Zymeworks (NasdaqGS:ZYME) Q3 2025 Earnings Call November 06, 2025 04:30 PM ET Speaker7Thank you for standing by. This is the conference operator. Welcome to the Zymeworks third quarter 2025 results conference call and webcast. As a reminder, all participants are in a listen-only mode, and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To ask a question, press star 11 on your telephone keypad. Should you need assistance during the conference call, you ...

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.

Initial Results from Ongoing Dose -Escalation Study of XmAb819 & Oncology Pipeline Update October 24, 2025 ® Today's Speakers Xencor Management Guest Speaker Bassil Dahiyat, Ph.D. President & Chief Executive Officer Co-director, Kidney Cancer Program City of Hope Comprehensive Cancer Center 2 John Desjarlais, Ph.D. Executive Vice President & Chief Scientific Officer Dane Leone Executive Vice President & Chief Strategy Officer Sumanta Pal, M.D., F.A.S.C.O. Professor, Department of Medical Oncology & Therapeu ...

WCLC 2025 Highlights DAIICHI SANKYO CO., LTD. September 17th (US)/ 18th (JP), 2025 Forward-Looking Statements Management strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sankyo discloses in this material are all classified as Daiichi Sankyo's future prospects. These forward looking statements were determined by Daiichi Sankyo based on information obtained as of today with certain assumptions, premises and future forecasts, and thus, there are vario ...