Xencor Reports First Quarter 2019 Financial Results
-- Management to Host Conference Call at
“At Xencor, we continue to leverage our protein engineering expertise to
rapidly generate a range of drug candidates with enhanced biologic
functionality or new therapeutic mechanisms. Our development focus is on
the growing set of opportunities provided by our XmAb® bispecific
Fc domains, which provide a core scaffold to create stable therapeutic
proteins with easily substituted antigen binding domains,” said
Recent Business and Clinical Highlights and Anticipated Upcoming Milestones
CD3 Bispecific Antibodies:
-
XmAb14045 (CD123 x CD3) is being evaluated through a Phase 1 study in
patients with relapsed or refractory acute myeloid leukemia and other
CD123-expressing hematologic malignancies. In
April 2019 , theFDA lifted the partial clinical hold that had been placed on this study inFebruary 2019 due to safety issues of cytokine release syndrome and pulmonary toxicities. The FDA’s decision followed discussion and agreement on amendments to the study protocol, including guidance on the monitoring and clinical management of cytokine release syndrome, and the Company is working with investigational sites to resume enrollment based on the amended protocol. - Initial data from the Phase 1 studies of XmAb13676 (CD20 x CD3) in patients with B-cell malignancies and XmAb18087 (SSTR2 x CD3) in patients with neuroendocrine tumors or gastrointestinal stromal tumors are expected in the second half of 2019.
Tumor Microenvironment (TME) Activating Bispecific Antibodies:
-
In
May 2019 , the first patient was dosed in DUET-3, a Phase 1, first-in-human clinical study to evaluate the safety and tolerability of XmAb23104 (PD-1 xICOS ), for the treatment of patients with advanced solid tumors. - Initiation of a Phase 1 study of XmAb22841 (CTLA-4 x LAG-3) as a monotherapy and in combination with pembrolizumab in patients with select advanced solid tumors is expected in the second quarter of 2019.
- Initial data from DUET-2, a Phase 1 study of XmAb20717 (PD-1 x CTLA-4) in patients with advanced solid tumors, are expected in the second half of 2019.
Cytokines:
- XmAb24306, an IL15/IL15Rα-Fc fusion protein, is currently in IND-enabling studies, and the Company will support Genentech's efforts to submit an IND application for this candidate in the second half of 2019.
Corporate:
-
In
April 2019 ,Xencor announced a research and license agreement withAstellas Pharma Inc. in which the companies are collaborating to generate bispecific antibodies directed toward an undisclosed anti-tumor target for the potential treatment of patients with cancer. Astellas will have an exclusive worldwide license to develop and commercialize novel drug candidates.Xencor received an upfront payment of$15 million and will be eligible to receive development, regulatory and sales milestone payments up to$240 million and high-single digit to low-double digit percentage royalties on net sales.
First Quarter Ended
Cash, cash equivalents, marketable securities and receivables totaled
Total revenue for the first quarter ended
Research and development expenditures for the first quarter ended
General and administrative expenses for the first quarter ended
Non-cash, stock-based compensation expense for the first quarter ended
Net income for the first quarter ended
The total shares outstanding were 56,349,389 as of
Financial Guidance
Based on current operating plans,
Conference Call and Webcast
About
Forward Looking Statements
Statements contained in this press release regarding matters that are
not historical facts are forward-looking statements within the meaning
of applicable securities laws, including, but not limited to, the
quotations from
Xencor, Inc. | ||||||||
Condensed Balance Sheets | ||||||||
(in thousands) | ||||||||
March 31, | December 31, | |||||||
2019 | 2018 | |||||||
(unaudited) | ||||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 21,858 | $ | 26,246 | ||||
Short-term marketable securities | 318,498 | 268,115 | ||||||
Accounts receivable | 137,676 | 10,187 | ||||||
Income tax receivable | 1,206 | 804 | ||||||
Other current assets | 9,433 | 10,375 | ||||||
Total current assets | 488,671 | 315,727 | ||||||
Property and equipment, net | 11,456 | 11,813 | ||||||
Long-term marketable securities | 172,472 | 236,108 | ||||||
Intangible assets, net | 12,737 | 11,969 | ||||||
Income tax receivable | 402 | 804 | ||||||
Other assets | 11,265 | 311 | ||||||
Total assets | $ | 697,003 | $ | 576,732 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities | ||||||||
Accounts payable and accrued liabilities | $ | 11,190 | $ | 13,459 | ||||
Deferred revenue | 59,244 | 40,079 | ||||||
Lease liabilities | 1,987 | 315 | ||||||
Income tax liability | 900 | — | ||||||
Total current liabilities | 73,321 | 53,853 | ||||||
Lease liabilities, net of current portion | 10,221 | 1,198 | ||||||
Deferred revenue, net of current portion | 3,896 | — | ||||||
Total liabilities | 87,438 | 55,051 | ||||||
Stockholders’ equity | 609,565 | 521,681 | ||||||
Total liabilities and stockholders’ equity | $ | 697,003 | $ | 576,732 | ||||
The 2018 balance sheet was derived from the 2018 annual financial statements included in the Form 10-K that was filed on February 26, 2019 |
Xencor Inc. | |||||||||
Condensed Statements of Comprehensive Income (Loss) | |||||||||
(in thousands, except share and per share data) | |||||||||
Three months ended March 31, | |||||||||
2019 | 2018 | ||||||||
(unaudited) | |||||||||
Revenues | $ | 111,939 | $ | — | |||||
Operating expenses: | |||||||||
Research and development | 28,183 | 26,087 | |||||||
General and administrative | 5,512 | 4,562 | |||||||
Total operating expenses | 33,695 | 30,649 | |||||||
Income (loss) from operations | 78,244 | (30,649 | ) | ||||||
Other income, net | 2,701 | 1,156 | |||||||
Income (loss) before income taxes | 80,945 | (29,493 | ) | ||||||
Income tax expense | 900 | — | |||||||
Net income (loss) | 80,045 | (29,493 | ) | ||||||
Other comprehensive income (loss) | |||||||||
Net unrealized gain (loss) on marketable securities | 1,316 | (393 | ) | ||||||
Comprehensive income (loss) | $ | 81,361 | $ | (29,886 | ) | ||||
Net income (loss) per share: | |||||||||
Basic net income (loss) per share | $ | 1.42 | $ | (0.62 | ) | ||||
Diluted net income (loss) per share | $ | 1.38 | $ | (0.62 | ) | ||||
Weighted-average number of common shares used in net |
56,302,967 | 47,753,922 | |||||||
Weighted-average number of common shares used in net |
58,009,878 | 47,753,922 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20190509005895/en/
Source:
Charles Liles
626-737-8118
cliles@xencor.com
Media Contact
Jason I. Spark
Canale Communications
619-849-6005
jason@canalecomm.com