Acquisition of Velinotamig - Cullinan Therapeutics is licensing velinotamig (BCMAxCD3) from Genrix Bio for global (ex-Greater China) rights across all indications[8] - Cullinan will pay Genrix Bio an upfront license fee of $20 million[40] - Genrix Bio is eligible to receive up to $292 million in development and regulatory milestones and $400 million in sales-based milestones[41] - Genrix Bio will also be eligible for tiered royalties from mid-single digits up to the mid-teens on potential ex-Greater China commercial sales[40] Velinotamig Clinical Development - Genrix Bio plans to initiate a Phase 1 study in China in autoimmune diseases later this year, with Cullinan planning to use the data to accelerate global clinical development[8, 27] - Velinotamig has Breakthrough Therapy Designation in China for relapsed/refractory multiple myeloma[27] - Phase 1 results of velinotamig in relapsed/refractory multiple myeloma showed an Overall Response Rate (ORR) of 85.4% at the RP2D target dose[30] - In the Phase 1 trial, 89.6% of patients experienced Cytokine Release Syndrome (CRS) of any grade, with 6.3% experiencing ≥Grade 3 CRS[34] Strategic Rationale - The acquisition complements Cullinan's CLN-978 (B cell depleter) and expands the opportunity to impact more patients across a broader range of autoimmune diseases[8] - Cullinan reiterates guidance to have cash resources into 2028 based on the current operating plan[8, 41]

Core Viewpoint - Jade Biosciences is advancing its investigational anti-APRIL monoclonal antibody, JADE101, for the treatment of IgA nephropathy, with new preclinical data to be presented at the 62nd European Renal Association Congress [1][2]. Company Overview - Jade Biosciences, Inc. is a biotechnology company focused on developing therapies for autoimmune diseases, with its lead candidate, JADE101, targeting the cytokine APRIL for IgA nephropathy [5]. - The company plans to initiate a first-in-human clinical trial for JADE101 in the second half of 2025 [5]. Product Details - JADE101 is designed to reduce pathogenic IgA levels, decrease proteinuria, and preserve kidney function in patients with IgA nephropathy [4]. - The antibody is engineered with half-life extension technology, allowing for dosing at intervals of at least eight weeks, enhancing patient convenience [4]. Upcoming Events - Jade Biosciences will host a conference call and webcast on June 9, 2025, to discuss the new data on JADE101 presented at the ERA Congress [2][3]. - The presentation titled "Discovery and Characterization of JADE101" will occur during the Focused Oral Session on Glomerular and Tubulo-Interstitial Diseases on June 6, 2025 [6].

Obexelimab: A Differentiated B Cell Therapy - Obexelimab is a potentially highly differentiated I&I franchise molecule targeting autoimmune diseases [5] - It is the first bifunctional B cell targeting (CD19 x FcγRIIb) antibody in Phase 3 trial for IgG4-Related Disease and Phase 2 trials for RMS and SLE [6] - The company estimates a potential multi-billion-dollar commercial opportunity for Obexelimab [6, 45, 120] - Zenas BioPharma had approximately $314 million in cash as of Q1 2025, funding operations into Q4 2026 [6, 121] Clinical Development and Trial Readouts - Phase 3 topline results for the INDIGO trial in IgG4-RD are expected around year-end 2025 [46] - Phase 2 primary endpoint (12-week) data for the MoonStone trial in RMS is expected in early Q4 2025 [46] - Phase 2 primary endpoint (24-week) data for the SunStone trial in SLE is expected in mid-2026 [46] - The Phase 3 INDIGO trial in IgG4-RD has completed enrollment with approximately 190 patients [67] Market Opportunity and Strategic Collaboration - The estimated prevalence of IgG4-RD patients in the U S is approximately 20,000 to 40,000, and approximately 20,000 to 40,000 collectively in the UK, Germany, France, Italy, and Spain alone [52] - The company estimates that Obexelimab represents a compelling $1 billion+ commercial revenue opportunity in the U S alone for IgG4-RD [75] - Bristol Myers Squibb (BMS) has rights to develop and commercialize obexelimab in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia [47, 110]

Core Insights - Jade Biosciences successfully completed a reverse merger and began trading on Nasdaq under the ticker symbol JBIO, raising approximately $300 million to date, which provides a cash runway through 2027 [1][2][3] Corporate Updates - The company has transitioned to a clinical-stage entity, with its lead candidate JADE101 expected to enter first-in-human studies in the second half of 2025 [2][4] - JADE101 is an investigational anti-APRIL monoclonal antibody aimed at treating IgA nephropathy (IgAN), a chronic autoimmune kidney disease [7][8] Pipeline Developments - JADE101's first-in-human clinical trial is anticipated to begin in the second half of 2025, with interim biomarker-rich data expected in the first half of 2026 [4][6] - A second development candidate, JADE201, has been nominated from the JADE-002 antibody discovery program [5] Financial Performance - As of March 31, 2025, the company had cash and cash equivalents of $49.9 million, with a net cash used in operating activities of $18.8 million for the first quarter of 2025 [6][10] - Research and Development (R&D) expenses totaled $20.0 million for the first quarter of 2025, including $10.0 million specifically for the development of JADE101 [6][10] - The net loss for the first quarter of 2025 was $38.2 million, which includes non-cash stock-based compensation of $2.4 million [10][13]

Core Insights - Cullinan Therapeutics has received approval from the European Medicines Agency (EMA) to initiate a clinical trial for CLN-978, a bispecific T cell engager targeting rheumatoid arthritis and systemic lupus erythematosus [1][3]. Company Overview - Cullinan Therapeutics, Inc. is a biopharmaceutical company focused on developing targeted therapies for autoimmune diseases and cancer, with a diversified portfolio of clinical-stage assets [6][7]. Product Details - CLN-978 is a novel CD19xCD3 bispecific T cell engager designed to target B cells effectively, including those with low CD19 levels, and offers a subcutaneous delivery option [4]. - The clinical trial for CLN-978 will assess its safety, pharmacokinetics, pharmacodynamics, and effects on disease activity in patients with difficult-to-treat rheumatoid arthritis [2][3]. Market Context - Rheumatoid arthritis affects approximately 5.3 million adults across several countries, with a significant unmet need for effective treatments as many patients do not achieve remission with current therapies [5].

Pipeline Highlights - VTAMA became the 1 most prescribed branded topical for psoriasis within 8 weeks of launch[10], and a major PBM/payer contract was executed[10] - RVT-3101, an anti-TL1A antibody, is Phase 3-ready for Ulcerative Colitis and Crohn's Disease, with final Phase 2b data expected in 1H 2023[19, 12] - Brepocitinib, a TYK2/JAK1 inhibitor, has initiated a Phase 3 trial in Dermatomyositis and completed enrollment in a global Phase 2B trial in SLE, with topline data expected in 2H 2023[10, 12] - IMVT-1402, a next-generation anti-FcRn, unveiled with initial Phase 1 data expected in mid-2023[10, 12] RVT-3101 Efficacy and Safety - RVT-3101 demonstrated statistically significant and clinically meaningful effects in a UC Phase 2b trial, with a placebo-adjusted delta (Pbo-adj Δ) of 21% for clinical remission and 27% for endoscopic improvement in the all-comers pooled group[22] - In biomarker-positive patients, RVT-3101 showed a Pbo-adj Δ of 41% for clinical remission and 46% for endoscopic improvement at the expected Phase 3 dose[22, 29] - RVT-3101 was well-tolerated in the Phase 2b study, with 45% of participants experiencing AEs in the pooled group, 2% with severe AEs, and 4% with serious AEs[37] VTAMA Market and Clinical Development - VTAMA leads other branded topicals in weekly TRx and became the 1 most prescribed branded topical for psoriasis 8 weeks into launch[44] - Phase 3 trials in atopic dermatitis (ADORING program) are underway, with topline data expected in 1H 2023[12, 48] - In a Phase 2b trial for atopic dermatitis, 49% of patients achieved IGA response and 51% achieved EASI75 response at week 8[56] Anti-FcRn Franchise (Batoclimab and IMVT-1402) - Batoclimab has multiple pivotal trials ongoing in Myasthenia Gravis (MG), Thyroid Eye Disease (TED), and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)[63] - IMVT-1402 is designed for maximum IgG reduction with minimal impact on LDL levels, with initial Phase 1 data expected in mid-2023[68, 65] Market Opportunities - Roivant is targeting multiple large I&I markets, including Psoriasis ($223 billion), Atopic Dermatitis ($122 billion), Crohn's Disease ($93 billion), and Ulcerative Colitis ($69 billion)[15]