Core Insights - Climb Bio Inc. (CLYM) is set for a data-rich year in 2026, with study results from its key programs expected to influence its strategic direction and future development phases [1] Drug Candidates - Budoprutug is an anti-CD19 monoclonal antibody designed for potent and durable B cell depletion, with both intravenous (IV) and subcutaneous (SC) administration options. It is being investigated for primary membranous nephropathy, immune thrombocytopenia, and systemic lupus erythematosus [2] - CLYM116 is a novel anti-APRIL monoclonal antibody aimed at promoting the degradation of APRIL, targeting B-cell-mediated diseases such as systemic lupus erythematosus, myasthenia gravis, and IgA nephropathy [3] Ongoing Trials & Upcoming Catalysts - A phase 2 study named PrisMN is evaluating Budoprutug's safety and efficacy in adult subjects with primary membranous nephropathy, enrolling 45 subjects and expected to complete in 2027 [4] - A phase 1b/2a study is assessing Budoprutug in immune thrombocytopenia, with initial efficacy data anticipated in the second half of 2026 [6] - A phase 1b study is evaluating Budoprutug in systemic lupus erythematosus, with preliminary efficacy data expected in the second half of 2026 [8] - A phase 1 study for the SC formulation of Budoprutug in healthy volunteers is ongoing, with initial data expected in the first half of 2026 [10] - Regulatory clearance for a phase 1 trial of CLYM116 has been obtained, with dosing expected to start by the end of 2025 and initial data anticipated mid-2026 [10] Financial Position - As of September 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $175.8 million, which is sufficient to fund operations through 2027 [11] Company Background - Climb Bio, formerly Eliem Therapeutics, went public on August 10, 2021, under the ticker symbol "ELYM" at an IPO price of $12.50 per share. The company rebranded to Climb Bio, Inc. and changed its ticker symbol to "CLYM" on October 3, 2024, reflecting a strategic focus on immune-mediated diseases [12] - CLYM's stock has traded between $1.05 and $3.25 over the past year, closing at $3.00 on December 12, 2025, representing a 30.43% increase [13]

Core Insights - Climb Bio, Inc. is advancing two monoclonal antibodies, CLYM116 for IgA nephropathy and budoprutug for primary membranous nephropathy, with promising preclinical and clinical data to be presented at the 2025 ASN Kidney Week [1][2][3] Group 1: CLYM116 Development - CLYM116 is a novel anti-APRIL monoclonal antibody designed to treat IgA nephropathy, showing favorable pharmacokinetic and pharmacodynamic profiles in preclinical models [1][2] - The antibody promotes APRIL degradation and enhances antibody recycling, leading to significant reductions in IgA levels [2][9] - CLYM116 employs a pH-dependent binding mechanism, potentially allowing for less frequent dosing and a favorable safety profile [9] Group 2: Budoprutug Clinical Data - Budoprutug is an anti-CD19 monoclonal antibody targeting B-cell mediated diseases, with long-term follow-up data from a Phase 1b trial indicating sustained control of proteinuria for up to three years in patients with primary membranous nephropathy [3][7] - In the trial, four patients received up to four doses of budoprutug, with three patients not requiring further immunosuppressive treatment [3] - No significant treatment-related adverse events were reported, supporting further investigation of budoprutug as a potential disease-modifying therapy [3][8] Group 3: Presentation Details - Climb Bio will present CLYM116 data at ASN Kidney Week on November 8, 2025, with a poster titled "Development and Characterization of CLYM116" [5] - The abstract for budoprutug's long-term remission data in primary membranous nephropathy is also available, highlighting its clinical significance [5][4]

Core Viewpoint - Climb Bio, Inc. is advancing its CLYM116 program, a preclinical-stage monoclonal antibody targeting APRIL for the treatment of IgA nephropathy, with a webcast event scheduled to discuss its potential and development strategy [1][2]. Company Overview - Climb Bio, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for immune-mediated diseases, with a pipeline that includes CLYM116 and budoprutug, an anti-CD19 monoclonal antibody [4]. CLYM116 Program Details - CLYM116 targets APRIL, a key driver of pathogenic B cell activity in autoimmune diseases, and employs a unique 'sweeper' mechanism to recycle the antibody and eliminate APRIL, potentially leading to best-in-class efficacy with less frequent dosing [2][5]. - The company plans to file an IND or CTA for CLYM116 in the second half of 2025, with a Phase 1 clinical trial to follow upon regulatory clearance [2][5]. Upcoming Webcast Event - The CLYM116 webcast event is scheduled for September 29, 2025, featuring Climb Bio's management and nephrologist Craig E. Gordon, and will be accessible via the company's website [1][3]. Research and Development Strategy - The event will cover an overview of IgA nephropathy, preclinical data comparing CLYM116 to a first-generation anti-APRIL monoclonal antibody, and the company's development strategy for CLYM116 [7].

Core Viewpoint - Climb Bio, Inc. is actively engaging with investors through participation in multiple upcoming healthcare conferences, showcasing its commitment to transparency and investor relations [1][2][3]. Group 1: Upcoming Conferences - Climb Bio will participate in the Cantor Global Healthcare Conference on September 5, 2025, featuring a fireside chat and one-on-one investor meetings [2]. - The company will also attend the Baird Global Healthcare Conference on September 9, 2025, with a similar format of fireside chat and one-on-one meetings [2]. - Additionally, Climb Bio is scheduled for the Morgan Stanley Annual Global Healthcare Conference on September 10, 2025, which will consist of one-on-one meetings only [2]. Group 2: Virtual Forum - Climb Bio will take part in the Stifel Virtual Immunology and Inflammation Forum on September 10, 2025, offering a presentation and one-on-one investor meetings [3]. - Live webcasts of these events will be accessible on the Climb Bio website, with replays available approximately two hours after each event and archived for at least 30 days [3]. Group 3: Company Overview - Climb Bio, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for immune-mediated diseases [4]. - The company's pipeline includes budoprutug, an anti-CD19 monoclonal antibody aimed at treating a range of B-cell mediated diseases, and CLYM116, an anti-APRIL monoclonal antibody currently in IND-enabling studies for IgA nephropathy [4].

Pipeline and Milestones - Alumis expects topline data from Phase 3 ONWARD trials for envudeucitinib in moderate-to-severe plaque psoriasis in early 1Q 2026[11] - Alumis anticipates topline data from Phase 2b LUMUS trial in systemic lupus erythematosus in 3Q 2026[11] - Alumis plans to initiate a Phase 2 clinical trial for A-005 in multiple sclerosis in 1H 2026[11] - Alumis is evaluating the development program for lonigutamab in thyroid eye disease[12] - Alumis expects Phase 1 data for its next program in 2026[12] Financial Position - Alumis had $486.3 million in cash as of June 30, 2025, providing runway into 2027[11] Envudeucitinib (TYK2 Inhibitor) - Envudeucitinib demonstrated a 15-20% increase in clinical response (PASI) with maximal target inhibition[23] - In the STRIDE trial, Envudeucitinib 40 mg BID showed a 64.1% PASI-75 response at Week 12[39] - Approximately 92% of diagnosed psoriasis patients are not treated with a biologic therapy, representing a market opportunity for Envudeucitinib[35] - Alumis is receiving $40 million near-term for Japan, <5% of Worldwide Psoriasis Market (estimated at $600M in 2024)[69] A-005 (CNS-Penetrant TYK2 Inhibitor) - A-005 achieves a CSF:Plasma (free drug) ratio of approximately 1:1, indicating full CNS penetration[75]

Core Insights - Spyre Therapeutics reported positive interim Phase 1 results for two next-generation TL1A antibodies, indicating they were well-tolerated and supported quarterly or biannual dosing with full TL1A engagement for up to 20 weeks [1][2] - The company initiated the Phase 2 SKYLINE-UC platform study to evaluate three optimized monotherapies and three potentially paradigm-changing combinations for ulcerative colitis [1][3] - Spyre is on track to begin the Phase 2 SKYWAY-RD basket study for TL1A inhibition in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis in Q3 2025 [1][10] - The company has a strong cash position of $526.6 million as of June 30, 2025, with an expected runway into the second half of 2028 [1][11] Development Pipeline Overview - Spyre's approach combines advanced antibody engineering, dose optimization, and rational therapeutic combinations to enhance efficacy and convenience in treating inflammatory bowel disease (IBD) and other immune-mediated diseases [3][15] - IBD affects approximately 2.4 million individuals in the U.S., while rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) affect over 1.5 million and nearly 3 million individuals, respectively [3][4] Financial Performance - Research and Development (R&D) expenses for Q2 2025 totaled $40.1 million, up from $32.6 million in Q2 2024, primarily due to increased clinical trial expenses [12] - General and Administrative (G&A) expenses were $11.8 million for Q2 2025, slightly higher than $11.5 million in Q2 2024 [12] - The net loss for Q2 2025 was $36.7 million, compared to a net loss of $38.8 million in Q2 2024, including non-cash stock-based compensation expenses [14][24]