On August 5, 2026 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported financial results for the second quarter ended June 30, 2026.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are excited to present XmAb819 results at ESMO (Free ESMO Whitepaper) this fall and for other fast-approaching key milestones across our wholly owned clinical pipeline," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Enrollment remains on track for updates later this year for XmAb942 in the XENITH-UC study and for our two B-cell depleting bispecifics, plamotamab and XmAb657, in their respective Phase 1 studies. And we recently started the Phase 1 study of XmAb412, our first XenLock bispecific antibody, and plan to have healthy participant data in the first half of 2027. Xencor’s focus on clinical execution and data delivery is setting us up for an accelerating tempo of anticipated readouts in 2027 and beyond."
"Consistent with our focus on efficient clinical decision-making, we have prioritized the ongoing combination study of XmAb541 and XmAb808, which provides tumor-targeted co-stimulation through CD28 agonism, after observing moderate anti-tumor activity from early monotherapy data of XmAb541. CLDN6 remains a challenging tumor target, and we hope to expand upon an emerging therapeutic window through the orthogonal targeting provided by XmAb808."
Wholly Owned Pipeline Overview
XmAb819 (ENPP3 x CD3), a potential first-in-class, tumor-targeted, T-cell engaging XmAb 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma and other tumors with high ENPP3 expression, including colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma
Clear cell renal cell carcinoma (ccRCC): On track to initiate a registration enabling study of XmAb819 as a monotherapy in advanced ccRCC during 2027.
•Phase 1 results for patients with advanced ccRCC were accepted for a proffered paper oral presentation at the European Society For Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, to be held October 23-27 in Madrid, Spain. The presentation during ESMO (Free ESMO Whitepaper) will focus on dose levels in intravenous expansion cohorts under evaluation as recommended Phase 3 doses (RP3D).
•Dose escalation of subcutaneous administration in advanced ccRCC is ongoing with evaluation for further development expected prior to a registration enabling study.
•A sub-study for patients with intermediate- or poor-risk advanced ccRCC who have progressed after nivolumab in combination with ipilimumab as a first-line treatment (IO doublet therapy) is planned to open for enrollment in the third quarter of 2026.
•A sub-study evaluating the combination of XmAb819 and anti-PD1 therapy in patients with advanced ccRCC is currently being planned.
Additional tumors with high ENPP3 expression
•A sub-study for patients with ENPP3+ advanced colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma began enrollment in the second quarter of 2026.
XmAb541 (CLDN6 x CD3) in combination with XmAb808 (B7-H3 x CD28), in Phase 1 clinical development for T-cell engagement of Claudin-6 expressing tumors, including high-grade serous ovarian cancer
XmAb541 development in the ongoing Phase 1 dose-escalation study in combination with XmAb808 has been prioritized. XmAb541 monotherapy expansion cohorts at the putative RP3D (60 mg dosed every 3 weeks) in high-grade serous ovarian carcinoma (TPS≥50) and germ cell tumors are expected to complete enrollment by year end, with the data supporting combination development with XmAb808. The Phase 1 dose-escalation study of XmAb541 and XmAb808 is ongoing and expected to reach the combination’s target dose range in 2027. Prioritization of the combination is anticipated to reduce projected overall XmAb541 program expense for 2027 and 2028.
XmAb541 Clinical Data
•Emerging data from XmAb541 monotherapy indicate clinical activity to date at the putative RP3D in heavily-pretreated patients, with an approximate 14% overall response rate (ORR) in patients with ovarian cancer and an approximate 28% ORR in patients with germ cell tumors, which supports further evaluation in combination with XmAb808 to provide tumor-targeted CD28 agonism and additional T-cell stimulation.
•Potential additional anti-tumor activity was observed at doses above 60 mg, but reversible hearing impairment limited XmAb541 drug exposure due to the frequency of dose interruptions and dose reductions. Hearing impairment is potentially on target for CLDN6, which is expressed on cochlear hair cells.
•Cytokine release syndrome (CRS) has been low grade and no cases of Grade ≥3 CRS were reported at any dose level. At the putative RP3D, Grade 1 CRS was reported in approximately 14% of patients, and Grade 2 CRS was reported in approximately 17%.
•No other clinically significant safety signals were observed, and the profile is supportive of future outpatient administration.
•Based on monotherapy data, in July 2026 the U.S. FDA granted Fast Track designation to XmAb541 for the treatment of patients with germ cell tumors who have relapsed following two or more lines of platinum therapy or were refractory to prior platinum therapy.
At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026, Xencor presented data demonstrating the co-expression of CLDN6 and B7-H3 on high-grade serous ovarian carcinoma cells. Preclinical testing demonstrated that XmAb808 promoted durable T-cell-directed killing of cancer cells with XmAb541, enhanced XmAb541-induced killing by exhausted T cells, and enhanced anti-tumor activity of XmAb541. CLDN6 and B7-H3 have low expression overlap on normal tissues, potentially localizing T-cell co-stimulation to tumor cells.
XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease
•Xencor is conducting the XENITH-UC Study, a global Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderately to severely active UC, whose disease has progressed after at least one conventional or advanced therapy.
•Enrollment expectations continue to support a XENITH-UC blinded interim analysis around year-end 2026 and reaching the primary endpoint of the 12-week induction period in 2H27. The primary endpoint of XENITH-UC is the percentage of patients achieving clinical remission defined by the modified Mayo score at week 12.
XmAb412 (TL1A x IL23p19), a potential best-in-class, extended half-life bispecific antibody for dual targeting of inflammatory pathways in autoimmune and inflammatory disease, in Phase 1 development and enrolling healthy participants
•XmAb412 robustly suppresses both TL1A and IL-23 inflammatory pathways and is predicted to have a human half-life between 60 and 70 days. XmAb412 supports high-concentration, low viscosity and citrate-free formulation suitable for subcutaneous dosing. XmAb412 is Xencor’s first novel bispecific antibody developed using the XenLock platform.
•Xencor initiated a first-in-human study of XmAb412 in the third quarter of 2026 and plans to present initial data from the study in 1H27.
Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in Phase 1 development for patients with rheumatoid arthritis (RA), who have progressed through prior standard-of-care treatment
•Xencor plans to provide an update on progress achieved in the Phase 1b study of plamotamab in RA in 2H26.
XmAb657 (CD19 x CD3), a clinical-stage, potent, extended half-life B-cell depleting bispecific T-cell engager in Phase 1 dose escalation, enrolling healthy participants and patients with idiopathic inflammatory myopathies, systemic scleroderma and Sjögren’s disease
•Xencor plans to provide an update on progress achieved in the Phase 1 study of XmAb657 in 2H26.
Recent Partnership Developments
•Alexion: In July 2026, Xencor announced that it will receive $105 million from Alexion pursuant to a settlement agreement that resolves the previously disclosed dispute regarding U.S. royalties from sales of Ultomiris. Under the settlement agreement, Alexion is obligated to pay Xencor in two equal installments. The first $52.5 million payment is anticipated in August 2026, the second $52.5 million payment within 14 days following the one-year anniversary of the date of the settlement agreement, and Alexion will have no further obligation to pay royalties on U.S. sales of Ultomiris. Xencor expects to continue receiving royalties on ex-U.S. sales of Ultomiris under the existing terms of its license agreement with Alexion. Ultomiris is a drug being developed and commercialized by Alexion and is its registered trademark.
•Zenas BioPharma: In May 2026, Zenas submitted a biologics license application (BLA) to the U.S. FDA for obexelimab in IgG4-related disease, and Xencor received a $10 million regulatory milestone payment in June 2026 in connection with this BLA submission. Obexelimab targets CD19 with its variable domain and uses an XmAb Immune Inhibitor Fc Domain. In November 2021, Xencor licensed obexelimab to Zenas, and under the license agreement, Xencor is eligible to receive up to $450 million in future milestone payments and tiered royalties on net sales that range from mid-single-digit to mid-teen percentages, dependent on geography.
Financial Guidance: Based on current operating plans, Xencor expects to end 2026 with between $420 million and $440 million in cash, cash equivalents and marketable debt securities, and to have sufficient cash resources to fund research and development programs and operations through 2028.
Financial Results for the Second Quarter Ended June 30, 2026
Cash, cash equivalents and marketable debt securities totaled $486.4 million as of June 30, 2026, compared to $610.8 million as of December 31, 2025.
Revenue for the second quarter ended June 30, 2026 was $51.2 million, compared to $43.6 million for the same period in 2025. Revenue earned in the second quarter of 2026 was primarily milestone revenue from Zenas BioPharma and royalty revenue from Alexion and Incyte.
As the Settlement Agreement with Alexion resolved the uncertainty surrounding the variable consideration associated with U.S. Ultomiris royalties, the Company recognized $27.6 million of royalty revenue during the second quarter ended June 30, 2026, representing royalty attributable to U.S. Ultomiris sales during the dispute period through June 30, 2026. The remaining $77.4 million of settlement consideration relates to royalty rights for periods subsequent to June 30, 2026 and will be recognized in the third quarter of 2026.
Research and development (R&D) expenses for the second quarter ended June 30, 2026 were $71.9 million, compared to $61.7 million for the same period in 2025. Increased R&D spending for the second quarter of 2026 compared to 2025 is primarily due to increased spending on pipeline programs, partially offset by lower stock-based compensation expense.
General and administrative (G&A) expenses for the second quarter ended June 30, 2026 were $16.4 million, compared to $15.1 million for the same period in 2025. G&A spending for the second quarter of 2026 compared to 2025 remained relatively consistent.
Other income, net, for the second quarter ended June 30, 2026 was $15.1 million, compared to $2.1 million for the same period in 2025. Increased other income, net, for the second quarter of 2026, compared to 2025, is primarily due to unrealized gains on an equity security.
Net loss attributable to Xencor for the second quarter ended June 30, 2026 was $21.7 million, or $(0.29) on a fully diluted per share basis, compared to net loss of $30.8 million, or $(0.41) on a fully diluted per share basis, for the same period in 2025.
(Press release, Xencor, AUG 5, 2026, View Source [SID1234669734])