Core Points - The webcast is focused on the initial Phase I dose escalation results for Xencor's XmAb819 [1] Group 1 - The conference is hosted by Megan, the conference operator, who introduces the event [1] - Charles Liles, Senior Director of Corporate Communications and Investor Relations, is set to take over the call [1]

Summary of Xencor XmAb® 819 Initial Phase I Dose Escalation Results Webcast Company and Industry Overview - **Company**: Xencor - **Product**: XmAb® 819 - **Industry**: Oncology, specifically targeting advanced clear cell renal cell carcinoma (ccRCC) Core Points and Arguments 1. **Positive Initial Results**: Xencor announced positive initial results from the Phase I dose escalation study of XmAb® 819 in advanced ccRCC, indicating potential for significant anti-tumor activity in heavily pretreated patients [2][20][29] 2. **T-cell Engager Mechanism**: XmAb® 819 is a first-in-class XmAb® 2+1 T-cell engager targeting ENPP3, designed to selectively engage tumor cells while minimizing effects on normal cells [8][19] 3. **Patient Population**: The study enrolled patients with a median of four prior systemic therapies, with over 36% having prior HIF2 inhibitor therapy, highlighting the advanced nature of the patient population [13][31] 4. **Efficacy Data**: The best overall response rate observed was 25%, with a disease control rate of 70%, which is unprecedented for monotherapy in this heavily pretreated population [20][29] 5. **Safety Profile**: The drug was well tolerated, with a low rate of adverse events (AEs) and only 4% of patients discontinuing due to AEs. The most common AEs included cytokine release syndrome (CRS), rash, and gastrointestinal symptoms [14][18][50] 6. **Dosing Strategy**: The study utilized a priming step followed by a target dose regimen, with pharmacokinetic (PK) profiles supporting biweekly dosing after the first cycle [10][12] 7. **Market Potential**: The global drug sales for renal cell carcinoma are projected to reach $12 billion by 2030, indicating a significant market opportunity for XmAb® 819 [27] 8. **Future Development**: Xencor plans to explore additional development opportunities in other tumor types expressing ENPP3, such as papillary renal cell, colorectal, and lung cancer [31] Additional Important Content 1. **Forward-Looking Statements**: The management made forward-looking statements regarding future product offerings and market conditions, emphasizing the uncertainty and risks involved [3][4] 2. **Dose Preparation Issues**: Initial dose preparation errors led to elevated drug levels and increased rates of CRS, but corrective measures have been implemented to prevent future occurrences [16][52] 3. **Combination Therapy Potential**: There is optimism about the potential for XmAb® 819 to be used in combination therapies, particularly as the drug shows promise in managing AEs and maintaining patient quality of life [25][66] 4. **Clinical Trial Dynamics**: Enrollment has accelerated as the study progresses, with a waitlist for patients indicating strong interest in the trial [55][56] 5. **Next Steps**: Xencor aims to establish a recommended Phase III dose for XmAb® 819 by 2026 and will continue to evaluate the drug's performance in various cohorts [26][79] This summary encapsulates the key points from the conference call regarding XmAb® 819, its clinical trial results, market potential, and future development strategies.

XmAb819 Clinical Trial - Key Findings - The Phase 1 dose-escalation study of XmAb819 in ccRCC showed a manageable safety profile, with most CRS events being Grade 1/2 and occurring during priming [47, 51, 136] - Correct dose preparation resulted in 4% Grade 3 CRS (2/51), while dose preparation errors led to 28% Grade 3 CRS (5/18) [40, 136] - In the target dose range, correct dose preparation resulted in 6% Grade 3 CRS (1/18), while dose preparation errors led to 50% Grade 3 CRS (3/6) [40, 136] - XmAb819 demonstrated an objective response rate (ORR) of 25% (95% CI: 9-49) and a disease control rate (DCR) of 70% (95% CI: 46-88) in the efficacy-evaluable target dose range (N=20) [55, 89, 125] - The median number of prior regimens for patients in the XmAb819 study was 4 (range: 1-8), with 70% having received ≥3 prior regimens [35, 89, 119] XmAb819 Development & Market Opportunity - Xencor is planning to start a pivotal study of XmAb819 as monotherapy in advanced ccRCC in 2027 [79, 104] - The global RCC market is expected to reach approximately $12 billion by 2030 [80] - In the U S, there are approximately 60,000 new cases of ccRCC per year [84] XmAb541 Early Results - Early data from the Phase 1 dose escalation study of XmAb541 showed promising anti-tumor activity in advanced ovarian cancer, endometrial cancer, and germ cell tumors [4, 93, 97] - The total sales in 1H25 for ovarian cancer drugs were $338 million, and for endometrial cancer drugs were $196 million [100]

Core Insights - Xencor, Inc. announced initial results from a Phase 1 dose-escalation study of XmAb819, a bispecific antibody targeting ENPP3 and CD3, for treating advanced clear cell renal cell carcinoma (ccRCC) [1] Company Overview - Xencor, Inc. is a clinical-stage biopharmaceutical company focused on developing engineered antibodies for cancer and autoimmune diseases [1] Study Details - The results of the ongoing Phase 1 study were presented at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics [1]

Core Insights - Xencor, Inc. is a clinical-stage biopharmaceutical company focused on developing engineered antibodies for cancer and autoimmune diseases [1] - The company will host a conference call and webcast on October 24 to discuss initial results from a Phase 1 dose-escalation study of XmAb819 [1] - XmAb819 is a bispecific antibody targeting ENPP3 and CD3, specifically developed for patients with advanced clear cell renal cell carcinoma [1] Company Overview - Xencor, Inc. is listed on NASDAQ under the ticker XNCR [1] - The company specializes in engineered antibodies, indicating a focus on innovative therapeutic approaches in the biopharmaceutical sector [1] Upcoming Events - The conference call and webcast are scheduled for October 24 at 1:30 p.m. ET (10:30 a.m. PT) [1] - This event will provide insights into the ongoing clinical study and its implications for the treatment of advanced clear cell renal cell carcinoma [1]

Group 1 - Taiwan Semiconductor Manufacturing Company (TSMC) reported better-than-expected earnings and provided an optimistic guidance, contributing to a positive opening in the stock market [1] - Xencor (XNCR) stock experienced an upgrade in its Relative Strength (RS) Rating from 62 to 78, indicating improved price performance [1] - Other companies such as Scholar Rock Holding, Ginkgo Bioworks Holdings, and Cytokinetics also received RS Rating upgrades, reflecting a trend of rising stock performance in the market [3] Group 2 - The IBD Relative Strength Rating is a tool that evaluates stock price behavior on a scale from 1 to 99, with higher scores indicating better performance [1] - Dianthus Therapeutics achieved an RS Rating upgrade, highlighting its strong performance in the medical sector [3] - The market is seeing a notable interest in medical stocks, with several companies joining IBD watchlists due to their recent performance [3]

Core Insights - Xencor, Inc. is a clinical-stage biopharmaceutical company focused on developing engineered antibodies for cancer and autoimmune diseases [1] - The company announced the upcoming presentation of initial results from a Phase 1 dose-escalation study of XmAb819, a bispecific antibody targeting ENPP3 and CD3, specifically in patients with clear cell renal cell carcinoma (ccRCC) [1] Company Overview - Xencor, Inc. is listed on NASDAQ under the ticker XNCR [1] - The company specializes in engineered antibodies, which are designed to treat various medical conditions, including cancer and autoimmune diseases [1] Study Details - The Phase 1 dose-escalation study focuses on XmAb819, which is a bispecific T-cell engaging antibody [1] - Initial results from this study will be presented at the AACR-NCI-EORTC Conference on Molecular Targets [1]

Group 1 - The article discusses the investment opportunities in Xencor (NASDAQ: XNCR) particularly in relation to its advancements in the RA program following promising NHL data [2] - The author operates the Biotech Analysis Central service, which provides in-depth analysis of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2] - The service aims to assist healthcare investors in making informed decisions through live chat and a range of analysis and news reports [2] Group 2 - The article does not provide any specific financial data or performance metrics related to Xencor or the biotech industry [1][3][4]

Group 1 - The article discusses the investment opportunities in Xencor (NASDAQ: XNCR) particularly in relation to its advancements in the RA program following promising NHL data [2] - The author operates the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and includes a library of over 600 biotech investing articles [2] - The service offers a model portfolio of more than 10 small and mid-cap stocks, along with live chat and various analysis reports to assist healthcare investors [2] Group 2 - The article does not contain any specific financial data or performance metrics related to Xencor or the broader biotech industry [1][3][4]

Core Viewpoint - Xencor (XNCR) shares experienced a significant increase of 7.3% in the last trading session, closing at $9.25, driven by strong trading volume and investor optimism regarding its engineered antibodies for cancer and autoimmune diseases [1] Company Summary - Xencor is projected to report a quarterly loss of $0.72 per share, reflecting a year-over-year change of -1.4% [2] - Expected revenues for Xencor are $25.66 million, which represents a substantial increase of 139.6% compared to the same quarter last year [2] - The consensus EPS estimate for Xencor has remained unchanged over the past 30 days, indicating a lack of recent earnings estimate revisions [4] Industry Summary - Xencor is part of the Zacks Medical - Drugs industry, where another company, Aclaris Therapeutics (ACRS), saw a decline of 1.6% in its last trading session, closing at $1.81 [5] - Aclaris is expected to report an EPS estimate of -$0.13, which is a change of -18.2% from the previous year [6]