Summary of Jade Biosciences (JBIO) FY Conference Call - July 14, 2025 Company Overview - **Company**: Jade Biosciences (JBIO) - **Focus**: Development of therapies for autoimmune diseases, specifically targeting IgA nephropathy with lead candidate JAD 101 [1][2] Pipeline and Product Development - **Lead Candidate**: JAD 101, aimed at treating IgA nephropathy, currently in preclinical stage with plans to enter clinical trials in 2025 [6][34] - **Additional Assets**: - JAD 102: Broader B cell depleting target, expected to enter the clinic in the first half of 2026 [7] - JAD 103: More advanced asset with clinical validation anticipated to enter the clinic in 2027 [8] Market Opportunity - **Market Size**: Over $10 billion branded opportunity in the IgA nephropathy space, with 170,000 patients in the US, 60-70% of whom require further treatment [11][12] - **Current Treatments**: Existing medications do not modify the disease or preserve kidney function, indicating a significant demand for new therapies [12] Competitive Advantage of JAD 101 - **Mechanism of Action**: JAD 101 is a fully human monoclonal antibody that neutralizes APRIL, designed to avoid large immune complex formation, which is a limitation of first-generation anti-APRIL antibodies [20][22] - **Pharmacokinetics**: JAD 101 has a half-life of 27 days, significantly longer than competitors, allowing for less frequent dosing (every eight weeks) [19][22] - **Clinical Differentiation**: Expected to provide superior efficacy with a focus on minimizing immune modulation, which is preferred by nephrologists [15][16] Clinical Trial Design - **Phase 1 Study**: Conventional single ascending dose study in healthy volunteers to assess safety, tolerability, pharmacokinetics, and immunogenicity, with interim data expected in the first half of 2026 [24][25] - **Biomarker Tracking**: Focus on measuring free APRIL reductions and downstream immunoglobulin changes to define dosing and frequency for future clinical development [25][27] Global Strategy - **Market Expansion**: Significant focus on the Asia-Pacific region due to a higher prevalence of IgA nephropathy, with plans to efficiently access these markets [30][34] Intellectual Property - **IP Landscape**: JAD 101 is a de novo antibody with IP filed, expected to have protection extending into the mid-2040s [32] Financial Position and Future Catalysts - **Cash Position**: $50 million in cash post-reverse merger, with an additional $205 million from a PIPE financing, providing funding through 2027 [36] - **Upcoming Catalysts**: - Initiation of clinical trials for JAD 101 by the end of 2025 - Phase 1 readout in the first half of 2026 - Entry into the clinic with JAD 102 in the first half of 2026 [34][36]

Core Viewpoint - AbbVie has entered into a definitive agreement to acquire Capstan Therapeutics for up to $2.1 billion in cash, aiming to enhance its immunology pipeline with innovative therapies [1][7]. Acquisition Details - The acquisition will incorporate Capstan's lead asset, CPTX2309, which is a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy currently in phase I development for treating B-cell-mediated autoimmune diseases [2][3]. - Capstan's proprietary tLNP platform technology, CellSeeker, will also be added, facilitating RNA delivery to engineer specific cell types within the body [2][7]. - The acquisition is subject to customary closing conditions, including regulatory approvals [3]. AbbVie's Acquisition Strategy - AbbVie has been actively pursuing acquisitions to strengthen its pipeline, particularly in the immunology sector, while also exploring early-stage deals in oncology and neuroscience [4]. - Since the beginning of 2024, AbbVie has signed over 20 early-stage deals, focusing on promising technologies that can enhance care standards in immunology, oncology, and neuroscience [4]. Recent Acquisitions - Earlier in 2024, AbbVie acquired rights to develop GUB014295 (ABBV-295), a long-acting amylin analog for obesity treatment, marking its entry into the obesity market [5]. - In January 2025, AbbVie completed the acquisition of Nimble Therapeutics, adding an investigational oral peptide IL23R inhibitor for psoriasis treatment and a proprietary peptide synthesis platform for autoimmune diseases [8].

Financial Data and Key Metrics Changes - The company reported approximately $570 million in cash, providing a runway into 2028 based on the current operating plan [7] - The overall response rate in the RESILIENT-one study was 35%, with a 40% response rate in patients who progressed after chemotherapy [17][18] - The median duration of response was just under nine months across all groups [18] Business Line Data and Key Metrics Changes - The company is advancing multiple clinical-stage programs, including CLN978 for autoimmune diseases and CLN619 for non-small cell lung cancer [6] - Zipilertinib, the oral EGFR tyrosine kinase inhibitor, has shown promising results in patients with EGFR exon 20 mutations, with breakthrough therapy designation by the FDA [11][12] Market Data and Key Metrics Changes - EGFR mutated non-small cell lung cancer accounts for 16% of all non-small cell lung cancer, with exon 20 mutations representing approximately 12%, translating to an annual incidence of about 3,000 to 5,000 patients in the U.S. [67] - The company noted that patients with exon 20 mutations tend to have a poorer prognosis, highlighting the unmet need for effective therapies [68] Company Strategy and Development Direction - The company plans to pursue regulatory interactions for a potential U.S. NDA filing in the second half of the year [22][23] - There is an expansive development program for zipilertinib across multiple patient segments, including relapsed refractory disease and frontline settings [69][70] - The company retains 50% of the rights for zipilertinib in the U.S. and has a co-development and co-commercialization arrangement with partners at Tahoe [77][78] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the clinical profile of zipilertinib, noting its favorable safety profile compared to existing therapies [75] - The company anticipates significant uptake of zipilertinib once it becomes available, particularly as an oral option for patients [60][62] Other Important Information - The RESILIENT-two study will provide data on patients with active brain metastases and those with uncommon EGFR mutations in the second half of the year [79] - The RESILIENT-three study is ongoing, comparing zipilertinib plus chemotherapy to standard care [72] Q&A Session Summary Question: What is the efficacy of zipilertinib in patients with brain metastases? - The drug has shown encouraging preliminary data in patients with brain metastases, with good disease control observed [84][86] Question: What is the breakdown of patients in real-world settings? - Most patients are heavily pretreated, often having received chemotherapy and amivantamab before seeking other options [88][90] Question: Is there any data on the role of MET amplification in exon 20? - The response to this question was not directly addressed in the provided content, indicating a need for further research [94]

Core Insights - Zenas BioPharma is advancing its obexelimab program through multiple clinical trials, with topline results expected in late 2025 for Immunoglobulin G4-Related Disease and early Q4 2025 for Relapsing Multiple Sclerosis [1][2][4] Clinical Trials - The Phase 3 INDIGO trial for Immunoglobulin G4-Related Disease is the largest clinical trial conducted for this condition, with topline results anticipated around year-end 2025 [1][4] - The Phase 2 MoonStone trial for Relapsing Multiple Sclerosis is concluding enrollment, with topline results expected early in Q4 2025 [1][4] - The Phase 2 SunStone trial for Systemic Lupus Erythematosus is expected to complete enrollment by year-end 2025, with topline results anticipated in mid-2026 [1][4] Leadership Changes - The company has strengthened its leadership team with the appointments of Lisa von Moltke, M.D., as Head of Research and Development and Chief Medical Officer, and Haley Laken, Ph.D., as Chief Scientific Officer [1][4] Financial Position - As of March 31, 2025, Zenas BioPharma reported cash, cash equivalents, and investments totaling $314.2 million, which is expected to fund operations into Q4 2026 [1][11] - License and collaboration revenue for Q1 2025 was $10 million, attributed to a sublicense agreement with Zai Lab [11] - Research and development expenses increased to $34.9 million in Q1 2025 from $22.6 million in Q1 2024, primarily due to clinical development costs for obexelimab [11] - General and administrative expenses rose to $12.4 million in Q1 2025 from $4.9 million in Q1 2024, driven by increased personnel costs and pre-commercialization activities [11] Product Overview - Obexelimab is a bifunctional monoclonal antibody designed to inhibit B cell function without depleting them, targeting autoimmune diseases [3][7][9] - The drug has shown clinical activity in five completed trials involving 198 patients, providing initial proof of concept for its efficacy [8]

Core Insights - Immunic, Inc. announced positive results from its phase 2 CALLIPER trial for vidofludimus calcium (IMU-838) in patients with progressive multiple sclerosis (PMS), showing a 20% reduction in the relative risk of 24-week confirmed disability worsening (24wCDW) events compared to placebo [1][2][8] Clinical Efficacy - In the overall PMS patient population (n=467), vidofludimus calcium reduced the relative risk of 24wCDW events by 20% compared to placebo, with a 30% reduction observed in the primary progressive multiple sclerosis (PPMS) subgroup (n=152) [2][8] - The drug also demonstrated a 15% reduction in the non-active secondary progressive multiple sclerosis (naSPMS) subgroup (n=268) [2] - A consistent reduction in disability worsening was noted in patients without gadolinium-enhancing lesions at baseline, with a 29% reduction in 24wCDW events compared to placebo [4][8] MRI Endpoints - Vidofludimus calcium reduced the annualized rate of thalamic brain volume loss by 20% compared to placebo, indicating a significant neuroprotective effect [5][16] - The total volume of new or enlarging T2 lesions showed a mean percent change of -0.22% for vidofludimus calcium versus +2.97% for placebo at month 24, highlighting the drug's efficacy in reducing lesion formation [6] Safety and Tolerability - The CALLIPER trial confirmed a favorable safety and tolerability profile for vidofludimus calcium, with treatment-emergent adverse events occurring in 69.4% of treated patients compared to 68.5% in the placebo group [9] - Serious adverse events were rare, observed in 8.1% of vidofludimus calcium-treated patients versus 6.5% in the placebo group, with no new safety signals identified [9] Future Directions - The company plans to advance vidofludimus calcium to a phase 3 registration study based on the positive results from the CALLIPER trial, particularly focusing on its potential as a neuroprotective treatment option for PMS [8][11] - Ongoing analysis of the full CALLIPER data set will be presented at upcoming scientific meetings, with the phase 3 clinical trial program for relapsing multiple sclerosis expected to be completed in 2026 [11][17]

Core Insights - CLN-978 is the first and only development-stage CD19 T cell engager to receive U.S. FDA IND clearance for autoimmune diseases, specifically targeting Sjögren's disease, systemic lupus erythematosus, and rheumatoid arthritis [1][3][4] - The study for CLN-978 in Sjögren's disease will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and disease activity effects [2][3] - There is a significant unmet need for effective therapies in Sjögren's disease, which affects an estimated four million Americans and currently has no approved treatments that comprehensively address its complexities [3][6] Company Overview - Cullinan Therapeutics, Inc. is focused on developing targeted therapies for autoimmune diseases and cancer, with a diversified portfolio of clinical-stage assets [7] - The company aims to create new standards of care by harnessing the immune system to eliminate diseased cells and has a strong emphasis on oncology and immunology [7] - CLN-978 is a bispecific T cell engager designed for convenient subcutaneous administration, potentially offering a new therapeutic option for patients with autoimmune diseases [4][7] Industry Context - Sjögren's disease is a chronic autoimmune condition that can lead to severe complications, affecting over 250,000 individuals in the U.S. alone [6] - The disease often coexists with other autoimmune disorders, highlighting the need for targeted therapies that address the root causes of these conditions [6] - Current treatments primarily address symptoms rather than disease progression, indicating a gap in the market for comprehensive therapeutic solutions [6]

Core Insights - Q32 Bio Inc. is a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis [1][2] - The company will participate in two investor conferences in March 2025, providing opportunities for engagement with investors [1] Company Overview - Q32 Bio targets potent regulators of the adaptive immune system to address autoimmune and inflammatory diseases [2] - The company is advancing bempikibart (ADX-914), a fully human anti-IL-7Rα antibody, currently in a Phase 2 program for the treatment of autoimmune diseases [3] Upcoming Events - Q32 Bio will present at the TD Cowen 45th Annual Health Care Conference on March 5, 2025, at 11:50 a.m. E.T. in Boston, MA [1] - The company will also participate in the Leerink Partners Global Healthcare Conference on March 11, 2025, with a fireside chat at 11:20 a.m. E.T. in Miami Beach, FL [1] - Webcasts of the presentations will be available on the company's website, with archived replays for 90 days [1]