Xencor Reports Second Quarter 2024 Financial Results
“Xencor’s clinical focus is developing high-potential, first-in-class bispecific T-cell engagers and additional XmAb® candidates that leverage our differentiated technology platforms. The expanding opportunities for engineered antibodies, T-cell engagers and other bispecifics have encouraged us to advance a range of new XmAb candidates, and we plan to announce our next candidates for clinical development in the coming months,” said
Bispecific Antibody Programs Advancing in
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XmAb819 (ENPP3 x CD3): XmAb819 is a bispecific T-cell engager in Phase 1 clinical development for patients with advanced clear cell renal cell carcinoma (ccRCC). XmAb819 is designed to engage the immune system, activating T cells for highly potent and targeted killing of tumor cells expressing ENPP3, an antigen highly expressed in ccRCC. Xencor’s XmAb 2+1 multivalent format used in XmAb819 enables greater selectivity of ENPP3-expressing tumor cells compared to normal cells, which express lower levels of ENPP3.
Xencor is advancing through dose-escalation cohorts in an ongoing Phase 1 study, and the Company anticipates reaching target dose levels by year end.
-
XmAb808 (B7-H3 x CD28): XmAb808 is a tumor-selective, co-stimulatory bispecific T-cell engager in Phase 1 clinical development, in combination with pembrolizumab for patients with advanced solid tumors. XmAb808 binds to the broadly expressed tumor antigen B7-H3 and is constructed with the XmAb 2+1 format. Co-stimulation is required for T cells to achieve full activation, and targeted CD28 bispecific antibodies may provide conditional co-stimulation of T cells when the antibodies are bound to tumor cells.
Xencor is advancing through dose-escalation cohorts in an ongoing Phase 1 study, and the Company anticipates reaching target dose levels by year end.
-
XmAb541 (CLDN6 x CD3): XmAb541 is a bispecific T-cell engager in Phase 1 clinical development for patients with advanced ovarian cancer and other solid tumor types. XmAb541 is designed to engage the immune system, activating T cells for highly potent and targeted killing of tumor cells expressing Claudin-6 (CLDN6), a tumor-associated antigen. Xencor’s XmAb 2+1 multivalent format used in XmAb541 enables greater selectivity for cells expressing CLDN6 over similarly structured Claudin family members, which may be expressed on normal tissue. The first patient was dosed in a Phase 1 dose-escalation study earlier this year.
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Vudalimab (PD-1 x CTLA-4): Vudalimab, a selective dual checkpoint inhibitor of PD-1 and CTLA-4, is advancing in multiple clinical studies, including a monotherapy study in patients with clinically defined high-risk metastatic castration-resistant prostate cancer (mCRPC; Study XmAb717-05), a study in combination with docetaxel in patients with mCRPC (Study XmAb717-04), and a study in combination with chemotherapy in patients with non-small cell lung cancer (Study XmAb717-06).
Xencor continues to anticipate a data update and decision whether to advance vudalimab for patients with mCRPC in the first half of 2025.
Recent Business Updates
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Regained exclusive worldwide rights to plamotamab (CD20 x CD3), a Phase 2 ready, subcutaneously administered, immune-cell directed bispecific T-cell engager.
Xencor advanced plamotamab through Phase 1 clinical development and is reviewing its potential for addressing unmet medical needs of patients.
- Concluded Phase 1 studies of XmAb564 (IL2-Fc in autoimmune disease) and XmAb662 (IL12-Fc in solid tumors) in the first half of 2024, consistent with prior guidance.
Financial Guidance: Based on current operating plans,
Financial Results for the Second Quarter and Six Months Ended
Cash, cash equivalents and marketable debt securities totaled
Revenues 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) for the second quarter ended
Non-cash, stock-based compensation expense for the six months ended
Net loss attributable to
The total shares outstanding were 61,766,054 as of
About
Forward-Looking Statements
Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. 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,” 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, planned clinical trials, projected financial resources, the quotations from
Selected Consolidated Balance Sheet Data | |||||
(in thousands) | |||||
|
2024 |
|
2023 |
||
(Unaudited) | |||||
Cash, cash equivalents and marketable debt securities - current |
$ |
480,140 |
$ |
551,515 |
|
Other current assets |
|
74,330 |
|
71,645 |
|
Marketable debt securities - long term |
|
104,862 |
|
145,512 |
|
Other long-term assets |
|
166,835 |
|
184,020 |
|
Total assets |
$ |
826,167 |
$ |
952,692 |
|
Total current liabilities |
|
80,076 |
|
84,709 |
|
Deferred income - long term |
|
104,081 |
|
125,183 |
|
Other long term liabilities |
|
79,469 |
|
73,667 |
|
Total liabilities |
|
263,626 |
|
283,559 |
|
Total stockholders' equity |
|
562,541 |
|
669,133 |
|
Total liabilities and stockholders’ equity |
$ |
826,167 |
$ |
952,692 |
Consolidated Statements of Loss and Comprehensive Loss | ||||||||||||
(in thousands, except share and per share data) | ||||||||||||
Three Months Ended |
Six Months Ended |
|||||||||||
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
(Unaudited) | ||||||||||||
Revenue |
$ |
16,960 |
|
$ |
45,523 |
|
$ |
29,765 |
|
$ |
64,485 |
|
Operating expenses | ||||||||||||
Research and development |
|
61,531 |
|
|
60,060 |
|
|
118,404 |
|
|
125,612 |
|
General and administrative |
|
17,746 |
|
|
11,460 |
|
|
31,533 |
|
|
25,613 |
|
Total operating expenses |
|
79,277 |
|
|
71,520 |
|
|
149,937 |
|
|
151,225 |
|
Loss from operations |
|
(62,317 |
) |
|
(25,997 |
) |
|
(120,172 |
) |
|
(86,740 |
) |
Other income (expense), net |
|
(4,974 |
) |
|
4,043 |
|
|
(15,828 |
) |
|
4,023 |
|
Loss before income tax |
|
(67,291 |
) |
|
(21,954 |
) |
|
(136,000 |
) |
|
(82,717 |
) |
Income tax expense |
|
117 |
|
|
— |
|
|
117 |
|
|
— |
|
Net loss |
|
(67,408 |
) |
|
(21,954 |
) |
|
(136,117 |
) |
|
(82,717 |
) |
Net loss attributable to non-controlling interest |
|
(1,445 |
) |
|
— |
|
|
(2,121 |
) |
|
— |
|
Net loss attributable to |
|
(65,963 |
) |
|
(21,954 |
) |
|
(133,996 |
) |
|
(82,717 |
) |
Other comprehensive income (loss) | ||||||||||||
Net unrealized gain (loss) on marketable debt securities |
|
(498 |
) |
|
1,765 |
|
|
(1,942 |
) |
|
5,093 |
|
Comprehensive loss attributable to |
$ |
(66,461 |
) |
$ |
(20,189 |
) |
$ |
(135,938 |
) |
$ |
(77,624 |
) |
Net loss per common share attributable to |
||||||||||||
Basic and Diluted |
$ |
(1.07 |
) |
$ |
(0.37 |
) |
$ |
(2.18 |
) |
$ |
(1.38 |
) |
Weighted average common shares used to compute net loss per share attributable to |
||||||||||||
Basic and Diluted |
|
61,676,444 |
|
|
59,807,558 |
|
|
61,444,384 |
|
|
59,922,784 |
|
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