Xencor (XNCR) 2025 Conference September 04, 2025 08:00 AM ET Speaker0Good morning. Welcome everyone to day two of the Cantor Global Healthcare Conference. It's a privilege to, welcome next, participating company, Zencore, and I'm joined by CEO, Basil Dahiat and EVP and CSO, Dane Leone. Thanks everyone in the room and on the webcast, for joining us. I'm Steve Seedhouse, biotech analyst with Canthar.Maybe to start, we'd love to invite perhaps you, Basil, just to give an introduction to current state of affair ...

Xencor (XNCR) FY 2025 Conference September 03, 2025 03:00 PM ET Speaker0All right. Well, thanks, everyone, for coming to the Xencor panel. I'm pleased to have Dane Leone, EVP and Chief Strategy Officer.Speaker1Thank you for having us at the Wells Fargo Conference. Pleasure to be here, and thanks for having us on stage.Speaker0I'll let you start off with an overview to introduce those who may not be familiar with the company and then I'll go into questions.Speaker1Great, thank you so much. So I'm the Chief S ...

XmAb Technology and Pipeline - Xencor's XmAb platform is used to engineer antibodies with enhanced properties, focusing on oncology and autoimmune diseases[4, 9, 10] - The pipeline includes T-cell engagers and bispecific antibodies targeting various cancers and autoimmune conditions, such as IBD and rheumatoid arthritis[10, 11] - Key programs include XmAb942 (TL1A inhibitor) for IBD, Plamotamab (CD20xCD3) for rheumatoid arthritis, and XmAb819 (ENPP3 x CD3) for ccRCC[11, 12] XmAb942: Anti-TL1A Antibody for IBD - XmAb942 is designed for potent TL1A inhibition, convenient subcutaneous dosing, and extended half-life, potentially enabling Q12W maintenance dosing[31] - Phase 1 study in healthy volunteers showed a +71 day estimated half-life and dose-dependent increases in total TL1A, supporting less frequent dosing[31, 45] - Phase 1 data also showed rapid and sustained reduction of free sTL1A below the lower limit of quantification (LLOQ) for at least 16 weeks from a single dose[49] XmAb942 Clinical Development and Market Opportunity - A Phase 2 study (XENITH-UC) in ulcerative colitis is planned, with a design to maximize drug exposure and potentially achieve greater efficacy[56, 61] - The global IBD drug market is projected to exceed $23 billion by 2030, with anti-TL1A therapies expected to capture a significant portion[14, 74] - Gastroenterologist surveys indicate high expected utilization of anti-TL1A drugs, with approximately 9 out of 10 expecting to use them as first or second-line advanced therapy[74] XmAb TL1A x IL23 Bispecific Program - Xencor is developing XENP53***, a TL1A x IL23p19 bispecific antibody, with lead candidate selection and GMP production underway for a planned first-in-human study in 2026[11, 71] - Preclinical data suggests competitive functional potency for both TL1A and IL23 inhibition compared to other agents[69, 70] Financial Position - Xencor reported $706.7 million in cash, cash equivalents, and marketable debt securities as of December 31, 2024, supporting the development and expansion of the TL1A program[89]

Summary of Xencor (XNCR) Update / Briefing April 29, 2025 Company Overview - **Company**: Xencor (XNCR) - **Focus**: Development of protein engineering and drug molecules for unmet medical needs, particularly in oncology and immunology Key Industry Insights - **Industry**: Inflammatory Bowel Disease (IBD) treatment - **Current Market Need**: High unmet medical need in IBD, with existing medications achieving remission in only 10% to 20% of patients [7][8] - **Target Population**: Over 3 million individuals affected by IBD in the U.S. and Europe [7] Core Program Updates - **XmAb942**: A high potency, half-life extended anti-TL1A antibody - **Phase I Study Results**: Positive interim results indicating safety and pharmacokinetics [2][12] - **Half-Life**: Estimated at greater than 71 days, promising for convenient dosing [14] - **Dosing Schedule**: Planned Q12 week subcutaneous maintenance dosing [11][21] - **TL1A by IL-23 P19 Bispecific**: A lead candidate designed to combine two effective mechanisms of action for IBD treatment - **Development Timeline**: First in human studies expected in 2026 [58] Clinical Development Plans - **Phase II Study (ZENITH UC)**: - Focus on patients with moderately to severely active ulcerative colitis who have failed previous therapies [19][21] - Primary endpoint: Clinical remission based on modified Mayo Score at week twelve [21] - Expected to start in the second half of 2025 [61] Competitive Landscape - **Comparison with Competitors**: XmAb942 expected to provide higher drug exposure and better clinical outcomes compared to leading first-generation anti-TL1A drugs [60] - **Dosing Frequency**: Over 90% of surveyed gastroenterologists believe that XmAb942's Q12 week dosing could significantly improve patient compliance [61] Future Directions - **Combination Therapies**: Emphasis on developing a combination strategy with IL-23 and TL1A targeting to enhance efficacy [49][54] - **Market Positioning**: Xencor aims to position XmAb942 as a first or second line treatment option in advanced IBD therapy [60] Important Considerations - **Safety Profile**: No significant safety signals observed in Phase II data for competing therapies [31] - **Patient Compliance**: A more convenient dosing schedule is expected to improve patient quality of life and adherence to treatment [42][43] Conclusion - Xencor is advancing its pipeline with promising data for XmAb942 and a bispecific candidate targeting TL1A and IL-23, aiming to address significant unmet needs in IBD treatment while enhancing patient experience through improved dosing regimens and safety profiles [66]