Xencor — October 26, 2026 Earnings Summary

Financial Performance:

• Cash runway extends into 2029.
• No revenue, earnings, or specific financial metric data (e.g., revenue, profit margins, debt) is disclosed in the presentation.

Guidance and Future Outlook:

• Initiation of the first registration-enabling study for XmAb819 in clear cell renal cell carcinoma (ccRCC) is targeted for year-end 2027.
• Full 400 μg/kg intravenous dosing cohort data and subcutaneous dosing data are expected in the first half of 2027.
• An End of Phase 1 meeting is planned for the first half of 2027 to inform a potential accelerated approval pathway and design for a global randomized control trial (RCT) using tivozanib as a control arm to support a Biologics License Application (BLA).
• Enrollment is ongoing for ENPP3+ basket study cohorts including papillary RCC (pRCC), colorectal cancer (CRC), and non-small cell lung cancer (NSCLC).
• A Phase 3 study for Xaluritamig (STEAP1 x CD3) in prostate cancer and Ewing sarcoma is planned for mid- to high-single digit royalty and up to $225 million in milestone payments.
• A Phase 3 study for ASP2138 (CLDN18.2 x CD3) in gastric/GEJ and pancreatic cancer is planned for high single- to low double-digit royalty and up to $232.5 million in milestone payments.

Business Segments and Product Lines:

• XmAb819 (ENPP3 x CD3): A novel XmAb® 2+1 bispecific antibody showing meaningful antitumor activity in advanced ccRCC.
  • Confirmed Objective Response Rate (cORR) was 30.0% at 100 μg/kg, 44.0% at 200 μg/kg, and 45.5% at 400 μg/kg.
  • Disease Control Rate (DCR) was 86.7% at 100 μg/kg, 64.0% at 200 μg/kg, and 81.8% at 400 μg/kg.
  • 400 μg/kg is proposed as the Recommended Phase 3 Dose (RP3D) for intravenous administration.
  • Activity observed in subgroups with prior HIF2α inhibitors (cORR 34.8%) and ≥2 prior VEGFR-TKIs (cORR 45.2%).
  • 76.0% of responders had ongoing responses at the data cut-off.
  • Enrollment is complete in the 400 μg/kg expansion cohort.
• XmAb541 + XmAb808: Combination therapy for high-grade serous ovarian carcinoma (HGSOC) with safety and early efficacy assessment ongoing.
• XmAb942: Xtend TL1A program for inflammatory bowel disease (IBD); progress update on the Phase 2b XENITH-UC study expected in the second half of 2027.
• XmAb412: TL1A x IL23p19 program for IBD; first-in-human study initiation planned.
• Plamotamab: Xencor regained rights to develop this CD20 x CD3 bispecific for rheumatoid arthritis (RA); initial dose-escalation data expected at ACR 2026.
• XmAb657: CD19 x CD3 program for idiopathic inflammatory myopathies (IIM), Sjögren's disease, and systemic sclerosis; final data and initial data updates expected from the first-in-human dose-escalation study.
• Xaluritamig (STEAP1 x CD3): Phase 3 program for prostate cancer and Ewing sarcoma.
• ASP2138 (CLDN18.2 x CD3): Phase 3 program for gastric/GEJ and pancreatic cancer.
• XmAb® 2+1 Format: Engineered to combine tumor selectivity with high potency, potentially sparing normal cells with low antigen density.

Market and Competitive Landscape:

• The global renal cell carcinoma (RCC) drug market is an estimated $11.7 billion annualized opportunity, split between TKI ($5B), IO ($5.6B), and HIF2α (~$1.1B) classes.
• XmAb819 cORR of 45% in the 400 μg/kg cohort exceeds monotherapy benchmarks for approved 2L/3L+ options (typically 17–23% ORR).
• Estimated addressable population of ~9,200 US patients treated post PD-1/PD-L1 inhibitor and ≥2 prior VEGFR-TKIs in 2025.
• U.S. 2030 Total Addressable Market (TAM) for ENPP3+ papillary RCC is estimated at ~$0.5 billion.
• U.S. 2030 TAM for ENPP3+ MSS colorectal cancer is estimated at +$1 billion.
• U.S. 2030 TAM for ENPP3+ NSCLC is estimated at +$3 billion.
• No guideline-recommended treatments currently exist for patients post PD-1/PD-L1 inhibitor plus ≥2 VEGFR-TKIs, or post triple-class exposure (PD-1/PD-L1, VEGFR-TKI, HIF2α).

Risks and Challenges:

• Forward-looking statements involve risks including potential delays in development timelines, negative preclinical or clinical trial results, reliance on third parties for development, and changes in the competitive landscape or standard of care.
• Safety events observed include Cytokine Release Syndrome (CRS), rash, and transaminase elevations, though most were low-grade, transient, and managed without treatment discontinuation.
• One participant experienced Grade 4 CRS and discontinued treatment due to approximately 10-fold higher exposure than intended at the first dose.
• 14.7% of subjects experienced dose delays due to transaminase elevations; 4.4% experienced dose delays due to rash.
• 6.7% of subjects discontinued treatment due to treatment-emergent adverse events (TEAEs).
• No deaths were reported related to the treatment.

Management Commentary and Tone:

• Management expressed confidence in the "accelerated pace of readouts" across the pipeline through 2027.
• The data supports continued development of XmAb819 as a monotherapy for advanced ccRCC and evaluation of combination strategies in earlier lines of treatment.
• Management plans to discuss an accelerated approval pathway for XmAb819 based on efficacy results in key subgroups (post IO-TKI).
• The 400 μg/kg dose is considered the RP3D for IV administration, with plans to explore Q3W dosing and subcutaneous formulations to reduce hospitalization.
• The presentation highlights the "XmAb® 2+1" format's ability to selectively kill high-density tumor cells while sparing normal cells with low antigen density.

Analyst Questions and Answers:

• No specific analyst questions and answers content is included in the provided presentation text.

Other Key Points:

• XmAb819 is a wholly owned program.
• Manufacturing activities for late-phase development have been initiated with a scalable process, 2000L scale drug substance, and 60-month stability for both drug substance and product.
• The Phase 1 study (NCT05433142) included 119 subjects across all IV doses and 68 subjects in expansion doses.
• Median time on treatment for the consolidated IV target dose patient population was 7.9 months.
• Median Progression-Free Survival (PFS) was not reached; the 6-month PFS Kaplan-Meier estimate was approximately 82%.
• A global randomized control trial design is proposed to compare XmAb819 against tivozanib in a post IO-TKI patient population to support a BLA.
• Xencor regained rights to develop new CD19-targeted antibodies.
• The presentation includes trademarks and tradenames of other organizations (e.g., BiTE®, ASCO, ESMO, NCCN).