Xencor Reports Second Quarter 2025 Financial Results
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“In our autoimmune portfolio, we recently initiated the Phase 2b XENITH-UC study of XmAb942, our potential best-in-class antibody targeting TL1A for inflammatory bowel disease, to rapidly identify a pivotal dose regimen for those with moderately to severely active ulcerative colitis. Also, in June we were granted regulatory authorization to proceed with the proof-of-concept study of plamotamab, our CD20 B-cell depleting TCE, in rheumatoid arthritis. For the remainder of the year, we expect to continue our global rollout of the XENITH-UC and plamotamab studies, and we also remain on-track to start a proof-of-concept study of XmAb657, our novel CD19 B-cell depleting TCE for the treatment of patients with autoimmune disease.”
Clinical Program Updates
Oncology
-
XmAb819 (ENPP3 x CD3), a first-in-class, tumor-targeted, T-cell engaging 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma (ccRCC). XmAb819 engages the immune system and activates T cells for highly potent and targeted lysis of tumor cells expressing ENPP3.
Xencor is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced ccRCC and plans to present initial dose-escalation data at a medical conference during the fourth quarter of 2025.
- XmAb541 (CLDN6 x CD3), a first-in-class, tumor-targeted, T-cell engaging 2+1 bispecific antibody in development for patients with advanced solid tumors expressing CLDN6. Like XmAb819, XmAb541 engages the immune system and activates T cells for highly potent and targeted lysis of tumor cells expressing CLDN6. A Phase 1 dose-escalation study to evaluate XmAb541 in patients with ovarian cancer, germ cell tumors, and other CLDN6-expressing tumor types is ongoing, with characterization of target dose levels anticipated to begin during 2025.
Autoimmune & Inflammatory Diseases
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Plamotamab (CD20 x CD3), a clinical stage, B-cell depleting bispecific T-cell engager for development in rheumatoid arthritis (RA).
Xencor is evaluating plamotamab in a Phase 1b/2a proof-of-concept study, for patients with RA have progressed through prior standard-of-care treatment. InJune 2025 ,Xencor received regulatory authorization to proceed with the study.
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XmAb942 (Xtend™ anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease. In the first half of 2025,
Xencor presented initial data from a Phase 1 study of XmAb942 in healthy volunteers. The results showed that XmAb942 was well tolerated at single and multiple doses and had a greater than 71-day half-life, which supports an every 12-week dosing in maintenance.Xencor recently initiated the global XENITH-UC Study, a Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe UC, whose disease has progressed after at least one conventional or advanced therapy.
Recent Partnership Developments
-
Incyte Corporation: In
June 2025 , Incyte announced that Monjuvi was approved by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma in combination with rituximab and lenalidomide. The approval was based on data from Incyte’s pivotal Phase 3 inMIND trial.Xencor earned a$25 million regulatory milestone payment in addition to non-cash royalty revenue from sales of Monjuvi®/Minjuvi® for the second quarter of 2025. Monjuvi® and Minjuvi® are registered trademarks of Incyte.
Additional Corporate Updates
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In July,
Xencor appointedRaymond Deshaies , Ph.D., to its board of directors.Dr. Deshaies is a pioneering biochemist and cell biologist with more than 25 years of experience in biotechnology and drug development. He recently served as senior vice president of global research at Amgen Inc., where he oversaw all research activities, including the nomination of over 50 clinical candidates, expansion of Amgen’s capabilities for discovering and optimizing multispecific drug candidates, and application of generative protein design to biologics discovery.
Financial Guidance: Based on current operating plans,
Financial Results for the Second Quarter Ended
Cash, cash equivalents and marketable debt securities totaled
Revenue for the second quarter ended
Research and development (R&D) expenses for the second quarter ended
General and administrative (G&A) expenses for the second quarter ended
Other income (expense), net, for the second quarter ended
Net loss attributable to
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 expectations for clinical progress, planned presentations of clinical data, new XmAb candidates and programs, planned and in process clinical trials, financial guidance, the quotations from
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| Selected Consolidated Balance Sheet Data | ||||
| (in thousands) | ||||
|
|
|
|||
|
2025 |
2024 |
|||
| (unaudited) | ||||
| Cash, cash equivalents and marketable debt securities - current |
$ |
403,426 |
$ |
449,846 |
| Other current assets |
|
109,724 |
|
127,755 |
| Marketable debt securities - long term |
|
260,399 |
|
256,833 |
| Other long-term assets |
|
105,875 |
|
117,511 |
| Total assets |
$ |
879,424 |
$ |
951,945 |
| Total current liabilities |
$ |
96,083 |
$ |
87,432 |
| Liabilities related to the sales of future royalties - long term |
|
94,736 |
|
115,159 |
| Other long term liabilities |
|
68,254 |
|
75,328 |
| Total liabilities |
|
259,073 |
|
277,919 |
| Total stockholders' equity |
|
620,351 |
|
674,026 |
| Total liabilities and stockholders’ equity |
$ |
879,424 |
$ |
951,945 |
|
|
||||||||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||
| (in thousands, except share and per share data) | ||||||||||||
|
Three Months Ended
|
Six Months Ended
|
|||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
|
| (unaudited) | (unaudited) | |||||||||||
| Revenue | ||||||||||||
| Collaborations, milestones, and royalties |
$ |
43,608 |
|
$ |
23,907 |
|
$ |
76,340 |
|
$ |
39,904 |
|
| Operating expenses: | ||||||||||||
| Research and development |
|
61,665 |
|
|
61,531 |
|
|
120,243 |
|
|
118,404 |
|
| General and administrative |
|
15,115 |
|
|
17,746 |
|
|
32,452 |
|
|
31,533 |
|
| Total operating expenses |
|
76,780 |
|
|
79,277 |
|
|
152,695 |
|
|
149,937 |
|
| Operating loss |
|
(33,172 |
) |
|
(55,370 |
) |
|
(76,355 |
) |
|
(110,033 |
) |
| Total other income (expense) |
|
2,097 |
|
|
(13,412 |
) |
|
(2,985 |
) |
|
(32,865 |
) |
| Loss before income tax (benefit) expense and noncontrolling interest |
|
(31,075 |
) |
|
(68,782 |
) |
|
(79,340 |
) |
|
(142,898 |
) |
| Income tax (benefit) expense |
|
(250 |
) |
|
— |
|
|
117 |
|
|
— |
|
| Net loss including noncontrolling interest |
|
(30,825 |
) |
|
(68,782 |
) |
|
(79,457 |
) |
|
(142,898 |
) |
| Net loss attributable to noncontrolling interest |
|
— |
|
|
(1,445 |
) |
|
(214 |
) |
|
(2,121 |
) |
| Net loss attributable to |
$ |
(30,825 |
) |
$ |
(67,337 |
) |
$ |
(79,243 |
) |
$ |
(140,777 |
) |
| Net loss per share attributable to |
$ |
(0.41 |
) |
$ |
(1.09 |
) |
$ |
(1.07 |
) |
$ |
(2.29 |
) |
| Weighted-average shares used in calculating (basic and diluted) |
|
74,278,872 |
|
|
61,676,444 |
|
|
73,974,715 |
|
|
61,444,384 |
|
| Other comprehensive income (loss): | ||||||||||||
| Net unrealized (loss) gain on marketable debt securities |
|
(97 |
) |
|
(498 |
) |
|
921 |
|
|
(1,942 |
) |
| Comprehensive loss |
|
(30,922 |
) |
|
(69,280 |
) |
|
(78,536 |
) |
|
(144,840 |
) |
| Less: comprehensive loss attributable to the noncontrolling interest |
|
— |
|
|
(1,445 |
) |
|
(214 |
) |
|
(2,121 |
) |
| Comprehensive loss attributable to |
$ |
(30,922 |
) |
$ |
(67,835 |
) |
$ |
(78,322 |
) |
$ |
(142,719 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20250806087279/en/
cliles@xencor.com
(626) 737-8118
For Media:
Inizio Evoke
cassidy.mcclain@inizioevoke.com
(619) 694-6291
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