, a decrease of $53.8 million or 78.4% [154]. - Net cash used in financing activities was $28.6 million for the three months ended March 31, 2025, compared to $13.6 million in 2024, an increase of $15.0 million or 110.3% [155]. - The company has received an aggregate of $1.3 billion to fund operations since inception, including $738.4 million from equity sales and $335.0 million from future royalties [144]. Clinical Trials and Product Development - Rosnilimab achieved a >90% reduction in PD-1 T cells and a >50% reduction in PD-1+ T cells, maintaining these effects for over 30 days [111]. - In the Phase 2b trial for moderate-to-severe rheumatoid arthritis, rosnilimab met its primary endpoint with statistical significance across all doses compared to placebo [112]. - The company initiated a Phase 1 clinical trial for ANB033 in October 2024, targeting CD122 to modulate NK cell and CD8 T cell activity [114]. - A Phase 1 clinical trial for ANB101 commenced in March 2025, focusing on BDCA2 modulation to inhibit interferon secretion in autoimmune diseases [115]. - The company anticipates reporting initial Phase 2 data for rosnilimab in ulcerative colitis in Q4 2025, following a 132-patient trial [113]. - The GSK collaboration includes multiple antibody programs, with ongoing trials for cobolimab in combination with dostarlimab for advanced non-small-cell lung cancer [121]. Regulatory Approvals and Agreements - The FDA approved Jemperli (dostarlimab) for advanced or recurrent deficient mismatch repair endometrial cancer in April 2021, with full approval granted in February 2023 [120]. - The company received an upfront payment of $10 million and a $5 million payment for existing drug supply from Vanda under a new licensing agreement [123]. Future Expectations - The company expects research and development expenses to increase as it advances its product candidates [128]. - The company expects general and administrative expenses to increase due to costs associated with being a publicly traded company and expanding its intellectual property portfolio [140].