Xencor Reports First Quarter 2017 Financial Results
"We have been focused on advancing our clinical development pipeline across the breadth of our portfolio," said
Recent Business Highlights and Anticipated Upcoming Milestones
XmAb5871: XmAb5871 is a first-in-class monoclonal antibody that targets CD19 with its variable domain, and uses Xencor's XmAb immune inhibitor Fc domain to target FcγRIIb, a receptor that inhibits B-cell function. XmAb5871 is currently in Phase 2 clinical studies for the treatment of IgG4-Related Disease (IgG4-RD) and systemic lupus erythematosus (SLE).
- Topline data from IgG4-RD Phase 2 trial expected in 2017
- Initial data from SLE Phase 2 trial expected in late 2018/early 2019
At the 3rd International Symposium on IgG4-Related Disease and Fibrosis in
XmAb®7195: XmAb7195 is a first-in-class monoclonal antibody that targets IgE with its variable domain and uses Xencor's XmAb Immune Inhibitor Fc domain to target FcγRIIb, resulting in three distinct mechanisms of action for reducing IgE levels. A subcutaneously administered formulation of XmAb7195 is currently in a Phase 1b study for the treatment of allergic disease.
- Topline data from subcutaneous administration Phase 1b trial expected in 2017
Bispecific Oncology Pipeline:
- Initial data from XmAb14045 Phase 1 trial expected in 2017, pending alignment on timing with Novartis
- Initial data from XmAb13676 Phase 1 trial expected in 2018, pending alignment on timing with Novartis
- Investigational New Drug (IND) application filing for XmAb®18087, a somatostatin receptor 2 (SSTR2) x CD3 bispecific antibody for the treatment of neuroendocrine tumors, expected in 2017
- IND application filing for XmAb®20717, a PD-1 x CTLA-4 dual checkpoint inhibitor for the treatment of multiple oncology indications, expected in 2018
At the
Partnered XmAb Programs: Nine pharmaceutical companies and the
- In
March 2017 ,Xencor was notified by its partner, CSL Limited, that CSL licenseeJanssen Biotech Inc. advanced CSL362 (now called talacotuzumab) to the Phase 3 portion of its ongoing Phase 2/3 study for the potential treatment of patients with AML. Talacotuzumab usesXencor's XmAb Cytotoxic Fc Domain. The trial initiation triggered a milestone payment toXencor from CSL Limited of$3.5 million .
Corporate:
- In
April 2017 ,Xencor announced the appointment ofKevin Gorman , Ph.D., to its Board of Directors. In March andApril 2017 , respectively,Xencor also announced thatBruce Carter , Ph.D., andRobert Baltera will not stand for re-election to the Board of Directors at the 2017 Annual Meeting of Stockholders.
First Quarter Ended
Cash, cash equivalents, and marketable securities totaled
Revenues for the first quarter ended
Research and development expenditures for the first quarter ended
General and administrative expenses in the first quarter ended
Non-cash, share based compensation expense for the first quarter ended
Net loss for the first quarter ended
The weighted-average shares outstanding used to compute net loss per share was 46,598,797 for the quarter ended
Financial Guidance
Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations beyond the end of 2020. Xencor expects to end 2017 with approximately
Conference Call and Webcast
Xencor will host a conference call today at
The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers, and referencing conference ID number: 10271460. A live webcast of the conference call will be available online from the investor relations section of the company website at www.xencor.com. The webcast will be archived on the company website for 30 days.
About
Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer. Currently, 11 candidates engineered with Xencor's XmAb® technology are in clinical development internally and with partners. Xencor's internal programs include: XmAb®5871 in Phase 2 development for the treatment of IgG4-Related Disease, and also for the treatment of Systemic Lupus Erythematosus; XmAb®7195 in Phase 1 development for the treatment of asthma and allergic diseases; XmAb®14045 in Phase 1 development for acute myeloid leukemia; XmAb®13676 in Phase 1 development for B-cell malignancies; XmAb®18087 in pre-clinical development for the treatment of neuroendocrine tumors; and
XmAb®20717 in pre-clinical development for the treatment of multiple cancers. Xencor's XmAb antibody engineering technology enables small changes to the structure of monoclonal antibodies resulting in new mechanisms of therapeutic action. Xencor partners include Novartis, Amgen, MorphoSys, Merck, CSL/Janssen, Alexion and Boehringer Ingelheim. For more information, please visit www.xencor.com.
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 the quotation from
Xencor, Inc. | |||||
Condensed Balance Sheets | |||||
(in thousands) | |||||
|
| ||||
2017 |
2016 | ||||
(Unaudited) |
|||||
Assets |
|||||
Current assets |
|||||
Cash and cash equivalents |
|
| |||
Short-term marketable securities |
141,225 |
115,608 | |||
Accounts receivable |
6,938 |
8,616 | |||
Prepaid expenses and other current assets |
4,365 |
2,901 | |||
Total current assets |
166,089 |
141,653 | |||
Property and equipment, net |
3,360 |
3,105 | |||
Long-term marketable securities |
237,865 |
273,340 | |||
Intangible assets, net |
10,886 |
10,362 | |||
Other assets |
103 |
103 | |||
Total assets |
|
| |||
Liabilities and stockholders' equity |
|||||
Current liabilities |
|||||
Accounts payable and accrued liabilities |
|
| |||
Current portion of deferred revenue |
95,788 |
95,521 | |||
Income taxes |
175 |
65 | |||
Total current liabilities |
106,875 |
106,286 | |||
Deferred rent, less current portion |
361 |
397 | |||
Deferred revenue, less current portion |
7,319 |
7,926 | |||
Total liabilities |
114,555 |
114,609 | |||
Stockholders' equity |
303,748 |
313,954 | |||
Total liabilities and stockholders' equity |
|
| |||
The 2016 balance sheet was derived from the 2016 annual financial statements included in the form 10-K that was filed on |
| |||||
Condensed Statements of Comprehensive Income (Loss) | |||||
(in thousands, except share and per share data) | |||||
Three months ended | |||||
2017 |
2016 | ||||
(Unaudited) |
(Unaudited) | ||||
Revenues |
|
| |||
Operating expenses: |
|||||
Research and development |
15,048 |
10,035 | |||
General and administrative |
4,811 |
3,950 | |||
Total operating expenses |
19,859 |
13,985 | |||
Loss from operations |
(15,519) |
(6,733) | |||
Other income, net |
1,054 |
335 | |||
Loss before income tax expense |
(14,465) |
(6,398) | |||
Income tax expense |
170 |
— | |||
Net loss |
(14,635) |
(6,398) | |||
Other comprehensive income |
|||||
Net unrealized gain on marketable securities |
245 |
619 | |||
Comprehensive loss |
|
| |||
Basic and diluted net loss per common share |
|
| |||
Basic and diluted weighted average number of common shares |
46,598,797 |
40,626,729 |
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