Xencor Reports First Quarter 2026 Financial Results
-- XmAb819 clear cell renal cell carcinoma (ccRCC) expansion cohort results to be presented at a medical conference in 2H26 --
-- XmAb412 (TL1A x IL23p19) first-in-human healthy participant study on-track for 3Q26 start --
-- Plamotamab and XmAb657 autoimmune studies on-track for 2H26 progress update --
“Xencor continues to execute across our wholly owned clinical pipeline, with significant progress in both oncology and autoimmune disease. We look forward to presenting expansion cohort data from our Phase 1 study of XmAb819 for the treatment of advanced clear cell renal cell carcinoma at a medical meeting in the second half of 2026, which will help support the initiation of our first pivotal study planned for 2027,” said
“Our TL1A pipeline continues to advance with strong enrollment in the global Phase 2b XENITH-UC Study of XmAb942 in ulcerative colitis supported by investigator enthusiasm for its potential best-in-class profile in moderately to severely active ulcerative colitis. We expect to complete a blinded interim analysis around year-end 2026 and complete the primary endpoint analysis for the study’s 12-week induction period during the second half of 2027. We also look forward to initiating the first-in-human study of XmAb412, our novel TL1A x IL23p19 bispecific antibody, in the third quarter of 2026. XmAb412 utilizes our novel XenLock™ Fab domain platform, which enables multi-specific biologics designed to address the very stringent requirements for high potency, long half-life and low immunogenicity in the treatment of autoimmune and inflammatory disease.”
Wholly Owned Pipeline Overview
XmAb819 (ENPP3 x CD3), a first-in-class, tumor-targeted T-cell engaging XmAb® 2+1 bispecific antibody in development for patients with advanced clear cell renal cell carcinoma (ccRCC).
-
Xencor plans to present expansion cohort data from the ongoing Phase 1 study to define a recommended Phase 3 target dose at a medical conference in 2H26 and support initiation of a pivotal study of XmAb819 in ccRCC planned for 2027. - Tumor expansion cohorts in ENPP3+ colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and papillary renal cell carcinoma (pRCC) are open to enrollment.
-
Xencor plans to initiate a sub-study in patients with advanced ccRCC who have not previously received treatment with a tyrosine kinase inhibitor (TKI) in 3Q26.
XmAb541 (CLDN6 x CD3), a first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in Phase 1 clinical development for patients with advanced gynecologic and germ cell tumors.
-
Xencor plans to present Phase 1 dose-escalation data to define a recommended Phase 3 target dose in 2H26 and evaluate plans for a pivotal study of XmAb541 during 2027. -
Additionally,
Xencor is initiating a new clinical study to evaluate the combination of XmAb541 and XmAb808 (B7H3 x CD28) for patients with CLDN6+ high-grade serous ovarian cancer. XmAb808 is a bispecific antibody designed to provide conditional co-stimulation of T cells.Xencor presented a poster characterizing preclinical combinations of XmAb808 with multiple CD3 T cell engaging bispecific antibodies, including XmAb541, at theAmerican Association for Cancer Research Annual Meeting inApril 2026 .
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. -
Xencor presented final results from the Phase 1 dose-escalation study of XmAb942 in healthy participants at Digestive Disease Week® (DDW) inMay 2026 . All dose levels and routes of administration were well tolerated. XmAb942’s immunogenicity profile supports best-in-class drug exposure, and no impacts of anti-drug antibodies on safety or tolerability or on the population pharmacokinetic model were observed. The estimated terminal half-life of 74 days supports the single subcutaneous injection 12-week dosing interval used during the maintenance treatment period in XENITH-UC. - Enrollment expectations support a XENITH-UC blinded interim analysis around year-end 2026 and reaching the primary endpoint of the 12-week induction period during the second half of 2027. The primary endpoint is percentage of patients achieving clinical remission defined by the modified Mayo score at week 12.
XmAb412 (TL1A x IL23p19), a novel bispecific antibody format using the XenLock™ platform for dual targeting of inflammatory pathways in autoimmune and inflammatory disease.
-
Xencor presented preclinical characterization of XmAb412 at DDW inMay 2026 . 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. -
Xencor plans to initiate a first-in-human study of XmAb412 in 3Q26.
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 (IIM).
-
Xencor plans to provide an update on progress achieved in the Phase 1 study of XmAb657 in 2H26.
Financial Guidance: Based on current operating plans,
Financial Results for the First Quarter Ended
Cash, cash equivalents and marketable debt securities totaled
Revenue for the first quarter ended
Research and development (R&D) expenses for the first quarter ended
General and administrative (G&A) expenses for the first quarter ended
Other expense, net, for the first quarter ended
Net loss attributable to
Company management will present at the
About
Forward-Looking Statements
Certain statements contained in this press release may constitute forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “indicates,” “supports,” and similar terms, or by express or implied discussions relating to Xencor’s business, including, but not limited to, statements regarding our expectations regarding regulatory and partnership milestone achievements, clinical pipeline advancements, planned receipt and presentations of clinical data, including the expected timing thereof, and planned and ongoing clinical trials, including the expected timing thereof, projected financial resources and financial guidance, including estimated cash, cash equivalents and marketable debt securities at year end and cash runway for research and development programs and operations, expectations for and estimates of future royalty revenues, the quotations from
|
|
|||||||
| Selected Consolidated Balance Sheet Data | |||||||
| (in thousands) | |||||||
|
|
|
||||||
|
|
2026 |
|
2025 |
||||
| (unaudited) | |||||||
| Cash, cash equivalents and marketable debt securities |
$ |
541,770 |
$ |
610,833 |
|||
| Other current assets |
|
|
98,478 |
|
|
164,590 |
|
| Other long-term assets |
|
|
96,598 |
|
|
100,072 |
|
| Total assets |
$ |
|
736,846 |
$ |
|
875,495 |
|
| Liabilities related to the sales of future royalties |
$ |
|
108,534 |
$ |
|
119,749 |
|
| Other current liabilities |
|
|
47,047 |
52,640 |
|||
| Non-current lease and other liabilities |
|
|
65,632 |
|
|
67,519 |
|
| Total liabilities |
|
|
221,213 |
|
|
239,908 |
|
| Total stockholders' equity |
|
|
515,633 |
|
|
635,587 |
|
| Total liabilities and stockholders’ equity |
$ |
|
736,846 |
$ |
|
875,495 |
|
|
|
|||||||
|
Consolidated Statements of Operations and Comprehensive Loss |
|||||||
|
(in thousands, except per share amounts) |
|||||||
|
|
|
|
|
||||
|
|
Three Months Ended
|
||||||
|
|
|
2026 |
|
|
|
2025 |
|
|
|
(Unaudited) |
||||||
|
Revenue |
|
|
|
||||
|
Collaborations, milestones, and royalties |
$ |
4,516 |
|
|
$ |
32,732 |
|
|
Operating expenses: |
|
|
|
||||
|
Research and development |
|
64,669 |
|
|
|
58,578 |
|
|
General and administrative |
|
17,709 |
|
|
|
17,337 |
|
|
Total operating expenses |
|
82,378 |
|
|
|
75,915 |
|
|
Operating loss |
|
(77,862 |
) |
|
|
(43,183 |
) |
|
|
|
|
|
||||
|
Total other expense |
|
(50,774 |
) |
|
|
(5,082 |
) |
|
|
|
|
|
||||
|
Loss before income tax expense and noncontrolling interest |
|
(128,636 |
) |
|
|
(48,265 |
) |
|
Income tax expense |
|
280 |
|
|
|
367 |
|
|
Net loss including noncontrolling interest |
|
(128,916 |
) |
|
|
(48,632 |
) |
|
|
|
|
|
||||
|
Net loss attributable to noncontrolling interest |
|
— |
|
|
|
(214 |
) |
|
Net loss attributable to |
$ |
(128,916 |
) |
|
$ |
(48,418 |
) |
|
|
|
|
|
||||
|
Net loss per share attributable to |
$ |
(1.71 |
) |
|
$ |
(0.66 |
) |
|
|
|
|
|
||||
|
Weighted-average shares used in calculating net loss per share (basic and diluted) |
|
75,247 |
|
|
|
73,667 |
|
|
|
|
|
|
||||
|
Other comprehensive income (loss): |
|
|
|
||||
|
Net unrealized (loss) gain on marketable debt securities |
|
(1,549 |
) |
|
|
1,018 |
|
|
Comprehensive loss |
|
(130,465 |
) |
|
|
(47,614 |
) |
|
Less: comprehensive loss attributable to the noncontrolling interest |
|
— |
|
|
|
(214 |
) |
|
Comprehensive loss attributable to |
$ |
(130,465 |
) |
|
$ |
(47,400 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20260506934755/en/
For Investors:
cliles@xencor.com
(626) 737-8118
For Media:
Inizio Evoke
cassidy.mcclain@inizioevoke.com
(619) 694-6291
Source: